Grace Therapeutics Anticipates GTx-104 NDA Approval
"During our third quarter of fiscal 2026 we continued to execute on our clinical and corporate goals, led by our pre-commercial planning in anticipation of potential FDA approval of our New Drug Application (NDA) for GTx-104 for the treatment of aSAH," said Prashant Kohli, CEO of Grace Therapeutics. "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 late breaking presentation at the Society of Vascular and Interventional Neurology annual meeting in November 2025. Our STRIVE-ON trial results continue to be well received by researchers, practitioners and industry leaders. 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."
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Grace Therapeutics Q3 Earnings Beat Expectations
- Earnings Performance: Grace Therapeutics reported a Q3 GAAP EPS of -$0.14, beating expectations by $0.14, indicating an improvement in financial performance despite still being in a loss position.
- Cash Flow Status: As of December 31, 2025, the company had cash and cash equivalents of $18.7 million, a decrease of $3.4 million from $22.1 million on March 31, 2025, reflecting operational funding pressures.
- Market Reaction: The earnings beat has increased market interest in Grace Therapeutics, potentially attracting more investors to monitor its future financial health.
- Future Outlook: Despite the current cash flow decline, the company must implement effective measures to improve its financial situation to ensure sustainable growth and maintain investor confidence.
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.
GRACE THERAPEUTICS Earnings Preview: Recent $GRCE Insider Trading, Hedge Fund Activity, and More
Earnings Release Date: GRACE THERAPEUTICS ($GRCE) is set to announce its quarterly earnings on June 24th, with analysts predicting $0 in revenue and a loss of -$0.32 per share.
Additional Information: The article includes a disclaimer that it is not financial advice and notes potential inaccuracies in the data presented.
Grace Therapeutics Announces Alignment with the FDA Supporting the Planned NDA Submission for GTx-104
FDA Meeting and NDA Submission: Grace Therapeutics announced a productive Type C meeting with the FDA regarding their GTx-104 drug, an injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH). The company plans to submit a New Drug Application (NDA) in Q2 2025 based on positive feedback from the FDA.
STRIVE-ON Trial Results: The STRIVE-ON trial demonstrated that GTx-104 significantly reduced clinically significant hypotension compared to oral nimodipine, with better patient outcomes and compliance. The trial's findings support GTx-104 as a promising treatment option for aSAH patients.
Matinas BioPharma Appoints Seasoned Biotech Leaders to Board of Directors
Board Appointments: Matinas BioPharma has appointed Keith Murphy and Edward Neugeboren as independent members of its Board of Directors, effective March 11, 2025, while thanking departing directors Matthew Wikler and Natasha Giordano for their service.
Product Development: The company is advancing its oral antifungal treatment MAT2203, which aims to provide a safer alternative to intravenous amphotericin B, having successfully completed a Phase 2 study in HIV patients with cryptococcal meningitis and planning further evaluation in a Phase 3 trial.
Grace Therapeutics Q3 Earnings Beat Expectations
- Earnings Performance: Grace Therapeutics reported a Q3 GAAP EPS of -$0.14, beating expectations by $0.14, indicating an improvement in financial performance despite still being in a loss position.
- Cash Flow Status: As of December 31, 2025, the company had cash and cash equivalents of $18.7 million, a decrease of $3.4 million from $22.1 million on March 31, 2025, reflecting operational funding pressures.
- Market Reaction: The earnings beat has increased market interest in Grace Therapeutics, potentially attracting more investors to monitor its future financial health.
- Future Outlook: Despite the current cash flow decline, the company must implement effective measures to improve its financial situation to ensure sustainable growth and maintain investor confidence.
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.
GRACE THERAPEUTICS Earnings Preview: Recent $GRCE Insider Trading, Hedge Fund Activity, and More
Earnings Release Date: GRACE THERAPEUTICS ($GRCE) is set to announce its quarterly earnings on June 24th, with analysts predicting $0 in revenue and a loss of -$0.32 per share.
Additional Information: The article includes a disclaimer that it is not financial advice and notes potential inaccuracies in the data presented.
Grace Therapeutics Announces Alignment with the FDA Supporting the Planned NDA Submission for GTx-104
FDA Meeting and NDA Submission: Grace Therapeutics announced a productive Type C meeting with the FDA regarding their GTx-104 drug, an injectable formulation of nimodipine for treating aneurysmal subarachnoid hemorrhage (aSAH). The company plans to submit a New Drug Application (NDA) in Q2 2025 based on positive feedback from the FDA.
STRIVE-ON Trial Results: The STRIVE-ON trial demonstrated that GTx-104 significantly reduced clinically significant hypotension compared to oral nimodipine, with better patient outcomes and compliance. The trial's findings support GTx-104 as a promising treatment option for aSAH patients.
Matinas BioPharma Appoints Seasoned Biotech Leaders to Board of Directors
Board Appointments: Matinas BioPharma has appointed Keith Murphy and Edward Neugeboren as independent members of its Board of Directors, effective March 11, 2025, while thanking departing directors Matthew Wikler and Natasha Giordano for their service.
Product Development: The company is advancing its oral antifungal treatment MAT2203, which aims to provide a safer alternative to intravenous amphotericin B, having successfully completed a Phase 2 study in HIV patients with cryptococcal meningitis and planning further evaluation in a Phase 3 trial.
