Biopharmaceutical

Maze Therapeutics Doses First Patient in Phase 2 HORIZON Clinical Trial Evaluating MZE829 as a Potential Treatment for APOL1 Kidney Disease

02/14/2025

Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Feb. 07, 2025 (GLOBE NEWSWIRE) — Maze Therapeutics, Inc. (Nasdaq: MAZE), a clinical-stage biopharmaceutical company harnessing the power of human genetics to develop novel, small molecule precision medicines for patients living with renal, cardiovascular, and metabolic diseases, today announced the first patient has been dosed in…

Read More

Regulus Therapeutics Announces Positive Clinical and Regulatory Updates from its Autosomal Dominant Polycystic Kidney Disease (ADPKD) Program for Farabursen (RGLS8429)

02/10/2025

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…

Read More

CG Pharmaceuticals: Progress of U.S. Phase 1b/2 Metastatic Pancreatic Cancer Clinical Trial at the ASCO Gastrointestinal Symposium

01/28/2025

Excerpt from the Press Release: ORINDA, Calif., Jan. 23, 2025 /PRNewswire/ — CG Pharmaceuticals (CG Pharma), a clinical biopharmaceutical company located in the San Francisco Bay Area, was established as an independent entity in 2024 after licensing ivaltinostat from CG Invites. The company has since been conducting various research projects on ivaltinostat in the U.S. including…

Read More

Zai Lab Announces Acceptance of New Drug Application for KarXT for the Treatment of Schizophrenia

01/22/2025

SHANGHAI & CAMBRIDGE, Mass.–(BUSINESS WIRE)–Zai Lab Limited (NASDAQ: ZLAB; HKEX: 9688) today announced that China’s National Medical Products Administration (NMPA) has accepted the New Drug Application (NDA) for KarXT for the treatment of schizophrenia in adults. Excerpt from the Press Release: “There are more than 8 million patients living with schizophrenia in China who face…

Read More

Mersana Therapeutics Announces Positive Initial Clinical Data from Phase 1 Clinical Trial of Emiltatug Ledadotin (XMT-1660); Initiation of Expansion in Triple Negative Breast Cancer

01/17/2025

– Emiltatug ledadotin observed to be generally well tolerated with differentiated safety and tolerability profile– Promising clinical activity observed in patients with triple-negative breast cancer (TNBC) previously treated with topoisomerase-1 inhibitor (topo-1) ADCs; confirmed responses observed across all enrolled tumor types– First expansion cohort initiated in patients with TNBC previously treated with at least one…

Read More

Verastem Oncology Announces FDA Acceptance and Priority Review of New Drug Application for Avutometinib in Combination with Defactinib for the Treatment of Recurrent KRAS Mutant Low-Grade Serous Ovarian Cancer

01/13/2025

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…

Read More

NRx Pharmaceuticals, Inc. (NASDAQ:NRXP) Files Initial Section of U.S. New Drug Application to the FDA for NRX-100 (IV Ketamine) for the Treatment of Suicidal Depression

01/09/2025

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…

Read More

Biomea Fusion Announces Positive Topline Results from Ongoing Phase II COVALENT-111 Study in Patients with Type 2 Diabetes

12/24/2024

Excerpt from the Press Release: REDWOOD CITY, Calif., Dec. 17, 2024 (GLOBE NEWSWIRE) — Biomea Fusion, Inc. (“Biomea” or “Biomea Fusion” or “the Company”) (Nasdaq: BMEA), a clinical-stage biopharmaceutical company dedicated to discovering and developing oral covalent small molecules to improve the lives of patients with diabetes, obesity, and genetically defined cancers, today announced positive…

Read More

Xenetic Biosciences, Inc. Enters into Clinical Trial Services Agreement with PeriNess Ltd. to Accelerate Development of DNase I Oncology Program

12/11/2024

Collaboration utilizes PeriNess’ expertise in clinical development of human recombinant DNase and bolsters efforts towards clinical proof-of-concept studies in multiple indications Excerpt from the Press Release: FRAMINGHAM, MA / ACCESSWIRE / December 5, 2024 / Xenetic Biosciences, Inc. (NASDAQ:XBIO) (“Xenetic” or the “Company”), a biopharmaceutical company focused on advancing innovative immuno-oncology technologies addressing hard to…

Read More

89bio Presents New Analyses Evaluating Pegozafermin and Potential Benefit of Non-Invasive Tests from the ENLIVEN Phase 2b Trial in MASH Patients at AASLD The Liver Meeting® 2024

11/20/2024

New post-hoc analyses reinforce pegozafermin’s potential anti-fibrotic effects and the potential utility of non-invasive tests which correlate to histological endpoints Excerpt from the Press Release: SAN FRANCISCO, Nov. 15, 2024 (GLOBE NEWSWIRE) —  89bio, Inc. (Nasdaq: ETNB), a clinical-stage biopharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of liver…

Read More