Acasti Pharma Inc - ACST STOCK NEWS

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.