FDA
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…
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– Marks historic milestone and opens new frontier in transplantation to address kidney shortage affecting millions of patients globally – Transplant was conducted at Massachusetts General Hospital and authorized by the U.S. FDA under a single Expanded Access protocol Excerpt from the Press Release: CAMBRIDGE, Mass.–(BUSINESS WIRE)–eGenesis, a biotechnology company developing human-compatible engineered organs to…
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Company will initiate Phase 1 study of CLN-619 for relapsed or refractory multiple myeloma, first MICA/B antibody clinical study in hematologic malignancies Follows ongoing clinical study of CLN-619 alone and in combination with pembrolizumab in solid tumors, with anticipated updated clinical data in Q2 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., March 01, 2024…
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Preclinical Studies Show DA-1726 Elicits Superior Weight Loss Compared to Semaglutide (Wegovy™) and Similar Weight Loss Compared to Tirzepatide (Mounjaro™), While Consuming More Food Initiation of Phase 1 Clinical Trial Expected to Occur in the First Half of 2024 Excerpt from the Press Release: CAMBRIDGE, Mass., Feb. 1, 2024 /PRNewswire/ — NeuroBo Pharmaceuticals, Inc. (Nasdaq:…
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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…
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Excerpt from the Press Release: LOS ANGELES–(BUSINESS WIRE)–Puma Biotechnology, Inc. (NASDAQ: PBYI), a biopharmaceutical company (the Company), announced the design of the Phase II trial of alisertib for the treatment of patients with HER2-negative, hormone receptor-positive metastatic breast cancer (PUMA-ALI-1201). Based on the Company’s interactions with the U.S. Food and Drug Administration (FDA), the Company…
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— Caribou met with the FDA and reached alignment on a pivotal trial in 2L LBCL with CB-010 versus a comparator arm of immunochemotherapy followed by HDCT and ASCT — — ANTLER Phase 1 trial continues dose expansion enrollment; initial dose expansion data and RP2D expected Q2 2024 — — Caribou plans to initiate Phase…
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Phase 1 single ascending and multiple ascending dose studies previously completed demonstrate safety, tolerability and dosing to reach optimal target engagement Excerpt from the Press Release: SAN FRANCISCO, Nov. 16, 2023 /PRNewswire/ — Lighthouse Pharmaceuticals, a clinical-stage biopharmaceutical company pioneering precision medicine for the treatment of Alzheimer’s and other diseases of aging, today announced clearance by…
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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…
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– 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…
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