Grace Therapeutics, Inc. GRCE
Grace Therapeutics, Inc. (Nasdaq: GRCE) is a CNS/neurology/psychiatry drug developer. Its lead program, GTx-104 (IV nimodipine), is in Phase 3 for Aneurysmal subarachnoid hemorrhage (aSAH). Its next catalyst on record is GTx-104: NDA resubmission following CRL (date not stated).
Upcoming catalysts
No catalyst is dated to the next 30 days or to an FDA action date.
Next further out: GTx-104 — NDA resubmission following CRL (date not stated). 1 catalyst on record beyond the next 30 days; subscribers see each with its filing sentence.
Pipeline
| Program | Indication | Modality | Stage |
|---|---|---|---|
| GTx-104 | Aneurysmal subarachnoid hemorrhage | small molecule | Phase 3 |
| GTx-102 | Ataxia-telangiectasia (pediatric) | small molecule | Phase 1 |
| GTx-101 | Postherpetic neuralgia | small molecule | Phase 1 |
Recent results and decisions
- Jul 28, 2026n/a FDA Type A meeting minutes received: CRL items are cGMP status of current CDMO, leachables data and excipient toxicology; no clinical deficiencies; company adds a second US-based manufacturer toward NDA resubmission (no date given).
As previously disclosed, the CRL did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data.
Filing - Apr 23, 2026CRL FDA issued a CRL for the GTx-104 NDA citing CMC (leachables data, CDMO manufacturing deficiencies) and non-clinical toxicology items; no additional clinical data requested.
In its CRL, the FDA referenced certain items in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections of the application, which Grace believes it can address in a resubmission of its NDA.
Filing - Nov 13, 2025accepted FDA accepted the GTx-104 NDA for review on Aug 22, 2025 with a PDUFA target date of April 23, 2026.
On August 22, 2025, the FDA accepted the Company’s NDA for GTx-104 for formal review, establishing April 23, 2026 as its PDUFA target date.
Filing
1 more on record.
For subscribers
- Cash runway against each catalyst, with the company's own runway statement
- Track record: every Phase 3 readout, FDA decision and guidance slip since 2014
- Expected move for each dated catalyst, from comparable past events
- Phase 2 evidence behind each Phase 3 readout
- Companies on the same target or class
- Full catalyst list with filing sentences, deals, registered trials, Excel export
Other phase 3 CNS/neurology/psychiatry companies
The free Monday brief
Last week's readouts and FDA decisions and the dated catalysts in the week ahead, each with its filing sentence.