Phase 1 maximal-use pharmacokinetics (PK) study completed in support of planned U.S. label expansionData to complement previously announced positive Phase 3 efficacy results on extremities, neck and trunkSupplemental NDA submission for extremities, neck and trunk indication expected in Q3 2026 WOBURN, Mass., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Biofrontera Inc. (Nasdaq: BFRI) (“Biofrontera” or the “Company”), a biopharmaceutical company specializing in the development and commercialization of photodynamic ther ...

NEW YORK, Feb. 17, 2026 (GLOBE NEWSWIRE) -- Psyence Biomedical Ltd. (Nasdaq: PBM) (“Psyence BioMed” or the “Company”), a biopharmaceutical company advancing nature-derived psilocybin and ibogaine therapies for unmet mental health needs, today announced the voting results from its Annual and Special Meeting of Shareholders (the “Meeting”), held at 9:00 a.m. Eastern Time on February 12, 2026. Shareholders voted in favour of all matters of business presented at the Meeting, including the election of directors, ...

Table of Contents As filed with the Securities and Exchange Commission on February 17, 2026 Registration No. 333-293396 UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 AMENDMENT NO. 2 FORM S-1 REGISTRATION STATEMENT UNDER THE SECURITIES ACT OF 1933 HCW BIOLOGICS INC. (Exact name of Registrant as specified in its charter) (State or Other Jurisdiction of Incorporation or Organization) Delaware 2834 82-5024477 Primary Standard Industrial Classification Code Number (I.R.S. Employer Ident ...

GLEN ALLEN, Va., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Adial Pharmaceuticals, Inc. (NASDAQ: ADIL) (“Adial” or the “Company”), a clinical-stage biopharmaceutical company focused on developing therapies for the treatment and prevention of addiction and related disorders, today announced that Cary Claiborne, CEO of Adial, will be presenting at the Oppenheimer 36th Annual Healthcare Life Sciences Conference which will be held virtually February 25 - 26, 2026. Adial’s presentation is scheduled for Wednesday, Februar ...

Core Insights - Palisade Bio, Inc. has appointed Dr. Bram Verstockt to its Clinical Advisory Board to enhance its Phase 2 development strategy for PALI-2108 in ulcerative colitis and fibrostenotic Crohn's disease [1][2] - The company plans to submit an Investigational New Drug (IND) application for PALI-2108 in ulcerative colitis in the first half of 2026 [1][8] Company Overview - Palisade Bio is a clinical-stage biopharmaceutical company focused on developing next-generation oral PDE4 inhibitor prodrugs aimed at chronic inflammatory and fibrotic diseases [11] - The lead program, PALI-2108, is designed for targeted delivery to the terminal ileum and colon, utilizing local bacterial bioactivation to convert the prodrug into an active PDE4 inhibitor [9][10] Clinical Development - PALI-2108 has shown a 100% clinical response in a Phase 1b trial for ulcerative colitis, with no serious adverse events reported [12] - The upcoming Phase 2 study will evaluate clinical remission, response, and pharmacodynamic biomarkers over a 12-week period, with an extension phase for maintenance of remission [13] Expert Contribution - Dr. Verstockt's expertise in inflammatory bowel disease and precision medicine will be crucial for optimizing patient selection, endpoint strategy, and disease monitoring in the Phase 2 studies [3][8] - His background in advanced imaging, biomarker integration, and multi-omics research will support the design of studies aimed at demonstrating durable efficacy and disease modification [3][6]

Core Insights - Outlook Therapeutics reported a significant net loss of $23.1 million for the first fiscal quarter of 2026, a stark contrast to a net income of $17.4 million in the same period last year, indicating a challenging financial environment for the company [3][20]. - The company is experiencing increasing adoption of its product LYTENAVA™ (bevacizumab gamma) in Europe, with plans for further market expansion in 2026 and 2027 [2][9]. - Outlook Therapeutics is actively engaging with the FDA regarding its investigational product ONS-5010, following a Complete Response Letter that requested additional confirmatory evidence [8][10]. Financial Performance - For the fiscal first quarter ended December 31, 2025, the adjusted net loss attributable to common stockholders was $13.5 million, an improvement from an adjusted net loss of $21.6 million in the same quarter of the previous year [4][24]. - Revenue was negatively impacted by an increase in returns reserve due to short-dated products shipped to support the launch of LYTENAVA in Europe, although unit sales more than doubled compared to the previous quarter [6][20]. - As of December 31, 2025, the company had cash and cash equivalents of $8.7 million, which does not include additional proceeds from its at-the-market offering program [7][23]. Product Development and Regulatory Updates - The company is planning to launch LYTENAVA in additional EU markets, including Ireland and the Netherlands in 2026, followed by France, Italy, and Spain in 2027 [2][9]. - A Type A meeting has been requested with the FDA to discuss the Complete Response Letter regarding ONS-5010, with the company expressing confidence in the evidence submitted for its Biologics License Application [8][10]. - ONS-5010/LYTENAVA™ is positioned as a potential first approved ophthalmic formulation of bevacizumab for retinal indications in the U.S. if regulatory approval is granted [15].

Strengthens Protection Around Broad Portfolio of Cancer-Targeting Drug Conjugates and Enabling Technologies Provides Key Coverage Across Europe Ahead of Planned 3Q26 Filing for Conditional Marketing Approval with the European Medicines Agency (EMA) for Iopofosine I 131 as a Treatment for Waldenström Macroglobulinemia FLORHAM PARK, N.J., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Cellectar Biosciences, Inc. (NASDAQ: CLRB), a late-stage clinical biopharmaceutical company focused on the discovery and development of dru ...

ANN ARBOR, Mich., Feb. 17, 2026 (GLOBE NEWSWIRE) -- Esperion (NASDAQ: ESPR) today announced that it has entered into a settlement agreement with Alkem Laboratories Ltd. (Alkem). This agreement resolves the patent litigation brought by Esperion against Alkem in response to Alkem’s Abbreviated New Drug Applications (ANDAs) seeking approval to market generic versions of NEXLETOL and NEXLIZET prior to the expiration of the applicable patents. Pursuant to the agreement, Alkem has agreed not to market a generic v ...

Core Viewpoint - Phathom Pharmaceuticals, Inc. will host a live webcast on February 26, 2026, to report its fourth quarter and full year 2025 financial results and provide a business update [1]. Company Overview - Phathom Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing novel treatments for gastrointestinal diseases [3]. - The company has in-licensed exclusive rights to vonoprazan, a first-in-class potassium-competitive acid blocker (PCAB), for the U.S., Europe, and Canada [3]. - Phathom markets vonoprazan in the U.S. as VOQUEZNA® for various gastrointestinal conditions, including heartburn associated with Non-Erosive GERD and treatment of H. pylori infection [3].

Core Insights - Cue Biopharma, Inc. announced promising preclinical safety and tolerability data for CUE-401, its lead autoimmune asset, indicating no adverse events were observed in two non-GLP studies [1][2] - The company is optimistic about CUE-401's potential as a first-in-class bifunctional tolerogenic agent for autoimmune diseases and plans to file an investigational new drug (IND) application in the coming months [2] Study Design and Key Data Highlights - Two non-GLP studies were conducted in mice (n=24) and non-human primates (NHPs) (n=6) to assess the safety and tolerability of CUE-401 using a step-up dosing schedule [3] - CUE-401 was administered intravenously with escalating doses of 1 mg/kg, 3 mg/kg, and 10 mg/kg, all of which were well tolerated [6] - In the core study, animals received escalating doses of 0.1 mg/kg, 0.3 mg/kg, and 1 mg/kg, with no adverse observations reported [6] About CUE-401 - CUE-401 is a novel bifunctional therapeutic that combines a TGF-beta breathing-mask moiety with a clinically validated interleukin 2 (IL-2) mutein, designed to promote immune regulation and tolerance through multiple mechanisms [4][5] - The therapeutic aims to regulate proinflammatory mechanisms, expand existing Tregs, and convert conventional CD4+ T cells into FOXP3+ induced Tregs [4] About Cue Biopharma - Cue Biopharma is a clinical-stage biopharmaceutical company focused on developing injectable biologics to selectively engage and modulate disease-specific T cells [5] - The company's proprietary platform, Immuno-STAT™, aims to harness the body's immune system without broad systemic immune modulation [5]