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

Grace Therapeutics, Inc.

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.

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