Acasti Pharma

Acasti Pharma, Inc. is a biopharmaceutical company, which engages in the development and commercialization of pharmaceutical applications of its licensed rights for cardiovascular diseases. It focuses on the research of prescription drugs using omega-3, fatty acids derived from krill oil. The company was founded by Henri Harland and Pierre Lemieux on February 1, 2002 and is headquartered in Laval, Canada.

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Grace Therapeutics, Inc. is a biopharmaceutical company, which engages in the development and commercialization of pharmaceutical applications of its licensed rights for cardiovascular diseases. It focuses on the research of prescription drugs using omega-3, fatty acids derived from krill oil. The company was founded by Henri Harland and Pierre Lemieux on February 1, 2002, and is headquartered in Princeton, NJ.

Name Change Reflects Extensive Scientific and Corporate Brand Equity Previously Established under Grace Therapeutics Grace Therapeutics will begin trading on Nasdaq under the trading symbol "GRCE" effective October 28, 2024 Virtual Key Opinion Leader Event to be held on November 20 th PRINCETON, N.J., Oct. 25, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTx-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that it is changing its name to Grace Therapeutics, Inc. (Grace Therapeutics).

Acasti Announces Corporate Name Change to Grace Therapeutics, Inc.

Data Readout Expected Early Calendar 2025; NDA Submission on Track for 1H Calendar 2025 Data Readout Expected Early Calendar 2025; NDA Submission on Track for 1H Calendar 2025

Acasti Announces Completion of Patient Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial of GTX-104

PRINCETON, N.J., Sept. 05, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company will participate in the H.C. Wainwright 26th Annual Global Investment Conference, to be held September 9th – 11th in New York, NY.

Acasti to Participate in the H.C. Wainwright 26th Annual Global Investment Conference

PRINCETON, N.J., Aug. 09, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced financial results and business highlights for the quarter ended June 30, 2024.

Acasti Announces First Fiscal Quarter 2025 Financial Results, Provides Business Update

Here is how Acasti Pharma (ACST) and Cigna (CI) have performed compared to their sector so far this year.

Is Acasti Pharma (ACST) Outperforming Other Medical Stocks This Year?

Company Anticipates Completion of Patient Enrollment in the STRIVE-ON Trial in Late 2024 to Early 2025, with Potential NDA Submission on Track for 1H Calendar 2025 Company Anticipates Completion of Patient Enrollment in the STRIVE-ON Trial in Late 2024 to Early 2025, with Potential NDA Submission on Track for 1H Calendar 2025

Acasti Announces Achievement of 50% Enrollment in Pivotal Phase 3 STRIVE-ON Safety Trial

PRINCETON, N.J., June 21, 2024 (GLOBE NEWSWIRE) --  Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced financial results and business highlights for the year ended March 31, 2024.

Acasti Announces Year-End 2024 Financial Results, Provides Business Update

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PRINCETON, N.J., May 28, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel, injectable formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company will be participating in the BIO International Convention taking place at the San Diego Convention Center from June 3-6, 2024.

Acasti Pharma to Attend BIO International Convention 2024

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PRINCETON, N.J., Feb. 12, 2024 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced financial results and business highlights for the quarter ended December 31, 2023.

Acasti Announces Third Fiscal Quarter 2024 Financial Results and Business Highlights

Accepted for Presentation at the 2024 International Stroke Conference Accepted for Presentation at the 2024 International Stroke Conference

Acasti Announces Poster Detailing its GTX-104 STRIVE-ON Trial

PRINCETON, N.J., Dec. 13, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel intravenous formulation of nimodipine being developed to address the high unmet medical needs for a rare disease, aneurysmal Subarachnoid Hemorrhage (aSAH), today announced that Chief Executive Officer Prashant Kohli will participate in the following investor and industry networking events in San Francisco, California during the week of January 7-12, 2024.

Acasti to Participate in Upcoming San Francisco Investor Conferences in January 2024

PRINCETON, N.J., Nov. 13, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced financial results and business highlights for the quarter ended September 30, 2023.

Acasti Announces Second Quarter 2024 Financial Results and Business Highlights

PRINCETON, N.J., Oct. 23, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced enrollment of the first patient in the Company's pivotal Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405). UTHealth Houston is the first site to enroll an aSAH patient in the STRIVE-ON trial.

Acasti Announces Dosing of First Patient in GTX-104 STRIVE-ON Trial

PRINCETON, N.J., Oct. 04, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that it will host a virtual KOL event titled GTX-104: a potential new treatment standard for rare and life-threatening aSAH on Wednesday, October 11, 2023 at 2:00pm ET.

Acasti Pharma to Host KOL Event on GTX-104: A Potential New Treatment Standard for Rare and Life-Threatening aneurysmal Subarachnoid Hemorrhage (aSAH)

PRINCETON, N.J., Sept. 26, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that it has closed a private placement of the Company's securities pursuant to the terms of a securities purchase agreement, dated September 24, 2023, by and between the Company and certain institutional and accredited investors (the “Purchase Agreement”). Pursuant to the terms of the Purchase Agreement, the Company issued and sold an aggregate of 1,951,371 common shares, no par value per share, pre-funded warrants (the “Pre-funded Warrants”) to purchase up to an aggregate of 2,106,853 common shares, each at a purchase price of $1.8481 per common share or Pre-funded Warrant (less $0.0001 per Pre-funded Warrant) and accompanying common warrants (the “Common Warrants”) to purchase up to an aggregate of 2,536,391 common shares, in a private placement priced at-the-market under Nasdaq rules. The private placement closed on September 25, 2023.

Acasti Announces $7.5 Million Private Placement Equity Financing

PRINCETON, N.J., Sept. 06, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company's management will be participating in the 25th Annual H.C. Wainwright Global Investment Conference, to be held September 11-13 , 2023 in New York, NY.

Acasti to Participate in the H.C. Wainwright Global Investment Conference

PRINCETON, N.J, Aug. 11, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) (Acasti or the Company), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced financial results and business highlights for the quarter ended June 30, 2023.

Acasti Announces First Quarter 2024 Financial Results and Business Highlights

PRINCETON, N.J., Aug. 09, 2023 (GLOBE NEWSWIRE) -- Acasti Pharma Inc. (Nasdaq: ACST) ("Acasti" or the "Company"), a late-stage, biopharma company advancing GTX-104 its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that a poster presenting a pharmacokinetic comparison of GTX-104 with oral nimodipine has been accepted for presentation at the 2023 Neurocritical Care Society (NCS) annual meeting, to be held in Phoenix, AZ August 15-18, 2023.

Acasti to Present GTX-104 Pharmacokinetic Comparison Data at Neurocritical Care Annual Meeting

STRIVE-ON is a pivotal Phase 3 trial of GTX-104 to evaluate its comparable safety and tolerability profile relative to oral nimodipine in patients hospitalized with aSAH LAVAL, QB, July 10, 2023 /PRNewswire/ -- Acasti Pharma Inc. (Nasdaq: ACST) ("Acasti" or the "Company"), a late-stage, biopharma company advancing GTX-104, today announced WuXi Clinical Development, Inc. ("WuXi Clinical"), a wholly owned subsidiary of WuXi AppTec, a global Contract Research Organization (CRO), will conduct Acasti's STRIVE-ON Phase 3 safety trial for GTX-104. GTX-104 is Acasti's novel, injectable nimodipine formulation for intravenous infusion (IV) that addresses high, unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH).

Acasti Announces WuXi Clinical as CRO to Conduct STRIVE-ON Pivotal Phase 3 Safety Trial for GTX-104 in aSAH Patients

LAVAL, QB, July 7, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company will effect a 1-for-6 reverse split of its issued and outstanding common shares. The reverse stock split will become effective July 10, 2023 at 12:01 a.m.

Acasti Pharma Announces 1-for-6 Reverse Stock Split

STRIVE-ON is the pivotal Phase 3 trial of GTX-104 to evaluate its comparable safety and tolerability profile relative to oral nimodipine in patients hospitalized with aSAH GTX-104 has been administered in over 150 healthy volunteers to-date and has demonstrated comparable safety profile to oral nimodipine Company confirms its projected cash runway through a potential GTX-104 New Drug Application (NDA) submission in the first half of calendar 2025 LAVAL, QC , July 5, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel injectable nimodipine formulation for intravenous infusion (IV) that addresses high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced that the Company has aligned with the U.S. Food and Drug Administration (FDA) on the protocol for its pivotal Phase 3 trial of GTX-104 and the FDA also provided guidance for a potential GTX-104 New Drug Application (NDA) package. Acasti has all the necessary information from the FDA to initiate its recently named STRIVE-ON (Safety, Tolerability, Randomized, IV and Oral Nimodipine) pivotal Phase 3 trial of GTX-104 to evaluate its safety and tolerability profile relative to oral nimodipine.

Acasti Announces Alignment with FDA on GTX-104 Pivotal Phase 3 Safety Trial Protocol and Confirms Planned Initiation of STRIVE-ON in aSAH Patients in Calendar Q4 2023

LAVAL, Québec, June 23, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced financial and operational results for the fiscal year ended March 31, 2023. Recent Highlights United States Food and Drug Administration (FDA) has confirmed the 505(b)(2) regulatory pathway for GTX-104 and that the GTX-104-002 PK study may have met the criteria for a scientific bridge.

Acasti Pharma Reports Fiscal Year 2023 Operational Results

LAVAL, QC , June 22, 2023 /PRNewswire/ -- Acasti Pharma Inc. ("Acasti" or the "Company") (Nasdaq: ACST), a late-stage, biopharma company advancing GTX-104, its novel formulation of nimodipine that addresses the high unmet medical needs for a rare disease, aneurysmal subarachnoid hemorrhage (aSAH), today announced the appointment of W. Taylor Kimberly, MD, PhD, Alejandro A.

News for Acasti Pharma Stock (ACST)