Category: Health

Unicycive Therapeutics (UNCY) – NDA Resubmission Accepted For FDA Review

Posted on by [email protected]


Thursday, October 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.

OLC Resubmission Given March 25, 2027 PDUFA Date. Unicycive announced that the FDA has accepted its NDA (New Drug Application) resubmission for OLC (oxylanthanum carbonate) for review. This follows the 30-day period after resubmission in which the FDA determined that it was sufficiently complete for review. The application received a PDUFA (Prescription Drug User Fee Act) date of March 25, 2027. This is the date the FDA must respond to the application by statute and aligns with the TDAPA program deadlines.

The NDA Contains Data From A New Manufacturing Partner. As we had expected, the resubmission was classified as Class 2 and received a six-month review. The CMC (Chemistry, Manufacturing, and Controls) section includes product manufacturing data from a new third-party manufacturing partner. The FDA inspected this manufacturer’s plant in March 2024 and gave a “No Action Indicated” status, the equivalent of a passing grade.


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Release – Unicycive Therapeutics Announces FDA Acceptance of Oxylanthanum Carbonate New Drug Application Resubmission and PDUFA Date of March 25, 2027

Posted on by [email protected]

October 21, 2026 7:05am EDT

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MOUNTAIN VIEW, Calif., Oct. 21, 2026 (GLOBE NEWSWIRE) — Unicycive Therapeutics, Inc. (“Unicycive” or the “Company”) (Nasdaq: UNCY), a clinical-stage biotechnology company developing therapies for patients with kidney disease, today announced that the U.S. Food and Drug Administration (FDA) has accepted the resubmission of its New Drug Application (NDA) for oxylanthanum carbonate (OLC), the Company’s investigational oral phosphate binder for the treatment of hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. The NDA was resubmitted following a Complete Response Letter (CRL) received in June 2026. The FDA has deemed the OLC resubmission a Class II with a six-month review period from the resubmission date, and set a Prescription Drug User Fee Act (PDUFA) target action date of March 25, 2027.

“We are pleased that the FDA has accepted the resubmission of our NDA for OLC and assigned a PDUFA date,” said Shalabh Gupta, M.D., Chief Executive Officer of Unicycive. “This resubmission includes CMC data from a new third-party drug product manufacturing vendor. The new vendor’s facility was last inspected by the FDA in March 2024 and received ‘No Action Indicated’ status. We hope to continue working with the FDA toward potential approval of this important medication to patients with CKD on dialysis who need additional treatment options for managing hyperphosphatemia.”

The Company does not know whether the FDA will decide to conduct a pre-approval inspection of the new third-party DP vendor. Additionally, if the original third-party manufacturing vendor is inspected in the near term and finds that its facility complies with current Good Manufacturing Practice (cGMP), the Company plans to seek FDA alignment on a shorter approval timeline.

The Company resubmitted the NDA following the second CRL, which cited deficiencies previously identified at the original third-party manufacturer of the drug product, which the FDA had not been able to re-inspect during the prior submission review.

The timing and outcome of any FDA inspection of the original third-party vendor will be determined solely by the FDA.

The NDA is supported by data from three clinical studies (a Phase 1 study in healthy volunteers, a bioequivalence study in healthy volunteers, and a tolerability study of OLC in CKD patients on dialysis), multiple preclinical studies, as well as CMC data. The FDA did not raise any concerns regarding OLC’s preclinical or clinical data, including safety data, included in the original NDA submission.

About Oxylanthanum Carbonate
OLC is an investigational oral phosphate binder that leverages proprietary nanoparticle technology to deliver high phosphate binding potency, reducing the number and size of pills that patients must take to treat hyperphosphatemia in patients with chronic kidney disease (CKD) on dialysis. Its potential best-in-class profile may have meaningful patient adherence benefits over currently available treatment options as it requires a lower pill burden. Unicycive is seeking FDA approval of OLC via the 505(b)(2) regulatory pathway. OLC is protected by a strong global patent portfolio including issued patents on composition of matter with exclusivity until 2031, and with the potential for patent term extension until 2035.

About Hyperphosphatemia
Hyperphosphatemia is a serious medical condition that occurs in nearly all patients with End Stage Renal Disease (ESRD). Annually there are over 450,000 individuals in the U.S. that require medication to control their phosphate levels.1 Uncontrolled hyperphosphatemia is strongly associated with increased death and hospitalization for CKD patients on dialysis. Treatment of hyperphosphatemia is aimed at lowering serum phosphate levels via two means: (1) restricting dietary phosphorus intake; and (2) using, on a daily basis, and with each meal, oral phosphate binding drugs that facilitate fecal elimination of dietary phosphate rather than its absorption from the gastrointestinal tract into the bloodstream.

1Flythe JE. Dialysis-Past, Present, and Future: A Kidney360 Perspectives Series. Kidney360. 2023 May 1;4(5):567-568. doi: 10.34067/KID.0000000000000145.

About Unicycive Therapeutics
Unicycive Therapeutics is a biotechnology company developing novel treatments for kidney diseases. Unicycive’s lead investigational treatment is oxylanthanum carbonate, a novel phosphate binding agent for the treatment of hyperphosphatemia in patients with chronic kidney disease who are on dialysis. Unicycive’s second investigational treatment UNI-494 is intended for the treatment of conditions related to acute kidney injury. It has been granted orphan drug designation (ODD) by the FDA for the prevention of Delayed Graft Function (DGF) in kidney transplant patients and has completed a Phase 1 dose-ranging safety study in healthy volunteers. For more information, please visit Unicycive.com and follow us on LinkedIn and X.

Forward-looking statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Unicycive’s expectations, strategy, plans or intentions. These forward-looking statements are based on Unicycive’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; Unicycive’s clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidates; Unicycive’s dependence on third parties for manufacturing; the possibility that FDA may require inspection of any vendor prior to approval, which could delay or prevent approval of its NDA; the risk that the inspection of the original or new third-party manufacturing vendor may not occur within a timeframe that benefits its regulatory timeline, or may result in adverse findings; risks related to business interruptions, which could seriously harm its financial condition and increase its costs and expenses; dependence on key personnel; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; market acceptance of its products; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties related to market conditions and other factors described more fully in the section entitled ‘Risk Factors’ in Unicycive’s Annual Report on Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. Any forward-looking statements contained in this press release speak only as of the date hereof, and Unicycive specifically disclaims any obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contacts:
Kevin Gardner
LifeSci Advisors
[email protected]

Media Contact:
Unicycive Therapeutics
[email protected] 

SOURCE: Unicycive Therapeutics, Inc.

Release – BODi Launches INSANITY “Liquid Shock” Energy Drink Designed For Sharper Focus, Improved Reaction Time, Physical Performance and a Huge Jolt of Energy

Posted on by [email protected]

October 21, 2026

Formulated to help unlock extreme mental and physical performance, taking you from fatigued to a colossal jolt of energy with sharper focus, zero sugar and just five calories per can

EL SEGUNDO, Calif.–(BUSINESS WIRE)– BODi (NASDAQ: BODI), the proactive wellness company delivering nutrition, supplements and proven fitness programs that help people take control of their health inside and out, today announced the launch of INSANITY Liquid Shock Energy Drink, a zero-sugar, ready-to-drink energy beverage designed to fuel demanding days when ordinary energy isn’t enough. From intense workouts to extreme challenges and long shifts, INSANITY Liquid Shock Energy Drink delivers sustained energy and sharper focus when it matters most.

Formulated to help unlock extreme mental and physical performance, INSANITY Liquid Shock Energy Drinks take you from fatigued to a colossal jolt of energy with sharper focus, zero sugar and just five calories per can.

Inspired by the unrivaled intensity of BODi’s iconic INSANITY training series that millions of users have done over the last 17 years, this drink brings that same relentless intensity to every sip. INSANITY Liquid Shock Energy combines 300 mg of caffeine with TeaCrine® and Dynamine® in a triple-energy formula leveraging these plant-derived stimulant alkaloids for energy and focus. The result is a powerful energy experience that also features a blend of nootropic and performance ingredients designed to support sharper focus, faster reaction time and physical performance, delivering a major jolt of sustained energy.

“Our INSANITY fitness programs challenge people to achieve extraordinary physical and mental results,” said Carl Daikeler, Co-Founder and CEO of BODi. “We wanted an energy drink to match that next-level intensity, and this new INSANITY Liquid Shock Energy Drink delivers. Formulated to go far beyond caffeine alone and other energy drinks, INSANITY Liquid Shock provides an incredible range of performance benefits in a single serve can. We’ve taken the essence of our world-famous INSANITY fitness programs and formulated a powerful energy drink designed for high-intensity achievers, athletes, students, and gamers.”

Five Benefits. One Can. Four Flavors.

INSANITY Liquid Shock Energy Drink goes beyond energy alone, combining caffeine, nootropic and performance ingredients to support the demands of the body and mind.

Available in four unhinged flavors, including Nuclear Sherbet, Off Your Rocket, Radioactive Sour Apple, and Sourmelon Panic, the INSANITY Liquid Shock Energy Drink delivers:

  • A Colossal Jolt: Triple INSANITY energy – 300 mg of caffeine combined with TeaCrine ® and Dynamine ®.
  • Sharper Focus: Alpha-GPC, L-Tyrosine and caffeine to support sharper focus.
  • Reaction Time Support: A nootropic-focused formula to support mental sharpness and response.
  • Physical Performance: L-Citrulline, Betaine, Taurine and caffeine to support physical output.
  • Zero Sugar: Just five calories per can.

Expanding INSANITY and BODi’s Performance Nutrition Portfolio

On November 12, BODi will further expand the INSANITY brand into performance nutrition with the launch of INSANITY Pre-Workout Powder, timed to coincide with the debut of INSANITY: Unhinged, the all-new fitness program featuring three-time HYROX World Champion Hunter McIntyre, launching exclusively on BODi.

Featuring 360 mg of caffeine, TeaCrine®, Dynamine® and performance-focused ingredients, INSANITY Pre-Workout Powder is designed to support energy, endurance, focus, strength and pump for those who push to their limits and still wake up hungry for more.

The INSANITY Liquid Shock Energy Drink and INSANITY Pre-Workout Powder extend the brand into performance nutrition, supporting BODi’s broader portfolio alongside Shakeology, the P90X Supplement System and P90X Energy Drinks.

INSANITY Liquid Shock Energy is available now on BODi.com in a 12-pack case for $29.99which comes to just $2.50 per can. For a limited time, anyone who buys one case can get a second case 50% off. The product will soon be available on Amazon and at other retailers.

Together, these launches reflect BODi’s continued focus on nutrition and performance, extending its iconic fitness franchises into complementary products that support consumers beyond the workout.

To learn more and discover BODi’s entire performance nutrition portfolio, go to: BODi.com.

About BODi and The Beachbody Company

BODi is a proactive wellness company delivering nutrition, supplements, and proven fitness programs that help people take control of their health inside and out. With nearly three decades of experience, BODi, formerly Beachbody, has evolved from a leader in home fitness into a comprehensive health and fitness ecosystem designed to help people achieve their goals and lead healthier, more fulfilling lives. Anchored by science-backed nutrition solutions like Shakeology and supported by its portfolio of proven fitness and habit-building programs, including P90X and INSANITY, BODi is creating a more accessible and effective path to long-term health.

Since its inception, BODi has supported more than 30 million customers in achieving lasting results. The company continues to innovate across nutrition and digital fitness to deliver simple, proven solutions for modern lifestyles.

To subscribe and shop, visit BODi.com. For company and investor information, please visit TheBeachbodyCompany.com.

Media Relations:
[email protected]

Investor Relations:
[email protected]

Source: BODi

Release – Cardiff Oncology Receives FDA Orphan Drug Designation for Onvansertib in Chronic Myelomonocytic Leukemia

Posted on by [email protected]

October 21, 2026

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SAN DIEGO, Oct. 21, 2026 (GLOBE NEWSWIRE) — Cardiff Oncology, Inc. (Nasdaq: CRDF), a clinical-stage biotechnology company leveraging PLK1 inhibition to develop novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to onvansertib for the treatment of patients with chronic myelomonocytic leukemia (CMML).

“CMML remains a difficult-to-treat hematologic malignancy with limited treatment options for patients, and 40-50% of myeloproliferative CMML1 patients harbor RAS-pathway mutations, which are associated with more aggressive disease,” said Mani Mohindru, PhD, President and Chief Executive Officer of Cardiff Oncology. “Receiving Orphan Drug Designation for onvansertib in CMML further validates the therapeutic potential of PLK1 inhibition in cancers with significant unmet need and adds to the growing body of evidence supporting this mechanism across both solid tumors and hematologic malignancies. We believe this designation highlights the broader clinical opportunity for onvansertib as a monotherapy as we continue advancing therapies for patients across cancers where new therapeutic approaches are urgently needed.”

Onvansertib is being evaluated in both company-sponsored and investigator-initiated clinical studies, including a Phase 1 investigator-initiated study in relapsed/refractory CMML. As presented at the 2025 American Society of Hematology (ASH) Annual Meeting, onvansertib was relatively well-tolerated as a monotherapy and demonstrated preliminary efficacy in approximately 40% of myeloproliferative CMML patients in the dose ranging trial. The responses included three patients experiencing clinical benefits (38%), with one each of the following: a 100% platelet response, normalization of White Blood Cells, WBC (baseline WBC count > 50 x 109/L), and spleen response. Additionally, one patient (12.5%) had optimal marrow response with bone marrow blast reduction from 8% to 2% facilitating for allogeneic hematopoietic stem transplant and 3 patients experienced stable disease (38%).

Orphan Drug Designation is granted by the FDA to support the development of therapies intended to treat rare diseases or conditions affecting fewer than 200,000 people in the United States. Benefits of the designation may include tax credits for qualified clinical trials, exemption from certain FDA user fees, and up to seven years of market exclusivity upon regulatory approval. Orphan Drug Designation does not alter the standard regulatory requirements or approval process.

About Onvansertib
Onvansertib is a highly specific, oral PLK1 inhibitor advancing toward a registrational trial in first-line RAS-mutated metastatic colorectal cancer (mCRC). In a randomized Phase 2 trial, onvansertib in combination with FOLFIRI/bevacizumab (first-line standard-of-care) demonstrated dose-dependent improvements in overall response rate and progression-free survival compared to standard-of-care alone, building on findings from a prior Phase 2 trial in second-line RAS-mutated mCRC. Based on these results, the Company has selected the 30 mg dose of onvansertib in combination with FOLFIRI/bevacizumab as the regimen to advance into the planned registrational trial in first-line patients with RAS-mutated mCRC.

Onvansertib is also being evaluated in multiple other cancers through investigator-initiated studies, including metastatic pancreatic ductal adenocarcinoma (mPDAC), small cell lung cancer (SCLC), triple-negative breast cancer (TNBC), and chronic myelomonocytic leukemia (CMML).

About Chronic Myelomonocytic Leukemia
Chronic myelomonocytic leukemia (CMML) is a rare and aggressive hematologic malignancy characterized by features of both myelodysplastic syndromes and myeloproliferative neoplasms. CMML primarily affects older adults and is associated with poor clinical outcomes, including progressive bone marrow failure and risk of transformation to acute myeloid leukemia (AML). Current treatment options remain limited, highlighting the need for novel targeted therapies that can improve outcomes for patients with this disease.

About Cardiff Oncology, Inc.
Cardiff Oncology is a clinical-stage biotechnology company advancing innovative cancer treatments focused on PLK1 inhibition, a validated oncology target with practice-changing potential. Our lead asset, onvansertib, is a highly specific, oral PLK1 inhibitor currently being evaluated for first-line treatment of RAS-mutated metastatic colorectal cancer (mCRC), addressing a large, underserved patient population with high unmet need. Onvansertib is also under investigation in other PLK1-driven cancers through ongoing investigator-initiated trials and has shown robust single agent clinical activity in hard-to-treat tumors. By targeting tumor vulnerabilities, we aim to overcome treatment resistance and deliver improved clinical outcomes for patients.

For more information, please visit https://www.cardiffoncology.com.

Forward-Looking Statements
Certain statements in this press release are forward-looking within the meaning of the Private Securities Litigation Reform Act of 1995. These statements may be identified using words such as “anticipate,” “believe,” “forecast,” “estimated” and “intend” or other similar terms or expressions that concern Cardiff Oncology’s expectations, strategy, plans or intentions. These forward-looking statements are based on Cardiff Oncology’s current expectations and actual results could differ materially. There are several 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, clinical trials involve a lengthy and expensive process with an uncertain outcome, and results of earlier studies and trials may not be predictive of future trial results; our clinical trials may be suspended or discontinued due to unexpected side effects or other safety risks that could preclude approval of our product candidate; results of preclinical studies or clinical trials for our product candidate could be unfavorable or delayed; our need for additional financing; risks related to business interruptions, including cyber-attacks on our information technology infrastructure, which could seriously harm our financial condition and increase our costs and expenses; uncertainties of government or third party payer reimbursement; dependence on key personnel; limited experience in marketing and sales; substantial competition; uncertainties of patent protection and litigation; dependence upon third parties; and risks related to failure to obtain FDA clearances or approvals and noncompliance with FDA regulations. There are no guarantees that our product candidate will be utilized or prove to be commercially successful. Additionally, there are no guarantees that future clinical trials will be completed or successful or that our product candidate will receive regulatory approval for any indication or prove to be commercially successful. Investors should read the risk factors set forth in Cardiff Oncology’s Form 10-K for the year ended December 31, 2025, and other periodic reports filed with the Securities and Exchange Commission. While the list of factors presented here is considered representative, no such list should be considered to be a complete statement of all potential risks and uncertainties. Unlisted factors may present significant additional obstacles to the realization of forward-looking statements. Forward-looking statements included herein are made as of the date hereof, and Cardiff Oncology does not undertake any obligation to update publicly such statements to reflect subsequent events or circumstances.

Investor Contact:
Candice Masse
astr partners
[email protected]

Media Contact:
Amy Bonanno
Lyra Strategic Advisory
[email protected]

Cencora to Acquire American Oncology Network for $2.4 Billion in Major Cancer Care Expansion

Posted on by [email protected]

Cencora (NYSE: COR) has announced an agreement to acquire American Oncology Network (OTCQX: AONC) in a transaction valued at up to $2.4 billion, expanding the pharmaceutical distribution giant’s presence in community-based cancer care. The deal, announced October 21, 2026, will add a physician-led network of more than 350 oncology providers operating across 21 states to Cencora’s growing healthcare services platform.

The acquisition represents another significant step in Cencora’s strategy to expand beyond traditional pharmaceutical distribution and strengthen its relationships with healthcare providers. By integrating American Oncology Network’s clinical infrastructure and practice management capabilities, Cencora aims to support independent cancer specialists while improving patient access to advanced treatments.

Under the agreement, American Oncology Network is valued at $2.3 billion at closing, with an additional $100 million potentially payable through contingent value rights tied to specified conditions. Cencora already owns approximately 4% of the company and has agreed to acquire the remaining equity interests, subject to a potential ownership rollover by existing shareholders.

If eligible shareholders retain a combined 25% stake, Cencora expects to pay approximately $1.7 billion at closing to increase its ownership to 75%. The transaction remains subject to regulatory approvals, shareholder approval, and customary closing conditions.

Founded in 2018, American Oncology Network provides operational and administrative support to independent oncology practices, allowing physicians to concentrate on patient care. Its services include practice management, technology, and access to integrated healthcare resources designed to help smaller cancer treatment centers compete in an increasingly complex healthcare environment.

For Cencora, the acquisition expands its physician-led oncology management services organization into 12 additional states. The company expects the combination to create opportunities to strengthen cancer treatment delivery, expand practice support capabilities, and improve operational efficiency.

The transaction also highlights the growing importance of community oncology as cancer treatments become increasingly specialized and expensive. Independent oncology practices face mounting challenges involving reimbursement, drug procurement, technology investment, and administrative costs. Larger healthcare organizations are responding by building networks that provide centralized resources while allowing physicians to retain control over clinical decisions.

The expansion comes as biotechnology companies continue developing innovative cancer treatments that could eventually reach patients through community oncology practices. Companies such as Greenwich LifeSciences (NASDAQ: GLSI), which is developing an investigational immunotherapy for breast cancer, and MAIA Biotechnology (NYSE American: MAIA), which is advancing a telomere-targeting cancer treatment, illustrate the broader pipeline of emerging oncology therapies. Neither company is involved in the announced transaction.

For investors, the deal underscores how pharmaceutical distribution companies are seeking additional growth opportunities in specialized healthcare services. Expanding into oncology practice management could provide Cencora with deeper relationships across the cancer treatment market while supporting demand for pharmaceutical products and services.

Cencora expects the acquisition to contribute positively to adjusted diluted earnings per share beginning in the second year following completion. The company also raised its fiscal 2026 adjusted earnings outlook to at least $17.90 per share, reflecting strength in its U.S. Healthcare Solutions business.

The acquisition illustrates a broader shift toward integrated cancer care, where pharmaceutical distribution, clinical services, and healthcare technology increasingly operate within connected networks. As cancer treatments continue evolving, companies capable of supporting both drug delivery and community-based medical practices could play a larger role in shaping the future of oncology care.

Lycia Therapeutics Targets $250 Million IPO as Biotech Market Rebounds

Posted on by [email protected]

Lycia Therapeutics is preparing to raise approximately $250 million through an initial public offering, becoming the latest biotechnology company seeking to capitalize on renewed investor interest in emerging drug developers. The South San Francisco-based company announced plans Tuesday to offer 14.7 million shares priced between $16 and $18 each, potentially valuing the business at approximately $950 million on a fully diluted basis.

The company intends to list on the Nasdaq under the ticker symbol LYCA, adding another early-stage biotechnology developer to a growing pipeline of healthcare IPOs. The offering comes as investors increasingly look beyond established pharmaceutical companies toward emerging businesses developing innovative treatments for diseases with significant unmet medical needs.

Lycia is developing a new class of medicines designed to eliminate disease-causing proteins from the body. Its proprietary LYTAC technology, short for Lysosomal Targeting Chimera, works by directing specific proteins toward the body’s natural cellular disposal system. Unlike traditional drugs that primarily block the activity of harmful proteins, Lycia’s approach aims to remove them altogether.

The technology is based on research associated with Nobel Prize-winning chemist Carolyn Bertozzi, who helped establish the company in 2019. Lycia is initially targeting autoimmune, inflammatory, and allergic diseases, areas where conventional treatments often require ongoing symptom management.

Its lead experimental treatment, LCA-0061, is being developed for food allergies and other allergic conditions. The therapy targets immunoglobulin E, or IgE, an antibody responsible for triggering many allergic reactions. Early Phase 1 results showed a mean maximum IgE reduction of 96% from baseline among treated participants in an initial small cohort, although larger studies will be needed to determine its safety and effectiveness in patients.

Lycia is also developing LCA-0321, an experimental treatment for Graves’ disease, an autoimmune condition affecting the thyroid. The candidate is designed to selectively eliminate disease-causing antibodies rather than broadly suppress the immune system.

Lycia’s focus on targeted therapies for autoimmune and inflammatory conditions also reflects broader innovation across the biotechnology sector. Eledon Pharmaceuticals (NASDAQ: ELDN) is developing tegoprubart, an investigational treatment designed to regulate immune system activity by targeting the CD40 ligand pathway, with applications in organ transplantation. Meanwhile, Gyre Therapeutics (NASDAQ: GYRE) is focused on developing treatments for inflammatory and fibrotic diseases, including liver-related conditions. Although these companies employ different scientific approaches, their development programs highlight growing interest in therapies that address specific biological mechanisms underlying complex diseases.

Proceeds from the IPO are expected to support clinical development of these programs, additional research activities, and general corporate operations. The company has already raised approximately $267 million from private investors, including several prominent life sciences investment firms.

The planned offering follows a series of biotechnology IPOs that suggest improving conditions for companies seeking public-market financing. City Therapeutics and Iambic Therapeutics recently completed offerings that raised approximately $350 million combined, highlighting investor interest in RNA-based medicines and artificial intelligence-driven drug discovery.

While these companies are pursuing different technologies, their emergence reflects a broader shift toward specialized drug development platforms that could generate multiple treatments across different diseases.

For investors, Lycia’s proposed IPO offers exposure to an emerging area of biotechnology known as targeted protein degradation. The technology could eventually expand treatment possibilities for diseases where existing therapies have limited effectiveness, although its clinical and commercial potential remains unproven.

The offering also carries substantial risks. Lycia remains an early-stage clinical developer without an approved commercial product, and its future valuation will depend heavily on clinical trial results, regulatory progress, and its ability to finance continued research.

As more biotechnology companies test public-market demand, Lycia’s offering could provide another indication of whether investor appetite for early-stage drug developers is strengthening heading into the final months of 2026.

Release – NanoViricides’ Revolutionary Broad-spectrum Drug Candidate NV-387 Has Successfully Demonstrated Excellent Indications for Safety and Toxicology in a Juvenile Mouse Pups Animal Study, Paving the Way for Pediatric Use in Clinical Trials

Posted on by [email protected]

Tuesday, 20 October 2026 08:45 AM

SHELTON, CT / ACCESS Newswire / October 20, 2026 / NanoViricides, Inc., a publicly traded company (NYSE American:NNVC) (the “Company”), and a clinical stage, leading global pioneer in the development of broad-spectrum antivirals based on host-mimetic nanomedicine technology that viruses cannot escape, announces that its broad-spectrum antiviral drug NV-387 has successfully demonstrated strong safety, tolerability, and toxicological parameters in an animal model study involving juvenile mouse pups.

This study is expected to pave the way for pediatric use of NV-387 in clinical trials in children possibly as young as 1 year old.

Pediatric drugs for Ebola, Mpox, and Measles, as well as RSV – to name a few of the Company’s current or contemplated clinical trial programs – are unmet medical needs.

NV-387 is an extremely broad-spectrum antiviral drug that has demonstrated strong effectiveness in relevant animal models of multiple human viral infections. These include RSV, COVID, Influenza, Mpox, Smallpox, and Measles.

The Impact of the Juvenile Animal Model Study of NV-387 Treatment

NV-387 Oral Gummies formulation is currently in a Phase II clinical trial for the treatment of Ebola in the Democratic Republic of Congo (DRC). The novel Ebola Bundibugyo virus is known to disproportionately affect children i. NanoViricides anticipates being able to add a pediatric cohort in a Phase III registrational clinical trial, assuming the drug is found to be effective in the current Phase II clinical trial. If successful, NV-387 will likely be the first and only treatment for Ebola virus infection in children. There is no approved treatment nor an approved vaccine for the Ebola Bundibugyo virus.

NV-387 is also currently in another Phase II clinical trial for the treatment of Mpox in the Democratic Republic of Congo (DRC). Mpox Clade I, which is the currently most prevalent version of this virus, is known to disproportionately affect children. There is no approved treatment for Mpox. If Phase II is successful, we intend to add a pediatric cohort in the following Phase III registrational clinical trial.

NV-387 as a Treatment for Measles was granted an Orphan Drug Designation as well as a Rare Pediatric Disease Drug Designation by the US FDA. Measles primarily affects children. There is no approved treatment for Measles. The Company intends to perform a Phase II and, if successful, a Phase III clinical trial for NV-387 as a Treatment for Measles, towards a US FDA Marketing Authorization Application. If the program is successful and MAA is granted, then the Company will be eligible for a Priority Review Voucher (PRV). A PRV can fetch around $200 million if sold to another Pharma company ii, enabling substantial revenues even prior to achieving significant commercial sales.

The Juvenile Animal Model Study of NV-387 Oral Gummies Treatment and Results

Under the conditions of this study, the No Observed Adverse Effect Level (NOAEL) was determined to be 1,230 mg/kg per dose administered three times daily, or 3,690 mg/kg/day, or a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. This was actually the highest dose level tested. Therefore, a Maximum Tolerable Dose (MTD) could not be estimated iii.

These numbers are indicative of extremely strong safety and will enable a wide range for dosing of NV-387 in pediatric clinical trials for the treatment of various viral diseases.

A 12 Day Repeated-Dose Safety/Tolerability, Toxicity and Toxicokinetic Study with a 14-Day Recovery Period in Juvenile Balb/c Mouse Pups, was conducted to evaluate the safety/tolerability, toxicity and toxicokinetic profile of NV-387 Oral Gummies, containing the active pharmaceutical ingredient (API) NV-387. The Juvenile Balb/c mouse pups received NV-387 Oral Gummies formulation doses three times daily for up to 12 consecutive days, followed by recovery period to assess persistence, reversibility, or delayed occurrence of any treatment-related effects.

NV-387 Oral Gummies were well tolerated at all dose levels, including the highest dose of 1,230 mg/kg per dose amounting to drug exposure of 3690 mg/kg/day, or a total cumulative drug exposure of 44,280 mg/kg over the 12 day dosing period. There was no mortality, systemic toxicity, treatment-related clinical observations, adverse effects on body weight gain, alterations in cardiovascular parameters, changes in clinical pathology, or treatment-related gross or microscopic pathological findings observed in either sex.

Most Recent Annual Report

The “Company” has previously reported that it has filed its Annual Report on Form 10-K for the fiscal year ending June 30, 2026 with the Securities and Exchange Commission (SEC) on Monday, September 28, 2026. The report can be accessed at the SEC website (https://www.sec.gov/ix?doc=/Archives/edgar/data/0001379006/000110465926111390/nnvc-20260630x10k.htm). The Company’s Financial Statements included in its Annual Report on Form 10-K for the fiscal year ended June 30, 2026, contained an audit report from its Independent Registered Public Accounting Firm with an explanatory paragraph emphasizing that the audit opinion expressed substantial doubt about its ability to continue as a going concern. Release of this information is required by Section 610(b) of the NYSE American Company Guide and does not reflect any change or amendment to any of the Company’s filings for the fiscal year ended June 30, 2026.

Management’s Plan of Financing Activities, in Particular, Financing Clinical Trials

Management believes that the Company is working on diseases of global importance with a potential for a high positive impact. In particular, the Phase II Clinical Trial of NV-387 Oral Gummies for the Treatment of Ebola Virus Disease in DRC, is addressing a global high priority concern.

The USA has been, laudably, and proudly, the largest provider of humanitarian and relief assistance in this Ebola outbreak, with almost $1.4 Billion in contributions. The USA has already provided $887 Million, and has pledged another $500 Million, of which $267 million has been released, according to the US Department of State iv. This includes support for various public health measures, on site personnel, as well as funding for clinical trials of drugs and vaccines that were already under the auspices of US Government agencies. All of these supported drugs require infusions, a procedure that is not scalable for response in such a rapidly growing outbreak that the current Ebola Bundibugyo virus outbreak has turned out to be.

We believe that NV-387 being the only oral treatment in clinical trial for Ebola, there is a strong potential for non-dilutive funding for this regulatory development of NV-387 towards licensure. Management is continuing to work on obtaining non-dilutive funding for NV-387 as a unique and novel broad-spectrum antiviral, that we believe is revolutionary in the field of treatment of viral diseases, and now, in particular, for Ebola.

Additionally, we plan on continuing our efforts at financing the Company, when opportune, through different equity-based funding routes. In particular, the Company has an “At-the-Market” facility with an investment brokerage house, for issuing and selling common shares directly to investors.

Additional details can be found in the annual report filing.

Forward Looking Statements

Certain matters discussed in this press release are ‘forward-looking statements’ intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995. In particular, the Company’s statements regarding trends in the marketplace, future revenues, earnings and Adjusted EBITDA, the ability to realize firm backlog and projected backlog, cost cutting measures, potential future results and acquisitions, are examples of such forward-looking statements. The forward-looking statements are subject to numerous risks and uncertainties, including, but not limited to, the timing of projects due to variability in size, scope and duration, the inherent discrepancy in actual results from estimates, projections and forecasts made by management, regulatory delays, changes in government funding and budgets, and other factors, including general economic conditions, not within the Company’s control. The factors discussed herein and expressed from time to time in the Company’s filings with the Securities and Exchange Commission could cause actual results and developments to be materially different from those expressed in or implied by such statements. The forward-looking statements are made only as of the date of this press release and the Company undertakes no obligation to publicly update such forward-looking statements to reflect subsequent events or circumstances.

ABOUT NANOVIRICIDES

NanoViricides, Inc. (the “Company”) (www.nanoviricides.com) is a publicly traded (NYSE-American, stock symbol NNVC) clinical stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide™ class of drug candidates and the nanoviricide™ technology are based on intellectual property, technology and proprietary know-how of TheraCour Pharma, Inc. The Company has a Memorandum of Understanding with TheraCour for the development of drugs based on these technologies for all antiviral infections. The MoU does not include cancer and similar diseases that may have viral origin but require different kinds of treatments.

The Company has obtained broad, exclusive, sub-licensable, field licenses to drugs developed in several licensed fields from TheraCour Pharma, Inc. The Company’s business model is based on licensing technology from TheraCour Pharma Inc. for specific application verticals of specific viruses, as established at its foundation in 2005.

Our lead drug candidate is NV-387, a broad-spectrum antiviral drug that we plan to develop as a treatment of RSV, COVID, Long COVID, Influenza, and other respiratory viral infections, as well as MPOX/Smallpox infections. Our other advanced drug candidate is NV-HHV-1 for the treatment of Shingles. The Company cannot project an exact date for filing an IND for any of its drugs because of dependence on a number of external collaborators and consultants. The Company is currently focused on advancing NV-387 into Phase II human clinical trials.

The Company is also developing drugs against a number of viral diseases including oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others. NanoViricides’ platform technology and programs are based on the TheraCour® nanomedicine technology of TheraCour, which TheraCour licenses from AllExcel. NanoViricides holds a worldwide exclusive perpetual license to this technology for several drugs with specific targeting mechanisms in perpetuity for the treatment of the following human viral diseases: Human Immunodeficiency Virus (HIV/AIDS), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Rabies, Herpes Simplex Virus (HSV-1 and HSV-2), Varicella-Zoster Virus (VZV), Influenza and Asian Bird Flu Virus, Dengue viruses, Japanese Encephalitis virus, West Nile Virus, Ebola/Marburg viruses, and certain Coronaviruses. The Company intends to obtain a license for RSV, Poxviruses, and/or Enteroviruses if the initial research is successful. As is customary, the Company must state the risk factor that the path to typical drug development of any pharmaceutical product is extremely lengthy and requires substantial capital. As with any drug development efforts by any company, there can be no assurance at this time that any of the Company’s pharmaceutical candidates would show sufficient effectiveness and safety for human clinical development. Further, there can be no assurance at this time that successful results against coronavirus in our lab will lead to successful clinical trials or a successful pharmaceutical product.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities. Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in preclinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

The phrases “safety”, “effectiveness” and equivalent phrases as used in this press release refer to research findings including clinical trials as the customary research usage and do not indicate evaluation of safety or effectiveness by the US FDA.

FDA refers to US Food and Drug Administration. IND application refers to “Investigational New Drug” application. cGMP refers to current Good Manufacturing Practices. CMC refers to “Chemistry, Manufacture, and Controls”. CHMP refers to the Committee for Medicinal Products for Human Use, which is the European Medicines Agency’s (EMA) committee responsible for human medicines. API stands for “Active Pharmaceutical Ingredient”. WHO is the World Health Organization. R&D refers to Research and Development.

Contact:
NanoViricides, Inc.
[email protected]

Public Relations Contact:
[email protected]

Source: NanoViricides, Inc.

Two Biotech IPOs Raise $350 Million as Investor Appetite for New Drug Developers Rebounds

Posted on by [email protected]

City Therapeutics and Iambic Therapeutics make strong Nasdaq debuts, highlighting renewed interest in RNA-based medicines and AI-powered drug discovery.

The biotechnology IPO market showed fresh signs of momentum last week as City Therapeutics (NASDAQ: CTY) and Iambic Therapeutics (NASDAQ: IAM) raised a combined $350 million in public offerings. Both companies attracted strong investor interest and delivered positive first-day trading performances, suggesting that demand for emerging drug developers may be improving despite broader market volatility.

City Therapeutics, a Cambridge, Massachusetts-based biotechnology company developing RNA interference (RNAi) medicines, raised approximately $200 million through an upsized initial public offering. The company sold 11.1 million shares at $18 each, exceeding its original fundraising target, and began trading on the Nasdaq on October 16.

Shares climbed approximately 24% during their first trading session, closing at $22.40 and giving the company a strong public-market debut.

Founded in 2023, City Therapeutics focuses on RNAi technology, which works by silencing specific genes responsible for producing disease-related proteins. Its lead candidate, CITY-FXI, is undergoing Phase 1 clinical testing for thromboembolic diseases, conditions involving potentially dangerous blood clots.

The company’s broader pipeline includes CITY-RBP4, targeting Stargardt disease and other retinal disorders, and CITY-TFR2, being developed for anemia associated with chronic diseases. The IPO proceeds will help advance these programs through clinical development.

Meanwhile, San Diego-based Iambic Therapeutics raised $150 million through the sale of approximately 9.4 million shares priced at $16 each. The company began trading on October 15 under the ticker IAM, with shares gaining approximately 13% during their first session.

Iambic represents a different segment of biotechnology innovation, combining artificial intelligence with automated laboratory experimentation to accelerate drug discovery.

Its proprietary technology uses AI models to analyze molecular structures, predict drug behavior, and identify promising therapeutic candidates. The company believes this approach can reduce the time and resources traditionally required to discover and develop new medicines.

Iambic’s lead clinical candidate, IAM1363, is an experimental cancer treatment discovered using its AI-powered platform. The company also maintains a pipeline of additional oncology programs and partnerships with established pharmaceutical companies.

Investor interest in Iambic was supported by prominent institutional backers, including ARK Investment Management and Duquesne Family Office, which indicated interest in purchasing up to $60 million of shares in the offering. Nvidia has also established an investment and technology relationship with the company.

The successful debuts arrive during a period when biotechnology companies have faced challenging financing conditions, with higher capital costs and investor caution limiting access to public markets.

However, these offerings suggest investors remain willing to support companies with differentiated technologies, promising drug pipelines, and credible development strategies.

The contrasting approaches of City Therapeutics and Iambic also highlight two important investment themes. RNA-based therapies are expanding the range of diseases that can potentially be treated through targeted genetic mechanisms, while artificial intelligence is creating new opportunities to improve drug discovery efficiency.

Still, both companies remain clinical-stage developers, meaning their long-term success depends on achieving favorable clinical trial results, securing regulatory approvals, and eventually commercializing their treatments.

For investors, the combined $350 million raised and positive trading debuts provide encouraging evidence that the biotechnology IPO market may be regaining momentum. Whether that momentum continues will depend on broader market conditions, future clinical milestones, and the performance of newly listed companies.

The strong reception for City Therapeutics and Iambic suggests that innovative biotechnology remains an attractive investment opportunity, particularly where emerging technologies offer the potential to address significant unmet medical needs.

The contrasting approaches of City Therapeutics and Iambic highlight growing investor interest in innovative drug development platforms. That interest extends to smaller publicly traded biotechnology companies advancing novel treatments, including Ocugen (NASDAQ: OCGN), which is developing gene therapies for inherited retinal diseases, and MAIA Biotechnology (NYSE American: MAIA), which is advancing its investigational telomere-targeting cancer treatment, ateganosine. While these companies pursue different scientific approaches, they reflect the broader investment focus on targeted therapies addressing unmet medical needs. Meanwhile, Merck KGaA’s $1.3 billion acquisition of Silence Therapeutics further underscores the strategic value pharmaceutical companies are placing on emerging RNA-based medicines.

Release – NeuroSense Files U.S. Patent Application for Traumatic Brain Injury

Posted on by [email protected]

CAMBRIDGE, Mass., Oct. 19, 2026 /PRNewswire/ — NeuroSense Therapeutics Ltd. (NASDAQ: NRSN) (“NeuroSense” or the “Company”), a late-stage clinical biotechnology company developing treatments for neurodegenerative diseases, today announced that it has filed a patent application with the U.S. Patent and Trademark Office covering methods of treating traumatic brain injury (TBI) and related central nervous system injuries with the combination of ciprofloxacin and celecoxib, the active ingredients of PrimeC.

The application covers the treatment of a broad range of brain injuries, from concussion and mild TBI to moderate and severe TBI, including blast-related injury, as well as their long-term consequences, such as chronic traumatic encephalopathy (CTE). If granted, the patent is expected to provide protection through 2047, subject to any extensions.

Traumatic brain injury (TBI) represents a major global healthcare challenge, affecting millions of people each year. TBI can result from falls, motor vehicle accidents, sports-related injuries and military-related trauma, including blast exposure. Its consequences can extend well beyond the initial event, potentially causing persistent cognitive, physical and behavioral impairment, with substantial burdens on patients, caregivers and healthcare systems. Despite this significant unmet medical need, there are currently no approved disease-modifying therapies specifically targeting the secondary neurological injury associated with TBI.

Following the initial trauma, TBI can trigger complex biological processes, including neuroinflammation, oxidative stress and progressive neuronal damage. Certain mechanisms overlap with pathways implicated in neurodegenerative disorders.

The patent filing also supports NeuroSense’s longer-term strategy of pursuing additional applications for PrimeC beyond its existing development programs. The Company views TBI as an opportunity to broaden PrimeC’s commercial potential and build additional long-term value around its lead asset. While ALS remains NeuroSense’s primary development priority, the Company is evaluating future TBI-focused research and development initiatives, through strategic collaborations, research grants and other non-dilutive funding opportunities.

“While ALS remains our primary focus, we believe PrimeC may have potential across a broader range of neurological conditions that share common underlying disease mechanisms,” said Alon Ben-Noon, Chief Executive Officer of NeuroSense. “TBI is a particularly compelling area given the large affected population, the long-term consequences of brain injury and the lack of approved disease-modifying treatments. This filing strengthens our intellectual property position and creates a foundation for future research, partnerships and non-dilutive funding opportunities, while maintaining our focus on advancing our core ALS program. We look forward to sharing further updates as our clinical and strategic initiatives advance.”

About NeuroSense

NeuroSense Therapeutics is a late-clinical stage biotechnology company developing novel treatments for severe neurodegenerative diseases, including amyotrophic lateral sclerosis (ALS) and Alzheimer’s disease. The Company’s lead product candidate, PrimeC, is a novel oral therapy designed to target multiple key biological pathways underlying disease progression, including neuroinflammation, oxidative stress and dysregulated iron metabolism.

NeuroSense has recently completed analysis of long-term follow-up data from its Phase 2b PARADIGM study in ALS, with results published in JAMA Neurology showing slower functional decline in participants who received PrimeC from study start than in those who initially received placebo. The Company also reported changes across multiple biomarkers associated with ALS, including microRNAs, consistent with PrimeC’s multi-target mechanism of action.

NeuroSense has received clearance from the U.S. Food and Drug Administration (FDA) to initiate its pivotal Phase 3 clinical trial (PARAGON) in ALS, to be conducted primarily in the United States. The Company is working with FDA on an optimized design for the study.

For additional information, we invite you to visit our website and follow us on LinkedIn, YouTube and X. Information that may be important to investors may be routinely posted on our website and these social media channels.

About PrimeC

PrimeC, NeuroSense’s lead drug candidate, is a novel extended-release oral formulation composed of a unique fixed-dose combination of two FDA-approved drugs: ciprofloxacin and celecoxib. PrimeC is designed to target several key mechanisms that contribute to neuron degeneration, inflammation, iron accumulation and impaired ribonucleic acid (“RNA”) regulation, with the potential to inhibit disease progression.

About ALS

Amyotrophic lateral sclerosis (“ALS”) is an incurable neurodegenerative disease that causes progressive paralysis and, typically, death within 3 years of symptoms onset. Every year, more than 5,000 people are diagnosed with ALS in the U.S. alone, with an annual disease burden of $1 billion. The number of people living with ALS is expected to grow by 24% by 2040 in the U.S. and EU.

Forward-Looking Statements

This press release contains “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 NeuroSense Therapeutics’ current expectations and are subject to inherent uncertainties, risks and assumptions that are difficult to predict and include statements regarding the Company’s development program, including for ALS and TBI, the potential issuance, scope and duration of patent protection arising from the Company’s patent application, including expected protection through 2047, subject to any extensions, the potential of PrimeC to treat TBI and related central nervous system injuries, the potential expansion of PrimeC beyond ALS and its potential commercial benefits and long-term value. Further, certain forward-looking statements are based on assumptions as to future events that may not prove to be accurate. The future events and trends may not occur and actual results could differ materially and adversely from those anticipated or implied in the forward-looking statements. These risks include the risk that the patent application will not result in an issued patent or that any patent granted will not provide the Company with the anticipated scope or duration of protection or will be challenged, invalidated or unenforceable; the risk that PrimeC will not demonstrate safety or efficacy in TBI or related conditions; the potential for delay in the timing of the Phase 3 clinical trial (PARAGON) in ALS; the risk that the Company will not be able to obtain financing on acceptable terms, or at all; the risk that the Company will not regain and maintain compliance with the Nasdaq listing requirements; the risk that non-dilutive grant funding for the PARAGON trial will not be awarded or will be delayed; uncertainty regarding outcomes and the timing of current and future clinical trials; the risk that PrimeC will not advance towards later-stage development; timing for reporting data, including from the study of PrimeC in Alzheimer’s disease; that the study will not be successful; and other risks and uncertainties set forth in NeuroSense’s filings with the Securities and Exchange Commission (SEC). You should not rely on these statements as representing our views in the future. More information about the risks and uncertainties affecting NeuroSense is contained under the heading “Risk Factors” in the Annual Report on Form 20-F filed with the Securities and Exchange Commission on March 31, 2026 and NeuroSense’s subsequent filings with the SEC. Forward-looking statements contained in this announcement are made as of this date, and NeuroSense undertakes no duty to update such information except as required under applicable law.

SOURCE NeuroSense

For further information: For further information: Email: [email protected] | Tel: +972-(0)9-799-6183

Merck to Acquire Silence Therapeutics for $1.3 Billion in Major Gene-Silencing Biotech Deal

Posted on by [email protected]

The $20-per-share acquisition represents a 130% premium as Merck expands its rare disease pipeline and strengthens its position in RNA-based medicines.

German pharmaceutical and technology company Merck KGaA has agreed to acquire Silence Therapeutics (NASDAQ: SLN) in an approximately $1.3 billion all-cash transaction, highlighting growing interest in gene-silencing therapies and rare disease treatments. The deal, announced Monday, October 19, offers Silence shareholders $20 per American Depositary Share (ADS), representing a substantial 130% premium to the company’s closing price of $8.68 on Friday.

The acquisition values Silence Therapeutics at approximately $1.3 billion in equity and $1.1 billion in enterprise value. The purchase price also represents an 82% premium to the company’s 30-day volume-weighted average share price, underscoring the strategic value Merck places on its emerging drug pipeline.

At the center of the transaction is divesiran, an experimental RNA-based treatment targeting polycythemia vera, a rare form of blood cancer characterized by the excessive production of red blood cells. The condition can increase the risk of blood clots, strokes, and other serious cardiovascular complications, often requiring patients to undergo regular blood removal procedures to control their red blood cell levels.

Divesiran uses small interfering RNA (siRNA) technology to selectively silence a gene involved in regulating iron metabolism. By limiting iron availability for red blood cell production, the therapy aims to reduce the need for frequent blood removal treatments while improving disease management.

Recent Phase 2 clinical trial results have strengthened the drug’s potential. In the SANRECO study, divesiran achieved an 88% response rate compared with 19% for patients receiving placebo. Patients receiving the experimental therapy also required significantly fewer blood removal procedures, providing encouraging evidence ahead of planned Phase 3 development.

One potential advantage of divesiran is its dosing schedule. The treatment is designed to be administered through an injection once every three months, potentially offering patients a more convenient alternative to therapies requiring more frequent administration.

For Merck, the acquisition represents another step in its strategy to expand into specialized treatments addressing significant unmet medical needs. The company previously acquired SpringWorks Therapeutics in 2025, strengthening its presence in rare diseases and oncology. Adding Silence Therapeutics provides access to a promising late-stage drug candidate and a broader platform for developing RNA-based medicines.

The transaction also highlights the growing importance of gene-silencing technology within the biotechnology industry. Unlike traditional medicines that target proteins after they are produced, siRNA therapies work by reducing the production of specific disease-related proteins, potentially offering more targeted treatment approaches.

For biotechnology investors, the 130% acquisition premium demonstrates how promising clinical data can significantly increase the strategic value of smaller drug developers. Large pharmaceutical companies continue seeking innovative assets to replenish their pipelines, diversify revenue streams, and establish positions in emerging treatment categories.

However, divesiran remains investigational and must successfully complete additional clinical testing before potentially receiving regulatory approval. Its commercial prospects will depend on demonstrating sustained effectiveness, safety, and competitive advantages over existing treatments.

The transaction has received unanimous approval from Silence Therapeutics’ board and is expected to close during the first quarter of 2027, subject to shareholder, regulatory, and court approvals.

The acquisition reinforces a broader trend in biotechnology: pharmaceutical companies are increasingly willing to pay substantial premiums for innovative therapies supported by promising clinical results. As RNA-based medicine continues advancing, smaller biotechnology companies developing differentiated treatments could attract further acquisition interest from larger industry players.

Release – Tonix Pharmaceuticals Announces Presentations at World Vaccine Congress Europe 2026

Posted on by [email protected]

October 15, 2026 7:00am EDT

BERKELEY HEIGHTS, N.J., Oct. 15, 2026 (GLOBE NEWSWIRE) — Tonix Pharmaceuticals Holding Corp. (Nasdaq: TNXP) (“Tonix” or “the Company”), a fully integrated, commercial-stage biopharmaceutical company, today announced an oral presentation on TNX-801, a live, attenuated, minimally replicative investigational vaccine platform based on horsepox virus to protect against mpox and other infectious diseases, and a working group session led by Tonix, “Vectored Vaccine Platforms: From Design to Improving Efficacy,” at the World Vaccine Congress Europe held in Amsterdam, Netherlands on October 19-21, 2026.

TNX-801 Presentation Details
Title: TNX-801 Vaccine Platform Safety and Efficacy
Date & Time: Oct. 21, 2026, 1:15 p.m. CEST
Session Category: Emerging & Infectious Diseases
Presenter: Farooq Nasar, Ph.D., MPH, Director, Virology, Research and Development Center (RDC), Tonix Pharmaceuticals

Other Session Details
Title: Working Group: Vectored Vaccine Platforms: From Design to Improving Efficacy
Date & Time: Oct 20, 2026, 11:30 a.m. CEST
Session Category: Working Groups
Presenters: Sina Bavari, Ph.D., Executive Vice President, Infectious Disease, RDC, Tonix Pharmaceuticals; Gabriella Worwa, DVM, Ph.D., Study Director, RDC, Tonix Pharmaceuticals; Matilu Mwau, Senior Principal Clinical Research Scientist, Professor of Infectious Diseases, Kenya Medical Research Institute (KEMRI)

About TNX-801
TNX-801 (recombinant horsepox virus) is an attenuated, minimally replicative, live virus vaccine platform based on horsepox in pre-clinical development to prevent mpox, smallpox, and other emerging infectious diseases. TNX-801 is expected to enter a Phase 1 study in 2027 pending FDA clearance of an Investigational New Drug Application (IND). TNX-801 is in the pre-IND stages of development.

Tonix Pharmaceuticals Holding Corp.
Tonix Pharmaceuticals* is a fully integrated, commercial-stage biopharmaceutical company focused on central nervous system (CNS) disorders, infectious diseases, and immunology conditions with high unmet medical needs. TONMYA® (cyclobenzaprine HCl sublingual tablets 2.8mg), the Company’s flagship internally conceived and developed medicine, is the first treatment for fibromyalgia 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 extending the science behind TONMYA in Phase 2 clinical studies to evaluate the potential of TNX-102 SL in major depressive disorder and acute stress disorder/acute stress reaction. Tonix is also advancing a pipeline of infectious disease programs, including Phase 2-ready monoclonal antibody TNX-4800 (anti-OspA mAb) for Lyme disease prevention in the U.S., and TNX-801 (horsepox, live virus vaccine), a vaccine in development for the prevention of mpox and smallpox. Within immunology, TNX-1500 (anti-CD40L mAb) is a Phase 2-ready, third-generation CD40 ligand inhibitor for the prevention of kidney transplant rejection. To learn more, visit www.tonixpharma.com.

*Tonix’s product development candidates, including TNX-102 SL for new, unapproved indications, 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. 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.

Investor Contacts
Deborah Elson
Tonix Pharmaceuticals
[email protected] 
[email protected] 

NanoViricides (NNVC) – Ebola Trial Reports Ongoing Enrollment Progress

Posted on by [email protected]

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.

Patient Enrollment and Treatment Continue. Nanoviricides provided an update on the progress of its Phase 2a trial in Ebola, including additional details on its design, endpoints, and objectives. The Phase 2a trial began treating patients with NV-387 in the Democratic Republic of Congo (DRC) in late September. The company reported that enrollment is continuing, with data expected in 1Q27. 

Stages Of Infection Are Emerging. The current outbreak of Ebola virus disease (EVD) in the DRC has been caused by a new variant of the Bundibugyo Ebolavirus (BDBV). The development of symptoms varies between patients, and its diagnosis is still being refined. During the first 5 to 7 days after initial infection, mild symptoms may not even be noticeable. Patients typically seek treatment after about 5 to 7 days, when they begin vomiting and have severe diarrhea. The trial is expected to enroll most patients at this stage.


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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 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. 

Ocugen (OCGN) – Ocugen Completes Licensing Agreement For MENA Region

Posted on by [email protected]


Thursday, October 15, 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.

Licensing Agreement Finalizes Terms Announced In July. Ocugen and Roots Pharmaceuticals have finalized a licensing agreement for the commercialization of OCU400 in the Middle East and North Africa. The license finalizes the terms that the two companies announced in July 2026. This advances Ocugen’s plan to market OCU400 worldwide.

Collaboration Covers A Large Territory. The agreement gives Kuwait-based Roots Pharmaceuticals and its strategic partner, Al-Dhow International Holding, exclusive rights for the Middle East and North Africa coastal countries (MENA region). Retinitis pigmentosa (RP) is estimated to have a higher incidence in this region than in the US and Europe, although we cannot project sales at this time.


Get the Full Report

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.