Grace Therapeutics details GTx-104 resubmission plan after CRL, sets cash runway to 2028

Grace Therapeutics, Inc. reported first quarter 2027 results on August 13, 2026, and gave an update on its path back to the FDA for GTx-104, its investigational IV formulation of nimodipine for aneurysmal subarachnoid hemorrhage (aSAH).

The company said it received FDA meeting minutes from a Type A meeting held to discuss the Complete Response Letter issued on April 23, 2026. The company said the CRL did not flag any clinical safety or efficacy problems or ask for more clinical data, and instead centered on the cGMP compliance status of its contract manufacturer, along with requests for additional leachables data time points and excipient toxicology risk assessments.¹ Grace said it intends to address each CRL item in its planned resubmission, including completing the required non-clinical studies.¹

To manage the manufacturing risk, the company has started a dual-source manufacturing strategy for GTx-104, moving to a second, U.S.-based contract manufacturer through a technology transfer already underway, while continuing to work through the CMC and non-clinical items in the CRL.¹ Resubmission timing will depend on whichever path is ready first: the new U.S. facility, which needs a full CMC package backed by 12 months of stability data, or the current manufacturer, if it resolves its FDA compliance issues in time.¹

On financing, Grace announced a $10 million private placement with new and existing institutional and accredited investors, with proceeds earmarked for the manufacturing and regulatory work needed to advance GTx-104.¹ As of August 11, 2026, cash and cash equivalents stood at $22.2 million.¹ The company said its existing cash should be sufficient to fund planned operations, including work on the CRL items, through the end of calendar 2028.¹

Separately, Grace recorded a $13.5 million impairment tied to its deprioritized GTx-101 and GTx-102 programs, following a strategic reevaluation in the quarter.¹