Grace Therapeutics reports fiscal 2026 results while advancing GTx-104 for aneurysmal subarachnoid hemorrhage treatment.
Stock Earnings Results
June 18, 2026
Table of Contents
June 18, 2026
Grace Therapeutics, Inc. (NASDAQ: GRCE) reported fiscal 2026 results and provided a business update focused on GTx-104, its lead drug candidate for aneurysmal subarachnoid hemorrhage, or aSAH.
Grace Therapeutics is a late-stage biopharma company developing drug delivery technologies for rare and orphan diseases. Its lead asset, GTx-104, is an injectable IV formulation of nimodipine designed for patients with aSAH.
Grace said it has scheduled a Type A meeting with the FDA after receiving a Complete Response Letter in April 2026 for its GTx-104 New Drug Application.
The FDA cited items related to Chemistry, Manufacturing, and Controls, non-clinical product toxicology risk assessments, additional leachable data time points, and cGMP deficiencies at the company’s contract manufacturing organization.
Importantly, Grace said no clinical deficiencies were identified.
Management said it believes the issues can be addressed in a resubmission and expects to provide a regulatory update after receiving official FDA meeting minutes.
For fiscal 2026, Grace reported a net loss of $7.8 million, or $0.47 per share, compared with a net loss of $9.6 million, or $0.79 per share, in fiscal 2025.
Research and development expenses decreased to $2.4 million from $9.5 million, mainly due to the close-out of the GTx-104 pivotal Phase 3 safety trial.
General and administrative expenses increased to $8.7 million from $7.2 million, driven by legal and due diligence costs tied to strategic initiatives, professional fees, and pre-commercial planning for GTx-104.
Grace ended fiscal 2026 with $17.0 million in cash and cash equivalents. The company said its cash is expected to fund planned operations for at least 12 months from the release date.
Grace said Phase 3 STRIVE-ON trial data was presented at multiple medical conferences over the past year.
The trial met its primary endpoint, with GTx-104 showing a 19% reduction in at least one incidence of clinically significant hypotension compared with oral nimodipine. Other measures favored GTx-104 or were comparable, including higher relative dose intensity and more favorable functional outcomes at 90 days.
The company also strengthened its intellectual property position. A new U.S. patent covering the IV dosing regimen for GTx-104 extends protection to 2043, while existing formulation patents provide protection to 2037.
GTx-104 has also received Orphan Drug Designation from the FDA, which could provide seven years of U.S. marketing exclusivity if approved and if required conditions are met.
Grace Therapeutics remains a regulatory execution story.
The CRL delayed the approval path, but the absence of clinical deficiencies is important because the issues appear focused on manufacturing, non-clinical, and CMC-related items rather than the core clinical data package.
The next major catalyst is the FDA meeting outcome. If Grace receives a clear path to resubmission, investor attention could shift back toward GTx-104’s potential role as an IV nimodipine option for aSAH patients.
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