Company Profile
Acasti Pharma Stock Price, News & Analysis
- Ticker:
- ACST
- Exchange:
- NASDAQ
- Sector:
- Biopharma
- Location:
- Canada and trades in the U
Why the stock is moving
Current closing-price context is not available for ACST.
Company overview
Late-Stage Cerebrovascular Company
Grace Therapeutics is a late-stage biopharmaceutical company developing GTx-104, a novel intravenous formulation of nimodipine for aneurysmal subarachnoid hemorrhage.
Clinical Role of GTx-104
Oral nimodipine is the current standard of care in aSAH, but critically ill patients may face swallowing difficulties, inconsistent absorption, interrupted dosing, and challenges in managing hypotension. GTx-104 is designed to provide more controlled nimodipine exposure through peripheral intravenous infusion.
Reformulation and Regulatory Strategy
GTx-104 applies a new intravenous formulation to an established active ingredient with a well-understood role in aSAH care. The program’s value proposition depends on demonstrating that controlled hospital administration can address practical limitations of oral nimodipine without changing the underlying therapeutic mechanism.
STRIVE-ON Evidence
The Phase 3 STRIVE-ON safety trial compared GTx-104 with oral nimodipine. The study reported a 19% lower incidence of clinically significant hypotensive events with GTx-104, alongside favorable observations in dose intensity, 90-day functional outcomes, and selected intensive-care resource measures.
Future catalysts
Following an FDA Complete Response Letter for the GTx-104 NDA, the company has scheduled a Type A meeting to clarify the resubmission path.
Grace Therapeutics plans to provide a regulatory update after receiving the meeting minutes and to prepare an NDA resubmission for GTx-104.
Recent news
- 01
Grace Therapeutics Announces $10 Million Private Placement
Source: Acasti Pharma
- 02
- 03
- 04
Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104
Source: Acasti Pharma
- 05
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Frequently Asked Questions
What does Acasti Pharma do?
Late-Stage Cerebrovascular Company Grace Therapeutics is a late-stage biopharmaceutical company developing GTx-104, a novel intravenous formulation of nimodipine for aneurysmal subarachnoid hemorrhage. Clinical Role of GTx-104 Oral nimodipine is the current standard of care in aSAH, but critically ill patients may face swallowing difficulties, inconsistent...
On which exchange is ACST stock listed?
Acasti Pharma (ACST) is associated with NASDAQ, Canada and trades in the U, Biopharma.
What is STRIVE-ON?
STRIVE-ON Evidence The Phase 3 STRIVE-ON safety trial compared GTx-104 with oral nimodipine.
Which conditions is Acasti Pharma targeting with STRIVE-ON?
Late-Stage Cerebrovascular Company Grace Therapeutics is a late-stage biopharmaceutical company developing GTx-104, a novel intravenous formulation of nimodipine for aneurysmal subarachnoid hemorrhage. Clinical Role of GTx-104 Oral nimodipine is the current standard of care in aSAH, but critically ill patients may face swallowing difficulties, inconsistent...
How does Acasti Pharma describe recent progress with STRIVE-ON?
Following an FDA Complete Response Letter for the GTx-104 NDA, the company has scheduled a Type A meeting to clarify the resubmission path. Grace Therapeutics plans to provide a regulatory update after receiving the meeting minutes and to prepare an NDA resubmission for GTx-104.
What is Late-Stage?
Late-Stage Cerebrovascular Company Grace Therapeutics is a late-stage biopharmaceutical company developing GTx-104, a novel intravenous formulation of nimodipine for aneurysmal subarachnoid hemorrhage.
What should investors watch for with Late-Stage?
Following an FDA Complete Response Letter for the GTx-104 NDA, the company has scheduled a Type A meeting to clarify the resubmission path. Grace Therapeutics plans to provide a regulatory update after receiving the meeting minutes and to prepare an NDA resubmission for GTx-104.
What is Cerebrovascular?
Late-Stage Cerebrovascular Company Grace Therapeutics is a late-stage biopharmaceutical company developing GTx-104, a novel intravenous formulation of nimodipine for aneurysmal subarachnoid hemorrhage.