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Acasti Pharma Inc. - $ACST STOCK NEWS

Welcome to our dedicated page for Acasti Pharma news (Ticker: $ACST), a resource for investors and traders seeking the latest updates and insights on Acasti Pharma stock.

Acasti Pharma, Inc. (NASDAQ: ACST) is a cutting-edge pharmaceutical company headquartered in Quebec, specializing in developing innovative drug delivery technologies. As a subsidiary of Neptune Technologies & Bioressources, Acasti leverages marine phospholipids to create products used in prescription medications, medical foods, and over-the-counter applications, targeting cardiometabolic disorders.

Acasti Pharma is at the forefront of addressing rare and orphan diseases with its late-stage specialty pharmaceutical development. The company is particularly known for its advanced drug delivery technologies that enhance the performance of existing drugs, offering faster onset of action, improved efficacy, reduced side effects, and more convenient delivery methods. This focus aims to increase treatment compliance and enhance patient outcomes.

The company's flagship development program is GTX-104, a novel formulation of nimodipine designed for intravenous infusion to treat aneurysmal subarachnoid hemorrhage (aSAH), a life-threatening condition. Recently, Acasti Pharma has made significant strides in advancing GTX-104 through pivotal Phase 3 clinical trials known as STRIVE-ON. The U.S. Food and Drug Administration (FDA) has confirmed the 505(b)(2) regulatory pathway for GTX-104, a critical milestone. Furthermore, Acasti has aligned with the FDA on the Phase 3 trial protocol, with patient dosing expected to start in the second half of 2023.

In the financial realm, Acasti reported substantial progress in its fiscal year ending March 31, 2023. The company maintained $27.9 million in cash, cash equivalents, and short-term investments, providing a runway through Q2 2025 to achieve key milestones, including a potential NDA filing for GTX-104. Additionally, the company has streamlined its operations, focusing resources exclusively on GTX-104 while evaluating strategic alternatives for other pipeline assets like GTX-101 and GTX-102.

Acasti’s financial health remains robust, with significant reductions in general and administrative expenses due to strategic realignment efforts. The company has also successfully raised an additional $7.5 million in a private placement, extending its cash runway into the first calendar quarter of 2026.

The company's leadership, led by CEO Prashant Kohli, has demonstrated a commitment to achieving critical milestones and enhancing shareholder value. With over 40 granted and pending patents and Orphan Drug Designation from the FDA, Acasti Pharma is well-positioned to bring new treatment options to markets with high unmet medical needs.

For more information, visit Acasti Pharma's website.

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Acasti Pharma (Nasdaq: ACST), a late-stage biopharma company, announced it will attend the BIO International Convention in San Diego from June 3-6, 2024. The focus will be on GTX-104, an injectable nimodipine formulation for aneurysmal subarachnoid hemorrhage (aSAH). CEO Prashant Kohli will hold meetings to explore partnerships and strategic opportunities. Interested parties can arrange meetings via the BIO International portal or by contacting mmoyer@lifesciadvisors.com.

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Acasti Pharma Inc. announced an extended cash runway into Q2 2026, well beyond the potential NDA submission for GTX-104 in 1H 2025. Patient enrollment for the pivotal STRIVE-ON Phase 3 trial continues as planned. Financially, the company reported a net loss of $2.4 million for Q3 2024, decreased from $3.9 million in Q3 2023.
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Acasti Pharma Inc. (ACST) announces that its pivotal Phase 3 STRIVE-ON safety trial has been accepted for presentation at the 2024 International Stroke Conference. The trial focuses on the safety and tolerability of GTX-104, a novel formulation of nimodipine, in patients with aneurysmal subarachnoid hemorrhage (aSAH). The trial design includes approximately 100 patients enrolled at 25 hospitals in the U.S., with the primary endpoint being comparative adverse events, including hypotension, between patients administered GTX-104 and oral nimodipine. The results will be presented at the conference on February 8th.
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Acasti Pharma Inc. (Nasdaq: ACST) announced CEO Prashant Kohli's participation in investor and industry networking events in San Francisco to present GTX-104, the novel intravenous formulation of nimodipine for aSAH treatment.
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Acasti Pharma Inc. (Nasdaq: ACST) announced the dosing of the first patient in the STRIVE-ON Phase 3 trial for GTX-104, secured $7.5 million in private placement equity financing, and presented positive results on the potential of GTX-104 as a new treatment standard for aSAH. The company also shared financial results for the quarter ended September 30, 2023, highlighting a net loss of $3.3 million.
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Acasti Pharma announces enrollment milestone in Phase 3 STRIVE-ON safety trial for GTX-104
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Acasti Pharma Inc. will host a virtual KOL event titled GTX-104: a potential new treatment standard for rare and life-threatening aSAH on October 11, 2023. The event will feature discussions on the high unmet medical need and current treatment landscape for aSAH patients. Acasti's lead clinical asset, GTX-104, a novel formulation of nimodipine, is currently in Phase 3 targeting aSAH as an intravenous infusion.
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Acasti Pharma Inc. has closed a private placement, raising approximately $7.5 million. The funds will be used for clinical trial expenses and other corporate purposes.
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Acasti Pharma to present at H.C. Wainwright Global Investment Conference
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Acasti Pharma Inc. (Nasdaq: ACST) announced financial results and business highlights for the quarter ended June 30, 2023, emphasizing the progress in executing the strategic vision for the development of GTX-104. The company is focused on the Pivotal STRIVE-ON Phase 3 Safety Trial for GTX-104, with the first patient expected to be dosed prior to the end of 2023. Cash and cash equivalents were $21.6 million, projected to fund the clinical development of GTX-104 until Q2 2025. Additionally, the company's pharmacokinetic comparison of GTX-104 with oral nimodipine was accepted for presentation at the 2023 Neurocritical Care Society (NCS) annual meeting.
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FAQ

What is Acasti Pharma's main focus?

Acasti Pharma specializes in developing advanced drug delivery technologies for treating rare and orphan diseases, particularly through its lead product, GTX-104.

What is GTX-104?

GTX-104 is an injectable formulation of nimodipine designed for intravenous infusion, targeting the treatment of aneurysmal subarachnoid hemorrhage (aSAH).

What financial milestones has Acasti Pharma achieved recently?

Acasti Pharma reported $27.9 million in cash and assets for the fiscal year ending March 31, 2023, and has extended its cash runway into the first calendar quarter of 2026 through a recent $7.5 million private placement.

What are the recent achievements of Acasti Pharma?

Acasti Pharma received FDA confirmation for the regulatory pathway of GTX-104, initiated the STRIVE-ON Phase 3 trial, and aligned its operations to focus exclusively on GTX-104.

What is the potential market for GTX-104?

The addressable market for GTX-104 in the United States is estimated to be about $300 million.

How does GTX-104 improve patient outcomes?

GTX-104 offers faster onset of action, enhanced efficacy, reduced side effects, and more convenient drug delivery, which can improve treatment compliance and patient outcomes.

What strategic changes has Acasti Pharma implemented?

Acasti Pharma has streamlined its operations to focus exclusively on GTX-104 and has restructured to reduce costs and extend its cash runway.

Who is leading Acasti Pharma?

Acasti Pharma is led by CEO Prashant Kohli, who has brought in a highly experienced management team with expertise in clinical trials and rare diseases.

What is the significance of Orphan Drug Designation for Acasti's products?

Orphan Drug Designation provides Acasti's products with seven years of market exclusivity post-launch in the United States, along with additional intellectual property protection.

Where can I get more information about Acasti Pharma?

For more details, visit Acasti Pharma’s official website at https://www.acastipharma.com/en.

Acasti Pharma Inc.

Nasdaq:ACST

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Medicinal and Botanical Manufacturing
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