NDA
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:…
Read More
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.…
Read More
Fast Track Designation Granted for use in patients being evaluated for Alzheimer’s Disease, Progressive Supranuclear Palsy, or Corticobasal Degeneration Excerpt from the Press Release: BOSTON, Aug. 28, 2024 /PRNewswire/ — Life Molecular Imaging (LMI) is pleased to announce that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to [18F]PI-2620 Injection, an investigational…
Read More
– Preclinical data suggest combination of ziftomenib and imatinib has potential to resensitize patients to imatinib and induce durable responses – – Proof-of-concept study evaluating ziftomenib and imatinib in patients with advanced GIST to begin in 1H 2025 – Excerpt from the Press Release: SAN DIEGO, Aug. 08, 2024 (GLOBE NEWSWIRE) — Kura Oncology, Inc.…
Read More
Excerpt from the Press Release: SAN FRANCISCO, April 25, 2024 /PRNewswire/ — Freedom Biosciences, Inc. (“Freedom Bio” or the “Company”), a clinical-stage biotechnology platform focused on developing next-generation neuropsychiatric therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has notified the Company that it may proceed with its FREE001-TRD-201 study for its lead program, FREE001,…
Read More
Company advances towards their second clinical trial for SynKIR™ platform treating patients with Diffuse Large B Cell Lymphoma and other B-cell Non-Hodgkin Lymphoma subtypes who are relapsed or refractory after standard of care, including CAR T therapies Excerpt from the Press Release: PHILADELPHIA, April 3, 2024 /PRNewswire/ — Verismo Therapeutics, a clinical-stage CAR T company developing…
Read More
Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Strand Therapeutics, the programmable mRNA company developing breakthrough therapies for cancer and other diseases, today announced the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application to initiate a Phase 1, first-in-human trial of STX-001, a multi-mechanistic synthetic self-replicating mRNA technology that expresses an…
Read More
BMF-219 is a novel covalent menin inhibitor designed to regenerate insulin-producing beta cells with the aim to cure type 1 diabetes Excerpt from the Press Release: REDWOOD CITY, Calif., Oct. 05, 2023 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing novel covalent small molecules to…
Read More
– Phase 2a NASH protocol on track to be submitted to the IND in Q4 2023, enrollment expected to begin in Q1 2024 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Sept. 21, 2023 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS, “Aligos”), a clinical stage biopharmaceutical company focused on developing novel therapeutics to…
Read More
Excerpt from the Press Release: OAKLAND, Calif., Sept. 21, 2023 /PRNewswire/ — Via Nova Therapeutics, Inc., a biotechnology company focused on discovering and developing therapeutics to treat viral infections with significant unmet medical need, today announced the clearance of its Investigational New Drug (IND) application from the U.S. Food and Drug Administration (FDA) for its…
Read More