Acasti Pharma, Inc. - ACST STOCK NEWS

Acasti Pharma Inc. (NASDAQ: ACST) announced a conference call on November 14, 2022, at 1 PM ET to discuss its corporate progress and financial results for Q2 2023 ending September 30, 2022. The call can be accessed via telephone or webcast. Acasti specializes in developing clinical stage drug candidates for rare diseases, with three lead assets holding Orphan Drug Designation from the FDA. These drug candidates aim to enhance efficacy and patient compliance, aligning with their mission to address unmet medical needs.

Acasti Pharma Inc. (Nasdaq: ACST) announced that a U.S. court has dismissed all stockholder litigation related to its 2021 acquisition of Grace Therapeutics. The court found no evidence of materially misleading statements or omissions in the company's disclosures regarding the merger. Initially, four lawsuits were filed; two were voluntarily dismissed, and the remaining cases were consolidated. This ruling is significant for Acasti as it mitigates potential legal risks associated with the merger and allows the company to focus on advancing its clinical stage drug candidates targeting rare diseases.

Acasti Pharma Inc. (NASDAQ: ACST) held its Annual General and Special Meeting of Shareholders on September 28, 2022. All five nominees were elected as directors, serving until the 2023 meeting. KPMG LLP was reappointed as independent auditor. Shareholders approved the compensation for named executive officers and amendments to the Stock Option and Equity Incentive Plans, increasing share issuance limits to 20%. Additionally, 220,000 stock options were granted to directors with a price of CDN$ 0.80 per share. Key clinical candidates target rare diseases and have received Orphan Drug Designation from the FDA.

Acasti Pharma Inc. (Nasdaq: ACST) will participate in the Lytham Partners Fall 2022 Investor Conference, scheduled virtually for September 28-29, 2022. The company's webcast presentation is set for 9:00 am ET on September 28 and can be accessed on their website. Acasti's management will also join a panel discussion on orphan drugs addressing rare diseases on the same day at 2:00 pm ET. Additionally, the management will hold one-on-one meetings throughout the event. Acasti specializes in drug delivery technologies for rare and orphan diseases, with three key assets receiving Orphan Drug Designation from the FDA.

Acasti Pharma has initiated a pharmacokinetic bridging study for its oral betamethasone spray, GTX-102, targeting Ataxia Telangiectasia (A-T), a rare genetic disorder in children. Conducted on 48 healthy subjects, this study compares GTX-102 to both an intramuscular injection and an oral solution of betamethasone. Results are expected by year-end 2022. If successful, Acasti plans to advance into Phase 3 trials in 2023. Additionally, Prashant Kohli has been appointed as Chief Commercial Officer.

Acasti Pharma will participate virtually in the H.C. Wainwright 24th Annual Global Investment Conference from September 12-16, 2022. Management will hold one-on-one meetings during the event, and a webcasted presentation will be available to registered attendees.

Acasti focuses on drug delivery technologies for rare diseases, with three lead assets granted Orphan Drug Designation by the FDA, ensuring seven years of marketing exclusivity. These assets target conditions such as Subarachnoid Hemorrhage, Ataxia-telangiectasia, and Postherpetic Neuralgia.

Acasti Pharma reported its financial results for Q1 ending June 30, 2022, revealing a net loss of $4.5 million, or $0.10 per share, with $38.4 million in cash reserves. The company is preparing to submit GTX-104's PK bridging study results to the FDA and plans to initiate a Phase 3 safety study in H1 2023. GTX-101 and GTX-102 are also on track for key studies, bolstered by FDA Orphan Drug Designation. R&D expenses increased to $2.6 million, emphasizing progress in clinical programs. The company anticipates sufficient funds to operate through March 2024.

Acasti Pharma will hold a conference call on August 11, 2022, at 1:00 PM Eastern Time to discuss its Q1 2023 financial results and corporate developments.

Acasti is a late-stage specialty pharma focused on drug delivery technologies for rare diseases, with three lead assets granted Orphan Drug Designation by the FDA. The company is positioned to improve treatment efficacy and patient compliance with innovative therapies targeting serious conditions.

Acasti Pharma has initiated a pharmacokinetic bridging study for GTX-101, a novel topical formulation of bupivacaine, to address postherpetic neuralgia (PHN). The study, involving 48 healthy subjects, aims to assess the drug's bioavailability compared to standard bupivacaine injections. Following FDA feedback and a Health Canada non-objection letter, the first dose was administered on July 26, 2022. Completion is anticipated by the end of 2022. GTX-101 is designed for ease of application and may reduce opioid prescriptions, addressing significant unmet pain relief needs in PHN patients.