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Acasti Pharma Inc. (Nasdaq: ACST) announced it has received FDA feedback regarding its proposed Phase 3 Safety Study for GTX-104, targeting aneurysmal Subarachnoid Hemorrhage (aSAH). The FDA supports Acasti's 505(b)(2) regulatory pathway and acknowledges the adequacy of the GTX-104-002 PK study as a scientific bridge. The Phase 3 trial will involve a randomized study across 25-30 U.S. sites, with safety as the primary endpoint. Acasti aims to quickly finalize and submit the clinical protocol to the FDA, and if successful, will file for NDA under Section 505(b)(2). The addressable market for GTX-104 is estimated at $300 million.
Acasti Pharma Inc. has announced the appointment of Prashant Kohli as the new CEO, succeeding Jan D'Alvise. The transition follows a mutual agreement for D'Alvise to step down from her role. Kohli, previously the Chief Commercial Officer, brings over 20 years of experience in commercialization and a strong background in managing strategies for drug candidates targeting rare diseases. Acasti is advancing its late-stage clinical program, GTX-104, into a Phase 3 safety study for treating Subarachnoid Hemorrhage (SAH). The company holds three drug candidates with Orphan Drug Designation from the FDA, enhancing its market exclusivity.
Acasti Pharma Inc. has announced the immediate resignation of board member Jean-Marie (John) Canan. The board expressed gratitude for his contributions and wishes him success in future endeavors. Acasti specializes in developing drug candidates for rare and orphan diseases, with three clinical assets: GTX-104 for Subarachnoid Hemorrhage, GTX-102 for Ataxia-telangiectasia, and GTX-101 for Postherpetic Neuralgia. Each asset has Orphan Drug Designation from the FDA, providing seven years of marketing exclusivity in the U.S. Acasti aims to enhance drug delivery technologies for improved patient outcomes.
Acasti Pharma Inc. has announced its voluntary delisting from the TSX Venture Exchange, effective March 27, 2023, while retaining its NASDAQ listing under ticker symbol ACST. This strategic move aims to streamline operations, as management believes the trading volume on TSXV does not justify the related expenses. The company emphasizes that this change will enhance liquidity and shareholder value by centralizing trading on NASDAQ. Additionally, Acasti confirms no financial ties with Silicon Valley Bank or Silvergate Bank, having financed operations through equity rather than debt.
Acasti Pharma Inc. (Nasdaq: ACST) announced CEO Jan D'alvise will present at the Oppenheimer 33rd Annual Healthcare Conference, scheduled for March 13-15, 2023. The presentation will be accessible on March 13 at 8:00 AM ET via a dedicated webcast link. Acasti will also facilitate virtual one-on-one meetings with investors during the conference. The company focuses on developing drug delivery technologies for rare diseases, with three lead candidates granted Orphan Drug Designation by the FDA, including GTX-104 for Subarachnoid Hemorrhage and GTX-102 for Ataxia-telangiectasia. For more information, visit Acasti's website.