Grace Therapeutics is developing GTx-104, an intravenous form of nimodipine for patients with aneurysmal subarachnoid hemorrhage, a type of brain bleed; FDA has not approved it.
Grace's case rests on GTx-104, an IV form of nimodipine for aneurysmal subarachnoid hemorrhage. In the Phase 3 STRIVE-ON safety trial, 28% of GTx-104 patients had clinically significant hypotension versus 35% on oral nimodipine. FDA's April 2026 complete response letter cited no clinical deficiencies; it cited the manufacturer's cGMP status, leachables data and excipient toxicology. Grace will resubmit through whichever manufacturing site is ready first. Cash of $22.2 million in August is expected to last through 2028.
Thesis checklist
1 risk needs attention
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Why it is in this state
The evidence, what would weaken it and the source filing
Next decision point
Tests: A manufacturing site gets ready for resubmission
Does either manufacturing site become ready so Grace can set a resubmission date?
Strong, inconclusive and weak outcomes
What to look for in the result and how each would move the checklist
Price and material events
Select an event marker to read the update below. Marker colors show Thesis status.
Grace is fixing GTx-104's manufacturing issues to resubmit after FDA's complete response letter
Phase 3-proven IV nimodipine chasing approval after a manufacturing-only CRL, with $17M and a Q2 2027 runway to close the CMC gap
GTx-104 received a CMC-only CRL after meeting Phase 3 endpoints; resubmission viability hinges on manufacturing remediation before cash runs out
GTx-104's first-cycle FDA review of IV nimodipine for aSAH is the binary event that will validate or invalidate Grace's single-asset thesis
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Disease areas: Neurology and pain
Catalyst calendar · Upcoming FDA decisions · Thesis changes
Cash: Market-data provider estimate; measurement period unavailable.
Debt: Market-data provider estimate; a complete comparable filing balance is unavailable.
Quarterly burn: Estimated from trailing free cash flow; measurement period unavailable.
Net cash and estimated runway require verified matching measurement periods. Missing debt components are not assumed to be zero.
Runway: No underlying guidance available.