Grace Therapeutics reveals details of Phase 3 STRIVE-ON safety trial presentation
Trial Presentation: Grace Therapeutics presented results from its Pivotal Phase 3 STRIVE-ON Safety Trial of GTx-104 for aSAH at the 2025 Neurocritical Care Society annual meeting in Montreal.
Trial Findings: Dr. H. Alex Choi reported that GTx-104 demonstrated safety and tolerability compared to oral nimodipine in a randomized trial involving 102 patients, focusing on clinically significant hypotension and other safety outcomes.
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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.
Biodesix Inc. (BDSX): Shares surged 10.57% after the company reported a 20% increase in Q3 2025 revenue to $21.8 million and a narrowed net loss. They raised their full-year revenue forecast to $84 million - $86 million, indicating sustained growth.
Exact Sciences Corp. (EXAS): The stock rose 7.78% following a Q3 2025 earnings report showing a 20% revenue increase to $851 million and a significantly narrowed net loss. The company also raised its full-year revenue guidance to $3.220 - $3.235 billion.
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.
