FDA
Excerpt from the Press Release: BOSTON and ATLANTA, Aug. 26, 2022 /PRNewswire/ — Inhibikase Therapeutics, Inc. (Nasdaq: IKT) (Inhibikase), a clinical-stage pharmaceutical company developing protein kinase inhibitor therapeutics to modify the course of Parkinson’s disease, Parkinson’s-related disorders and other diseases of the Abelson Tyrosine Kinases, today announced that the U.S. Food and Drug Administration (FDA)…
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The first-of-its-kind, CRISPR-based therapeutic aims to stop the progression of Duchenne muscular dystrophy in a single-patient dosing Excerpt from the Press Release: BOSTON–(BUSINESS WIRE)–Cure Rare Disease (CRD) – a Boston-based 501c3 nonprofit biotech – announces the approval from the U.S. Food and Drug Administration (FDA) to administer its very first therapeutic. The drug, named CRD-TMH-001, treats…
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Company to Move Forward with Key U.S. Regulatory Applications – Investigational New Drug and Orphan Drug Designation BOSTON, July 26, 2022 (GLOBE NEWSWIRE) — Aisa Pharma, Inc. a privately-funded, clinical-stage biopharmaceutical company, today announced that the Data Safety Monitoring Board (DSMB) for the RECONNOITER Phase 2 study of Aisa’s Profervia® once-daily novel, oral calcium-channel antagonist…
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– 200mg and 400mg Once-Daily Doses Achieved Strong Exposure Multiples Over EC90 and Were Generally Safe and Well-Tolerated – Plan to Initiate Phase 2 Study in 4Q 2022 Excerpt from the Press Release: WATERTOWN, Mass.–(BUSINESS WIRE)–Enanta Pharmaceuticals, Inc. (NASDAQ: ENTA), a clinical-stage biotechnology company dedicated to creating novel, small molecule drugs for viral infections and liver…
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Phase 2a trial initiation planned for the first half of 2023 subject to IND clearance and available capital Excerpt from the Press Release: NEWTON, Mass. and GENEVA, Switzerland, July 28, 2022 (GLOBE NEWSWIRE) — Acer Therapeutics Inc. (Nasdaq: ACER) (Acer) and its collaboration partner, RELIEF THERAPEUTICS Holding SA (SIX: RLF, OTCQB: RLFTF, RLFTY) (Relief), today…
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LBS-008 (a/k/a Tinlarebant) is the Company’s orally administered tablet for the treatment of Stargardt disease (STGD1) There are currently no approved treatments for STGD1 Approximately 30,000 patients in the U.S. suffer from STGD1 A 2-year Phase 2 trial in adolescent STGD1 and a global Phase 3 trial in adolescent STGD1 are ongoing The Phase 3,…
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Represents First Ever Epigenomic Controller, a New Class of Programmable mRNA Therapeutics, to Receive IND Clearance Phase 1/2 Clinical Trial Expected to Launch in 2H’22 and Will Evaluate the Safety and Preliminary Antitumor Activity of OTX-2002 Excerpt from the Press Release: CAMBRIDGE, Mass., July 14, 2022 /PRNewswire/ — Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”), today announced that it has received…
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CAMBRIDGE, Mass.–(BUSINESS WIRE)–LG Chem recently announced the enrollment of first subject in Phase 1 clinical trial of LG203003, LG Chem’s second NASH (non-alcoholic steatohepatitis) drug in development. Excerpt from the Press Release: LG203003 received clearance from the U.S. Food and Drug Administration (FDA) in March 2022 for the Company’s Investigational New Drug (IND) application to…
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FDA indicates the Company may proceed with the Phase 3 clinical study of buntanetap for the treatment of Parkinson’s disease Excerpt from the Press Release: BERWYN, Pa., July 7, 2022 /PRNewswire/ — Annovis Bio, Inc. (NYSE: ANVS) (“Annovis” or the “Company”), a late-stage clinical drug platform company addressing neurodegenerative diseases, announced today that the Company…
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– REACH is the first Phase 3 trial for this rare, progressive, and debilitating muscular disease –– Losmapimod is an oral small molecule that has the potential to be the first therapy to treat FSHD, the second most common form of muscular dystrophy –– U.S. Food and Drug Administration (FDA) granted Fast Track Designation in 2021 –…
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