Grace Therapeutics reports Q2 EPS (6c) vs (30c) last year

“During our second quarter of 2026 we continued to execute on our clinical and corporate goals, led by FDA acceptance for review of our NDA for GTx-104 for the treatment of aSAH,” said Prashant Kohli, CEO of Grace Therapeutics (GRCE). “Acceptance of our NDA for review is another significant milestone for the Company and further demonstrates our ability to execute as we continue to advance this important innovation for aSAH patients. Our NDA is supported by a robust data package including positive results from our STRIVE-ON trial, which provided evidence of improved clinical outcomes in aSAH patients treated with GTx-104 as well as potential medical and pharmacoeconomic benefits of GTx-104 in the treatment of aSAH. We were pleased to see these data highlighted in a presentation at the Neurocritical Care annual meeting, where the results were well received by the conference attendees. Also this quarter, the U.S. Patent and Trademark Office issued a new method of use patent covering the dosing regimen for IV administration of nimodipine used in our STRIVE-ON trial for GTx-104. This new patent coverage on the dosing regimen should be included in the label for GTx-104 if it is approved by the FDA, adding a new layer and extending the duration of our intellectual property protections. We believe that if our NDA for GTx-104 is approved by the FDA, our strong U.S. and international patent estate will help to maximize the long-term market value of GTx-104 and correspondingly deliver value for our shareholders.” The standard of care for aSAH has not seen meaningful innovation in nearly 40 years, and we believe that if GTx-104 is approved, our STRIVE-ON trial results point to a very promising role for GTx-104 in the treatment of these patients. We look forward to continuing to engage with the FDA during their review as they work toward the PDUFA target date of April 23, 2026.”