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  • Acasti Pharma (ACST) Stock Surges Following Major Clinical Trial Milestone

    Acasti Pharma (ACST) Stock Surges Following Major Clinical Trial Milestone

    The shares of Acasti Pharma Inc. (NASDAQ: ACST) saw a sharp rise when the company reported that its clinical studies were making substantial progress. The day before, ACST shares had a noteworthy 19.53% increase, ultimately ending at $3.06. Growing investor trust in the company’s continuous research activities is reflected in this increasing trend.

    Acasti Completed STRIVE-ON Trial Patient Enrollment

    An essential stage in the assessment of GTX-104, patient registration for Acasti’s Phase 3 STRIVE-ON safety study is now complete. This trial is a prospective, open-label, randomized, parallel-group research design that compares GTX-104 with oral nimodipine in a cohort of 100 patients hospitalized for aneurysmal subarachnoid hemorrhage (aSAH).

    About twenty-five hospitals throughout the country are participating in this significant trial, illustrating the wide-ranging cooperation needed to further this study.

    An Understanding of Aneurysmal Subarachnoid Hemorrhage (aSAH)

    The characteristic feature of the potentially fatal medical condition known as aneurysmal subarachnoid hemorrhage is blood seeping into the subarachnoid space, which is the region between the brain and bone. Serious difficulties can result from an aneurysm burst, which is frequently the source of this illness.

    According to statistics, more than 30% of individuals with aSAH pass away within a month of the bleeding, and over 70% either die or become dependent on treatment for the rest of their lives. Every year, over 50,000 people in the United States alone receive a diagnosis of aSAH; instances have also been documented in China and the European Union.

    ACST’s Future Expectations and Regulatory Pathway

    The completion of enrollment in the STRIVE-ON trial marks a significant achievement for Acasti, occurring ahead of its anticipated timeline. The company is optimistic that if GTX-104 receives approval, it could revolutionize treatment protocols for patients with aSAH, particularly addressing the challenges associated with the administration of oral nimodipine.

    Acasti (ACST) expects to announce data results from the STRIVE-ON trial in early 2025 and aims to submit a New Drug Application to the U.S. Food and Drug Administration in the first half of next year, aligning with its strategic goals. The primary endpoint of the trial focuses on safety, specifically evaluating comparative adverse events, such as hypotension, between the two patient groups.

  • Why Acasti (ACST) Stock Rose 22% In After Hours Trades?

    Acasti Pharma Inc. (ACST) shares were rising 22.04% to trade at $0.659 in after-hours at last check. As of the last check, shares of Ascasti Pharma Inc. (ACST) had risen 22.04% to $0.659 in after-hours trading. On Tuesday, Acasti stock closed at $0.54, up 10.20% from the previous close. Volume for Acasti stock increased to 33.61 million shares, which was higher than the average daily volume of 13.28 million shares during the 50-day period.

    ACST shares dropped -25.10 percent over the last year, while they gained 2.86% over the last week. ACST stock fell -18.37% in the past six months, and 109.30% over the past three months. ACST’s current market value is $108.06 million, and as of June 22 it has 200.12 million shares outstanding. ACST stock experienced a boost from releasing its year-end report for fiscal 2021.

    ACST has updated what?

    Acasti is a biopharmaceutical innovator specializing in OM3 fatty acids produced from krill oil and delivered as free fatty acids and phospholipid esters bound to phospholipids. There is extensive clinical evidence that using OM3 fatty acids to lower triglycerides in patients who have hypertriglyceridemia, or HTG will be safe and effective. ACST has developed CaPre, a medication for treating severe HTG, a phospholipid OM3 product.

    Acasti yesterday announced its financial and operating results for the fiscal year that ended March 31, 2021. ACST also provided an update on acquisition of Grace Therapeutics and the CaPre strategic evaluation process.

    Financial Highlights:

    • Operating loss for the year ended March 31, 2020 was $16.4 million compared to $24.4 million for 2020.
    • For the reported period, ACST posted a net loss of $19.7 million or $0.17 per share, a decrease of $5.8 million compared with the net loss of $25.5 million or $0.30 per share a year ago.
    • The cost of R&D before depreciation, amortization, and stock-based compensation for the year ended March 31, 2021 was $2.9 million, compared with $13.2 million for the same period last year.
    • In March 2021, cash and cash equivalents totaled $50.9 million, compared with $14.2 million in March 2020.

    Acquisition strategy:

    Acasti (ACST)’s management and board evaluated dozens of companies and undertook comprehensive due diligence on several finalist candidates as part of its formal process to explore and evaluate a range of strategic alternatives to enhance shareholder value.

    By combining with Grace, ACST plans to create a “rare disease” company whose advanced drug delivery technologies will not only enable ACST to rapidly advance current assets through clinical trials, but also foster in-house development of new treatment options.