Tag: Biotech

Release – Cadrenal Therapeutics Announces up to $8.8 Million Private Placement Priced At-The-Market Under Nasdaq Rules

Posted on by [email protected]

PONTE VEDRA, Fla., June 30, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD) (the “Company”), a biopharmaceutical company advancing late-stage novel therapies for life-threatening immune and thrombotic conditions, today announced that it has entered into a definitive agreement with a single healthcare-focused institutional investor for the issuance and sale of 960,000 shares of its common stock (or pre-funded warrants in lieu thereof), series C-1 warrants to purchase up to an aggregate of 960,000 shares of common stock and series C-2 warrants to purchase up to an aggregate of 960,000 shares of common stock, at a combined purchase price of $3.125 per share (or pre-funded warrant in lieu thereof) and accompanying warrants in a private placement priced at-the-market under Nasdaq rules.

H.C. Wainwright & Co. is acting as the exclusive placement agent for the offering.

The series C-1 warrants will have an exercise price of $3.00 per share, will be exercisable beginning on the effective date of stockholder approval of the issuance of the shares of common stock issuable upon exercise of the series C-1 warrants (the “Stockholder Approval Date”) and will expire five years after the later of (i) the Stockholder Approval Date and (ii) the effective date of a resale registration statement registering for resale all of the shares of common stock underlying the series C-1 warrants. The series C-2 warrants will have an exercise price of $3.00 per share, will be exercisable immediately upon issuance, and will expire twenty-four months after the effective date of a resale registration statement registering for resale all of the shares of common stock and the shares of common stock underlying the series C-2 warrants.

The aggregate gross proceeds to the Company from the offering are expected to be $3 million, before deducting placement agent fees and other offering expenses. The potential additional gross proceeds to the Company from the series C-1 warrants and the series C-2 warrants, if fully exercised on a cash basis, will be approximately $5.8 million. No assurance can be given that any of the warrants will be exercised, or that the Company will receive cash proceeds from the exercise of the warrants. The offering is expected to close on or about July 1, 2026, subject to the satisfaction of customary closing conditions. The Company intends to use the net proceeds from the offering for working capital purposes.

The securities described above were offered in a private placement under Section 4(a)(2) of the Securities Act of 1933, as amended (the “Act”) and Regulation D promulgated thereunder and, along with the shares of common stock underlying the warrants sold in the offering, have not been registered under the Act or applicable state securities laws. Accordingly, such securities may not be offered or sold in the United States absent registration with the Securities and Exchange Commission (“SEC”) or an applicable exemption from such registration requirements. Pursuant to a registration rights agreement, the Company has agreed to file one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Cadrenal Therapeutics, Inc.

Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being investigated as a first-in-class 12-LOX inhibitor for heparin-induced thrombocytopenia (HIT), a deadly immune-mediated thrombotic disorder, and Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKI). 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, those with left ventricular assist devices, and potentially, those with Kawasaki disease (KD), an acute self-limited febrile illness that primarily affects children <5 years old, and the leading cause of acquired heart disease in developed countries.

Safe Harbor

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 the closing of the offering, the satisfaction of customary closing conditions related to the offering, the expected gross proceeds from the offering, the Company seeking stockholder approval, receipt of stockholder approval, the filing of one or more registration statements with the SEC covering the resale of the unregistered securities to be issued in the offering, the intended use of net proceeds from the offering, the potential exercise of the warrants for cash prior to their expiration and the Company’s receipt of potential proceeds therefrom, net proceeds anticipated to extend the Company’s cash runway into first quarter of 2027; and the Company’s cash runway anticipated to be extended into second half of 2027 to advance partnering opportunities for tecarfarin in Kawasaki Disease (potential rare pediatric disease designation) and CAD-1005 in CSA-AKI and HIT.

Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the ability to close the offering, the ability of the Company to obtain stockholder approval, the ability of the Company to advance partnering opportunities for tecarfarin in Kawasaki Disease (potential rare pediatric disease designation) and CAD-1005 in CSA-AKI and HIT; the ability to raise sufficient capital to continue progress of its product candidates; the ability to derive the results needed for an NDA submission; 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, visit https://www.cadrenal.com/ and connect with the Company on LinkedIn.

For more information, please contact:

Lytham Partners, LLC, Robert Blum, Managing Partner, 602-889-9700, [email protected]

Unicycive Therapeutics (UNCY) – Delay in Manufacturing Inspection Leads To Complete Response Letter (CRL)

Posted on by [email protected]


Wednesday, July 01, 2026

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.

We Now Expect Product Approval Around YE2026. Unicycive announced it has received a CRL (Complete Response Letter) stating that the NDA for OLC (oxylanthanum carbonate), its phosphate binder for patients on dialysis, has not been approved. The reason stated is that the FDA has not conducted its required inspection of the third-party manufacturing vendor. This step is expected to be completed during the summer, allowing for an NDA resubmission and approval near YE2026.

All Other Steps In The NDA Review Appear To Be Complete. The FDA inspection appears to have been the only remaining step for OLC approval. After a meeting with the FDA, steps to resolve manufacturing issues with the third-party vendor were identified, addressed, and the plant readied for inspection. The review of clinical efficacy and safety data was completed in 2025, with no new issues raised. Product labeling and packaging discussions have been ongoing, typically the last step before approval.


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NeuroSense Therapeutics Ltd. (NRSN) – Phase 2 RoAD Trial Findings In Alzheimer’s Disease Reported

Posted on by [email protected]


Thursday, June 25, 2026

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.

New Data Supports Mechanism of Action. NeuroSense reported data from its Phase 2 RoAD trial testing PrimeC in Alzheimer’s Disease (AD). The study was designed to evaluate safety, efficacy, and disease-associated biomarkers. The results showed changes consistent with the prevention of degeneration and neuronal cell death. We believe these data support PrimeC’s mechanism and its benefits, providing proof of concept for further studies.

Study Design. The Phase 2 RoAD trial was a placebo-controlled study testing PrimeC in Alzheimer’s disease. The trial enrolled eight patients who were randomized to receive PrimeC or placebo for 52 weeks. Three participants completed a 12-month follow-up period, with CSF and plasma samples evaluated at three timepoints.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Boundless Bio Pivots From Cancer to a Rare Genetic Disease in a Reverse Merger With Serapha Bio

Posted on by [email protected]

In a transaction that illustrates how struggling clinical-stage biotechs are increasingly being repurposed as vehicles for more promising assets, Boundless Bio (Nasdaq: BOLD) announced Tuesday it has entered into a definitive all-stock merger agreement with privately held Serapha Bio. The deal will see Serapha combine with Boundless Bio and effectively take over the public company, pivoting the combined entity away from Boundless’s cancer research and toward Serapha’s gene editing therapy for a serious inherited disease. Boundless Bio shares surged approximately 75% on the news to around $2.50.

Upon completion, the combined company will operate under the name Serapha Bio and is expected to trade on Nasdaq under the new ticker symbol “AATD” — a direct reference to the disease its lead program targets.

The Structure of the Deal

This is a reverse merger, a structure in which a private company merges into a public one to gain a stock market listing without conducting a traditional IPO. The ownership split makes the dynamic clear: pre-merger Boundless Bio stockholders are expected to own approximately 3.7% of the combined company, while pre-merger Serapha stockholders — including investors participating in the concurrent financing — will own approximately 96.3%.

Two features make this transaction particularly notable for shareholders. First, alongside the merger, Serapha is raising $230 million in a concurrent private placement co-led by RTW Investments and RA Capital Management, with participation from a syndicate of top healthcare investors and mutual funds. That level of institutional backing provides the combined company with substantial capital to advance its lead program through clinical development. Second, prior to closing, Boundless Bio expects to declare a cash dividend to its pre-merger stockholders to distribute excess net cash, currently estimated at approximately $44 million to $48 million. That dividend, combined with the stock’s jump, gives existing Boundless holders both an immediate cash return and continued exposure to the new program.

What Serapha Is Actually Developing

Serapha’s lead program, SERP-01, is an investigational in vivo base editing therapy targeting Alpha-1 Antitrypsin Deficiency, a serious inherited genetic disorder that can cause progressive lung and liver disease. The therapy specifically targets the SERPINA1 E342K mutation — known as the PiZZ genotype — which is the most common cause of severe AATD. The company has reported proof-of-concept data demonstrating restoration of serum AAT to normal levels, an encouraging early signal for a disease that currently has limited treatment options.

The asset has an international development backstory. Serapha licensed SERP-01, developed as YOLT-202 in Greater China, from YolTech Therapeutics in June 2026 in exchange for an upfront cash payment and a minority equity stake. Under the agreement, YolTech is eligible to receive regulatory and commercial milestones totaling over $2 billion plus tiered royalties, while retaining development and commercialization rights for the Greater China territory. YolTech has been enrolling AATD patients in an investigator-initiated trial at Renji Hospital in Shanghai.

The Small Cap Biotech Read

For investors tracking the small and microcap biotech space, this transaction reflects a pattern that has become increasingly common in 2026. Clinical-stage companies whose original programs have stalled or been deprioritized are valuable to private biotechs precisely because of what they already possess: a Nasdaq listing, a cash balance, and an existing shareholder base. Rather than navigate the lengthy and uncertain IPO process, a promising private company like Serapha can access public markets, raise institutional capital, and advance its lead asset all in a single coordinated transaction.

The base editing space in particular has attracted significant investor attention as next-generation gene editing technologies move from theoretical promise toward clinical proof of concept. With $230 million in fresh capital, validated early data, and a clear regulatory target in a serious genetic disease, the newly formed Serapha Bio enters the public market positioned to advance one of the more closely watched programs in the in vivo base editing field. The transaction is expected to close in the fourth quarter of 2026, subject to stockholder approval and customary closing conditions.

Eledon Pharmaceuticals (ELDN) – Eledon Presents Data Update From Phase 2 Trial With Clinical Trial Plans

Posted on by [email protected]


Tuesday, June 23, 2026

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.

Long-Term Outcomes Favor Tegoprubart. Eledon presented long-term data from its Phase 2 BESTOW trial at the American Transplantation Congress (ATC). The BESTOW trial tested tegoprubart as part of the immunosuppressive regimen for patients receiving kidney transplants. Data from the Open Label Extension study showed consistent improvements in kidney function and a reduction in rejection episodes. Importantly, the side effect profile continues to show significant  improvements over tacrolimus, the standard of care.

Trial Background. The Phase 2 BESTOW trial was a double-blind study testing tegoprubart as an immunosuppressive after kidney transplantation. An active comparator arm included tacrolimus as an immunosuppressive. The primary endpoint of the trial was eGFR (estimated Glomerular Filtration Rate) and BPAR (Biopsy Proven Acute Rejection) episodes. Following the completion of the 12-month course of treatment, patients were given the option to continue in an Open Label Extension (OLE) study.


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*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

MAIA Biotechnology (MAIA) – Stream Of Clinical Milestones Reported In June Shows Ateganosine Progress

Posted on by [email protected]


Monday, June 22, 2026

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.

Strong Progress Reported In Both Clinical Trials. MAIA currently has two clinical trials in progress. Both trials are testing the combination of ateganosine (aka THIO) and the checkpoint inhibitor cemiplimab (Libtayo, from Regeneron) as a third-line treatment for advanced non-small cell lung cancer (NSCLC). During June, MAIA opened two additional clinical sites for Phase 2 and reported strong enrollment progress in Phase 3.

Initial Phase 3 Enrollment Rate Has Been Strong. The Phase 3 THIO-104 trial began treating patients in early December. Within six months, the company opened 34 clinical sites and began treating 29 patients across 6 countries (select European countries, Turkey, Taiwan, and Georgia). THIO-104 has a target enrollment of 300 patients that will be randomized 1:1 to receive either the combination regimen or “investigator’s choice” of standard chemotherapies.


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This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Cadrenal Therapeutics (CVKD) – Phase 2a Trial For New CAD-1005 Indication Announced

Posted on by [email protected]


Tuesday, June 16, 2026

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.

New Trial Planned In Cardiac Surgery-Associated Acute Kidney Injury. Cadrenal announced plans for a Phase 2a trial in Cardiac Surgery-Associated Acute Kidney Injury (CSA-AKD). The trial is designed to demonstrate proof of concept and generate data on safety, measures of renal injury, and biomarkers of the 12-LOX inflammatory pathway. This would provide data on CAD-1005 in CSA-AKD as well as its other indications in development.

Trial Design. The trial is expected to test CAD-1005 using its intravenous formulation in Intensive Care Unit (ICU) settings later in FY2026. This data could be used in several development indications for CAS-1005, including the HIT (heparin-induced thrombocytopenia) indication, which is planned to begin Phase 3 later in FY2026-27. At this time, Cadrenal plans to use the data to form a development partnership for the CSA-AKI indication.


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Equity Research is available at no cost to Registered users of Channelchek. Not a Member? Click ‘Join’ to join the Channelchek Community. There is no cost to register, and we never collect credit card information.

This Company Sponsored Research is provided by Noble Capital Markets, Inc., a FINRA and S.E.C. registered broker-dealer (B/D).

*Analyst certification and important disclosures included in the full report. NOTE: investment decisions should not be based upon the content of this research summary. Proper due diligence is required before making any investment decision. 

Release – MAIA Biotechnology Activates and Opens Enrollment at Second U.S. Clinical Site for International Phase 2 THIO-101 Expansion Trial

Posted on by [email protected]

June 10, 2026 9:15am EDT

Additional data from MAIA’s THIO-101 expansion may further support an accelerated approval filing with the FDA

Potential breakthrough therapy holds substantial commercial opportunity in a projected $70 billion global non-small cell lung cancer market by 20301

CHICAGO, June 10, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that it has activated the second U.S. clinical site in its Phase 2 THIO-101 expansion trial at Central Alabama Research in Homewood, Alabama. The expansion part of THIO-101 evaluates MAIA’s lead investigational therapy, ateganosine, a dual-action molecule incorporating telomere targeting and immunogenicity, as a third-line (3L) treatment for non-small cell lung cancer (NSCLC) in patients who have previously failed treatment with checkpoint inhibitors (CPIs) and chemotherapy.

Parts A and B of the Phase 2 THIO-101 Phase 2 trial provided key inputs for MAIA’s market strategy by identifying optimal dosing for a well-defined patient population. The THIO-101 expansion trial is ongoing in Europe and Asia with 44 active sites in 6 countries along with 2 in the U.S. The additional data from the trial’s expansion may further support an accelerated approval filing with the FDA.

“Adding our second U.S. site reflects strong execution of our clinical strategy and continued momentum in the expansion of the THIO-101 trial,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “Broadening our site footprint enables more efficient patient enrollment as we advance the program under the FDA Fast Track designation and work toward upcoming interim data milestones.”

David J. Mooney, M.D., oncology physician at Central Alabama Research and principal investigator for THIO-101 in Alabama commented, “We look forward to bringing ateganosine treatment to our cancer center. There’s a large regional patient pool across the Southeast, including underserved and rural populations, that can greatly benefit from a novel therapy in this hard-to-treat NSCLC setting with very limited treatment options.”

In parallel with the Phase 2 clinical trial, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 patients. MAIA has received regulatory approval to screen patients in Taiwan, Turkey, select European Medicines Agency (EMA) countries, and Georgia.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.

Forward Looking Statements

MAIA cautions that all statements, other than statements of historical facts contained in this press release, are forward-looking statements. Forward-looking statements are subject to known and unknown risks, uncertainties, and other factors that may cause our or our industry’s actual results, levels or activity, performance or achievements to be materially different from those anticipated by such statements. The use of words such as “may,” “might,” “will,” “should,” “could,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “project,” “intend,” “future,” “potential,” or “continue,” and other similar expressions are intended to identify forward looking statements. However, the absence of these words does not mean that statements are not forward-looking. For example, all statements we make regarding (i) the initiation, timing, cost, progress and results of our preclinical and clinical studies and our research and development programs, (ii) our ability to advance product candidates into, and successfully complete, clinical studies, (iii) the timing or likelihood of regulatory filings and approvals, (iv) our ability to develop, manufacture and commercialize our product candidates and to improve the manufacturing process, (v) the rate and degree of market acceptance of our product candidates, (vi) the size and growth potential of the markets for our product candidates and our ability to serve those markets, and (vii) our expectations regarding our ability to obtain and maintain intellectual property protection for our product candidates, are forward looking. All forward-looking statements are based on current estimates, assumptions and expectations by our management that, although we believe to be reasonable, are inherently uncertain. Any forward-looking statement expressing an expectation or belief as to future events is expressed in good faith and believed to be reasonable at the time such forward-looking statement is made. However, these statements are not guarantees of future events and are subject to risks and uncertainties and other factors beyond our control that may cause actual results to differ materially from those expressed in any forward-looking statement. Any forward-looking statement speaks only as of the date on which it was made. We undertake no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise, except as required by law. In this release, unless the context requires otherwise, “MAIA,” “Company,” “we,” “our,” and “us” refers to MAIA Biotechnology, Inc. and its subsidiaries.

Investor Relations Contact
+1 (872) 270-3518
[email protected]

GSK Pays $10.6 Billion for Nuvalent in Its Largest Acquisition in Over a Decade

Posted on by [email protected]

The biotech acquisition market just recorded one of its most significant transactions of 2026. GSK (LSE/NYSE: GSK) announced Tuesday it has entered into a definitive agreement to acquire Nuvalent Inc. (Nasdaq: NUVL), a Cambridge, Massachusetts-based clinical-stage biopharmaceutical company focused on precision oncology, for $10.6 billion in an all-cash tender offer at $124 per share. The price represents a 40% premium to Nuvalent’s last closing price and a 26% premium to its 30-day volume-weighted average price. Net of cash acquired, GSK’s aggregate investment is approximately $9.4 billion.

Nuvalent shares surged nearly 40% in premarket trading. GSK shares slipped approximately 1.5% in London as the market processed the scale of the commitment.

The deal marks GSK’s largest acquisition in more than a decade and the first major transaction under the leadership of new CEO Luke Miels, who took over from Emma Walmsley in January 2026. It signals a deliberate strategic pivot — GSK is moving aggressively into oncology as it confronts patent expiration pressures on established products, including its blockbuster shingles vaccine Shingrix, and seeks to close the gap with rival AstraZeneca, whose oncology sales accounted for 44% of total revenue last year.

What GSK Is Actually Buying

Founded in 2017, Nuvalent has built its pipeline around precisely targeted therapies for non-small cell lung cancer, one of the largest and most commercially significant oncology indications globally. Its two lead assets are zidesamtinib, a ROS1 inhibitor, and neladalkib, an ALK inhibitor — both of which have received FDA Breakthrough Therapy Designation and Orphan Drug Status and are currently under active FDA review.

FDA target decision dates are September 18, 2026 for zidesamtinib and November 27, 2026 for neladalkib. Subject to approval, both drugs are expected to launch before year-end 2026, with combined peak annual sales potential estimated at $3 billion to $4 billion. The pipeline also includes NVL-330, a potential best-in-class HER2 inhibitor currently in Phase I trials for HER2-altered non-small cell lung cancer, adding a third growth platform beyond the two near-term approvals.

GSK expects the acquisition to be accretive to sales and core operating profit in 2027 and accretive to core earnings per share in 2029, inclusive of synergies and pipeline reprioritization. The company plans to complement Nuvalent’s lung cancer platform with its own Ris-Rez B7-H3 antibody-drug conjugate, creating an integrated oncology franchise in one of the sector’s highest-priority therapeutic areas.

The Small Cap Biotech Signal

GSK paying $10.6 billion for a clinical-stage company with no approved products and no commercial revenue carries a specific and powerful message for small and microcap biotech investors. The premium reflects the value of FDA Breakthrough Therapy Designation, validated mechanism of action, late-stage regulatory visibility, and a clearly defined commercial opportunity in a large patient population.

The broader biotech M&A environment is accelerating. Patent cliffs across major pharmaceutical companies are creating urgency to acquire external innovation, and the pipeline of clinical-stage companies with validated oncology assets in the sub-$2 billion market cap range remains deep. When large pharma assigns a $10.6 billion value to a pre-revenue biotech, it resets the reference point for how the market values similar-stage assets across the sector.

Upon completion of the tender offer and merger, Nuvalent common stock will be delisted from Nasdaq.

Release – Eledon Announces Updated Data from Investigator-Initiated Islet Transplant Trial of Tegoprubart in Patients with Type 1 Diabetes (T1D) at UChicago Medicine

Posted on by [email protected]
Primary Logo

June 8, 2026

PDF Version

– All 12 patients in study (100%) achieved insulin independence, producing their own insulin and no longer requiring exogenous insulin therapy to manage their T1D

– All 12 patients also achieved an HbA1c below 6.5%, with a mean most recent HbA1c of approximately 5.4%, representing an approximately 2.6% average improvement in HbA1c from baseline

– No severe hypoglycemic episodes were reported post-transplant, compared with a history of recurrent severe hypoglycemic events prior to transplantation in all enrolled patients

IRVINE, Calif., June 08, 2026 (GLOBE NEWSWIRE) — Eledon Pharmaceuticals, Inc. (“Eledon”) (NASDAQ: ELDN) today announced updated results from an investigator-initiated trial evaluating tegoprubart, its investigational anti-CD40L antibody, as part of a calcineurin inhibitor-free immunosuppression regimen in patients with type 1 diabetes undergoing allogeneic islet cell transplantation at the University of Chicago Medicine Transplant Institute. The results were presented by trial investigator Piotr Witkowski, M.D., Ph.D., Director of the Pancreas and Islet Transplant Program at UChicago Medicine, at the American Diabetes Association 86th Scientific Sessions, taking place June 5-9, 2026, in New Orleans, Louisiana.

All patients treated in the study (n=12) showed rapid improvement in glycemic control following islet transplantation and treatment with tegoprubart, with stable islet graft function observed across the cohort over a median and maximum post-transplant follow-up period of 8 and 22 months, respectively. All 12 patients achieved insulin independence, meaning that they no longer needed chronic, exogenous insulin therapy to manage their T1D. Also, all patients demonstrated a most recent hemoglobin A1C (“HbA1c”) below the diabetic threshold of 6.5%, with a mean most recent HbA1c of approximately 5.4% across the cohort.

While all patients enrolled reported recurrent severe hypoglycemic events pre-transplant, no severe hypoglycemic episodes were reported following transplantation. Severe hypoglycemia is a serious complication of type 1 diabetes that may require emergency medical intervention and can cause loss of consciousness, seizures, injury, or death. Recurrent severe hypoglycemic episodes can significantly impact patients’ daily activities and quality of life.

Higher levels of post-transplant islet cell engraftment were observed with the tegoprubart-based immunosuppression regimen than in historical patients treated with a tacrolimus-based immunosuppression regimen at UChicago Medicine. There were no rejection episodes, and no patients developed de novo donor-specific HLA antibodies. Tegoprubart-based immunosuppression was generally well tolerated, with immunosuppression-related adverse events generally successfully treated by lowering the mycophenolic acid dose, if necessary. Additionally, no evidence of nephrotoxicity, hypertension or neurotoxicity, which are commonly associated with tacrolimus-based immunosuppression regimens, was observed. These findings further support the potential of CD40L blockade to enable effective islet graft protection while avoiding the toxicities of calcineurin inhibitors such as tacrolimus.

The investigator-initiated pilot study enrolled 12 adults with long-standing T1D undergoing allogeneic islet transplantation at UChicago Medicine with a median duration of diabetes of approximately 33 years and mean HbA1c of approximately 8.0% prior to transplantation. Participants received tegoprubart, as part of a calcineurin inhibitor-free immunosuppression regimen. Calcineurin inhibitors such as tacrolimus are commonly used to prevent transplant rejection but can be associated with kidney toxicity, hypertension, neurological side effects, and harm to insulin-producing islet cells, limiting their suitability for long-term use in patients with T1D receiving an islet cell transplant.

“T1D patients have been waiting decades for a potential functional cure, and it is exciting to see the progress being made in that direction through the emerging promise of tegoprubart,” said David-Alexandre C. Gros, M.D., Chief Executive Officer of Eledon. “For people who have difficulty managing T1D, a regimen that may protect an islet cell graft without the long-term burden associated with calcineurin inhibitors, the current standard of care, could be transformational. We are proud to support this important research effort led by Dr. Witkowski and the team at UChicago Medicine. We also look forward to working closely with the FDA towards our goal of receiving regulatory guidance on a path to market for tegoprubart in islet cell transplantation later this year.”

“Insulin independence without the burden of traditional immunosuppression has long been one of cell replacement therapy’s biggest goals,” said Aaron Kowalski, Ph.D., Chief Executive Officer of Breakthrough T1D. “Results like these show that this goal is becoming increasingly achievable. Breakthrough T1D is proud to fund this important study.”

This UChicago Medicine-initiated clinical trial is funded by Breakthrough T1D, with initial support from The Cure Alliance. Breakthrough T1D has also committed to fund a second study evaluating tegoprubart as part of a calcineurin inhibitor-free immunosuppression drug regimen to prevent islet transplant rejection in individuals with T1D and chronic kidney disease.

About Islet Transplantation for Type 1 Diabetes

Pancreatic islet transplantation is a minimally invasive procedure developed to provide blood glucose control for subjects with type 1 diabetes and minimize or eliminate dependence on insulin. During the procedure, pancreatic islets containing insulin-producing beta cells are isolated from the pancreas of a deceased organ donor and infused through a small catheter into the patient’s liver. The islet cells lodge in small blood vessels in the liver and release insulin. After the procedure, subjects remain on immunosuppression therapy to prevent transplant rejection.

About Eledon Pharmaceuticals and tegoprubart

Eledon Pharmaceuticals, Inc. is a clinical stage biotechnology company that is developing immune-modulating therapies for the management and treatment of life-threatening conditions. The Company’s lead investigational product is tegoprubart, an anti-CD40L antibody with high affinity for the CD40 Ligand, a well-validated biological target that has broad therapeutic potential. The central role of CD40L signaling in both adaptive and innate immune cell activation and function positions it as an attractive target for non-lymphocyte depleting, immunomodulatory therapeutic intervention. The Company is building upon a deep historical knowledge of anti-CD40 Ligand biology to conduct preclinical and clinical studies in kidney allograft transplantation, xenotransplantation, islet cell transplantation, liver allograft transplantation and amyotrophic lateral sclerosis (ALS). Eledon is headquartered in Irvine, California. For more information, please visit the Company’s website at www.eledon.com.

Follow Eledon Pharmaceuticals on social media: LinkedIn; X

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. Any statements about the company’s planned clinical trials, the development of product candidates, expected or future results of tegoprubart trials and its ability to prevent rejection in connection with islet cell transplantation, as well as other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “estimates,” “intends,” “predicts,” “projects,” “targets,” “looks forward,” “could,” “may,” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are inherently uncertain and are subject to numerous risks and uncertainties, including: risks relating to the safety and efficacy of our drug candidates; risks relating to clinical development timelines, including interactions with regulators and clinical sites, as well as patient enrollment; and risks relating to costs of clinical trials and the sufficiency of the company’s capital resources to fund planned clinical trials. Actual results may differ materially from those indicated by such forward-looking statements as a result of various factors. These risks and uncertainties, as well as other risks and uncertainties that could cause the company’s actual results to differ significantly from the forward-looking statements contained herein, are discussed in our quarterly 10-Q, annual 10-K, and other filings with the U.S. Securities and Exchange Commission, which can be found at www.sec.gov. Any forward-looking statements contained in this press release speak only as of the date hereof and not of any future date, and the company expressly disclaims any intent to update any forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contact:

Stephen Jasper
Gilmartin Group
(858) 525 2047
[email protected]

Media Contact:

Jenna Urban
CG Life
(212) 253 8881
[email protected]

Source: Eledon Pharmaceuticals

Release – Cocrystal Pharma Appoints James Sapirstein, Biopharma Industry Leader with Extensive Antiviral Development Experience, as Chief Executive Officer

Posted on by [email protected]

June 03, 2026

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BOTHELL, Wash., June 03, 2026 (GLOBE NEWSWIRE) — Cocrystal Pharma Inc. (Nasdaq: COCP) (“Cocrystal” or the “Company”), a clinical-stage biotechnology company developing novel therapeutics to meet the growing need for effective, safe antiviral treatments, has appointed James Sapirstein Chief Executive Officer, effective immediately. The Company also plans to appoint Mr. Sapirstein as a member of the Board of Directors. He has extensive pharmaceutical industry leadership and development experience. Mr. Sapirstein replaces Sam Lee and Jim Martin, who served as Co-Chief Executive Officers. Sam Lee will continue as President and transition to Chief Scientific Officer, and Jim Martin will continue as Chief Financial Officer.

“James brings the right experience in the biopharma business as we’re accelerating the advancement of multiple clinical programs,” said Roger Kornberg, Ph.D., Chairman of Cocrystal Pharma. “We have known him for many years, and our management team and board are appreciative of his decision to join us as Chief Executive Officer.”

Mr. Sapirstein commented, “Cocrystal’s pipeline comprises transformative antivirals developed using its structure based drug discovery platform. We are well positioned with the right technology and team to create meaningful benefits for patients as well as our shareholders. The potential to address the need for new antivirals is highly motivating for me with my product development and launch background.”

Mr. Sapirstein has participated in or led 23 product launches. He has also driven numerous business development transactions. Mr. Sapirstein was Chief Executive Officer of Contravir Pharmaceuticals, served as the founding Chief Executive Officer of Tobira Therapeutics, and as Executive Vice President, Metabolic and Endocrinology, for Serono Laboratories.

Earlier in his career, he held senior marketing and commercialization positions, at Gilead Sciences and director of international marketing of the infectious disease division at Bristol Myers Squibb.

Mr. Sapirstein is a member of several industry boards and previously served as Chairman of BioNJ as well as Biotechnology Innovation Organization board member for more than a decade. He is also a founding member of the board of advisors of the Miami Biotech Collective.

About Cocrystal Pharma’s Structure-Based Drug Discovery Platform

Cocrystal Pharma is leveraging its structure based drug discovery platform technology to design next generation antiviral candidates that precisely target viral replication mechanisms. By binding to highly conserved regions of viral enzymes, the Company’s compounds aim to maintain potency against mutating strains while minimizing off target effects, offering potentially safer, broad spectrum antiviral solutions. This approach streamlines candidate identification and optimization, enabling more rapid progression of promising therapies with robust resistance and safety profiles.

The Company’s platform provides a three dimensional structure of inhibitor complexes at near-atomic resolution, providing immediate insight to guide Structure Activity Relationships. This helps identify novel binding sites and enables a rapid turnaround of structural information through highly automated X-ray data processing and refinement. This technology permits the development of novel broad spectrum antivirals.

About Cocrystal Pharma

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 hepatitis C viruses. Cocrystal employs unique structure based technologies to create viable antiviral drugs. For more information, visit www.cocrystalpharma.com.

Release – Cadrenal Therapeutics to Showcase Phase 3-Ready CAD-1005 and Novel 12-LOX Platform at BIO International Convention 2026 Partnering Event

Posted on by [email protected]

PONTE VEDRA, Fla., June 03, 2026 (GLOBE NEWSWIRE) — Cadrenal Therapeutics, Inc. (Nasdaq: CVKD), a biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions, today announced its participation in the BIO International Convention 2026 Partnering Event (BIO 2026) taking place June 22-25, 2026, at the San Diego Convention Center.

The Company’s executive management team will host partnering meetings to discuss development and commercialization opportunities for its differentiated pipeline, headlined by CAD-1005, a Phase 3-ready 12-lipoxygenase (12-LOX) inhibitor being investigated for the treatment of patients with Heparin-Induced Thrombocytopenia (HIT), and tecarfarin, a late-stage oral Vitamin K antagonist (VKA) for being investigated for the treatment of patients with conditions for which current anticoagulation profiles are ineffective or suboptimal.

“BIO 2026 comes at a pivotal moment for Cadrenal as we prepare to initiate our Phase 3 registration trial for CAD-1005,” said Quang X. Pham, Chief Executive Officer of Cadrenal Therapeutics. “With Orphan Drug and Fast Track designations from the FDA, we believe we are uniquely positioned to address the significant unmet need in HIT, a condition where no new therapies have been approved in over two decades. We look forward to engaging with potential partners who share our vision of the potential to bring this breakthrough mechanism to patients.”

Highlighting CAD-1005: A Potential First-in-Class Solution for HIT
At the forefront of Cadrenal’s portfolio is CAD-1005, the only selective 12-LOX inhibitor known to us to be currently in clinical development. CAD-1005 is being investigated to target the root cause of HIT-a severe, immune-mediated reaction to heparin that causes life-threatening blood clots and low platelet counts. Unlike current therapies that only reduce the risk of thrombotic complications, CAD-1005 is being investigated to interrupt the immune signaling feedback loop that drives the development and persistence of HIT.

The Company recently completed an End-of-Phase 2 (EOP2) meeting with the FDA, which provided guidance on the registration path for a single pivotal Phase 3 trial. This follows Phase 2 data demonstrating that CAD-1005 could reduce thrombotic events in patients with HIT.

Unlocking the Potential of the 12-LOX Platform
Beyond HIT, Cadrenal is leveraging the BIO 2026 partnering forum to explore broader applications for its proprietary 12-LOX inhibitor platform. Emerging research indicates that 12-LOX may play a central role in inflammatory signaling across high-impact disease areas, including atherosclerosis, microvascular thrombosis, and metabolic conditions such as diabetes and obesity. Additionally, 12-LOX is a potential target for therapy and prevention of cancer.

The Company’s platform represents a novel approach to modulating inflammation without the broader systemic suppression associated with traditional anti-inflammatory agents. Cadrenal aims to identify strategic collaborations to accelerate the development of its second-generation oral 12-LOX inhibitors (CAD-2000) for these chronic, large-market indications.

Tecarfarin: A Potentially Superior Anticoagulant for Complex Cases
Cadrenal will also present opportunities for tecarfarin, its late-stage oral anticoagulant. Tecarfarin is being designed with the goal of being uniquely metabolized in ways that avoid the drug-drug interactions and renal clearance issues common with warfarin and direct oral anticoagulants (DOACs). Tecarfarin has already received FDA Orphan Drug and Fast Track designations for two specific high-risk populations – patients with End-Stage Renal Disease (ESRD) and Atrial Fibrillation (AFib), and patients with implanted mechanical circulatory support devices, including Left Ventricular Assist Devices (LVADs).

About Cadrenal Therapeutics, Inc.
Cadrenal Therapeutics, Inc. is a late-stage biopharmaceutical company advancing novel therapies for life-threatening immune and thrombotic conditions. Its lead program, CAD-1005, is being researched as 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, as well as 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 those with left ventricular assist devices, and frunexian, a parenteral Factor XIa inhibitor intended for use in acute hospital settings.

Release – MAIA Biotechnology Receives FDA Clearance to Open U.S. Enrollment in Ongoing Phase 2 THIO-101 Trial Expansion

Posted on by [email protected]

June 03, 2026 9:45am EDT

Additional data from THIO-101 trial expansion studies may further support a potential Accelerated Approval filing with FDA

FDA-cleared IND updates detail latest efficacy data and enriched manufacturing protocols

CHICAGO, June 03, 2026 (GLOBE NEWSWIRE) — MAIA Biotechnology, Inc. (NYSE American: MAIA) (“MAIA”, the “Company”), a clinical-stage biopharmaceutical company focused on developing targeted immunotherapies for cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared an amendment to update its investigational new drug (IND) application which enables MAIA to open U.S. enrollment for the expansion of the Phase 2 THIO-101 trial of its lead candidate, ateganosine, as a treatment for advanced non-small cell lung cancer (NSCLC). Ateganosine is a novel dual mechanism of action drug candidate incorporating telomere targeting and immunogenicity. Ateganosine sequenced with a monoclonal antibody checkpoint inhibitor is being evaluated as a therapy for patients in ongoing Phase 2 and Phase 3 clinical trials.

MAIA obtained FDA clearance of its updated IND highlighting MAIA’s improved efficiencies to its manufacturing capabilities, including new manufacturers, formulation and storage conditions for ateganosine, and MAIA is now cleared to enroll patients in the U.S. for the expansion of the Phase 2 THIO-101 study of patients receiving advanced third-line (3L) NSCLC treatment. In addition to the U.S., the THIO-101 study is ongoing at 44 clinical sites in six countries. MAIA recently activated its first U.S. clinical site at Summit Medical Group in New Jersey.

In July 2025, the FDA granted Fast Track designation for ateganosine for the treatment of NSCLC. This designation allows for more frequent FDA communication, potential rolling review, and eligibility for Accelerated Approval and Priority Review. The additional data from the expansion studies may further support a filing for FDA Accelerated Approval.

“Up to five U.S. clinical sites are planned for THIO-101 Parts C and D this year, and we expect to activate a second U.S. site in the coming weeks,” said Vlad Vitoc, M.D., Founder and Chief Executive Officer of MAIA. “To date, data has shown overall survival (OS) beyond two years for eight patients treated with ateganosine in Parts A and B of THIO-101. We believe this bodes well for Parts C and D evaluations which are specific to third-line treatment care only, where the unmet need for improved clinical outcomes is most urgent.”

K. Robinson Lewis, Senior Vice President and Head of Regulatory and Quality for MAIA, commented, “We are excited about the prospects for our U.S. trials following FDA clearance of our amended IND. The unmet need for effective third-line NSCLC treatments is widespread in the U.S. Based on strong clinical data documented so far, we are confident in the potential of our therapy to address this significant and substantially underserved patient population.”

In parallel with THIO-101, MAIA is actively screening and enrolling patients in a pivotal Phase 3 clinical trial, THIO-104, designed to assess overall survival for ateganosine sequenced with a CPI compared to investigator’s choice of chemotherapy in a 1:1 randomization of up to 300 third-line NSCLC patients.

About Ateganosine

Ateganosine (THIO, 6-thio-dG or 6-thio-2’-deoxyguanosine) is a first-in-class investigational telomere-targeting agent currently in clinical development to evaluate its activity in non-small cell lung cancer (NSCLC). Telomeres, along with the enzyme telomerase, play a fundamental role in the survival of cancer cells and their resistance to current therapies. The modified nucleotide 6-thio-2’-deoxyguanosine induces telomerase-dependent telomeric DNA modification, DNA damage responses, and selective cancer cell death. Ateganosine-damaged telomeric fragments accumulate in cytosolic micronuclei and activates both innate (cGAS/STING) and adaptive (T-cell) immune responses. The sequential treatment of ateganosine followed by PD-(L)1 inhibitors resulted in profound and persistent tumor regression in advanced, in vivo cancer models by induction of cancer type–specific immune memory. Ateganosine is presently developed as a second or later line of treatment for NSCLC for patients that have progressed beyond the standard-of-care regimen of existing checkpoint inhibitors.

About THIO-101 Phase 2 Clinical Trial

THIO-101 is a multicenter, open-label, dose finding Phase 2 clinical trial. It is the first trial designed to evaluate ateganosine’s anti-tumor activity when followed by PD-(L)1 inhibition. The trial is testing the hypothesis that low doses of ateganosine administered prior to cemiplimab (Libtayo®) will enhance and prolong immune response in patients with advanced NSCLC who previously did not respond or developed resistance and progressed after first-line treatment regimen containing another checkpoint inhibitor. The trial design has two primary objectives: (1) to evaluate the safety and tolerability of ateganosine administered as an anticancer compound and a priming immune activator (2) to assess the clinical efficacy of ateganosine using Overall Response Rate (ORR) as the primary clinical endpoint. The expansion of the study will assess overall response rates (ORR) in advanced NSCLC patients receiving third line (3L) therapy who were resistant to previous checkpoint inhibitor treatments (CPI) and chemotherapy. Treatment with ateganosine followed by cemiplimab (Libtayo®) has shown an acceptable safety profile to date in a heavily pre-treated population. For more information on this Phase II trial, please visit ClinicalTrials.gov using the identifier NCT05208944.

About MAIA Biotechnology, Inc.

MAIA is a targeted therapy, immuno-oncology company focused on the development and commercialization of potential first-in-class drugs with novel mechanisms of action that are intended to meaningfully improve and extend the lives of people with cancer. Our lead program is ateganosine (THIO), a potential first-in-class cancer telomere targeting agent in clinical development for the treatment of NSCLC patients with telomerase-positive cancer cells. For more information, please visit www.maiabiotech.com.