GRCE news

Latest 2 stories · newest Jul 28, 2026

GRCE

Grace Recieves Positive FDA Meeting Minutes

Grace Therapeutics announced the FDA did not identify safety or efficacy deficiencies after a Type A meeting, clearing clinical pathways for GTx-104. The good news is offset by the need to resolve manufacturing compliance issues.

Regulatory Jul 28, 2026 sentiment +0.70 SEC filing ↗

GRCE

Grace Therapeutics receives FDA CRL for GTx-104 NDA; schedules Type A meeting

Grace Therapeutics announced it received a Complete Response Letter from the FDA for its GTx-104 new drug application with issues related to manufacturing controls and non-clinical data, but no clinical deficiencies. The company has scheduled a Type A meeting with the FDA to clarify the resubmission…

Regulatory Jun 18, 2026 sentiment -0.25 SEC filing ↗

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