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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 (Nasdaq: ACST) announced an update on its plans to acquire Grace Therapeutics and its fiscal results for the year ended March 31, 2021. The acquisition aims to enhance shareholder value by leveraging Grace’s innovative drug delivery technologies and diverse pipeline addressing rare diseases. Acasti expects over $60 million in cash post-acquisition, providing operational runway for clinical developments. For FY 2021, Acasti reported a reduced net loss of $19.7 million, down from $25.5 million in FY 2020, as R&D expenses declined significantly from $13.2 million to $2.9 million.
Acasti Pharma announced receiving a notice from Nasdaq regarding potential delisting due to non-compliance with the $1.00 bid price requirement as of May 10, 2021. The company plans to request a hearing before the Nasdaq Hearings Panel to avoid delisting and intends to present a compliance plan, including the possible implementation of a share consolidation. Acasti aims to regain compliance by November 8, 2021, in connection with its proposed acquisition of Grace Therapeutics, Inc. Further updates will be provided regarding the hearing process.
Acasti Pharma Inc. has announced a definitive agreement to acquire Grace Therapeutics, a private biopharmaceutical company. This acquisition focuses on a pipeline for rare and orphan disease treatments, including three clinical-stage assets with Orphan Drug Designation from the FDA. The deal is expected to close with approximately $64 million in cash to further develop these assets. The combined entities aim to enhance clinical outcomes by utilizing innovative drug delivery technologies for conditions with significant unmet medical needs.
Acasti Pharma Inc. (NASDAQ: ACST) provided an update on its "at-the-market" (ATM) equity offering program. Since January 27, 2021, Acasti issued 20,159,229 common shares for gross proceeds of $21.7 million, sold at an average price of $1.0747 per share. The company now has 200,119,659 shares outstanding. The raised capital enhances Acasti's balance sheet, offering flexibility for evaluating strategic alternatives.
Acasti Pharma announced its third-quarter financial results for fiscal 2021, reporting a net loss of $3.2 million ($0.03 per share), a significant decrease from $12.1 million ($0.14 per share) in Q3 2020. The loss from operations was $2.0 million, down from $6.1 million a year prior, primarily due to lower R&D and operational expenses. Cash reserves stood at $26.5 million, up from $14.2 million since March 2020. Acasti is engaged in a strategic review process with Oppenheimer & Co., aimed at enhancing shareholder value, although outcomes remain uncertain.
Acasti Pharma Inc. (NASDAQ: ACST) announced the results of its Annual and Special Meeting of Shareholders held on September 30, 2020. Key outcomes include the election of Roderick N. Carter, Jean-Marie Canan, Jan D’Alvise, and Donald Olds as directors. KPMG LLP was appointed as the Corporation's auditors. Shareholders passed advisory votes approving the compensation of named executive officers and the frequency of future ‘say-on-pay’ votes. Amendments to the Stock Option Plan and Equity Incentive Plan were also approved, pending TSX-V final approval.
Acasti Pharma Inc. (ACST) has begun a formal process to explore strategic alternatives to enhance shareholder value, engaging Oppenheimer & Co. as a financial advisor. The company has not committed to any specific outcome or timeline for these efforts. Concurrently, Acasti plans to complete detailed analyses of the TRILOGY 2 data, including secondary endpoints and pooling results from TRILOGY 1 and 2. The company cautions that forward-looking statements in this press release involve risks and uncertainties, and actual results may differ.
Acasti Pharma has appointed Brian D. Ford as the new Chief Financial Officer, effective September 14, 2020, after the resignation of Jean-Francois Boily. Ford, with over 30 years of experience in finance, brings valuable skills in mergers and acquisitions and strategic transactions, previously serving at medical clinics and Telesta Therapeutics. CEO Jan D’Alvise expressed confidence that Ford's expertise will enhance Acasti's value. The company is currently evaluating strategic options and opportunities moving forward.
Acasti Pharma Inc. (NASDAQ: ACST) has filed a management proxy statement for its annual and special meeting on September 30, 2020. The meeting will be held virtually at 1:00 p.m. ET, allowing shareholders to listen, submit questions, and vote online. The record date for eligible shareholders has been changed to September 8, 2020. Additionally, the board has proposed amendments to the Stock Option Plan and the Equity Incentive Plan, establishing a fixed stock option and equity incentive pool representing 15% of outstanding shares. Jean-François Boily has resigned as Vice-President, Finance.
Acasti Pharma (NASDAQ: ACST) announced top-line results from its Phase 3 TRILOGY 2 study, evaluating its drug candidate CaPre for severe hypertriglyceridemia. The study reported a 30.4% median triglyceride reduction among patients on CaPre, similar to the 30.5% in the previous TRILOGY 1. However, the primary endpoint was not met, with a placebo-corrected reduction of 12.4% and a p-value of 0.19. Consequently, Acasti will not file for a New Drug Application with the FDA and will not pursue further trials for CaPre.
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