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Acasti Pharma, Inc. (NASDAQ: ACST) is a cutting-edge pharmaceutical company headquartered in Quebec, specializing in developing innovative drug delivery technologies. As a subsidiary of Neptune Technologies & Bioressources, Acasti leverages marine phospholipids to create products used in prescription medications, medical foods, and over-the-counter applications, targeting cardiometabolic disorders.
Acasti Pharma is at the forefront of addressing rare and orphan diseases with its late-stage specialty pharmaceutical development. The company is particularly known for its advanced drug delivery technologies that enhance the performance of existing drugs, offering faster onset of action, improved efficacy, reduced side effects, and more convenient delivery methods. This focus aims to increase treatment compliance and enhance patient outcomes.
The company's flagship development program is GTX-104, a novel formulation of nimodipine designed for intravenous infusion to treat aneurysmal subarachnoid hemorrhage (aSAH), a life-threatening condition. Recently, Acasti Pharma has made significant strides in advancing GTX-104 through pivotal Phase 3 clinical trials known as STRIVE-ON. The U.S. Food and Drug Administration (FDA) has confirmed the 505(b)(2) regulatory pathway for GTX-104, a critical milestone. Furthermore, Acasti has aligned with the FDA on the Phase 3 trial protocol, with patient dosing expected to start in the second half of 2023.
In the financial realm, Acasti reported substantial progress in its fiscal year ending March 31, 2023. The company maintained $27.9 million in cash, cash equivalents, and short-term investments, providing a runway through Q2 2025 to achieve key milestones, including a potential NDA filing for GTX-104. Additionally, the company has streamlined its operations, focusing resources exclusively on GTX-104 while evaluating strategic alternatives for other pipeline assets like GTX-101 and GTX-102.
Acasti’s financial health remains robust, with significant reductions in general and administrative expenses due to strategic realignment efforts. The company has also successfully raised an additional $7.5 million in a private placement, extending its cash runway into the first calendar quarter of 2026.
The company's leadership, led by CEO Prashant Kohli, has demonstrated a commitment to achieving critical milestones and enhancing shareholder value. With over 40 granted and pending patents and Orphan Drug Designation from the FDA, Acasti Pharma is well-positioned to bring new treatment options to markets with high unmet medical needs.
For more information, visit Acasti Pharma's website.
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.
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