Acasti Receives Extension to Regain Compliance with NASDAQ Minimum Bid Price RuleLAVAL, Québec, Jan. 25, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announces that it has received notification from the NASDAQ Listing Qualifications Department ("NASDAQ") that it is eligible for an additional 180 calendar days, or until July 24, 2023, to regain compliance with the minimum $1.00 per share requirement for continued listing.
Acasti Pharma to Present at Lytham Partners Investor Select Conference on January 31LAVAL, Québec, Jan. 24, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced Jan D’Alvise, CEO, will present and host one-on-one meetings with investors at the Lytham Partners Investor Select Conference, taking place virtually on January 31, 2023.
Acasti Pharma to Present at Sidoti Virtual Investor Conference on January 18LAVAL, Québec, Jan. 13, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced Jan D’alvise, CEO, will present and host one-on-one meetings with investors at the Sidoti January Virtual Investor Conference, taking place on January 18-19, 2023.
Acasti to Host Conference Call on Tuesday, January 10, 2023 to Discuss Results from Recent Phase 1 PK Studies for GTX-101 and GTX-102 That Met All Outcome MeasuresLAVAL, Québec, Jan. 05, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that it will host a conference call on Tuesday, January 10, 2023 at 4:30 p.m. ET to review the recently reported preliminary topline results from two separate Phase 1 pharmacokinetic (PK) studies for GTX-101 and GTX-102. Both studies successfully met all target outcome measures.
Acasti Announces Preliminary Topline Results Met All Outcome Measures in the Pharmacokinetic Bridging Study for GTX-102, the Company’s Drug Candidate for the Treatment of Ataxia TelangiectasiaLAVAL, Québec, Dec. 28, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announces that the preliminary topline results of the pharmacokinetic (PK) bridging study for GTX-102 met all outcome measures. The objectives of the study were to evaluate the bioavailability, pharmacokinetics, and safety of GTX-102, a novel, concentrated oral-mucosal metered spray of betamethasone in healthy volunteers. This new formulation is intended to improve the neurological symptoms of Ataxia Telangiectasia (A-T) in a pediatric population for which there are currently no FDA-approved therapies. GTX-102 can be sprayed conveniently over the tongue of A-T patients, who often have difficulties swallowing. This PK study was the next step in the proposed 505(b)(2) regulatory pathway for GTX-102.
Acasti Pharma Announces Preliminary Topline Results Met All Primary Outcome Measures in the Single Dose Pharmacokinetic Study for GTX-101, the Company’s Drug Candidate for the Treatment of Postherpetic Neuralgia (PHN)LAVAL, Québec, Dec. 22, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that preliminary topline results for its single-dose, pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug in the U.S., bupivacaine subcutaneous injectable, met all primary outcome measures for the study. The final clinical study report is anticipated to be received by the Company in the first half of 2023. This PK study was the next step in the proposed 505(b)(2) regulatory pathway for GTX-101 and provides important information on the dose and dosing frequency in humans for future planned clinical studies.
Acasti Pharma to Present at Q4 Investor SummitLAVAL, Québec, Nov. 09, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, today announced that Jan D’Alvise, President and CEO of Acasti Pharma will be presenting virtually at the Q4 Investor Summit. The Company will be conducting a webcasted presentation and participating in one-on-one meetings with investors.
Acasti Announces Court Dismissal of Stockholder LitigationLAVAL, Québec, Sept. 30, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announced today that a U.S. court has dismissed the remaining stockholder litigation filed in connection with the Company’s acquisition of Grace Therapeutics, Inc. (“Grace”) via merger in August 2021 (the “Merger”). As previously disclosed, four stockholder lawsuits were filed against Acasti and certain of its directors and officers in connection with the Merger, claiming that the Company’s public disclosures relating to the Merger misstated or omitted material information and violated Section 14(a) of the U.S. Securities Exchange Act of 1934. Two of the four cases were voluntarily dismissed. The remaining two cases were consolidated before Judge Katherine Polk Failla in the United States District Court for the Southern District of New York. Acasti and the individual defendants filed a motion to dismiss on February 25, 2022. In a 45-page opinion released earlier today, Judge Failla granted the motion to dismiss in its entirety, finding that the consolidated complaint failed to allege any facts showing that Acasti made a materially misleading statement or material omission in its Merger-related disclosures. Accordingly, subject to any appeal that may be taken in response to today’s ruling, all four stockholder suits filed in connection with the Merger have now been dismissed.
Acasti Announces Voting Results from 2022 Annual and Special Meeting of ShareholdersLAVAL, Québec, Sept. 29, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (NASDAQ: ACST and TSX-V: ACST), a late-stage, specialty pharma company advancing three clinical stage drug candidates addressing rare and orphan diseases, announced today the voting results from its Annual General and Special Meeting of Shareholders (the “Meeting”) which was held virtually on Wednesday September 28, 2022.
Acasti Pharma Announces Initiation of Pharmacokinetic Study for GTX-101, the Company’s Drug Candidate for the Treatment of Postherpetic NeuralgiaLAVAL, Quebec, July 27, 2022 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (“Acasti” or the “Company”) (Nasdaq: ACST and TSX-V: ACST), today announces the initiation of its planned pharmacokinetic (PK) bridging study to evaluate the relative bioavailability of GTX-101 compared to the reference listed drug bupivacaine in 48 healthy subjects. Feedback from FDA was obtained on the study protocol, and the non-objection letter was received on July 12th from Health Canada. The First-Subject, First-Dose was administered on July 26th. The PK study is the next step in the proposed 505(b)(2) regulatory pathway for GTX-101. This study is expected to be completed by the end of calendar 2022 as planned and will provide important information on the dose and dosing frequency in humans.
