BOSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Bicara Therapeutics Inc. (Nasdaq: BCAX), a clinical-stage biopharmaceutical company committed to bringing transformative bifunctional therapies to patients with solid tumors, today announced that Claire Mazumdar, PhD, MBA, Chief Executive Officer, will present at the J.P. Morgan 2026 Healthcare Conference on Monday, January 12, 2026 at 11:15 a.m. PT. A live webcast of the presentation will be accessible through the Investor Relations section of Bicara’s website unde ...

Core Insights - BioVaxys Technology Corp. has appointed Dr. Marianne Stanford as Scientific Advisor, bringing extensive experience in vaccine development and immunotherapy [1][4] - Dr. Stanford previously led the R&D at IMV Inc., where she developed the DPX™ vaccine portfolio, demonstrating enhanced efficacy in cancer models through innovative combinations [1][2] - The company focuses on novel immunotherapies using the DPX platform, targeting cancers and infectious diseases, with ongoing clinical trials for multiple products [4] Company Overview - BioVaxys Technology Corp. is a clinical-stage biopharmaceutical company based in British Columbia, Canada, dedicated to developing immunotherapies for various diseases [4] - The DPX platform is designed to generate specific and robust immune responses, with a clinical pipeline that includes MVP-S for advanced cancers and other immunotherapies [4] Dr. Stanford's Background - Dr. Stanford holds a PhD in Microbiology and Immunology and has a strong background in viral immunotherapy and oncology, enhancing her role at BioVaxys [3] - Her previous role as Chief Scientific Officer at Mara Renewables Corp. involved the commercialization of bio-based nutrition products, showcasing her leadership in scientific research [2]

New PDUFA Target Action Date of January 14, 2026 set by FDAMIAMI, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Fortress Biotech, Inc. (Nasdaq: FBIO) (“Fortress”) and its majority-owned subsidiary, Cyprium Therapeutics, Inc. (“Cyprium”), today announced that the U.S. Food and Drug Administration (“FDA”) has accepted the resubmission of the New Drug Application (“NDA”) for CUTX-101 (copper histidinate), intended to treat Menkes disease in pediatric patients. The resubmission has been accepted as a Class 1 resubmission a ...

A target discovery agreement to identify disease-specific T-cell receptors (TCRs) in rheumatoid arthritis A data licensing agreement to access Adaptive’s proprietary TCR-antigen datasets for research and development in multiple immunology applications SEATTLE, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Adaptive Biotechnologies Corporation (NASDAQ: ADPT), a commercial stage biotechnology company that aims to translate the genetics of the adaptive immune system into clinical products to diagnose and treat disease, tod ...

CLEVELAND, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Abeona Therapeutics Inc. (Nasdaq: ABEO) today announced the appointment of Mohamad Tabrizi, M.S., M.B.A., as Senior Vice President, Chief Business Officer (CBO). In this role, Mr. Tabrizi will lead the Company’s corporate strategy and business development functions, as well as drive operating efficiency for the Company. “Mohamad brings a wealth of experience in strategic planning and business development,” said Vish Seshadri, Chief Executive Officer of Abeona. “W ...

BOSTON, Dec. 15, 2025 (GLOBE NEWSWIRE) -- Tiziana Life Sciences, Ltd. (Nasdaq: TLSA) (“Tiziana” or the “Company”), a biotechnology company developing breakthrough immunomodulation therapies with its lead development candidate, intranasal foralumab, a fully human, anti-CD3 monoclonal antibody, today announced the withdrawal of the proposed public offering of common shares due to market conditions. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there ...

Core Insights - The interim analysis of RAD 101 shows that 92% of evaluable patients achieved concordance with MRI imaging, indicating significant tumor uptake in brain metastases [1][2] - The company plans to initiate a pivotal study by the end of 2026, bolstered by the positive interim data from the Phase 2b trial [3] Company Overview - Radiopharm Theranostics is a clinical-stage biopharmaceutical company focused on developing innovative oncology radiopharmaceuticals for high unmet medical needs [1][10] - The company is listed on ASX (RAD) and NASDAQ (RADX) and has a pipeline that includes one Phase 2 and four Phase 1 trials targeting various solid tumors [10] Clinical Trial Details - The Phase 2b clinical trial is evaluating the diagnostic performance of RAD 101 in 30 individuals with confirmed recurrent brain metastases from solid tumors [8] - The primary objective is to assess concordance between RAD 101 positive lesions and those seen in conventional MRI imaging [8] Market Opportunity - The U.S. market opportunity for RAD 101 is estimated to exceed $500 million annually, positioning it among the top three imaging agents in the market [3] - Over 300,000 patients are diagnosed with brain metastases annually in the U.S., highlighting a significant patient population for RAD 101 [4][3] Technology and Innovation - RAD 101 is a novel imaging agent targeting fatty acid synthase (FASN), which is overexpressed in many solid tumors, including brain metastases [9] - The integration of RAD 101 PET with standard MRI could enhance patient management and treatment decisions for brain metastases [3]

Core Insights - FibroGen's roxadustat has received Orphan Drug Designation from the FDA for treating myelodysplastic syndromes (MDS), indicating a significant treatment gap in this area [2][3] - The company plans to submit the Phase 3 protocol for roxadustat in the fourth quarter of 2025 [1][2] Company Overview - FibroGen, Inc. is a biopharmaceutical company focused on developing novel therapies for cancer and anemia [7][8] - Roxadustat is already approved in Europe, Japan, and other countries for treating anemia in chronic kidney disease (CKD) patients [6][8] Treatment Landscape - Approximately 58,000 patients in the U.S. are diagnosed with lower-risk MDS (LR-MDS), with 85% suffering from anemia [2] - Current first-line treatments achieve transfusion independence in less than 50% of patients, highlighting the need for more effective options [2][4] - Roxadustat has shown benefits in transfusion independence compared to placebo in patients with high transfusion burden [2][4] Drug Mechanism - Roxadustat is an oral medication that promotes red blood cell production by increasing endogenous erythropoietin, improving iron absorption, and downregulating hepcidin [5] Market Potential - The FDA's Orphan Drug Designation provides benefits such as market exclusivity for seven years post-approval, which could enhance the commercial prospects for roxadustat [3]

5 1 ®®Resistance to venetoclax (Venclexta and Venclyxto, Abbvie / Genentech), the $2.5 billion blockbuster Chronic Lymphocytic Leukemia (CLL) therapy, is emerging as a therapeutic challenge, with leukemic cells persisting over time, even with combination therapy 2,3Studies show that sphingosine kinase 2 (SPHK2) is overexpressed in venetoclax-resistant cancer cells and that SPHK2 inhibition may reduce T-cell-induced activation and proliferation of venetoclax-resistant CLL cancer cells and resensitize previou ...

WASHINGTON, Dec. 15, 2025 /PRNewswire/ -- Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today announced the submission of a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for imsidolimab, a novel IgG4 IL-36 receptor antagonist, to treat generalized pustular psoriasis (GPP). Imsidolimab inhibits IL-36 receptor signaling, addressing the deficiency in the endogenous IL-36RA regulator commonly seen in GPP patients due to IL36RN gene mutations. GPP is a rare, chronic, life ...