NDA

ABM Announces First Patient Dosed in Phase I Clinical Trial of MEK Inhibitor for Solid Tumor

05/09/2023

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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Comanche Biopharma Announces FDA Clearance of Investigational New Drug (IND) Application for CBP-4888, an siRNA Investigational Therapy for the Treatment of Preeclampsia

04/10/2023

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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Akero Therapeutics Announces Positive End-of-Phase 2 Meeting with the FDA and SYNCHRONY Phase 3 Program for Efruxifermin in NASH

04/04/2023

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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Intellia Therapeutics Announces FDA Clearance of Investigational New Drug (IND) Application for NTLA-2002, an In Vivo CRISPR-Based Investigational Therapy for the Treatment of Hereditary Angioedema (HAE)

03/08/2023

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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Kura Oncology Announces First Patients Dosed in Phase 2 Registration-Directed Trial of Ziftomenib in NPM1-Mutant Acute Myeloid Leukemia

02/16/2023

– 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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Gracell Biotechnologies Announces FDA Clearance of the IND Application for Phase 1b/2 Clinical Trial of FasTCAR-T GC012F for the Treatment of Relapsed/Refractory Multiple Myeloma

02/08/2023

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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Tango Therapeutics Announces FDA Clearance of Investigational New Drug Application for TNG462; Provides Additional Business Updates

02/06/2023

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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Executing in a Year of Correction: Doing More with Less

02/02/2023

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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LAPIX Therapeutics Inc. Announces a Successful Conclusion of its Pre-IND Meeting Request with the U.S. FDA

02/01/2023

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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Taiho Oncology Announces Publication in The New England Journal of Medicine of Pivotal Data for Futibatinib in Previously Treated Patients With Metastatic Intrahepatic Cholangiocarcinoma

01/25/2023

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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