GTx-104 (nimodipine IV) PDUFA Date (Grace Therapeutics)

Name: FDA PDUFA Decision: GTx-104 (nimodipine IV)
Start: 2026-04-23

FDA PDUFA decision date for GTx-104 (nimodipine IV) is April 23, 2026. Developed by Grace Therapeutics. Indication: Aneurysmal subarachnoid hemorrhage (aSAH). Current status: Verifying.

Indication

Aneurysmal subarachnoid hemorrhage (aSAH)

Regulatory details

Company: Grace Therapeutics
Therapeutic area: Neurology / CNS
Application type: NDA
Review type: Standard
PDUFA date: 2026-04-23
Outcome: Pending

GTx-104 (nimodipine IV) PDUFA Date — Grace Therapeutics