Small-Cap Grace Therapeutics Touts Positive Data From Brain Hemorrhage Study
Phase 3 Trial Results: Grace Therapeutics, Inc. announced positive topline data from its Phase 3 STRIVE-ON trial for GTx-104, showing a 19% reduction in clinically significant hypotension compared to oral nimodipine in patients with aneurysmal subarachnoid hemorrhage (aSAH), along with improved patient outcomes and comparable safety profiles.
Funding Announcement: The company also revealed a private placement of approximately $30 million to support the development of GTx-104, with an expected US new drug application submission in the first half of 2025.
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Biotech Stocks Soar in After-Hours Trading: TCMD, BDSX, and EXAS Take the Lead
Tactile Systems Technology Inc. (TCMD): The company saw a 22.13% increase in after-hours trading after reporting a strong Q3 2025 earnings with net income rising to $8.2 million and revenue climbing 17% year-over-year. They also raised their full-year revenue guidance to $317 million - $321 million.
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Rani Therapeutics (RANI) and Grace Therapeutics Inc. (GRCE): Rani's shares increased 5.12% ahead of a presentation at ObesityWeek 2025, while Grace's stock rose 6.11% following the full exercise of common warrants tied to a previous funding round, securing additional capital for their drug candidate.
Grace Therapeutics Announces Submission of New Drug Application to U.S. Food and Drug Administration for GTx-104
NDA Submission for GTx-104: Grace Therapeutics has submitted a New Drug Application (NDA) to the FDA for GTx-104, an injectable formulation of nimodipine aimed at treating aneurysmal subarachnoid hemorrhage (aSAH), supported by positive results from the Phase 3 STRIVE-ON safety trial.
Financial Implications and Market Potential: The NDA submission could trigger up to $7.6 million in financing warrants, and GTx-104's Orphan Drug Designation may provide seven years of marketing exclusivity, addressing significant unmet medical needs in aSAH treatment.
