Acasti Pharma Inc Stock Price, News & Analysis

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.