FDA
Excerpt from the Press Release: SAN DIEGO and SHANGHAI, May 4, 2023 /PRNewswire/ — ABM Therapeutics, an innovative clinical-stage biopharmaceutical company, with an emphasis on developing drugs with high blood–brain barrier (BBB) penetration for CNS diseases including brain metastases, today announced that the first patient was successfully dosed with ABM-168 in the United States. MEK…
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Excerpt from the Press Release: SOUTH SAN FRANCISCO, Calif.–(BUSINESS WIRE)–Vega Therapeutics, Inc., a clinical stage biotechnology company developing novel therapies for rare blood disorders, today announced that its clinical trial program for VGA039 has been initiated. The first subject has been dosed in the Phase 1 study of VGA039 (NCT05776069), a multinational clinical trial being…
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Excerpt from the Press Release: CONCORD, Mass., March 30, 2023 /PRNewswire/ — Comanche Biopharma Corp., a biopharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has cleared an investigational new drug (IND) application for Comanche’s novel, siRNA therapy to treat preeclampsia. Preeclampsia is a prevalent hypertensive disorder of pregnancy for which there…
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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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QTORIN™ rapamycin generally well-tolerated; no drug related severe adverse events and no observed rapamycin in systemic circulation 100% of participants were either “Much Improved” or “Very Much Improved” as rated by the Clinician Global Impression of Change following 12-weeks of QTORIN™ rapamycin End of Phase 2 meeting completed with U.S. Food and Drug Administration in…
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Excerpt from the Press Release: MALVERN, Pa., March 10, 2023 (GLOBE NEWSWIRE) — Galera Therapeutics, Inc. (Nasdaq: GRTX), a clinical-stage biopharmaceutical company focused on developing and commercializing a pipeline of novel, proprietary therapeutics that have the potential to transform radiotherapy in cancer, today announced the presentation of a net treatment benefit analysis of Phase 3…
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Based upon observed efficacy and safety profile, Praxis intends to engage with the FDA in an end of Phase 2 meeting and initiate a ulixacaltamide Phase 3 study for the treatment of essential tremor in 2H23 Ulixacaltamide demonstrated improvement in modified Activities of Daily Living (mADL) primary efficacy endpoint relative to placebo that did not…
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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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