Biopharmaceutical

Biomea Fusion Announces First Patient Dosed with Chronic Lymphocytic Leukemia (CLL) in COVALENT-101 Trial

11/01/2022

COVALENT-101 now includes patients with relapsed/refractory (R/R) CLL BMF-219 is the first menin inhibitor in the clinic for CLL Preclinical data presented at ASCO 2022 demonstrated the potency of BMF-219, a covalent menin inhibitor, across varying cytogenetic risk profiles and Rai stages, indicating broad activity with over 98% cell lethality in these CLL models at…

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Neurocrine Biosciences Initiates Phase 2 Clinical Study Evaluating NBI-1117568 in Adults with Schizophrenia

11/01/2022

NBI-1117568 is an Investigational, First-in-Class, Muscarinic M4 Selective Agonist Excerpt from the Press Release: SAN DIEGO, Oct. 27, 2022 /PRNewswire/ — Neurocrine Biosciences, Inc. (Nasdaq: NBIX), a leading neuroscience-focused biopharmaceutical company, today announced the first patient has been randomized for its Phase 2 placebo-controlled, inpatient clinical study evaluating the efficacy, safety, tolerability, and pharmacokinetics of investigational compound…

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Verastem Oncology Appoints Anil Kapur to Board of Directors

10/27/2022

Excerpt 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 the appointment of Anil Kapur to its Board of Directors, effective October 20, 2022. Mr. Kapur is the Executive Vice President, Corporate Strategy and Chief Commercial Officer at Geron Corporation. “Anil’s deep…

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Harbour BioMed Announces Dosing of First Patient in Phase I Trial of B7H4x4-1BB Bispecific Antibody in the United States

10/26/2022

Excerpt from the Press Release: CAMBRIDGE, Mass., ROTTERDAM and SUZHOU, China, Oct. 20, 2022 /PRNewswire/ — Harbour BioMed (“HBM”, HKEX: 02142) announced that, it has successfully completed the dosing of first patient in the global phase I trial of B7H4x4-1BB bispecific antibody HBM7008 in the United States. This study will evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics,…

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Enrollment Completed in Phase 3 PATHFNDR-1 Study Evaluating Oral Paltusotine for the Treatment of Acromegaly

10/24/2022

Topline results for PATHFNDR-1 study expected in Q3 2023 Excerpt from the Press Release: SAN DIEGO, Oct. 13, 2022 (GLOBE NEWSWIRE) — Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced the completion of enrollment in the Phase 3 PATHFNDR-1 study. PATHFNDR-1 is one of two ongoing, placebo-controlled Phase 3 studies evaluating the safety and efficacy of…

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BridgeBio Pharma Presents 12-month Results from Phase 2 Study of BBP-418 in Limb-Girdle Muscular Dystrophy Type 2i (LGMD2i)

10/20/2022

Novel assay developed to assess the extent of alpha-dystroglycan (⍺DG) glycosylation, the core pathology of LDMD2i, from muscle biopsy samples Increase in the ratio of glycosylated αDG to total αDG from baseline towards normal levels, suggesting that the investigational oral therapy, BBP-418, has the potential to address the root cause of LGMD2i Large, sustained reduction…

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Aligos Therapeutics Initiates Dosing In Healthy Volunteers With siRNA Drug Candidate ALG-125755

10/20/2022

Single ascending doses to be evaluated in healthy volunteers in Q4 2022 Single ascending doses to be evaluated in subjects with chronic hepatitis B beginning in Q1 2023 Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif., Oct. 14, 2022 (GLOBE NEWSWIRE) — Aligos Therapeutics, Inc. (Nasdaq: ALGS), a clinical stage biopharmaceutical company focused on…

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Lyell Immunopharma Announces FDA Clearance of its IND for LYL845, a TIL Product Candidate Enhanced with its Novel Epigenetic Reprogramming Technology for Solid Tumors

10/19/2022

Autologous TIL therapy enhanced with Lyell’s Epi-R™ reprogramming technology designed to create polyclonal T cell populations with properties of durable stemness and improved function Phase 1 trial to initially enroll patients with relapsed and/or refractory metastatic or locally advanced melanoma and subsequently expand into non-small cell lung cancer and colorectal cancer Initial data presentation expected…

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Exelixis Expands Clinical Trial Collaboration and Supply Agreement with Bristol Myers Squibb to Include the Fixed-Dose Combination of Nivolumab and Relatlimab in Combination with XL092 in Phase 1b STELLAR-002 Trial

10/18/2022

— Agreement enables evaluation of XL092 in combination with an additional immune checkpoint inhibitor — Excerpt from the Press Release: ALAMEDA, Calif.–(BUSINESS WIRE)–Exelixis, Inc. (Nasdaq: EXEL) today announced the expansion of its June 2021 Clinical Trial Collaboration and Supply Agreement with Bristol-Myers Squibb Company (NYSE: BMY) to include the use of the fixed-dose combination of…

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ImpediMed Announces U.S. Launch of Lymphedema Prevention Program with GenesisCare a Global Organization Dedicated to Care of Cancer Patients

10/17/2022

Excerpt from the Press Release: CARLSBAD, Calif. and BRISBANE, Australia, Oct. 4, 2022 /PRNewswire/ — ImpediMed Limited (ASX.IPD) is pleased to announce the signing of a Global Strategic Commercial Partnership and pilot program with GenesisCare. The pilot program will consist of an initial roll out of five (5) SOZO® units to establish lymphedema screening services…

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