---
schema_version: "secwatch.filing_event.v1"
accession: "0001140361-26-029837"
form_type: "8-K"
ticker: "GRCE"
cik: "0001444192"
company_name: "Grace Therapeutics, Inc."
filed_at: "2026-07-28T11:16:15+00:00"
generated_at: "2026-07-28T11:20:09.747680+00:00"
event_type: "regulatory"
sentiment: "neutral"
materiality_score: 0.75
calibrated_materiality_score: 0.75
confidence: "high"
source: SEC EDGAR
---

# Grace Therapeutics gets FDA Type A minutes; no clinical deficiencies; adds U.S. manufacturing site for GTx-104

## Summary
- FDA did not identify any clinical safety or efficacy deficiencies and did not request additional clinical data.
- CRL items relate to cGMP compliance at contract manufacturer, leachables data, and excipient toxicology risk assessments.
- Company pursuing dual-source manufacturing strategy, adding a U.S.-based contract manufacturer.
- No single path to resubmission designated; resubmission may be supported by either or both manufacturers.
- STRIVE-ON trial met primary endpoint with 19% reduction in clinically significant hypotension vs oral nimodipine.

## SEC filing metadata
- accession: 0001140361-26-029837
- form_type: 8-K
- ticker: GRCE
- cik: 0001444192
- company_name: Grace Therapeutics, Inc.
- filed_at: 2026-07-28T11:16:15+00:00
- event_type: regulatory
- sentiment: neutral
- materiality_score: 0.75
- calibrated_materiality_score: 0.75
- confidence: high
- sec_items: 8.01, 9.01
- EDGAR index: https://www.sec.gov/Archives/edgar/data/1444192/000114036126029837/0001140361-26-029837-index.htm
- EDGAR primary document: https://www.sec.gov/Archives/edgar/data/1444192/000114036126029837/ef20078866_8k.htm

## Machine-readable alternates
- HTML: https://secwatch.observer/filing/0001140361-26-029837
- JSON: https://secwatch.observer/filing/0001140361-26-029837.json
- Plain text: https://secwatch.observer/filing/0001140361-26-029837.txt

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