secwatch.observer — SEC 8-K summary
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Issuer:     Grace Therapeutics, Inc. (GRCE)
CIK:        0001444192
Form:       8-K
Filed at:   2026-06-18T12:01:22+00:00
Accession:  0001140361-26-025667
Event type: earnings
Sentiment:  negative
Materiality: 0.75
Item codes: 2.02, 9.01
LLM model:  deepseek-v4-flash:cloud@v2

Grace Therapeutics FY2026 net loss $7.8M; FDA CRL for GTx-104; Type A meeting set
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- Net loss of $7.8M ($0.47 loss per share) for FY2026, improved from $9.6M loss in FY2025.
- Cash and equivalents $17.0M at March 31, 2026; expected to fund operations at least 12 months.
- FDA issued Complete Response Letter for GTx-104 NDA in April 2026; no clinical deficiencies cited; Type A meeting scheduled.
- Phase 3 STRIVE-ON trial met primary endpoint; 19% reduction in clinically significant hypotension vs oral nimodipine.
- New U.S. patent (No. 12,414,943) for IV dosing regimen extends GTx-104 IP protection to 2043.

Source:
  EDGAR index:    https://www.sec.gov/Archives/edgar/data/1444192/000114036126025667/0001140361-26-025667-index.htm
  Primary doc:    https://www.sec.gov/Archives/edgar/data/1444192/000114036126025667/ef20076145_8k.htm
  HTML page:      https://secwatch.observer/filing/0001140361-26-025667

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