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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) celebrates Rare Disease Day on February 28, 2023, highlighting its commitment to developing therapies for rare diseases. Acasti is focused on three clinical-stage candidates: GTX-104 for subarachnoid hemorrhage (affecting 50,000 patients in the US), GTX-102 for ataxia telangiectasia (4,500 patients in the US), and GTX-101 for postherpetic neuralgia (120,000 patients in the US). Each drug has received Orphan Drug Designation from the FDA, granting seven years of marketing exclusivity. Acasti aims to improve clinical outcomes for these underserved populations through innovative drug delivery technologies.
Acasti Pharma Inc. (Nasdaq: ACST) reported its Q3 financial results for the period ended December 31, 2022. The company has significant clinical updates, anticipating FDA guidance on its GTX-104 Phase 3 study design in Q1 2023. Successful topline results for GTX-102 and GTX-101 have been achieved, meeting primary outcome measures. Acasti ended the quarter with $31.3 million in cash. Research and development expenses rose to $2.5 million from $2.2 million year-over-year, while operating losses decreased from $4.5 million to $4.2 million. The management is optimistic about progressing its drug candidates further in 2023.
Acasti Pharma Inc. (NASDAQ: ACST) will host a conference call on February 14, 2023, at 1:00 PM ET to discuss its third-quarter financial results for the period ending December 31, 2022, and provide updates on corporate progress. The conference call can be accessed via telephone or webcast. Acasti is focused on developing clinical-stage drug candidates for rare diseases, with three lead assets, GTX-104, GTX-102, and GTX-101, each receiving Orphan Drug Designation from the FDA. This designation provides seven years of marketing exclusivity post-launch in the U.S. Acasti holds over 40 granted and pending patents for its drug delivery technologies.
Acasti Pharma Inc. (ACST) announced that it has received a 180-day extension from NASDAQ to regain compliance with the minimum bid price of $1.00 per share, extending the deadline to July 24, 2023. Previously, Acasti was notified in July 2022 for not maintaining the required bid price for 30 consecutive business days. To regain compliance, Acasti's stock must close above $1.00 for at least 10 consecutive business days. Despite the bid price issue, the company meets NASDAQ’s other continued listing requirements. Acasti focuses on developing drug candidates for rare diseases, with three lead assets targeting specific medical conditions.
Acasti Pharma, a late-stage specialty pharma company, is set to present at the Lytham Partners Investor Select Conference on January 31, 2023. CEO Jan D’Alvise will host one-on-one investor meetings during the virtual event. Acasti specializes in developing drug candidates for rare diseases, including GTX-104 for Subarachnoid Hemorrhage, GTX-102 for Ataxia-telangiectasia, and GTX-101 for Postherpetic Neuralgia. Each candidate has received Orphan Drug Designation from the FDA, granting them seven years of marketing exclusivity in the U.S. Acasti’s webcast presentation will be available on their website at 9:00 AM ET on January 31, 2023.
Acasti Pharma Inc. (Nasdaq: ACST, TSX-V: ACST) announced that CEO Jan D’alvise will present at the Sidoti January Virtual Investor Conference on January 18-19, 2023. The presentation is scheduled for 3:15 PM ET on January 18 and will be accessible live online. Acasti Pharma focuses on developing drug candidates for rare diseases, with three lead assets—GTX-104 for Subarachnoid Hemorrhage, GTX-102 for Ataxia-telangiectasia, and GTX-101 for Postherpetic Neuralgia—each having received Orphan Drug Designation from the FDA. The company aims to enhance patient outcomes through innovative drug delivery technologies.
Acasti Pharma Inc. (ACST) announced a conference call on January 10, 2023, to discuss preliminary topline results from Phase 1 pharmacokinetic studies for its drug candidates GTX-101 and GTX-102. Both studies met all primary outcome measures. GTX-101 aims to relieve pain from Postherpetic Neuralgia, while GTX-102 targets neurological symptoms of Ataxia Telangiectasia in children. The next steps include a Type B meeting with the FDA and a potential Phase 3 study for GTX-102 in late 2023. Acasti holds multiple patents and Orphan Drug Designation for its leading assets.
Acasti Pharma Inc. (Nasdaq: ACST) announced positive preliminary results from its pharmacokinetic (PK) bridging study for GTX-102, a novel oral-mucosal spray formulation. The study, involving 48 healthy adults, indicated that GTX-102 met all primary objectives related to bioavailability and safety. This formulation targets Ataxia Telangiectasia (A-T) in children, where no FDA-approved therapies currently exist. Following these results, Acasti plans to advance GTX-102 into Phase 3 trials, with a Type B meeting with the FDA anticipated in early 2023 to finalize study design.
Acasti Pharma announced that preliminary results from a pharmacokinetic (PK) bridging study for GTX-101, a new formulation of bupivacaine for treating Postherpetic Neuralgia (PHN), met all primary outcomes. The study involved 48 healthy subjects and assessed three dose levels, demonstrating GTX-101's potential for once or twice daily applications, challenging existing treatments like lidocaine patches. Looking ahead, Acasti plans a multiple ascending dose study followed by a Phase 2 efficacy study. The market for PHN treatment is significant, with a potential addressable market of $2.5 billion.
Acasti Pharma Inc. reported its Q2 results for the period ended September 30, 2022, highlighting financial and operational progress. The company anticipates receiving FDA guidance on its Phase 3 study for GTX-104 by early 2023 and plans to start patient enrollment soon after. Acasti has initiated several pharmacokinetic studies for its drug candidates GTX-102 and GTX-101, expecting results by the end of 2022. Financially, Acasti reported a net loss of $4.9 million for the quarter and had $34.9 million in cash. Management believes current funds can sustain operations into March 2024.
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