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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 announced its corporate name change to Grace Therapeutics, effective October 28, 2024, when it will begin trading on Nasdaq under the symbol 'GRCE'. The name change reflects the company's connection to Grace Therapeutics, which developed GTx-104 before merging with Acasti in 2021. The company has fully enrolled its STRIVE-ON trial for GTx-104, a novel injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH), with data readout expected in early 2025 and NDA submission planned for first half 2025. Recent corporate developments include restructuring to a biopharma model, management team rebuilding, pipeline prioritization, legacy asset divestment, and re-domiciling to Delaware.
Acasti Pharma Inc. (Nasdaq: ACST) has announced the completion of patient enrollment in its Phase 3 STRIVE-ON safety trial for GTX-104, a novel injectable formulation of nimodipine for aneurysmal subarachnoid hemorrhage (aSAH). The trial, involving 100 patients across approximately 25 U.S. hospitals, compares GTX-104 to oral nimodipine in a 1:1 ratio. Prashant Kohli, CEO of Acasti, expressed excitement about this milestone, achieved ahead of schedule.
The company anticipates a data readout from the STRIVE-ON trial in early 2025 and plans to submit a New Drug Application to the FDA in the first half of 2025. The primary endpoint of the trial is safety, measured by comparative adverse events, including hypotension, between the two patient groups. If approved, GTX-104 could potentially address challenges with oral nimodipine administration and transform the standard of care for aSAH patients.
Acasti Pharma (Nasdaq: ACST) announced its participation in the upcoming Life Sciences Investor Forum on September 19, 2024. CEO Prashant Kohli will present live at 12:30 PM EDT, showcasing the company's progress on GTX-104, a novel injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH).
The event, hosted by VirtualInvestorConferences.com, offers investors an interactive platform to engage with the company in real-time. One-on-one meetings will be available on September 19 & 23. For those unable to attend live, an archived webcast will be provided. Investors are encouraged to pre-register and perform system checks to ensure smooth participation.
Acasti Pharma Inc. (ACST) announced its participation in the H.C. Wainwright 26th Annual Global Investment Conference from September 9-11, 2024, in New York. CEO Prashant Kohli will be available for one-on-one meetings on September 9-10. The company's corporate presentation will be accessible on-demand starting September 9th at 7:00 AM EDT.
Acasti is a late-stage biopharma company developing GTX-104, a novel injectable formulation of nimodipine. This treatment targets high unmet medical needs for aneurysmal subarachnoid hemorrhage (aSAH), a rare disease. The conference participation offers an opportunity for investors to learn more about Acasti's progress and potential in addressing this critical medical condition.
Acasti Pharma Inc. (Nasdaq: ACST) has announced financial results and business updates for Q1 FY2025. Key highlights include:
1. Surpassed 50% enrollment in Phase 3 STRIVE-ON safety trial for GTX-104
2. Anticipates 100% enrollment by late 2024 or early 2025
3. NDA submission planned for H1 2025
4. Net loss of $2.6 million ($0.24 per share), down from $4.0 million in Q1 FY2024
5. R&D expenses increased to $2.7 million from $1.1 million year-over-year
6. Cash position of $19.4 million, projected runway into Q2 2026
The company is progressing well with its novel injectable formulation of nimodipine (GTX-104) for treating aneurysmal subarachnoid hemorrhage (aSAH), a rare disease.
Acasti Pharma (Nasdaq: ACST) has achieved a significant milestone in its pivotal Phase 3 STRIVE-ON safety trial for GTX-104, a novel injectable formulation of nimodipine targeting aneurysmal subarachnoid hemorrhage (aSAH). The company announced that over 50% of the 100-patient enrollment target has been reached. The trial, comparing IV GTX-104 with oral nimodipine, focuses on safety, particularly adverse events like hypotension. Enrollment began in October 2023, and the company expects to complete it by late 2024 to early 2025, with a potential NDA submission in the first half of 2025. CEO Prashant Kohli attributes this progress to the dedication of clinical trial sites and the Acasti team. Dr. Abhishek Ray from Case Western Reserve University highlighted the challenges of oral nimodipine in aSAH patients and the promise of GTX-104 as an IV alternative.
Acasti Pharma (NASDAQ: ACST) released its year-end 2024 financial results and provided a business update. The company highlighted the ongoing Phase 3 STRIVE-ON trial for GTX-104, a novel injectable nimodipine formulation targeting aneurysmal subarachnoid hemorrhage (aSAH). Patient enrollment is on track, with a potential NDA submission expected in H1 2025. A $7.5 million private placement in September 2023 has extended Acasti's cash runway into Q2 2026. For fiscal year 2024, Acasti reported a net loss of $12.9 million, a significant improvement from the $42.4 million loss in 2023, mainly due to non-recurring asset impairments. R&D expenses dropped to $4.7 million from $10.0 million year-over-year, while G&A expenses decreased to $6.4 million from $7.6 million. As of March 31, 2024, Acasti held $23 million in cash and cash equivalents.
Acasti Pharma (Nasdaq: ACST), a late-stage biopharma company, announced it will attend the BIO International Convention in San Diego from June 3-6, 2024. The focus will be on GTX-104, an injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH). CEO Prashant Kohli will hold meetings to explore partnerships and strategic opportunities. Interested parties can arrange meetings via the BIO International portal or by contacting mmoyer@lifesciadvisors.com.
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