Grace Therapeutics, Inc. ( (GRCE) ) has released its Q2 earnings. Here is a breakdown of the information Grace Therapeutics, Inc. presented to its investors.
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Grace Therapeutics, Inc. is a late-stage biopharmaceutical company focused on developing innovative drug delivery technologies for rare and orphan diseases, with a particular emphasis on their lead clinical asset, GTx-104, an IV infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH).
In its recent second quarter 2026 earnings report, Grace Therapeutics announced the U.S. FDA’s acceptance for review of their New Drug Application (NDA) for GTx-104, a significant milestone for the company. The FDA has set April 23, 2026, as the target date for the review. The company also highlighted the issuance of a new U.S. patent covering the dosing regimen for GTx-104, which extends their intellectual property protection.
Key financial highlights from the report include a reduction in net loss to $0.9 million for the quarter, compared to $3.4 million in the same period the previous year. This improvement was primarily due to decreased research and development expenses following the completion of the Phase 3 STRIVE-ON safety trial. Additionally, the company secured $4.0 million in funding through the exercise of common warrants, bolstering their cash position to approximately $20.0 million as of October 31, 2025.
The STRIVE-ON trial demonstrated positive outcomes for GTx-104, showing a reduction in clinically significant hypotension and improved functional outcomes compared to oral nimodipine. These results, along with the company’s robust patent portfolio, position Grace Therapeutics to potentially maximize the market value of GTx-104 upon FDA approval.
Looking ahead, Grace Therapeutics remains focused on advancing GTx-104 through the regulatory process, with hopes of FDA approval in 2026. The company is optimistic about the long-term market potential of GTx-104 and its ability to address unmet medical needs in aSAH patients, thereby delivering value to shareholders.