NDA
The planned Phase 3 program consists of three trials, SYNCHRONY Histology, SYNCHRONY Real-World, and SYNCHRONY Outcomes to evaluate the safety and efficacy of efruxifermin (EFX) in patients with NASH SYNCHRONY Histology and SYNCHRONY Real-World are expected to begin enrollment in the second half of this year Consistent with the encouraging clinical profile to date reported…
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NTLA-2002 is a single dose, in vivo genome editing candidate designed to prevent potentially life-threatening swelling attacks in people with HAE Excerpt from the Press Release: CAMBRIDGE, Mass., March 02, 2023 (GLOBE NEWSWIRE) — Intellia Therapeutics, Inc. (NASDAQ:NTLA), a leading clinical-stage genome editing company focused on developing potentially curative therapies leveraging CRISPR-based technologies, today announced…
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– Phase 1 trial showed 30% CR rate among 20 NPM1-mutant AML patients treated at recommended Phase 2 dose – – Phase 2 registration-directed trial expected to enroll 85 patients in the U.S. and Europe – Excerpt from the Press Release: SAN DIEGO, Feb. 09, 2023 (GLOBE NEWSWIRE) — Kura Oncology, Inc. (Nasdaq: KURA), a…
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BCMA/CD19 dual-targeting FasTCAR-T GC012F has demonstrated deep responses and favorable safety profile in proof of concept clinical studies Company plans to initiate Phase 1b/2 clinical trial in the U.S. in second quarter of 2023 Excerpt from the Press Release: SAN DIEGO Calif., and SUZHOU and SHANGHAI, China, Feb. 3, 2023 /PRNewswire/ — Gracell Biotechnologies Inc. (“Gracell”…
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TNG908 granted Orphan Drug Designation in U.S. for the treatment of malignant glioma Excerpt from the Press Release: BOSTON, Jan. 25, 2023 (GLOBE NEWSWIRE) — Tango Therapeutics, Inc. (NASDAQ: TNGX), a clinical-stage biotechnology company committed to discovering and delivering the next generation of precision cancer medicines, today announced that the U.S. Food and Drug Administration…
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Excerpt from the Press Release: As we begin a new year, a singular message rings true across all pockets of the life science industry – we must ‘do more with less.’ This message was echoed during the recent JP Morgan Healthcare Conference and will continue to resonate throughout the year. The macroeconomic conditions facing our…
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Excerpt from the Press Release: BOSTON, Jan. 26, 2023 (GLOBE NEWSWIRE) — LAPIX Therapeutics, Inc. (“LAPIX”), a biopharma company focused on developing novel, orally bioavailable immune system restoration therapies for autoimmune diseases and oncology, today announced the successful outcome of its pre-IND meeting request with the U.S. Food and Drug Administration (FDA). The meeting’s objective…
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Excerpt from the Press Release: PRINCETON, N.J., January 18, 2023 – Taiho Oncology, Inc. today announced the publication of results from the pivotal Phase 2 FOENIX*-CCA2 clinical trial of futibatinib in the January 19, 2023 issue of The New England Journal of Medicine (NEJM). The article, “Futibatinib for Intrahepatic Cholangiocarcinoma with FGFR2 Fusions/Rearrangements,” reports on…
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IND demonstrates Mirati’s leadership in KRAS, representing the Company’s third KRAS or KRAS-signaling program to enter clinical development Excerpt from the Press Release: SAN DIEGO, Jan. 19, 2023 /PRNewswire/ — Mirati Therapeutics, Inc. (NASDAQ: MRTX), announced today the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application of MRTX1133, a potential…
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Excerpt from the Press Release: CAMBRIDGE, Mass., ROTTERDAM, Netherlands and SUZHOU, China, Jan. 12, 2023 /PRNewswire/ — Harbour BioMed (the”Company”, HKEX: 02142) announced that the U.S. Food and Drug Administration (FDA) has cleared the investigational new drug (IND) application to commence clinical trials of its globally first-in-class fully human monoclonal antibody HBM1020 targeting B7H7 (also known…
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