---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-016324"
form_type: "8-K"
ticker: "GRCE"
cik: "0001444192"
company_name: "Grace Therapeutics, Inc."
filed_at: "2026-04-23T23:59:59+00:00"
generated_at: "2026-05-15T04:30:06.547752+00:00"
event_type: "regulatory"
sentiment: "negative"
materiality_score: 0.85
calibrated_materiality_score: 0.85
confidence: "high"
source: SEC EDGAR
---

# FDA issues Complete Response Letter for Grace Therapeutics' GTx-104 NDA; cites CMC and non-clinical issues

## Summary
- FDA CRL for GTx-104 (nimodipine IV) in aSAH; no additional clinical data requested.
- Cited leachables data, non-clinical toxicology, and manufacturing deficiencies at CMO.
- Company plans Type A meeting with FDA and intends to resubmit after resolving cited items.
- STRIVE-ON trial met primary endpoint; 19% reduction in hypotension vs. oral nimodipine.
- No deaths deemed drug-related; favorable functional outcomes and higher dose intensity observed.

## SEC filing metadata
- accession: 0001140361-26-016324
- form_type: 8-K
- ticker: GRCE
- cik: 0001444192
- company_name: Grace Therapeutics, Inc.
- filed_at: 2026-04-23T23:59:59+00:00
- event_type: regulatory
- sentiment: negative
- materiality_score: 0.85
- calibrated_materiality_score: 0.85
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1444192/000114036126016324/0001140361-26-016324-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1444192/000114036126016324/ef20070593_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-016324
- JSON: https://secwatch.observer/filing/0001140361-26-016324.json
- Plain text: https://secwatch.observer/filing/0001140361-26-016324.txt

This AI-assisted summary is a reading aid. Review the linked SEC EDGAR filing before relying on any specific claim.