NDA
Excerpt from the Press Release: BERWYN, Pa., Oct. 6, 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 U.S. Food and Drug Administration (FDA) has authorized the Phase 2/3 clinical study of buntanetap in moderate Alzheimer’s Disease (AD). Following the…
Enrollment continues in clinical trial of MB-106 under Mustang’s IND; next data disclosure anticipated 4Q 2022 Ongoing clinical trial of MB-106 at Fred Hutch continues to demonstrate high efficacy, durable responses, and favorable safety profile across wide range of hematologic malignancies Excerpt from the Press Release: WORCESTER, Mass., Oct. 06, 2022 (GLOBE NEWSWIRE) — Mustang…
Initiation of Phase 1/2a Clinical Trial Expected to Occur in Q4 2022 Excerpt from the Press Release: CAMBRIDGE, Mass., Sept. 30, 2022 (GLOBE NEWSWIRE) — Immuneering Corporation (Nasdaq: IMRX), a biopharmaceutical company that aims to create medicines for all patients with solid tumors driven by RAS mutations and other MAPK pathway activation events, today announced…
Excerpt from the Press Release: SAN FRANCISCO, CA / ACCESSWIRE / September 29, 2022 / Napo Pharmaceuticals, Inc. (“Napo”), the wholly-owned subsidiary of Jaguar Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”) today announced the activation by the U.S. Food and Drug Administration (FDA) of the Investigational New Drug (IND) application for Napo’s NP-300, a novel…
CE-VST-01-JC is a novel, allogeneic, off-the-shelf, T cell therapy that targets the JC Virus, the virus that causes progressive multifocal leukoencephalopathy (PML) ASCEND-JC is a randomized, double-blind, placebo-controlled, phase 2 study with sites planned across US, Europe, and Canada Licensed and developed in collaboration with QIMR Berghofer Medical Research Institute’s Professor Rajiv Khanna; NIH’s Irene…
Submission follows completion of first-in-class trial demonstrating significant improvements in A1c reduction with investigational therapy targeting the root causes of type 2 diabetes. Excerpt from the Press Release: SAN FRANCISCO–(BUSINESS WIRE)–Better Therapeutics, Inc. (NASDAQ: BTTX), a prescription digital therapeutics (PDT) company developing a novel form of cognitive behavioral therapy (CBT) to address the root causes…
Excerpt from the Press Release: SAN DIEGO, Aug. 08, 2022 (GLOBE NEWSWIRE) — TRACON Pharmaceuticals, Inc. (Nasdaq: TCON), a clinical stage biopharmaceutical company utilizing a cost-efficient, CRO-independent product development platform to advance its pipeline of novel targeted cancer therapeutics and to partner with other life science companies, today announced that the company submitted an Investigational…
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…
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…
Investigational New Drug Application Submitted by Omega Represents the First Epigenomic Controller in a New Class of Programmable mRNA Therapeutics Excerpt from the Press Release: CAMBRIDGE, Mass., June 15, 2022 /PRNewswire/ — Omega Therapeutics, Inc. (Nasdaq: OMGA) (“Omega”) today announced the submission of an Investigational New Drug (IND) application to the U.S. Food and Drug…