Grace Therapeutics Inc. (GRCE), a late-stage biopharmaceutical company, on Thursday announced financial results for the fiscal year ending March 31, 2026, and provided updates on the NDA resubmission for GTx-104 in treating aneurysmal subarachnoid hemorrhages.
FY 2026:
The company reported a net loss of $7.8 million or $0.47 per share in the fiscal year 2026, lower than the second quarter loss of $9.6 million or $0.79 per share in the previous year.
R&D expenses amounted to $2.4 million, while in 2025 the same was $9.5 million. The decrease was primarily attributable to the completion of the Phase 3 STRIVE-ON trial for GT-104. Cash and cash equivalents held by the company on March 31, 2026, totaled $170 million.
Operational Highlights:
The company is developing GTx-104 as a treatment for aneurysmal subarachnoid hemorrhages.
Aneurysmal subarachnoid hemorrhages (aSAH) are rare, accounting for only 5% of strokes reported annually. Caused by a weak blood vessel in the outer layers of the brain, the onset of an aSAH is sudden, and has a high frequency among patients below 60 years of age. Decline may be marked by the buildup of cerebrospinal fluid in the subarachnoid space between the brain and skull, a condition called hydrocephalus. Thus, early and immediate care is imperative.
The drug nimodipine is a vasodilator that has shown considerable success in crossing the blood-brain-barrier to relieve vascular pressure. However, administration previously was solely through oral or parenteral routes.
The GTx-104 is an injectable formulation of nimodipine developed for intravenous infusion. The affected patient must be administered the drug within 96 hours of the aSAH to assure meaningful results.
The Phase 3 STRIVE-ON study evaluated GTx-104 in a randomized, open-label trial with 102 patients receiving the IV drug or oral nimodipine. The company reported that the study met its primary endpoint successfully, with a 19% reduction of hypotension in patients treated with IV nimodipine.
The company submitted a new drug application (NDA) for GTx-104 in June 2025 and received a complete response letter (CRL) from the FDA in April of this year. Issues were raised regarding the chemistry, manufacturing, and controls (CMC) process of the drug, which the company believes can be addressed within a short time period. A Type A meeting was also scheduled with the FDA to facilitate a resubmission of the NDA.
If approved, GTx-104 may be the first new standard-of-care treatment for aSAH in over 40 years.
GRCE closed Thursday at $2.38, up 7.21%.
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June 19, 2026 16:46 ET Major central banks continued to dominate the economic news flow this week too, led by the Federal Reserve, as they announced their latest policy decisions. The Federal Reserve policy session was in focus as it was the first to be led by the new chief Kevin Warsh. In Europe, central banks of the U.K. and Switzerland announced their rate decisions. In Asia, the Bank of Japan drew attention for its policy moves, while data out of China threw some light on the state of the economy.