企業プロフィール
Acasti Pharma 株価・ニュース・カタリスト
- ティッカー:
- ACST
- 取引所:
- NASDAQ
- セクター:
- Biopharma
- 所在地:
- Canada and trades in the U
株価変動の要因
Current closing-price context is not available for ACST.
企業概要
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.
今後のカタリスト
- Resubmission of the GTx-104 NDA after completion of manufacturing remediation, technology-transfer, and stability requirements.
最近のニュース
- 01
- 02
- 03
- 04
- 05
類似銘柄
事業成熟度、治療領域、カタリスト傾向が近い同業銘柄です。