Acasti Pharma (ACST) FDA Approvals

Acasti Pharma's Drug in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Acasti Pharma (ACST). Over the past two years, Acasti Pharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as GTX-104. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

GTX-104 FDA Regulatory Timeline and Events

GTX-104 is a drug developed by Acasti Pharma for the following indication: IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH). This drug is under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Results - September 22,2025

Phase 3

• Drug: GTX-104
• Announced Date: September 22, 2025
• Indication: IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH)

Grace Therapeutics, Inc. announced that results from its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH (the STRIVE-ON trial–NCT05995405) were presented at the 2025 Neurocritical Care Society annual meeting, held in Montreal, Quebec, Canada September 18-21, 2025.

Grace Therapeutics, Inc. announced results from its Phase 3 STRIVE-ON safety trial of GTx-104 presented at the 2025 Neurocritical Care Society annual meeting, held in Montreal, Quebec, Canada, September 18–21, 2025.

In an oral presentation titled “Safety and Tolerability of GTx-104 (Nimodipine Injection for I.V. Infusion) Compared with Oral Nimodipine in Patients with Aneurysmal Subarachnoid Hemorrhage,” Dr. H. Alex Choi highlighted that GTx-104 is safe and well tolerated in aSAH patients.

The trial compared 50 patients receiving GTx-104 by intravenous infusion with 52 patients on standard oral nimodipine. GTx-104 reduced episodes of drug-related hypotension and showed improvements in ICU length of stay and lower need for mechanical ventilation.

These findings suggest GTx-104 could offer a better alternative to oral nimodipine for hospitalized aSAH patients. Attendees at the conference responded positively, noting the potential for improved blood pressure management and dose compliance.

Provided Update - September 18,2025

• Drug: GTX-104
• Announced Date: September 18, 2025
• Indication: IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH)

Grace Therapeutics, Inc announced that the U.S. Patent and Trademark Office has issued a U.S. Patent No. 12,414,943, titled "Nimodipine Parenteral Administration".

Grace Therapeutics, Inc. announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 12,414,943, titled “Nimodipine Parenteral Administration.” This first method-of-use patent for the company’s novel injectable GTx-104 formulation covers the IV dosing regimen tested in the Phase 3 STRIVE-ON safety trial and extends patent protection through 2043.

The new grant adds a key pillar to Grace’s multi-layered intellectual property estate, which already includes five composition patents on the GTx-104 formulation running until 2037. Combined with its FDA Orphan Drug Designation, offering seven years of U.S. marketing exclusivity upon approval, the company expects to safeguard its innovative I.V. nimodipine therapy for aneurysmal subarachnoid hemorrhage patients.

CEO Prashant Kohli said the patent strengthens the proprietary foundation established by the STRIVE-ON trial and pharmacokinetic studies, positioning GTx-104 for robust market exclusivity and long-term shareholder value.

FDA Accepted - August 27,2025

NDA

• Drug: GTX-104
• Announced Date: August 27, 2025
• Indication: IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH)

Grace Therapeutics, Inc. announced that on August 22, 2025 the U.S. Food and Drug Administration (FDA) accepted the Company's New Drug Application (NDA) for GTx-104 for formal review.

On August 22, 2025, Grace Therapeutics announced that the U.S. Food and Drug Administration accepted its New Drug Application (NDA) for GTx-104, an innovative intravenous form of nimodipine designed to treat patients with aneurysmal subarachnoid hemorrhage (aSAH). The submission is backed by comprehensive data from the Phase 3 STRIVE-ON safety trial, which showed improved clinical outcomes and safety compared to the standard oral treatment.

The FDA set April 23, 2026 as the Prescription Drug User Fee Act (PDUFA) target date for its review and decision on GTx-104. This acceptance represents a key milestone for Grace Therapeutics as it advances toward offering a potentially breakthrough therapy for aSAH, a condition that has seen few meaningful innovations in nearly 40 years.

Grace Therapeutics is a late-stage biopharma company developing GTx-104 to fill a critical treatment gap in aSAH care.

NDA Filing - June 25,2025

NDA

• Drug: GTX-104
• Announced Date: June 25, 2025
• Indication: IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH)

Grace Therapeutics, Inc. announced the submission to the U.S. Food and Drug Administration (FDA) of the Company's New Drug Application (NDA) for GTx-104.

Grace Therapeutics, Inc. has reached a major milestone by submitting a New Drug Application (NDA) to the U.S. Food and Drug Administration for its product candidate, GTx-104. This innovative drug is an injectable formulation of nimodipine, designed for IV infusion to address aneurysmal subarachnoid hemorrhage (aSAH) and its critical unmet needs. The NDA package includes comprehensive data from the successful Phase 3 STRIVE-ON safety trial that demonstrated positive outcomes, including a reduction in episodes of clinically significant hypotension and improved patient recovery compared to oral nimodipine. The submission could also trigger up to $7.6 million in warrant exercises tied to earlier financing. Grace Therapeutics looks forward to engaging with the FDA during the review process, hoping that GTx-104 will become a breakthrough treatment option for aSAH patients.

Provided Update - April 9,2025

FDA Type C Meeting

• Drug: GTX-104
• Announced Date: April 9, 2025
• Indication: IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH)

Grace Therapeutics, Inc. announced details of the Company's Type C meeting with the U.S. Food and Drug Administration (FDA).

Grace Therapeutics, Inc. recently held a Type C meeting with the U.S. Food and Drug Administration (FDA) to review GTx-104, an injectable formulation of nimodipine being developed for aneurysmal subarachnoid hemorrhage (aSAH) patients. During the meeting, the FDA provided feedback on the completed Phase 3 STRIVE-ON safety trial and on the planned New Drug Application (NDA) submission, which includes requirements for clinical, non-clinical, and chemistry, manufacturing, and control (CMC) data. Based on the FDA’s feedback, the company is confident that their current data package will be sufficient for an NDA submission. Grace Therapeutics’ CEO, Prashant Kohli, described the interactions as positive and productive, noting that the review helped align the substance and structure of the upcoming NDA. The company plans to file the NDA for GTx-104 in the second quarter of 2025.

Enrollment Update - September 25,2024

Phase 3

• Drug: GTX-104
• Announced Date: September 25, 2024
• Indication: IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH)

Acasti Pharma Inc announced that patient enrollment has been completed in the Company's Phase 3 STRIVE-ON safety trial (the STRIVE-ON trial–NCT05995405)..

Acasti Pharma Inc. announced that patient enrollment is now complete in its Phase 3 STRIVE-ON safety trial (NCT05995405). This trial is an important step for the company as it compares the safety of GTX-104—its novel injectable formulation of nimodipine—with traditional oral nimodipine in patients hospitalized for aneurysmal subarachnoid hemorrhage (aSAH). Approximately 100 patients are being treated across about 25 hospitals in the United States. The trial is designed as an open-label, randomized study, with safety as the primary endpoint by measuring comparative adverse events such as hypotension. Acasti anticipates that early data from the trial will be available in early 2025. If GTX-104 shows improved safety and ease of administration over oral nimodipine, it could offer a new standard of care for aSAH patients.

Acasti Pharma FDA Events - Frequently Asked Questions

Has Acasti Pharma received FDA approval?

As of now, Acasti Pharma (ACST) has not received any FDA approvals for its therapy in the last two years.

What drugs has Acasti Pharma submitted to the FDA?

In the past two years, Acasti Pharma (ACST) has reported FDA regulatory activity for GTX-104.

What is the most recent FDA event for Acasti Pharma?

The most recent FDA-related event for Acasti Pharma occurred on September 22, 2025, involving GTX-104. The update was categorized as "Results," with the company reporting: "Grace Therapeutics, Inc. announced that results from its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 in aSAH (the STRIVE-ON trial–NCT05995405) were presented at the 2025 Neurocritical Care Society annual meeting, held in Montreal, Quebec, Canada September 18-21, 2025."

What conditions do Acasti Pharma's current drugs treat?

Currently, Acasti Pharma has one therapy (GTX-104) targeting the following condition: IV infusion for patients experiencing Subarachnoid Hemorrhage (SAH).