Grace Therapeutics, Inc. (Nasdaq: GRCE) disclosed on June 18, 2026, that the U.S. Food and Drug Administration issued a Complete Response Letter for its New Drug Application for GTx-104, a drug candidate for treating aneurysmal subarachnoid hemorrhage (aSAH), and that a Type A meeting with the FDA has been scheduled to clarify the path to resubmission.
The CRL was issued on April 23, 2026. The FDA cited items in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections of the application. No clinical deficiencies were identified. The company said it believes the cited items can be addressed in a resubmission.
#FDA Cites CMC and Manufacturing Issues, No Clinical Deficiencies
The items referenced in the CRL relate to additional leachable data time points for commercial product, non-clinical product toxicology risk assessments, and current Good Manufacturing Practices deficiencies with Grace Therapeutics' contract manufacturing organization.
Grace Therapeutics said it plans to provide a regulatory update after receiving official minutes from the Type A meeting. The timing of any NDA resubmission has not been disclosed.
"Since receipt of the FDA's Complete Response Letter in April 2026, we have been working diligently on addressing the cited items, and we look forward to a constructive discussion with the FDA as we continue to prepare our resubmission," said Prashant Kohli, Chief Executive Officer of Grace Therapeutics, in the press release.
aSAH is a type of stroke caused by the rupture of a brain aneurysm, which results in bleeding in the subarachnoid space between the brain and skull. The condition accounts for approximately 5% of all strokes and an estimated 42,500 U.S. hospital-treated patients annually. GTx-104 is a nanoparticle-based, injectable formulation of nimodipine designed for intravenous infusion, targeting this patient population.
#Phase 3 STRIVE-ON Trial Data Presented at Five Conferences
Grace Therapeutics presented Phase 3 STRIVE-ON safety trial results at five major medical conferences during the fiscal year ended March 31, 2026. These included the 2026 American Academy of Neurology in April 2026 and the 2025 Neurocritical Care Society in September 2025.
The trial, which enrolled 102 patients, met its primary endpoint. Patients receiving GTx-104 had a 19% reduction in at least one incidence of clinically significant hypotension compared to oral nimodipine (28% versus 35%). At 90 days, 29% more patients on GTx-104 than on oral nimodipine had favorable functional outcomes.
In addition, 54% of patients on GTx-104 achieved a relative dose intensity of 95% or higher, compared to 8% on oral nimodipine. Adverse events were reported as comparable between the two arms, and no deaths were determined to be related to either drug.
#Fiscal 2026 Net Loss Narrows as R&D Spending Declines
Grace Therapeutics reported a net loss of $7.8 million, or $0.47 per share, for the fiscal year ended March 31, 2026. This compares to a net loss of $9.6 million, or $0.79 per share, for the fiscal year ended March 31, 2025.
Research and development expenses fell to $2.4 million from $9.5 million in the prior year, a decrease the company attributed to the close-out of the GTx-104 Phase 3 safety trial during the first calendar quarter of 2026.
General and administrative expenses rose to $8.7 million from $7.2 million, driven by non-recurring legal and due diligence costs tied to strategic initiatives and increased costs related to pre-commercial planning for GTx-104.
The company held $17.0 million in cash and cash equivalents at March 31, 2026, compared to $22.1 million at March 31, 2025. Grace Therapeutics said it believes existing cash will be sufficient to sustain planned operations for at least 12 months from the date of the release.
The company also disclosed that the U.S. Patent and Trademark Office issued Patent No. 12,414,943 covering the IV dosing regimen for GTx-104, extending intellectual property protection to 2043.
The outcome of the Type A meeting, the timing and success of any NDA resubmission, and the company's ability to address all items cited in the CRL remain key uncertainties. GTx-104 has not received FDA approval, and there is no guarantee that a resubmission will result in clearance. Regulatory, manufacturing, and financial risks could affect the company's ability to advance the program.