NDA
Patent Enhances IP Estate for Lead Asset; Combined with Anticipated Biologics Exclusivity, Market Protections Extend Over 20 Years Excerpt from the Press Release: PRINCETON, N.J., Jan. 22, 2026 (GLOBE NEWSWIRE) — PDS Biotechnology Corporation (Nasdaq: PDSB) (“PDS Biotech” or the “Company”), a late-stage immunotherapy company focused on transforming how the immune system targets and kills…
THE COMPANY EXPECTS TO RELEASE TOPLINE RESULTS FOR SKNJCT-003 PHASE 2 CLINICAL TRIAL BEFORE THE END OF Q1 2026 AND REQUEST END-OF-PHASE 2 (EOP2) WITH THE FOOD AND DRUG ADMINISTRATION (FDA) IN H1 2026 Excerpt from the Press Release: PHILADELPHIA, Dec. 15, 2025 (GLOBE NEWSWIRE) — Medicus Pharma Ltd. (NASDAQ: MDCX) (“Medicus” or the “Company”),…
73% of trial participants (11/15 participants) improved on the Overall Cutaneous Venous Malformations Investigator Global Assessment (Overall cVM-IGA) at Week 12; 67% of trial participants (10/15 participants) rated as “Much Improved” (+2) or “Very Much Improved” (+3) on the Overall cVM-IGA at Week 12 Achieved statistical significance on multiple pre-specified clinician-reported and patient-reported efficacy endpoints,…
Excerpt from the Press Release: SAN DIEGO–(BUSINESS WIRE)–Alume Biosciences, a late-clinical stage biotechnology company developing nerve-illuminating technology to enhance surgical safety, today announced the publication of first-in-human data from a Phase 1 clinical trial evaluating bevonescein (ALM-488) in head and neck surgeries. The original research article titled, “Intraoperative Nerve-Specific Fluorescence Imaging in Head and Neck…
Excerpt from the Press Release: BOSTON & SHENZHEN, China–(BUSINESS WIRE)–Signet Therapeutics, a clinical-stage biotech company leveraging organoid- and AI-driven cancer drug discovery, announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation for SIGX1094, the world’s first potential targeted therapy for diffuse gastric cancer (DGC). This designation is designed to accelerate…
Topline data from an interim analysis of the fourth cohort of its Phase 1b Multiple-Ascending Dose (MAD) clinical trial showed continued mechanistic dose response Exploratory results of imaging-based biomarkers continued to show reduction in height-adjusted total kidney volume (htTKV) growth rate Successful End-of-Phase 1 meeting with the U.S. Food and Drug Administration (FDA) with agreement…
PDUFA target action date is June 30, 2025 If approved, avutometinib in combination with defactinib would be the first-ever FDA-approved treatment specifically for adults with recurrent KRAS mutant LGSOC cerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Verastem Oncology (Nasdaq: VSTM), a biopharmaceutical company committed to advancing new medicines for patients with cancer, today announced that the…
Excerpt from the Press Release: WILMINGTON, Del., Dec. 30, 2024 /PRNewswire/ — NRx Pharmaceuticals, Inc. (Nasdaq: NRXP) (“NRx”, the “Company”), a clinical-stage biopharmaceutical company, today announced the transmission of first section of its New Drug Application (NDA) for NRX-100 (ketamine) for electronic filing with the U.S. Food & Drug Administration (FDA). NRX-100 was initially granted…
Recurrent low-grade serous ovarian cancer is a rare cancer with no FDA-approved treatments Company seeking accelerated approval and priority review of its NDA submission in patients with KRAS mutant low-grade serous ovarian cancer; FDA filing decision expected before the end of 2024 with potential for FDA approval decision by mid-2025 Excerpt from the Press Release:…
Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–HiFiBiO Therapeutics, a clinical stage biotechnology company focused on immune modulation, today announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for HFB200604. HFB200604 is a best-in-class BTLA agonist monoclonal antibody, developed using HiFiBiO’s proprietary Drug Intelligence Science (DIS®) platform.…