Grace Therapeutics receives FDA Type A meeting minutes on GTx-104 resubmission path
Grace Therapeutics announced it received the FDA's official minutes from a Type A meeting on the April 23, 2026 Complete Response Letter for GTx-104. The company says the FDA cited facility-level cGMP issues at its contract manufacturer and additional leachables and excipient data, and it is adding a second, U.S.-based contract manufacturer as a backup route to resubmission. The filing gives no resubmission date, so the timing of a possible approval remains open.
Key points
- FDA Type A meeting minutes received; CRL issued April 23, 2026 for GTx-104 new drug application
- FDA did not identify clinical safety or efficacy deficiencies and did not request additional clinical data
- Company is pursuing a dual-source manufacturing strategy with a second U.S.-based contract manufacturer; no single resubmission path has been designated
- Corporate presentation updated July 28, 2026 to reflect the path to NDA resubmission
The filing
Written by AI on Nov 9, 2026, 10:08 AM ET, from this filing only. Written later: this filing was briefed after the fact, when past filings were added to the site, so the brief may be read with hindsight; the filing itself is the record of what was known on July 28, 2026.
Briefs are written by AI from the filing text and can contain mistakes — open the filing before acting on anything. Impact (1-5) and tone are the AI's reading of the filing for shareholders, not a price forecast. Not investment advice.