Grace Therapeutics plans NDA resubmission after FDA CRL for GTx-104
Grace Therapeutics is preparing to resubmit its New Drug Application for GTx-104, an intravenous formulation of nimodipine for aneurysmal subarachnoid haemorrhage (aSAH), after the FDA issued a Complete Response Letter in April 2026. The Princeton, New Jersey company has scheduled a Type A meeting with the agency to clarify what is required before it can advance the submission, and expects to issue a regulatory update once official meeting minutes are received.
The CRL, issued on 23 April 2026, cited deficiencies in the Chemistry, Manufacturing and Controls and Non-Clinical sections of the application. Specifically, the FDA requested additional leachable data time points for the commercial product, non-clinical product toxicology risk assessments, and correction of current Good Manufacturing Practice deficiencies at Grace's contract manufacturing organisation. No clinical deficiencies were identified, which the company views as a meaningful distinction given the strength of the underlying Phase 3 dataset.
Trial data and competitive positioning
The Phase 3 STRIVE-ON safety trial enrolled 102 patients and met its primary endpoint. Patients receiving GTx-104 experienced a 19% relative reduction in clinically significant hypotension compared with oral nimodipine (28% versus 35%). Secondary outcomes also favoured the IV candidate: 54% of GTx-104 patients achieved a relative dose intensity of 95% or higher, compared with 8% on oral nimodipine, and 29% more GTx-104 patients had favourable functional outcomes at 90 days. ICU readmissions, ICU days and ventilator days were all lower in the GTx-104 arm. These results were presented at five major neurology and critical care conferences between September 2025 and April 2026, including the American Academy of Neurology annual meeting.
aSAH is a rare and life-threatening stroke subtype, affecting an estimated 42,500 US patients per year. Oral nimodipine has been the standard of care for decades, and the company's chief executive, Prashant Kohli, has described FDA approval of GTx-104 as representing "the first meaningful innovation in the standard of care for these patients in more than 40 years." The unmet need is well recognised clinically: unconscious or dysphagic patients in ICU settings cannot reliably take oral capsules, and the oral formulation is associated with hypotension and dosing errors. An IV-administered option would address several of these limitations simultaneously.
Financial position and IP estate
Grace reported a net loss of $7.8 million for the fiscal year ended 31 March 2026, narrowing from $9.6 million in the prior year. R&D expenditure fell sharply to $2.4 million from $9.5 million, reflecting the close-out of the STRIVE-ON trial. General and administrative costs rose to $8.7 million, partly due to pre-commercial planning activity and non-recurring legal and due diligence costs. The company held $17.0 million in cash at the year end, and management has stated it believes this is sufficient to fund planned operations for at least 12 months from the date of the announcement.
Intellectual property coverage has been extended following the grant of US Patent No. 12,414,943, which covers the IV dosing regimen used in STRIVE-ON and runs to 2043. Combined with five earlier composition patents providing protection to 2037 and an Orphan Drug Designation granting seven years of US marketing exclusivity post-approval, the IP estate represents a layered barrier to generic competition.
The near-term focus will be the outcome of the Type A FDA meeting. If the agency's feedback confirms that the CMC and non-clinical items are addressable without additional clinical work, a resubmission could follow within months. Investors will watch for guidance on resubmission timing, as well as any indication of whether the contract manufacturing issues require a site remediation or a change of manufacturer.