Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Clinical Progress During 1Q26 Reviewed. Ocugen reported 1Q26 loss of $19.1 million or $(0.06) per share, slightly higher than we estimated. On its quarterly conference call, management reiterated several important clinical milestones in the coming year. The company also completed an offering of $115 million in Convertible Senior Notes, which we estimate is enough cash to bring its three lead products to market and fund operations through early 2028. The proposal to allow for a reverse split has been dropped from the Annual Meeting agenda.
Senior Note Offering Provides Sufficient Cash For Product Introductions. The cash balance on March 31, 2026, was $32.2 million, including proceeds of $37.5 million from warrant exercise in 1Q26. Today, the company completed the sale of $115 million in 6.75% Convertible Senior Notes. including an option for the buyer to purchase an additional $15 million in the next 13 days. These Notes should add about $99.5 million to the cash balance. Based on our estimates, we believe this is sufficient to fund operations through the filing of the BLAs and product introductions expected in 2026-2028.
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Positive 12-month data from the OCU410 Phase 2 ArMaDa clinical trial for geographic atrophy (GA) indicates a statistically significant (p<0.05) 31% reduction in lesion size and 27% EZ preservation (correlated to visual function) in optimal dose for Phase 3
About 20% of patients demonstrated no progression of disease and 75% of subjects showed > 30% reduction in Iesion growth compared to control, with a favorable safety and tolerability profile
Allows robust registrational Phase 3 trial design, a potential combined U.S./EU trial with 300 subjects, with adaptive design powered at over 95%
Trial enrollment complete for OCU400 for retinitis pigmentosa (RP) and OCU410ST for Stargardt disease registration trials, and on target to complete two Biologics License Application (BLA) submissions by 2027
The closing of a private offering of $115 million aggregate principal amount ($130 million if overallotment is exercised) of 6.75% convertible senior notes due 2034, with a conversion premium of 45%, is expected to extend cash runway into 2028, subject to customary closing conditions
The Company expects to utilize $32.7 million of net proceeds from the Notes to retire the Avenue debt (12.5% interest rate)
MALVERN, Pa., May 05, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today reported first quarter 2026 financial results along with a general business update.
With the recent offering, the Company is expected to have cash, cash equivalents, and restricted cash of $112.1 million, at closing, which includes the Avenue debt payoff. The Company will use the remaining net proceeds for general corporate purposes and expects to extend cash runway into 2028. The offering is expected to close on May 7, 2026, subject to customary closing conditions and includes an option to retire the debt with a cash payment. If the remaining Janus Henderson warrants are exercised, the Company will receive an additional $15 million in gross proceeds increasing expected cash, cash equivalents, and restricted cash to $127.1 million.
“In the first few months of 2026, we have completed enrollment of two of our late-stage programs and are diligently working toward initiating our first BLA submission for RP and registration trial for dry AMD later this year,” said Dr. Shankar Musunuri, Chairman, Chief Executive Officer, and Co-Founder of Ocugen. “We are executing well against our plans with the highest productivity per employee rate compared to our peers, adequate cash runway with the recent offering, and key milestone achievement to create long-term value creation for our patients and shareholders.”
Enrollment for liMeliGhT, the first and largest gene therapy registrational trial for broad RP patients (N=140), was completed, reflecting strong engagement from investigators and patients. The OCU400 Phase 3 clinical trial includes representation of a wide range of genetic mutations associated with early to advanced stages of clinical and/or genetic diagnosis of RP (over 25 genetic mutations), and patient response is intended to support the gene-agnostic mechanism of action of Ocugen’s novel modifier gene therapy platform. The Company plans to initiate the rolling BLA submission for OCU400 in the third quarter of 2026 and complete the BLA submission by the second quarter of 2027.
Manufacturing readiness for OCU400 is well underway and completion of process performance qualification (PPQ) batches remains on track for the second quarter of 2026. Approximately 300,000 people in the U.S. and Europe are living with RP, and OCU400 is intended as a treatment for early to advanced cases of RP, with potential approval in the fourth quarter of 2027.
GARDian3 clinical trial enrollment and dosing were completed ahead of schedule. GARDian3 is a multicenter, randomized, masked, pivotal Phase 2/3 confirmatory registration trial designed to evaluate the efficacy and safety of OCU410ST in patients with all mutations of Stargardt disease. The study enrolled 63 subjects diagnosed with Stargardt disease. Subjects randomized to the treatment group received a one-time subretinal injection of OCU410ST in the eye with poorer visual acuity, while the untreated control group did not receive any treatment. The primary endpoint is to evaluate the reduction in atrophic lesion size at 12 months. Key secondary endpoints include improvements in best corrected visual acuity (BCVA) and low luminance visual acuity (LLVA), compared to controls. Observational endpoints include preservation of Ellipsoid Zone (EZ), which correlates to visual function. While demonstrating functional benefit via visual acuity within 12 months can be challenging due to the disease’s natural history, it is believed that preservation of EZ will serve as a meaningful and early indicator of visual function.
The interim outcome analysis of 24 subjects at 8 months post-OCU410ST (16 treated and 8 controls) is planned for the third quarter of 2026. Topline results are expected in the second quarter of 2027 with the BLA submission by mid-2027. Interim outcome analysis via adaptive design is typically introduced in pivotal trials to minimize risk. OCU410ST represents a potential first-in-class, one-time modifier gene therapy for all 100,000 patients in the U.S. and Europe with Stargardt disease.
Topline 12‑month data from the OCU410 Phase 2 ArMaDa clinical trial for geographic atrophy secondary to dry age-related macular degeneration was announced in March 2026 and demonstrates a statistically significant (p< 0.05) reduction in lesion growth (31%) versus control at 12 months with the optimal dose—medium dose—intended for Phase 3. The data suggest a potential 2X treatment benefit compared to 15% and 22% reductions reported for currently approved therapies at 12 and 24 months, respectively.
In the Phase 2 study, the safety and efficacy of OCU410 in patients with GA secondary to dAMD are being assessed. Fifty-one (51) patients aged 50 years and older with GA lesions within the foveal or non-foveal region were randomized 1:1:1 to receive a single subretinal administration of OCU410 at the medium dose, high dose, or no treatment in the control group. The primary endpoint was change in GA lesion size at 12 months, measured in square millimeters by fundus autofluorescence, an FDA-accepted structural endpoint used in recent GA registration trials. Exploratory endpoints included assessment of EZ preservation. The data showed no disease progression in approximately 20% of treated subjects, and 75% of treated subjects demonstrated greater than 30% reduction in lesion growth. The Company plans to initiate the OCU410 Phase 3 registrational trial in the third quarter of 2026 with potential BLA filing by 2028. As a potential one-time treatment for life, OCU410 could eliminate the treatment burden and patient fatigue with up to 40% drop-out rates reported with current approved therapies and provide a one-time solution for the 2-3 million patients in the U.S. and Europe with GA. OCU410 has potential to become a new standard of care for patients across the globe.
Executive leadership has participated in significant investor and industry conferences, including the U.S. Department of Commerce 2026 Certified Trade Mission to Singapore; Oppenheimer’s 3rd Annual Innovation on the Island Biotech Summit; and the 2026 Cell & Gene Meeting on the Mediterranean, hosted by the Alliance for Regenerative Medicine. Through these forums, Ocugen reached a wide audience and informed them about the importance of changing the treatment paradigm for blindness diseases by potentially bringing transformative modifier gene therapies to the masses.
“We are actively pursuing a variety of business development opportunities to prepare for global commercialization,” said Dr. Musunuri. “Potential commercial partnerships will allow us to effectively provide market access to patients who are in desperate need for rescue from blindness diseases globally while growing shareholder value.”
Business Updates
Novel Modifier Gene Therapy Platform—Targeting Three BLA Filings in the Next Three Years
OCU400
Completed Phase 3 liMeliGhT enrollment (N=140 subjects). Topline Phase 3 data expected in the first quarter of 2027, advancing OCU400 towards potential approval in the fourth quarter of 2027 as a treatment option for early- to late-stage RP.
OCU410ST
Early completion of enrollment and dosing—less than nine months—in the Phase 2/3 pivotal confirmatory trial (N=63 subjects). Plan to submit the BLA for OCU410ST by mid-2027.
OCU410
Announced positive 12-month topline data from the Phase 2 ArMaDa clinical trial. On track to meet with FDA/EMA to align on the Phase 3 study design and initiate Phase 3 by the third quarter of 2026.
Other Programs
OCU200
Completed Phase 1 clinical trial enrollment in the first quarter of 2026.
OCU500
NIAID intends to initiate the OCU500 Phase 1 clinical trial in the second quarter of 2026.
First Quarter 2026 Financial Results
The Company received $37.5 million in gross proceeds inclusive of $15 million, due to exercised warrants, in the first quarter of 2026. The Company’s cash, cash equivalents, and restricted cash totaled $32.2 million as of March 31, 2026, compared to $18.9 million as of December 31, 2025. With the recent offering, the Company is expected to have cash, cash equivalents, and restricted cash of $112.1 million, at closing, which includes the Avenue debt payoff.
The Company had 338.3 million shares of common stock outstanding as of March 31, 2026
Total operating expenses for the three months ended March 31, 2026 were $19.4 million and included research and development expenses of $11.3 million and general and administrative expenses of $8.1 million, compared to total operating expenses for the three months ended March 31, 2025 of $16.0 million that included research and development expenses of $9.5 million and general and administrative expenses of $6.5 million.
Ocugen reported a $(0.06) net loss per common share for the three months ended March 31, 2026 compared to a $(0.05) net loss per common share for the three months ended March 31, 2025.
Conference Call and Webcast Details Ocugen has scheduled a conference call and webcast for 8:30 a.m. ET today to discuss the financial results and recent business highlights. Ocugen’s senior management team will host the call, which will be open to all listeners. There will also be a question-and-answer session following the prepared remarks.
Attendees are invited to participate on the call or webcast using the following details:
Dial-in Numbers: (800) 715-9871 for U.S. callers and (646) 307-1963 for international callers
Conference ID: 4973685
Webcast: Available on the events section of the Ocugen investor site.
A replay of the call and archived webcast will be available for approximately 45 days following the event on the Ocugen investor site.
About Ocugen, Inc. Ocugen, Inc. is a pioneering biotechnology leader in gene therapies for blindness diseases. Our breakthrough modifier gene therapy platform has the potential to address significant unmet medical need for large patient populations through our gene-agnostic approach. Unlike traditional gene therapies and gene editing, Ocugen’s modifier gene therapies address the entire disease—complex diseases that are potentially caused by imbalances in multiple gene networks. Currently we have programs in development for inherited retinal diseases and blindness diseases affecting millions across the globe, including retinitis pigmentosa, Stargardt disease, and geographic atrophy—late-stage dry age-related macular degeneration. Discover more at www.ocugen.com and follow us on X and LinkedIn.
Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, including, but not limited to, strategy, business plans and objectives for Ocugen’s clinical programs, plans and timelines for the preclinical and clinical development of Ocugen’s product candidates, including the therapeutic potential, clinical benefits and safety thereof, expectations regarding timing, success and data announcements of current ongoing preclinical and clinical trials, including the timing of enrollment and data readouts, the ability to initiate new clinical programs, Ocugen’s financial condition and expected cash runway into 2028, statements regarding qualitative assessments of available data, potential benefits, expectations for ongoing clinical trials, anticipated regulatory filings and anticipated development timelines, statements regarding potential market size and commercial possibilities of Ocugen’s product candidates, which are subject to risks and uncertainties. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from our current expectations, including, but not limited to, the risks that preliminary, interim and top-line clinical trial results may not be indicative of, and may differ from, final clinical data; that unfavorable new clinical trial data may emerge in ongoing clinical trials or through further analyses of existing clinical trial data; that earlier non-clinical and clinical data and testing of may not be predictive of the results or success of later clinical trials; that that clinical trial data are subject to differing interpretations and assessments, including by regulatory authorities; uncertainties related to whether the offering of the Notes will be completed on anticipated terms or at all; the impact of the offering of the Notes on the market price of the Company’s common stock; and risks related to the potential dilution to holders of the Company’s common stock. These and other risks and uncertainties are more fully described in our annual and periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. Except as required by law, we assume no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
MALVERN, Pa., May 05, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen”) (NASDAQ: OCGN) today announced the pricing of $115 million aggregate principal amount of 6.75% Convertible Senior Notes due 2034 (the “notes”) in a private offering (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Ocugen also granted the initial purchaser of the notes a 13-day option to purchase up to an additional $15 million aggregate principal amount of the notes. The sale of the notes to the initial purchaser is expected to close on May 7, 2026, subject to customary closing conditions, and is expected to result in approximately $99.5 million (or approximately $112.6 million if the initial purchaser exercises its option to purchase additional notes in full) in net proceeds to Ocugen after deducting the initial purchaser’s discount and estimated offering expenses payable by Ocugen.
The offering price of the notes is 90% of the principal amount of notes. Ocugen intends to use approximately $32.7 million of the net proceeds from the offering to fully repay the outstanding principal amount of, plus accrued and unpaid interest on, the loan outstanding under its Loan and Security Agreement with affiliates of Avenue Capital Group (the “Avenue Loan Agreement”), and pay the related prepayment fee and other fees and expenses in connection therewith. Ocugen expects to use the remaining net proceeds from the offering, including any additional proceeds from the initial purchaser’s exercise of its option to purchase additional notes, for general corporate purposes.
The notes will be Ocugen’s general unsecured obligations and will rank senior in right of payment to all of its future indebtedness that is expressly subordinated in right of payment to the notes, equal in right of payment to all of its existing and future liabilities that are not so subordinated, and junior to all of its secured indebtedness, to the extent of the value of the assets securing such indebtedness. Interest will be payable semi-annually in arrears. The notes will bear interest at a rate of 6.75% per year. Interest will be payable semi-annually in arrears on May 15 and November 15 of each year, beginning on November 15, 2026. The notes will mature on May 15, 2034, unless earlier repurchased, redeemed or converted.
Ocugen may not redeem the notes prior to May 15, 2029. Ocugen may redeem for cash all or any portion of the notes (subject to certain limitations), at its option, on or after May 15, 2029 and prior to the 41st scheduled trading day immediately preceding the maturity date, if the last reported sale price of Ocugen’s common stock has been at least 130% of the conversion price then in effect for at least 20 trading days (whether or not consecutive) during any 30 consecutive trading day period (including the last trading day of such period) ending on, and including, the trading day immediately preceding the date on which Ocugen provides notice of redemption at a redemption price equal to 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest to, but excluding, the redemption date. Holders of the notes may require Ocugen to repurchase for cash all or any portion of their notes on May 15, 2032 at a repurchase price equal to 100% of the principal amount of notes to be repurchased, plus accrued and unpaid interest to, but excluding May 15, 2032. In addition, holders of the notes will have the right to require Ocugen to repurchase all or a portion of their notes upon the occurrence of a fundamental change (as defined in the indenture governing the notes) at a purchase price of 100% of their principal amount plus any accrued and unpaid interest to, but excluding, the relevant fundamental change repurchase date.
The notes may not be converted prior to the earlier of (i) May 15, 2027 and (ii) the “reserved share effective date” (as defined in the indenture governing the notes), which is effectively the date on which Ocugen reserves the maximum number of shares of common stock underlying the notes. The notes will be convertible at an initial conversion rate of 372.7866 shares of Ocugen’s common stock per $1,000 principal amount of notes (equivalent to an initial conversion price of approximately $2.68 per share, which represents a conversion premium of approximately 45% to the last reported sale price of $1.85 per share of Ocugen’s common stock on The Nasdaq Capital Market on May 4, 2026). Conversions of the notes may be settled in cash, shares of Ocugen’s common stock, or a combination thereof, at Ocugen’s election; provided that unless and until the reserved share effective date occurs, conversions of the notes will be settled via cash settlement.
The notes were only offered to qualified institutional buyers pursuant to Rule 144A under the Securities Act. Neither the notes nor the shares of Ocugen’s common stock potentially issuable upon conversion of the notes, if any, have been, or will be, registered under the Securities Act or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States except pursuant to an applicable exemption from such registration requirements.
This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including but not limited to, statements regarding the anticipated use of proceeds from the offering, including the repayment of the Avenue Loan Agreement; the completion of the offering, and other statements contained in this press release that are not historical facts. Ocugen may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from Ocugen’s current expectations, including, but not limited to: risks related to the offering and uncertainties related to market conditions; the impact of the offering on the market price of Ocugen’s common stock; and risks related to the potential dilution to holders of Ocugen’s common stock. These and other risks and uncertainties are more fully described in Ocugen’s periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that Ocugen files with the SEC. Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
MALVERN, Pa., May 04, 2026 (GLOBE NEWSWIRE) — Ocugen, Inc. (“Ocugen” or the “Company”) (NASDAQ: OCGN), a pioneering biotechnology leader in gene therapies for blindness diseases, today announced its intention to offer, subject to market conditions and other factors, $115 million aggregate principal amount of Convertible Senior Notes due 2034 (the “notes”) in a private offering (the “offering”) to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended (the “Securities Act”). Ocugen also expects to grant the initial purchaser of the notes a 13-day option to purchase up to an additional $15 million aggregate principal amount of the notes. The offering is subject to market and other conditions, and there can be no assurance as to whether or when the offering may be completed, or as to the actual size or terms of the offering.
Ocugen intends to use approximately $32.7 million of the net proceeds from the offering to fully repay the outstanding principal amount of, plus accrued and unpaid interest on, the loan outstanding under its Loan and Security Agreement with affiliates of Avenue Capital Group and pay the related prepayment fee and other fees and expenses in connection therewith. Ocugen expects to use the remaining net proceeds from the offering, including any additional proceeds from the initial purchaser’s exercise of its option to purchase additional notes, for general corporate purposes.
The notes will be Ocugen’s general unsecured obligations and will rank senior in right of payment to all of its future indebtedness that is expressly subordinated in right of payment to the notes, equal in right of payment to all of its existing and future liabilities that are not so subordinated, and junior to all of its secured indebtedness, to the extent of the value of the assets securing such indebtedness. Interest will be payable semi-annually in arrears. The notes may be converted into cash, shares of Ocugen’s common stock or a combination thereof, at Ocugen’s election. The interest rate, conversion rate and other terms of the notes are to be determined upon pricing of the offering.
The notes will only be offered to qualified institutional buyers pursuant to Rule 144A under the Securities Act. Neither the notes nor the shares of Ocugen’s common stock potentially issuable upon conversion of the notes, if any, have been, or will be, registered under the Securities Act or the securities laws of any other jurisdiction, and unless so registered, may not be offered or sold in the United States except pursuant to an applicable exemption from such registration requirements.
This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful.
Cautionary Note on Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995, which are subject to risks and uncertainties, including but not limited to, statements regarding the proposed terms of the notes; the anticipated terms of the notes; the size of the offering, including the initial purchaser’s option to purchase additional notes; the anticipated use of proceeds from the offering, including the repayment of the existing loan facility; the completion of the offering, and other statements contained in this press release that are not historical facts. Ocugen may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks, and uncertainties that may cause actual events or results to differ materially from Ocugen’s current expectations, including, but not limited to: uncertainties related to market conditions and whether the offering will be completed on the anticipated terms or at all; the impact of the offering on the market price of Ocugen’s common stock; risks related to the potential dilution to holders of Ocugen’s common stock; and uncertainties regarding the conversion price and other terms of the notes. These and other risks and uncertainties are more fully described in Ocugen’s periodic filings with the Securities and Exchange Commission (SEC), including the risk factors described in the section entitled “Risk Factors” in the quarterly and annual reports that Ocugen files with the SEC. Any forward-looking statements that Ocugen makes in this press release speak only as of the date of this press release. Except as required by law, Ocugen assumes no obligation to update forward-looking statements contained in this press release whether as a result of new information, future events, or otherwise, after the date of this press release.
Post-closing combined company has revenue-producing commercial asset and a robust pipeline of products and product candidates to address multiple therapeutic areas with a focus on fibrosis and inflammatory diseases.
China innovation engine provides cost-efficient vehicle for discovery and early-stage development of targeted protein degraders and degrader-antibody conjugates.
Strengthened leadership team in U.S., coupled with China operating presence to support future global growth.
SAN DIEGO, May 04, 2026 (GLOBE NEWSWIRE) — Gyre Therapeutics, Inc. (“Gyre”, “Gyre Therapeutics” or the “Company”) (Nasdaq: GYRE), an innovative, commercial-stage biopharmaceutical company dedicated to advancing fibrosis-first therapies across organ systems affected by chronic diseases, today announced the closing of its acquisition of Cullgen Inc. (Cullgen), a privately-held, clinical-stage biopharmaceutical company focused on the discovery and development of targeted protein degrader (TPD) and degrader antibody conjugate (DAC) therapies, in an all-stock transaction valued at approximately $300 million.
Following the closing of the acquisition, Cullgen became a wholly owned subsidiary of Gyre, and the former Chief Executive Officer of Cullgen, Dr. Ying Luo, was appointed President and Chief Executive Officer and as a member of the Gyre Board of Directors. Ping Zhang will continue at Gyre as Chairman of the Board of Directors. The new combined entity will continue to be listed on the Nasdaq Capital Market under the ticker “GYRE”.
Dr. Luo, President and Chief Executive Officer of Gyre, commented, “We are eager to move forward as a U.S.- and China-based fully integrated biopharmaceutical company. Through this combination, we have created an entity that not only offers a commercial-stage product with ETUARY®, on the market in China for the treatment of lung fibrosis, but also a full-spectrum pipeline of products from discovery to Phase 3, primarily focused on fibrosis and inflammatory diseases. This includes our lead product candidate, F351 (hydronidone) for the treatment of chronic hepatitis B (CHB)-induced liver fibrosis, as well as a strong preclinical and clinical pipeline, including TPDs and DACs.”
Mr. Zhang, Chairman of Gyre, commented, “This combination occurs at an exciting time for Gyre as we recently received priority review status from the Center for Drug Evaluation of China’s National Medical Products Administration for the F351 NDA in March. We are also exploring the expansion of F351’s development in ex-China territories including the U.S. In addition, we have completed enrollment in our 52-week Phase 3 ETUARY® trial for pneumoconiosis, and have also enrolled the first patient in a Phase 3 study evaluating ETUARY® in a new indication: radiation-induced lung injury with or without immune checkpoint inhibitor-related pneumonitis, further strengthening our late-stage inflammatory portfolio. Additionally, we believe the innovative discovery engine that has produced several promising degraders and DACs acquired from Cullgen strengthens our asset portfolio and provides long-term value to Gyre.”
About Gyre Pharmaceuticals
Gyre Pharmaceuticals Co., Ltd., a subsidiary of Gyre Therapeutics, Inc. (“Gyre Pharmaceuticals”), is a commercial-stage biopharmaceutical company committed to the research, development, manufacturing and commercialization of innovative drugs for organ fibrosis. Its flagship product, ETUARY® (pirfenidone capsule), was the first approved treatment for IPF in the People’s Republic of China (PRC) in 2011 and has maintained a prominent market share over the past several years. In addition, Gyre Pharmaceuticals’ pipeline includes F351 (hydronidone), a structural analogue of pirfenidone, which demonstrated statistically significant fibrosis regression after 52 weeks of treatment in a pivotal Phase 3 clinical trial in CHB-associated liver fibrosis in the PRC. F351 received Breakthrough Therapy designation by the CDE of the NMPA in March 2021. Gyre Pharmaceuticals is also developing treatments for PD, RILI with or without immune-related pneumonitis, COPD, PAH and ALF/ACLF. As of December 31, 2025, Gyre Therapeutics owns a 69.7% equity interest in Gyre Pharmaceuticals.
About Gyre Therapeutics
Gyre Therapeutics is a biopharmaceutical company headquartered in San Diego, CA, primarily focused on the development and commercialization of F351 for liver fibrosis including MASH in the U.S., and, with its recent acquisition, now has a portfolio of highly selective targeted protein degrader product candidates designed to potently and efficiently eliminate therapeutically relevant proteins in patients, as well as preclinical programs including next-generation degrader-antibody conjugates.
In the PRC, Gyre Therapeutics is advancing a broad pipeline through its controlling interest in Gyre Pharmaceuticals, including therapeutic expansions of ETUARY, and development programs for F573, and F528.
Advisory and Legal Counsel
Moelis & Company LLC is acting as financial advisor to the special committee to Gyre’s Board of Directors, and Gyre’s legal counsel is Gibson, Dunn & Crutcher LLP.
Mintz, Levin, Cohn, Ferris, Glovsky & Popeo, P.C. is serving as legal counsel to Cullgen.
Esperion Therapeutics (Nasdaq: ESPR), the Ann Arbor-based commercial-stage biopharmaceutical company behind a growing portfolio of cardiometabolic therapies, is set to leave public markets after striking a definitive acquisition agreement with ARCHIMED, a Europe-headquartered healthcare-focused private equity firm with €9 billion in assets under management.
Under the terms of the deal announced May 1, 2026, Esperion shareholders will receive $3.16 per share in cash at closing — a 58% premium to the company’s closing share price on April 30 — along with one non-tradeable contingent value right (CVR) that entitles holders to participate in up to $100 million in additional milestone payments tied to future commercial performance. The total equity value of the transaction reaches approximately $1.1 billion on a fully diluted basis, assuming full achievement of those milestones.
The CVR Structure: Upside With Conditions
The contingent payment component is split into two tranches. The first is tied to annual U.S. net sales of bempedoic acid-containing products — primarily NEXLETOL and NEXLIZET — in calendar year 2027. Shareholders can receive up to $40 million in aggregate if those products surpass $350 million in annual sales, with a pro-rated payout if sales fall between $300 million and $350 million.
The second tranche is tied to ENBUMYST, Esperion’s bumetanide-based therapy, and pays out $60 million in aggregate if annual U.S. net sales hit or exceed $160 million in any single calendar year through December 31, 2030.
This CVR structure places meaningful commercial risk on post-close performance, particularly for ENBUMYST, which is the earlier-stage product of the two. Investors accepting the deal should weigh the probability of those sales thresholds being met before banking on the full $1.1 billion figure.
Why This Deal Makes Strategic Sense
Cardiovascular disease remains the leading cause of death globally, and the market for non-statin LDL-C lowering therapies has been steadily expanding. Esperion’s NEXLETOL and NEXLIZET have established commercial infrastructure in the U.S. and regulatory approvals in more than 40 countries, giving ARCHIMED a platform with real geographic reach and an active pipeline.
ARCHIMED’s exclusive focus on healthcare industries and its international network across Europe, North America, and Asia positions it to potentially accelerate Esperion’s international commercial strategy — something that can be difficult to execute efficiently inside a small-cap public company under the constraints of quarterly earnings pressure.
Deal Mechanics and Timeline
Debt financing for the acquisition is being provided by Pharmakon Advisors, LP, a specialized life sciences lender that has deployed up to $11 billion across 73 investments. The transaction carries no financing condition, which reduces deal risk meaningfully.
Esperion’s Board of Directors unanimously approved the deal and is recommending shareholder approval. The transaction is expected to close in the third quarter of 2026, pending shareholder vote and regulatory clearance. Moelis & Company is advising ARCHIMED, while Centerview Partners is advising Esperion.
Once the deal closes, Esperion will be delisted from Nasdaq and operate as a privately held company — removing a once-public cardiometabolic pure-play from the small-cap biotech universe.
Robert LeBoyer, Senior Vice President, Equity Research Analyst, Biotechnology, Noble Capital Markets, Inc.
Refer to the full report for the price target, fundamental analysis, and rating.
Phase 3 Design Announced. Cadrenal held an end-of-Phase-2 meeting with the FDA to discuss the results of the CAD-1005 trial and receive guidance for the design of Phase 3. Following the receipt of the Meeting Minutes, the preliminary design for Phase 3 in HIT (Heparin-Induced Thrombocytopenia) has been announced. The trial is expected to begin in late FY2026 to early FY2027, with an NDA possible in FY2019.
HIT Is A Serious Condition. HIT is a potentially life-threatening immune reaction to heparin, an anticoagulant currently used in an estimated 12 million cardiac surgeries. HIT affects up to 5% of these patients, forming immune complexes that can activate platelets and cause excessive clotting. About 50% experience thrombosis, as well as embolisms, skin necrosis, and other cardiac events that can be fatal. CAD-1005 is a selective inhibitor of the 12-LOX immune pathway that causes HIT. This contrasts with other drugs that control symptoms and secondary morbidities following the immune response.
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Ongoing Phase 1b human challenge study with oral, direct-acting protease inhibitor is designed to demonstrate proof-of-concept as a preventive and a treatment
Fully enrolled first cohort is assessing the infectivity of the human challenge inoculum
There are no approved treatments or vaccines for norovirus, the leading cause of acute gastroenteritis across all age groups and geographies with a $60 billion annual economic burden
FDA Fast Track designation granted for CDI-988 underscores the lack of approved therapies and seriousness of norovirus infection
BOTHELL, Wash., April 30, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma, Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”) announces that the mechanism of action and clinical advancement of its first oral protease inhibitor CDI-988 were featured today in an oral presentation at the 39th International Conference on Antiviral Research (ICAR 2026) in Prague, Czech Republic. The presentation, titled “First Oral Direct-Acting Antiviral CDI-988 for Norovirus Infection Prevention and Treatment: Novel Mechanism of Action and Phase 1 Study Results,” was delivered by Sam Lee, Ph.D., President and co-CEO of Cocrystal. Presentation slides are available on the Company’s website here.
“It was an honor to share our progress with CDI-988 with the global antiviral research community attending ICAR 2026,” said Dr. Lee. “Following favorable Phase 1 data, we have advanced CDI-988 into a Phase 1b study under a human challenge model that provides an efficient framework to rapidly demonstrate proof of concept as a preventive and as a treatment for norovirus infection. We have now completed enrollment of the stage 1 study cohort, which will establish the infectivity rate of the GII.2 (Snow Mountain Virus) challenge inoculum. This is a critical step in validating infectivity in the study cohorts.
“Multiple norovirus vaccine clinical studies have been initiated over the past decade, yet none have led to an approval in part due to the virus’s extensive genetic variation and drift, spanning 10 genogroups and 49 genotypes,” Dr. Lee added. “CDI-988 is designed to target the highly conserved region of the 3CL protease across all known norovirus strains, including GII.4 and the re-emerging GII.17 variants, as well as all coronaviruses. We believe this compound could offer a much‑needed option for prevention and treatment in a convenient oral formulation that can be readily stockpiled in advance of norovirus outbreaks.”
CDI-988 is a first, oral direct-acting antiviral and was developed using Cocrystal’s proprietary structure-based drug discovery platform technology. As presented by Dr. Lee, in preclinical studies CDI-988 showed favorable gastrointestinal-targeted pharmacokinetics at the site of norovirus infection and also demonstrated potent antiviral activity in GII.4-infected human enteronoid model systems.
In a completed randomized, double‑blind, placebo‑controlled single‑ and multiple‑ascending dose Phase 1 study in healthy adults, CDI‑988 was generally safe and well tolerated across doses up to 1,200 mg, with headache as the most common treatment‑emergent adverse event and no serious adverse events reported. These results, together with a no-observed adverse effect of 1,000 mg/kg in GLP toxicology studies, support CDI-988’s further clinical development in norovirus.
The ongoing Phase 1b randomized, double‑blind, placebo‑controlled challenge study (NCT07198139) is being conducted at Emory University School of Medicine in collaboration with the University of North Carolina. The study is designed to enroll up to 40 healthy adults, ages 18 to 49, in staged cohorts. The stage 1 infectivity cohort, now fully enrolled, will be followed by prevention and treatment cohorts in which CDI‑988 is administered at 1,200 mg twice daily for five days. The primary efficacy endpoint is reduction in the incidence of clinical symptoms, with secondary endpoints including reduction in viral shedding, disease severity, safety and pharmacokinetics.
CDI‑988 has been granted Fast Track designation by the U.S. Food and Drug Administration (FDA) for the treatment and prophylaxis of norovirus infection, underscoring the serious nature of norovirus disease and the lack of approved therapies. Fast Track status is intended to facilitate development and expedite the review of drugs that address unmet medical needs, providing opportunities for more frequent FDA interactions, rolling review of a potential New Drug Application and potential eligibility for Priority Review.
Hosted by the International Society for Antiviral Research (ISAR), the International Conference on Antiviral Research (ICAR) brings together leading scientists, researchers and industry professionals from around the world to discuss the latest advancements and breakthroughs in antiviral research. ICAR provides a variety of networking opportunities allowing members to connect with colleagues and establish new scientific relationships and collaborations with leaders in the antiviral field.
About Cocrystal Pharma, Inc.
Cocrystal Pharma, Inc. is a clinical-stage biotechnology company discovering and developing novel antiviral therapeutics that target the replication process of noroviruses, influenza viruses, coronaviruses (including SARS-CoV-2), and rhinoviruses. Cocrystal employs unique structure-based technologies and Nobel Prize-winning expertise to create viable antiviral drugs. For further information about Cocrystal, please visit www.cocrystalpharma.com.
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding any implications that CDI-988 is able to prevent and/or treat norovirus infections. The words “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events. Some or all of the events anticipated by these forward-looking statements may not occur. Important factors that could cause actual results to differ from those in the forward-looking statements include, but are not limited to, the risks and uncertainties arising from delays arising from raw materials and labor shortages, supply chain disruptions and other business interruptions including any adverse impacts on our ability to obtain raw materials for and otherwise proceed with studies as well as similar problems with our vendors and our current and any future clinical research organization (CROs) and contract manufacturing organizations, the progress and results of the studies including any adverse findings or delays, the ability of us and our CROs to recruit volunteers for, and to otherwise proceed with, clinical studies, our and our collaboration partners’ technology and software performing as expected, financial difficulties experienced by certain partners, the results of any current and future preclinical and clinical studies, general risks arising from clinical studies, receipt of regulatory approvals, regulatory changes and any adverse developments which may arise therefrom, and general economic adverse effects from the ongoing conflict with Iran. Further information on our risk factors is contained in our filings with the SEC, including the “Risk Factors” in Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2025. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Investor Contact: Alliance Advisors IR Jody Cain 310-691-7100 [email protected]
STAFFORD, Texas, April 30, 2026 (GLOBE NEWSWIRE) — Greenwich LifeSciences, Inc. (Nasdaq: GLSI) (the “Company”), a clinical-stage biopharmaceutical company focused on its Phase III clinical trial, FLAMINGO-01, which is evaluating Fast Track designated GLSI-100, an immunotherapy to prevent breast cancer recurrences, today provided an update on its Form 10-K filing for the fiscal year ending December 31, 2025.
The Form 10-K for the fiscal year ending December 31, 2025 is still being audited by the auditors who are both trying to reach agreement on the final figures. They have indicated that they expect to complete their audits before the end of May in conjunction with the filing of Form 10-Q for the period ending March 31, 2026.
The final adjustments are focused on accounts payable, which are related to the large global Phase III clinical trial underway and the unexpectedly large increase in screening and patient enrollment in Europe in 2024 and 2025.
As previously announced, the Company’s ending cash balance as of March 31, 2026 is approximately $10.5 million, which is unaudited and is subject to change following the completion of the Company’s financial review for Q1 2026.
About FLAMINGO-01 Open Label Phase III Data
More than 1,300 patients have been screened with a current screen rate of approximately 800 patients per year. The 250 patient non-HLA-A*02 arm is now fully enrolled, where all patients received GLSI-100, which is 5 times more treated patients and recurrence rate data than the approximately 50 patients treated in the Phase IIb trial. The Primary Immunization Series (PIS), which includes the first 6 GLSI-100 injections over the first 6 months and is required to reach peak protection, is followed by 5 booster injections given every 6 months to prolong the immune response, thereby providing longer-term protection.
In the non-HLA-A*02 arm, a preliminary analysis of recurrence rates after the PIS is completed shows an approximately 70-80% reduction in recurrence rate.
This observation is trending similarly to the Phase IIb trial results and hazard ratio where HLA-A*02 patients were treated and where breast cancer recurrences were reduced up to 80% compared to a 20-50% reduction in recurrence rate by other approved products.
The immune response at baseline prior to any GLSI-100 treatment, the increasing immune response during the PIS, and the safety profile of non-HLA-A*02 patients is trending similarly to the HLA-A*02 arms of FLAMINGO-01 and to the Phase IIb study.
The AACR Meeting 2026 delayed-type-hypersensitivity (DTH) poster can be downloaded here.
The frequency of DTH reactions increased by approximately 4x (290%) in the total open-label non-HLA-A*02 population, increasing from 5.2% of the patients experiencing a DTH reaction at baseline, prior to any GLSI-100 administration, to 20.4% of the patients experiencing a DTH reaction in month 4 or month 6 (McNemar, p < 0.001).
As reported in Table 1 of the poster, each HLA-A type exhibited more frequent immune reactivity after treatment with GLSI-100 than at baseline with frequency increasing from 100% to 700%.
Baseline DTH reaction prior to any treatment suggests that GP2 may be a natural antigen and that GP2 specific T cells may exist in some patients prior to any treatment with GLSI-100. Baseline immune response to GP2 prior to any vaccination with GP2 was also observed in the Phase IIb trial and is being observed in the blinded randomized arms of FLAMINGO-01, where HLA-A*02 only patients are being vaccinated.
Analysis of the open label data from FLAMINGO-01 has been conducted in a manner that maintains the study blind. The open label recurrence rate, immune response, and safety data is based on the patients enrolled to date in FLAMINGO-01 and the data provided by the clinical sites so far, which is not completed or fully reviewed, and is thus preliminary. While comparing any preliminary FLAMINGO-01 data to the Phase IIb clinical trial data may be possible, these preliminary results are not a prediction of future results, and the results at the end of the study may differ.
About GLSI-100 Phase IIb Study
In the prospective, randomized, single-blinded, placebo-controlled, multi-center (16 sites led by MD Anderson Cancer Center) Phase IIb clinical trial of HLA-A*02 breast cancer patients, 46 HER2/neu 3+ over-expressor patients were treated with GLSI-100, and 50 placebo patients were treated with GM-CSF alone. After 5 years of follow-up, there was an 80% or greater reduction in cancer recurrences in the HER2/neu 3+ patients who were treated with GLSI-100, followed, and remained disease free over the first 6 months, which we believe is the time required to reach peak immunity and thus maximum efficacy and protection. The Phase IIb results can be summarized as follows:
80% or greater reduction in metastatic breast cancer recurrence rate over 5 years of follow-up with a peak immune response at 6 months and well-tolerated safety profile.
The PIS elicited a potent immune response as measured by local skin tests and immunological assays.
About FLAMINGO-01 and GLSI-100
FLAMINGO-01 (NCT05232916) is a Phase III clinical trial designed to evaluate the safety and efficacy of Fast Track designated GLSI-100 (GP2 + GM-CSF) in HER2 positive breast cancer patients who had residual disease or high-risk pathologic complete response at surgery and who have completed both neoadjuvant and postoperative adjuvant trastuzumab based treatment. The trial is led by Baylor College of Medicine and currently includes US and European clinical sites from university-based hospitals and academic and cooperative networks with plans to open up to 150 sites globally. In the double-blinded arms of the Phase III trial, approximately 500 HLA-A*02 patients are planned to be randomized to GLSI-100 or placebo, and up to 250 patients of other HLA types are planned to be treated with GLSI-100 in a third arm. The trial has been designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, where 28 events will be required. An interim analysis for superiority and futility will be conducted when at least half of those events, 14, have occurred. This sample size provides 80% power if the annual rate of events in placebo-treated subjects is 2.4% or greater.
For more information on FLAMINGO-01, please visit the Company’s website here and clinicaltrials.gov here. Contact information and an interactive map of the majority of participating clinical sites can be viewed under the “Contacts and Locations” section. Please note that the interactive map is not viewable on mobile screens. Related questions and participation interest can be emailed to: [email protected]
About Breast Cancer and HER2/neu Positivity
One in eight U.S. women will develop invasive breast cancer over her lifetime, with approximately 300,000 new breast cancer patients and 4 million breast cancer survivors. HER2 (human epidermal growth factor receptor 2) protein is a cell surface receptor protein that is expressed in a variety of common cancers, including in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels.
About Greenwich LifeSciences, Inc.
Greenwich LifeSciences is a clinical-stage biopharmaceutical company focused on the development of GP2, an immunotherapy to prevent breast cancer recurrences in patients who have previously undergone surgery. GP2 is a 9 amino acid transmembrane peptide of the HER2 protein, a cell surface receptor protein that is expressed in a variety of common cancers, including expression in 75% of breast cancers at low (1+), intermediate (2+), and high (3+ or over-expressor) levels. Greenwich LifeSciences has commenced a Phase III clinical trial, FLAMINGO-01. For more information on Greenwich LifeSciences, please visit the Company’s website at www.greenwichlifesciences.com and follow the Company’s Twitter at https://twitter.com/GreenwichLS.
Forward-Looking Statement Disclaimer
Statements in this press release contain “forward-looking statements” that are subject to substantial risks and uncertainties. All statements, other than statements of historical fact, contained in this press release are forward-looking statements. Forward-looking statements contained in this press release may be identified by the use of words such as “anticipate,” “believe,” “contemplate,” “could,” “estimate,” “expect,” “intend,” “seek,” “may,” “might,” “plan,” “potential,” “predict,” “project,” “target,” “aim,” “should,” “will,” “would,” or the negative of these words or other similar expressions, although not all forward-looking statements contain these words. Forward-looking statements are based on Greenwich LifeSciences Inc.’s current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict, including statements regarding the intended use of net proceeds from the public offering; consequently, actual results may differ materially from those expressed or implied by such forward-looking statements. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. These and other risks and uncertainties are described more fully in the section entitled “Risk Factors” in Greenwich LifeSciences’ Annual Report on the most recent Form 10-K for the year ended December 31, 2024, and other periodic reports filed with the Securities and Exchange Commission. Forward-looking statements contained in this announcement are made as of this date, and Greenwich LifeSciences, Inc. undertakes no duty to update such information except as required under applicable law.
FDA provided critical guidance for the advancement of CAD-1005 to pivotal Phase 3 in HIT
Phase 2 data showed a greater than 25% absolute reduction in thrombotic events when CAD-1005 was added to standard anticoagulant therapy
PONTE VEDRA, Fla., April 30, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company developing innovative treatments for life-threatening immune and thrombotic conditions, today announced a major regulatory milestone after successfully completing its End-of-Phase 2 (EOP2) meeting with the U.S. Food and Drug Administration (FDA) and receiving guidance on key elements of the Phase 3 pivotal trial for CAD-1005, the Company’s investigational first-in-class 12-lipoxygenase (12-LOX) inhibitor for heparin-induced thrombocytopenia (HIT).
The meeting with the FDA provided critical guidance on protocol design, study population, dosing, background therapy, exposure, the safety database, and the primary endpoint of new or worsening thrombotic events. After considering FDA feedback on a pivotal registration study, Cadrenal plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT.
“This successful EOP2 meeting marks an important regulatory milestone for Cadrenal and our CAD-1005 program,” said Quang X. Pham, Chairman and Chief Executive Officer of Cadrenal Therapeutics. “Building on our Phase 2 experience with CAD-1005 in HIT and now with FDA guidance for Phase 3, Cadrenal is positioned to pursue a pivotal trial for the first new therapy for HIT in more than two decades.”
Planned Phase 3 HIT Trial Design
Cadrenal’s planned pivotal Phase 3 study – the first randomized, blinded, placebo-controlled registration trial in HIT – will evaluate CAD-1005 in approximately 120 patients across up to 50 clinical centers worldwide and is intended to support a projected NDA submission in 2029. Patients with suspected HIT will be randomized to CAD-1005 or placebo while receiving standard-of-care anticoagulant therapy and treated for up to 14 days during hospitalization. The primary endpoint – centrally adjudicated – is the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis.
“CAD-1005 is being investigated for the treatment of immune-mediated thrombocytopenia by targeting the underlying pathophysiologic mechanisms that current therapies do not,” said James Ferguson, M.D., Chief Medical Officer of Cadrenal Therapeutics. “Interrupting the vicious cycle of platelet activation in HIT with CAD-1005 could be an important addition to our therapeutic armamentarium for this devastating condition.”
About Heparin-Induced Thrombocytopenia (HIT)
Heparin is the most widely used in-hospital anticoagulant, with more than 12 million patients receiving it in the United States each year. Heparin-induced thrombocytopenia (HIT) is a potentially life-threatening immune-mediated complication of heparin administration that occurs when antibodies to heparin activate platelets, leading to clots throughout the circulatory system, markedly lowering platelet counts, and increasing the risk of bleeding. Complications of HIT include deep vein thrombosis, pulmonary embolism, stroke, myocardial infarction, amputation, and death, with mortality rates for HIT exceeding 20% in some studies. CAD-1005 is the only treatment in clinical development that targets the underlying immune drivers of HIT.
About CAD-1005
CAD-1005 is an investigational therapy under evaluation for the treatment of suspected HIT. CAD-1005 is designed to selectively inhibit 12-LOX, a pathway integral to the primary immune mechanisms that drive HIT. Unlike existing therapies for HIT, which are directed only at preventing thrombotic complications, this approach targets the primary underlying cause of HIT. CAD-1005 has received Orphan Drug Designation (ODD) and Fast Track designation from the U.S. Food and Drug Administration, as well as orphan drug status from the European Medicines Agency.
About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is a first-in-class 12-LOX inhibitor for treating heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder. CAD-1005 has received Orphan Drug and Fast Track designations from the U.S. Food and Drug Administration and orphan drug status from the European Medicines Agency. Second-generation 12-LOX oral therapeutics are also in development for chronic indications.
The Company’s broader pipeline includes tecarfarin, a late-stage oral vitamin K antagonist designed to prevent heart attacks, strokes, and deaths from blood clots in patients requiring chronic anticoagulation, including those with end-stage kidney disease and left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.
Any statements in this press release about future expectations, plans, and prospects, as well as any other statements regarding matters that are not historical facts, may constitute “forward-looking statements.” The words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potentially,” “predict,” “project,” “should,” “target,” “will,” “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These statements include, without limitation, statements regarding Cadrenal’s plans to advance to a pivotal Phase 3 in HIT; plans to advance directly to a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT; Cadrenal being positioned to pursue a pivotal trial for the first new therapy for HIT in more than two decades; the planned pivotal Phase 3 study evaluating CAD-1005 in approximately 120 patients across up to 50 clinical centers worldwide and being intended to support a projected NDA submission in 2029; the protocol design including patients with suspected HIT being randomized to CAD-1005 or placebo while receiving standard-of-care anticoagulant therapy and treated for up to 14 days during hospitalization with the primary endpoint – centrally adjudicated – being the incidence of new or worsening thrombotic events in patients with Serotonin Release Assay (SRA)-confirmed HIT, with at least one planned interim analysis; and interrupting the vicious cycle of platelet activation in HIT with CAD-1005 being an important addition to our therapeutic armamentarium for this devastating condition. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to continue to progress CAD-1005; the ability to successfully plan a pivotal Phase 3 study; the ability to successfully plan and conduct a randomized, blinded, placebo-controlled Phase 3 study evaluating CAD-1005 added to the current standard of care for patients with HIT; the ability of the Company’s planned Phase 3 pivotal trial to support a projected NDA in 2029; the ability to interrupt the vicious cycle of platelet activation in HIT with CAD-1005; the Company’s ability to raise sufficient funding to commence and complete its planned Phase 3 trial, and the other risk factors described in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, and the Company’s subsequent filings with the Securities and Exchange Commission, including subsequent periodic reports on Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. Any forward-looking statements contained in this press release speak only as of the date hereof and, except as required by federal securities laws, the Company specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events, or otherwise.
For more information, please contact: Lytham Partners, LLC Robert Blum, Managing Partner 602-889-9700 [email protected]
Near-Term Clinical Milestones and Combination Strategy Position Program for Next Stage of Value Creation
ATLANTA, GA – April 29, 2026 – GeoVax Labs, Inc. (Nasdaq: GOVX), a clinical-stage biotechnology company developing immunotherapies and vaccines against cancers and infectious diseases, today outlined near-term development milestones and strategic priorities for its oncology program, Gedeptin®, as the Company advances toward Phase 2 clinical initiation and potential partnership opportunities.
With oncology treatment increasingly defined by combination regimens, the ability to integrate into established therapeutic backbones is becoming a key factor in clinical and commercial success. GeoVax believes the convergence of upcoming clinical milestones and increasing industry focus on combination approaches creates a timely opportunity to advance Gedeptin’s development and strategic positioning.
Advancing Toward Phase 2 Clinical Execution
GeoVax is advancing Gedeptin with a focus on integration into combination treatment regimens, particularly alongside immune checkpoint inhibitors (ICIs) and other established oncology backbones. The Company believes this approach aligns with the evolving treatment landscape and may support broader applicability across multiple tumor types. GeoVax is preparing to initiate a Phase 2 clinical trial evaluating Gedeptin, in combination with an ICI, as a first-line neoadjuvant treatment in patients with resectable locally advanced head and neck cancer, with trial initiation targeted for 2027.
The study is designed to evaluate:
Tumor response in the neoadjuvant setting
Biomarker-driven immune activation
Event-free survival outcomes
This trial is expected to represent a key step in establishing clinical validation for Gedeptin in combination immuno-oncology strategies.
Expanding Development Across Additional Solid Tumors
In parallel with its lead clinical program, GeoVax is planning to advance preclinical and translational work evaluating Gedeptin across additional solid tumor indications. These efforts are intended to (a) identify tumor settings where combination approaches may provide the greatest clinical benefit, (b) support expansion beyond head and neck cancer and, (c) inform future clinical development strategies.
Positioned for Strategic Collaboration
GeoVax is actively pursuing opportunities to advance Gedeptin through clinical development partnerships, combination-focused collaborations and potential licensing or co-development arrangements.
“We are entering an important phase of development for Gedeptin, with a focus on clinical execution and advancing discussions around potential partnerships,” said David A. Dodd, Chairman and Chief Executive Officer of GeoVax. “As combination therapy becomes more common across oncology, we believe Gedeptin is well positioned to be integrated into these regimens and contribute to improved treatment outcomes.”
Supported by an Established Clinical and Scientific Foundation
GeoVax has established a clinical and scientific foundation to support Gedeptin’s advancement into its next stage of development, including:
Completed Phase 1/2 clinical experience in advanced head and neck cancer
Engagement of an Oncology Advisory Board with deep immuno-oncology expertise
Expanded intellectual property supporting combination use with checkpoint inhibitors
This foundation is intended to support both continued clinical progression and engagement with potential partners.
About Gedeptin®
Gedeptin® is a gene-directed enzyme prodrug therapy (GDEPT) delivered intratumorally using a non-replicating viral vector encoding purine nucleoside phosphorylase (PNP). Following administration of a systemically delivered prodrug, the encoded enzyme converts the prodrug into a cytotoxic agent directly within the tumor microenvironment.
About GeoVax
GeoVax Labs, Inc. is a clinical-stage biotechnology company focused on the development of vaccines and immunotherapies addressing high-consequence infectious diseases and solid tumor cancers. GeoVax’s priority program is GEO-MVA, a Modified Vaccinia Ankara (MVA)–based vaccine targeting mpox and smallpox. The program is advancing under an expedited regulatory pathway, with plans to initiate a pivotal Phase 3 clinical trial in the second half of 2026, to address critical global needs for expanded orthopoxvirus vaccine supply and biodefense preparedness. In oncology, GeoVax is developing Gedeptin®, a gene-directed enzyme prodrug therapy (GDEPT) designed to enhance immune checkpoint inhibitor activity. Gedeptin has completed a multicenter Phase 1/2 clinical trial in advanced head and neck cancer and is being advanced into combination strategies, including planned neoadjuvant and first-line settings. GeoVax’s broader pipeline includes the development of GEO-CM04S1, a next-generation COVID-19 vaccine candidate being evaluated in immunocompromised and other patient populations. GeoVax maintains a global intellectual property portfolio supporting its infectious disease and oncology programs and continues to evaluate strategic partnerships and funding opportunities aligned with its development priorities. For more information, visit www.geovax.com.
Forward-Looking Statements
This release contains forward-looking statements regarding GeoVax’s business plans. The words “believe,” “look forward to,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “could,” “target,” “potential,” “is likely,” “will,” “expect” and similar expressions, as they relate to us, are intended to identify forward-looking statements. We have based these forward-looking statements largely on our current expectations and projections about future events and financial trends that we believe may affect our financial condition, results of operations, business strategy and financial needs. Actual results may differ materially from those included in these statements due to a variety of factors, including whether: GeoVax is able to obtain acceptable results from ongoing or future clinical trials of its investigational products, GeoVax’s immuno-oncology products and preventative vaccines can provoke the desired responses, and those products or vaccines can be used effectively, GeoVax’s viral vector technology adequately amplifies immune responses to cancer antigens, GeoVax can develop and manufacture its immuno-oncology products and preventative vaccines with the desired characteristics in a timely manner, GeoVax’s immuno-oncology products and preventative vaccines will be safe for human use, GeoVax’s vaccines will effectively prevent targeted infections in humans, GeoVax’s immuno-oncology products and preventative vaccines will receive regulatory approvals necessary to be licensed and marketed, GeoVax raises required capital to complete development, there is development of competitive products that may be more effective or easier to use than GeoVax’s products, GeoVax will be able to enter into favorable manufacturing and distribution agreements, and other factors, over which GeoVax has no control.
Further information on our risk factors is contained in our periodic reports on Form 10-Q and Form 10-K that we have filed and will file with the SEC. Any forward-looking statement made by us herein speaks only as of the date on which it is made. Factors or events that could cause our actual results to differ may emerge from time to time, and it is not possible for us to predict all of them. We undertake no obligation to publicly update any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Company on track to initiate a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study in the first half of 2027, pending FDA agreement
Phase 2 field study expected to test a two-dose regimen of TNX-4800 subcutaneous with an initial Spring dose followed by a Summer booster two months later; the primary endpoint is Lyme disease prevention for six months
TNX-4800 is expected to provide protection against Lyme disease within two days of the first dose for the peak of the U.S. Lyme season
BERKELEY HEIGHTS, N.J., April 29, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or the “Company”), a fully integrated, commercial biotechnology company, announced presentation of Phase 1 data and plans for an adaptive Phase 2 field study of TNX-4800 (formerly known as mAb 2217LS)1,2 for the prevention of Lyme disease in the U.S., at the 4th Annual Ticks and Tickborne Diseases Symposium. The Phase 2 study is expected to initiate in the first half of 2027, pending FDA agreement.
The Phase 1 study was conducted by a team at UMass Chan Medical School led by Mark S. Klempner, MD, Professor of Medicine at UMass Chan and an inventor of TNX-4800. The adaptive Phase 2 field study is being planned by Tonix, which licensed TNX-4800 from UMass Chan Medical School in 2025.
TNX-4800 is a long-acting bactericidal (or borreliacidal), human monoclonal antibody (mAb) that targets the outer surface protein A (OspA) of Borrelia burgdorferi, the spirochete bacteria that causes 99.9% of Lyme disease cases in the U.S.3,4 TNX-4800 was engineered to include a crystallizable fragment (Fc) domain that provides an extended half-life. Tonix is developing TNX-4800 for the prevention of Lyme disease during the U.S. tick season. There are currently no marketed U.S. Food and Drug Administration (FDA)-approved vaccines or prophylactics to protect against Lyme disease.
“We plan to initiate an adaptive Phase 2 field study in the first half of 2027 pending FDA agreement,” said Seth Lederman, MD, Chief Executive Officer of Tonix Pharmaceuticals. “We intend to test a two-dose regimen of TNX-4800, with the first dose administered in the Spring and a second dose administered two months later, for protection against Lyme disease for six months following the initial dose as the primary endpoint. We believe the Phase 1 pharmacokinetic (PK) data support this study design. Each fixed subcutaneous (SC) dose is expected to provide exposures comparable to the 5 mg/kg SC dose evaluated in Phase 1. We have scheduled a meeting with the FDA early in the third quarter of 2026. We look forward to advancing the clinical investigation of TNX-4800 as we strive to overcome the major public health challenges posed by Lyme disease.”
Dr. Lederman continued, “As a long-acting monoclonal antibody that offers passive immunity against the Lyme-causing bacteria within two days, we believe TNX-4800 offers significant advantages over the alum-based combination multi-OspA subunit vaccine in late-stage clinical development. Lyme disease vaccines that elicit antibodies to OspA take more than six months to offer protection and require complex immunization schedules which are obstacles to adherence. A previously approved alum-based OspA subunit vaccine was withdrawn due to poor uptake,6 potentially relating to its complex immunization schedule. We believe TNX-4800’s differentiating characteristics could offer meaningful improvements for people seeking protection from Lyme disease.”
A copy of the poster is available under the Scientific Presentations tab on the Tonix website at www.tonixpharma.com.
Adaptive Phase 2 Field Study Plans Pending FDA agreement, the Company plans to initiate an adaptive field study in the first half of 2027. The Company plans to study TNX-4800 in a randomized, double-blind, placebo-controlled, adaptive Phase 2 field study to evaluate the efficacy of a two-dose regimen of TNX-4800 SC, in preventing the first occurrence of confirmed Lyme disease during the primary efficacy surveillance period (Day 3 through Month 6 following administration). The two-dose regimen of TNX-4800 was selected for the Phase 2 field study based on the pharmacokinetic results of the Phase 1 study. Each fixed dose is expected to provide exposures comparable to the 5 mg/kg dose evaluated in Phase 1. The first dose will be administered in the Spring and the second booster dose will be administered two months later. Participants will include adolescents and adults 16 years of age and older in Lyme-endemic areas in the U.S. The primary endpoint will be the prevention of Lyme disease for six months (comparison of TNX-4800 group and placebo group) following the initial dose. The Company has scheduled a Type C meeting with the FDA early in the third quarter of 2026 to discuss the planned adaptive Phase 2 field study design.
The Company expects to have Good Manufacturing Practice (GMP) investigational product available for clinical testing in early 2027.
About TNX-4800 TNX-4800 (formerly known as mAb 2217LS) is a long-acting bactericidal, human monoclonal antibody with an engineered extended half-life that targets the outer-surface protein A (OspA) on Lyme-causing Borrelia bacteria. When TNX-4800-containing blood is ingested by the tick, TNX-4800 either kills or blocks the maturation of Borrelia burgdorferi in the mid-gut of infected deer ticks. The Company in-licensed TNX-4800 from UMass Chan Medical School in 2025. Published work in animals showed that TNX-4800 serum levels of at least 21 μg/ml, were approximately 95% effective at preventing infection of non-human primates after six days of exposure to ticks infected with Borrelia burgdorferi.1,2 TNX-4800 was derived from mAb 2217 by amino acid substitutions in its Fc domain, which serve to prolong the serum half-life. As a monoclonal antibody, TNX-4800 is designed to provide passive immunity against Lyme disease within two days without relying on the recipient’s immune system to generate antibodies. TNX-4800 also avoids the complex immunization schedules required for an alum-based combination multi-OspA subunit vaccine in development7 and the FDA-approved alum-based OspA subunit vaccine that was withdrawn from the market.8 TNX-4800 is protected by Issued US Patent US 10,457,721, which is licensed from UMass Chan with expiry in January 2036, excluding any possible Patent Term Extension based on the duration of the clinical trials and the FDA approval process.
TNX-4800 Phase 1 Study Results TNX-4800 was studied in a randomized, double-blind, sequential dose-escalation study (NCT04863287) that evaluated safety, tolerability, PK, and immunogenicity of TNX-4800 in healthy adults. 44 subjects were randomized, and 41 completed the study. Subjects received a single SC dose of placebo or TNX-4800 at 0.5, 1.5, 5, or 10 mg/kg. Safety was assessed via clinical and lab evaluations. Results showed no significant clinical or laboratory safety signals. All drug-related adverse events were mild or moderate, except for a single severe adverse event that was deemed not drug-related. Drug exposure increased by approximately 25 times for a 20-times increase in dose. Serum TNX-4800 was measurable at the earliest sampling time of two days, indicating rapid systemic absorption. TNX-4800 concentrations remained quantifiable up to 12 months in the majority of participants. At the highest dose of TNX-4800 tested in rats with 1.5-fold higher exposure compared to 10 mg/kg cohort, no adverse toxicity was observed, thus the highest dose tested was considered No Observed Adverse Effect Level (NOAEL). Confirmed anti-drug antibodies (ADSs) were observed transiently in <10% of treated participants, with no impact on PK. TNX-4800 was determined to be generally safe and well tolerated.
About Lyme Disease In the U.S., Lyme disease is caused by the spirochete bacteria Borrelia burgdorferi. Lyme disease remains the most common vector-borne infection in the United States, and its incidence is climbing each year, due to the expanding the habitat range for ticks.8 Approximately 87 million people in the United States live, work, or vacation in a tick-endemic area placing them at risk of contracting the disease.9 It occurs most commonly in the Northeast, mid-Atlantic, and upper-Midwest regions. Lyme disease bacteria are transmitted through the bite of infected Ixodes ticks. Typical symptoms include fever, headache, fatigue, and a characteristic skin rash called erythema migrans. If left untreated, infection can spread to joints, heart, and nervous system. Laboratory testing is helpful if used correctly and performed with FDA-cleared tests. Although many cases of Lyme disease can be treated successfully with antibiotics, diagnosis and treatment are often delayed or missed. Chronic Lyme is considered an Infection Associated Chronic Illness (IACI), and is a chronic, debilitating disease state characterized by joint and muscle pain, fatigue, and other symptoms.10
Citations 1Schiller ZA, et al. J Clin Invest. 2021 131(11):e144843. 2Wang Y, et al. J Infect Dis. 2016. 214(2):205-11. 3Marques AR, et al. Emerg Infect Dis. 2021. 27(8):2017-2024. 4Pritt BS, et al. Lancet Infect Dis. 2016. 6(5):556-564. 5 Nigrovic LE, et al. Epidemiol Infect. 2006. Aug 8;135(1):1-8. 6Comstedt P, et al. Vaccine. 2015 33(44):5982-8. 7Connaught’s (ImuLyme™) and SmithKline Beecham’s (LYMErix™) Lyme disease vaccines were withdrawn. Nigrovic LE, et al. Epidemiol Infect. 2007 135(1):1-8. 8Gomes-Solecki M, et. al. Clin Infect Dis. 2020 70(8):1768-1773. 9Kugeler KJ, et al. Emerg Infect Dis. 2021. 27(2):616-619. 10National Academies of Sciences, Engineering, and Medicine. 2025. Charting a Path Toward New Treatments for Lyme Infection-Associated Chronic Illnesses. Washington, DC: The National Academies Press. https://doi.org/10.17226/28578.
Tonix Pharmaceuticals Holding Corp. Tonix Pharmaceuticals* is a fully integrated, commercial-stage biotechnology company focused on central nervous system (CNS) and immunology treatments in areas of high unmet medical need. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8 mg) is the first new treatment for fibromyalgia in adults in more than 15 years. Tonix’s CNS commercial infrastructure supports its marketed products, including its acute migraine products, Zembrace® Symtouch® (sumatriptan injection 3 mg) and Tosymra® (sumatriptan nasal spray 10 mg). Tonix is investigating TONMYA in Phase 2 clinical trials to evaluate its potential in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of immunology programs, including TNX-4800, a Phase 2 ready long-acting human anti-Borrelia OspA monoclonal antibody (mAb) for the prevention of Lyme disease in the U.S., and TNX-1500, a Phase 2 ready third-generation CD154/CD40 ligand (CD40L) inhibitor for the prevention of kidney transplant rejection. In addition, Tonix is progressing TNX-2900 (intranasal potentiated oxytocin), which is Phase 2 ready for the treatment of Prader-Willi syndrome, a rare disease. To learn more, visit www.tonixpharma.com.
*Tonix’s product development candidates are investigational new drugs or biologics; their efficacy and safety have not been established and have not been approved for any indication.
Zembrace SymTouch and Tosymra are registered trademarks of Tonix Medicines. TONMYA is a registered trademark of Tonix Pharma Limited. All other marks are property of their respective owners.
Forward Looking Statements Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995 including those relating to the completion of the offering, the satisfaction of customary closing conditions, the intended use of proceeds from the offering and other statements that are predictive in nature. These statements may be identified by the use of forward-looking words such as “anticipate,” “believe,” “forecast,” “estimate,” “expect,” and “intend,” among others. There are a number of factors that could cause actual events to differ materially from those indicated by such forward-looking statements. These factors include, but are not limited to, risks related to the failure to successfully launch and commercialize TONMYA® and any of our approved products; risks related to the failure to obtain FDA clearances or approvals and noncompliance with FDA regulations; risks related to the timing and progress of clinical development of our product candidates; our need for additional financing; uncertainties of patent protection and litigation; uncertainties of government or third party payor reimbursement; limited research and development efforts and dependence upon third parties; and substantial competition. As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. Tonix does not undertake an obligation to update or revise any forward-looking statement. Investors should read the risk factors set in the Company’s Annual Report on Form 10-K for the year ended December 31, 2025, as filed with the SEC on March 12, 2026, and periodic reports filed with the SEC on or after the date thereof. Tonix does not undertake an obligation to update or revise any forward-looking statement. All of Tonix’s forward-looking statements are expressly qualified by all such risk factors and other cautionary statements. The information set forth herein speaks only as of the date thereof.
Italian biopharmaceutical group Chiesi has agreed to acquire Nasdaq-listed KalVista Pharmaceuticals (KALV) for $27.00 per share in an all-cash deal valued at approximately $1.9 billion — the company’s largest acquisition in its 90-year history and a major bet on the rare disease space.
For small-cap investors, this is the kind of exit story worth paying attention to. KalVista entered 2026 trading around $15, carried a market cap under $1 billion, and was viewed by many on the Street as an under-the-radar rare disease play. Today, shareholders are looking at a 36% premium to the stock’s 30-day volume-weighted average price — a meaningful payday for those who did their homework on this one early.
What Chiesi Is Really Buying
At the center of the deal is EKTERLY (sebetralstat), a novel plasma kallikrein inhibitor and the first-ever oral, on-demand treatment for hereditary angioedema (HAE) — a rare and potentially life-threatening genetic condition that causes unpredictable episodes of severe tissue swelling. Prior to sebetralstat, patients were largely dependent on injectable therapies to treat attacks, making the oral option a meaningful advancement in disease management.
Since its U.S. launch in July 2025, EKTERLY generated $49 million in global net product revenue through year-end — a strong showing for a first-year rare disease drug in a market that typically takes time to penetrate. The drug is already approved in the U.S., EU, UK, Japan, and several other markets, with a pediatric NDA filing targeting children aged 2-11 planned for Q3 2026.
Strategic Fit and Commercial Ambition
For Chiesi, this isn’t simply a product acquisition — it’s infrastructure. The Italian company has been methodically building out its rare disease unit, Chiesi Global Rare Diseases, and EKTERLY fits squarely into its rare immunology focus. More practically, the deal significantly expands Chiesi’s commercial footprint in the United States, where rare disease market penetration requires both strong science and boots on the ground.
Chiesi has pegged sebetralstat as a meaningful contributor toward its 2030 strategic revenue target of €6 billion — a signal that this asset is expected to carry real commercial weight within the combined organization, not just serve as a pipeline placeholder.
Deal Terms and Timeline
Chiesi will launch a tender offer for all outstanding KALV shares at $27.00 per share. The transaction carries no financing condition and is expected to close in Q3 2026, pending regulatory approvals and at least a majority of shares being tendered. Lazard is advising Chiesi while Centerview Partners is in KalVista’s corner.
The Bigger Picture
The KalVista deal is a reminder of what the small and microcap space consistently delivers — asymmetric outcomes. A company that spent years building a single, differentiated asset in a rare disease niche is now commanding nearly $2 billion from one of Europe’s more acquisitive biopharma groups. As rare disease M&A continues to accelerate driven by major players looking to diversify away from primary care blockbusters, investors with conviction in well-positioned small-cap biotechs may want to keep watching the HAE and broader rare immunology landscape for the next opportunity.
