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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) announces significant patent developments for its lead drug candidates. The European Patent Office intends to grant a patent for GTX-104, an IV formulation for subarachnoid hemorrhage, valid until 2037. The U.S. Patent and Trademark Office has allowed a patent for GTX-102, an oral mucosal formulation for ataxia-telangiectasia, also valid until 2037. Additionally, Japan granted a patent for GTX-101, a topical spray for postherpetic neuralgia, valid until 2036. These patents enhance Acasti's intellectual property and potentially streamline the regulatory approval process.
Acasti Pharma Inc. (Nasdaq: ACST, TSX-V: ACST) announced that CEO Jan D’Alvise will present at the 32nd Annual Oppenheimer Healthcare Conference from March 15-17, 2022. The presentation is scheduled for March 16 at 12:40 PM ET and will be available via webcast. Acasti specializes in drug delivery technologies targeting orphan diseases, with three lead clinical assets—GTX-104, GTX-102, and GTX-101—each having Orphan Drug Designation from the U.S. FDA. The company aims to improve treatment compliance and patient outcomes.
Acasti Pharma Inc. (Nasdaq: ACST) provided a business update and financial results for the third quarter of fiscal 2022. The company reported a net loss of $3.8 million ($0.09 per share), up from a loss of $3.2 million a year earlier, mainly due to increased research and development expenses. GTX-104's pivotal PK bridging study is progressing with positive interim results, and GTX-102 and GTX-101 are on schedule. Acasti expects significant milestones in 2022 that could enhance shareholder value by addressing rare diseases.
Acasti Pharma Inc. (NASDAQ: ACST) announced a conference call on February 14, 2022, at 1:00 PM ET to discuss its corporate progress and fiscal Q3 results for the year ending December 31, 2021. The call can be accessed via phone or webcast, with a replay available afterward. Acasti focuses on developing drug delivery technologies for orphan diseases, with three lead clinical assets, GTX-104, GTX-102, and GTX-101, each receiving Orphan Drug Designation from the FDA, potentially offering seven years of market exclusivity in the U.S. and a strong patent portfolio.
Acasti Pharma Inc. (Nasdaq: ACST) announced that President and CEO Jan D’Alvise will present at the H.C. Wainwright BioConnect 2022 Conference held virtually from January 10-13, 2022. The presentation will be available on-demand starting at 7:00 AM Eastern Time on January 10, 2022. Acasti specializes in drug delivery technologies for rare diseases and has three lead clinical assets granted Orphan Drug Designation by the FDA. These assets target conditions like Subarachnoid Hemorrhage, Ataxia-Telangiectasia, and Postherpetic Neuralgia.
Acasti Pharma announced positive interim results for GTX-104 in a pivotal pharmacokinetic study, indicating favorable bioavailability compared to oral nimodipine. The study met primary endpoints for Maximum Concentration on Day 1 and Area Under Curve on Day 3. No serious adverse events were reported, with only mild effects observed. The company anticipates reporting full results in H1’22 and aims to proceed with a Phase 3 Safety Study post-results. GTX-104's potential market is estimated at $300M in the US, with 50,000 patients affected annually.
Acasti Pharma Inc. (Nasdaq: ACST) announced that its President and CEO, Jan D’Alvise, will participate in the Benzinga All Access event on December 2, 2021, at 12:00 PM ET. The event will feature an interview conducted by Spencer Israel, aimed at providing insights into the company's developments. Acasti, a specialty pharma company, focuses on drug delivery technologies for rare diseases. They have received Orphan Drug Designation for three clinical assets, targeting conditions like Subarachnoid Hemorrhage, Ataxia-telangiectasia, and Postherpetic Neuralgia.
Acasti Pharma has announced the annual grant of 2,077,900 stock options to its employees, executives, and directors under its Stock Option Plan. Each option allows the purchase of one common share at an exercise price of CDN $2.05, expiring in ten years. Directors' options will vest over 12 months, while those for executives and employees will vest over 36 months. Acasti focuses on drug delivery technologies for rare diseases, holding Orphan Drug Designation for its three lead assets, each targeting serious conditions with no existing treatments.
Acasti Pharma announced its second quarter fiscal 2022 results, reporting a net income of $1.0 million or $0.03 per share, a significant improvement over the net loss of $6.1 million in the prior year. The company completed a successful merger with Grace Therapeutics, acquiring clinical assets for rare diseases. It initiated a PK bridging study for GTX-104, with results expected in H1 2022. Acasti holds $50.8 million in cash, providing an operating runway of at least two years. The company has secured multiple patents, enhancing its intellectual property portfolio.
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