Grace Therapeutics CEO Says FDA Application Will Bring First Innovation in 40 Years
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Jun 18 2026
0mins
"Since receipt of the U.S. Food and Drug Administration's (FDA) Complete Response Letter in April 2026, we have been working diligently on addressing the cited items, and we look forward to a constructive discussion with the FDA as we continue to prepare our resubmission," said Prashant Kohli, CEO of Grace Therapeutics. "FDA approval of our New Drug Application for GTx-104 for the treatment of aSAH would represent the first meaningful innovation in the standard of care for these patients in more than 40 years. As evidenced by the response among researchers, practitioners and industry leaders to the presentation of our Phase 3 STRIVE-ON trial results at major medical conferences throughout the fiscal year, we believe there is a significant desire in the marketplace for an intravenously administered nimodipine. We are confident in the robust data package supporting our NDA, and that the issues identified by the FDA can be successfully addressed in our resubmission."
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About GRCE
Grace Therapeutics, Inc. is a late-stage biopharma company with drug candidates addressing rare and orphan diseases. Its novel drug delivery technologies have the potential to improve the performance of marketed drugs by achieving faster onset of action, and reduced side effects. Its lead clinical asset, GTx-104, is an intravenous infusion targeting aneurysmal Subarachnoid Hemorrhage (aSAH), a rare and life-threatening medical emergency in which bleeding occurs over the surface of the brain in the subarachnoid space between the brain and skull. The nanoparticle technology of GTx-104 facilitates aqueous formulation of insoluble nimodipine for a standard peripheral IV infusion. Its other pipeline includes GTX-102, which is targeted as the first potential therapy for the treatment of ataxia-telangiectasia (AT) in a pediatric population and GTx-101, which is a topical administration via a bioadhesive, film-forming polymer, for the treatment of pain associated with postherpetic neuralgia.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Grace Therapeutics Reports FY 2026 Financial Results and NDA Update
- Financial Performance: Grace Therapeutics reported a net loss of $7.8 million for FY 2026, translating to a loss of $0.47 per share, which is an improvement from the $9.6 million loss in the previous year, indicating effective cost management efforts by the company.
- R&D Expense Reduction: The company’s R&D expenses dropped to $2.4 million in FY 2026 from $9.5 million in 2025, primarily due to the completion of the Phase 3 STRIVE-ON trial for GT-104, reflecting enhanced efficiency in research and development.
- NDA Progress: After submitting the NDA for GTx-104 in June 2025, the company received a complete response letter from the FDA in April 2026 regarding CMC issues, but plans to address these concerns promptly for resubmission, with potential approval marking the first new standard of care for aSAH in over 40 years.
- Clinical Trial Success: The STRIVE-ON study successfully met its primary endpoint, showing a 19% reduction in hypotension among patients treated with IV nimodipine, which strongly supports the market potential of GTx-104 and could significantly enhance treatment outcomes for aSAH patients.
See More
Grace Therapeutics Under Investigation for Securities Violations
- Investigation Launched: The Schall Law Firm has announced an investigation into Grace Therapeutics (NASDAQ:GRCE) for potential violations of securities laws, focusing on whether the company issued false or misleading statements and failed to disclose material information to investors.
- FDA Response: On April 23, 2026, Grace announced that the U.S. FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA), highlighting issues in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections related to leachables data and manufacturing deficiencies.
- Stock Price Plunge: Following the FDA's negative feedback, Grace's shares plummeted nearly 45.5% on the same day, indicating extreme market pessimism about the company's future prospects, which may undermine investor confidence significantly.
- Investor Rights: The Schall Law Firm encourages affected investors to reach out for discussions about their rights, showcasing the firm's expertise in securities class action lawsuits and shareholder rights litigation, potentially providing legal support for investors.
See More
Pomerantz LLP Investigates Claims for Grace Therapeutics Investors
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of investors in Grace Therapeutics, focusing on whether the company and its executives have engaged in securities fraud or other unlawful business practices, which could severely impact investor rights.
- FDA Response Letter: On April 23, 2026, Grace announced that its New Drug Application for GTx-104 received a Complete Response Letter from the FDA, citing issues related to leachables data and manufacturing deficiencies, indicating significant compliance challenges in drug development.
- Stock Price Plunge: Following the FDA's negative feedback, Grace's stock price fell by $1.96, a 45.48% drop, closing at $2.35 per share, reflecting market pessimism regarding the company's future prospects.
- Potential Legal Consequences: The investigation by Pomerantz LLP could lead to a class action lawsuit, and if fraud is confirmed, Grace may face substantial damages, further affecting its market reputation and investor confidence.
See More
Pomerantz LLP Investigates Grace Therapeutics for Securities Fraud
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of investors in Grace Therapeutics, focusing on whether the company and its executives engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and the company's reputation.
- FDA Response Letter: On April 23, 2026, Grace announced that the FDA issued a Complete Response Letter for its New Drug Application for GTx-104, citing issues in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections, potentially delaying the product's market entry.
- Stock Price Plunge: Following the FDA announcement, Grace's stock price fell by $1.96, a 45.48% drop, closing at $2.35 per share, indicating a severe market reaction and pessimism regarding the company's future prospects.
- Potential Legal Consequences: The investigation by Pomerantz LLP could lead to a class action lawsuit, and if fraud is confirmed, it may have significant implications for Grace's financial health and shareholder equity, further exacerbating investor losses.
See More
Grace's Drug FDA Rejection Leads to Stock Plunge
- FDA Rejection: Grace Therapeutics' application for GTx-104 to treat aneurysmal subarachnoid hemorrhage was rejected by the FDA due to issues in Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections, resulting in a 49% drop in stock price this week, marking its worst performance since September 2020.
- Analyst Downgrades: Craig-Hallum cut its price target for Grace from $11 to $4 while maintaining a 'Buy' rating, believing the company has enough runway to address the FDA's deficiencies, although shares are unlikely to recover until more visibility is provided.
- Management's Response: CEO Prashant Kohli expressed confidence in the robust data package supporting their NDA submission and stated that the CMC issues identified by the FDA can be successfully addressed in a resubmission, with plans to meet with the FDA to clarify resubmission timelines.
- Retail Investor Sentiment: Despite the stock's decline, retail sentiment on Stocktwits remained 'bullish', with users highlighting that the FDA's cited issues are fixable and expecting a rebound, indicating market confidence in the company's future prospects.
See More
Grace Therapeutics Faces FDA Rejection for New Drug Application
- FDA Complete Response Letter: Grace Therapeutics' New Drug Application for GTx-104 was rejected by the FDA due to issues in chemistry, manufacturing, and controls (CMC) and non-clinical sections, hindering progress in treating aneurysmal Subarachnoid Hemorrhage (aSAH).
- Clinical Trial Data: GTx-104 demonstrated clinical benefits in the Phase 3 STRIVE-ON trial, showing a 19% reduction in the incidence of clinically significant hypotension compared to oral Nimodipine, providing supportive data for future applications.
- Death Event Analysis: The GTx-104 group reported 8 deaths compared to 4 in the oral Nimodipine group, with all deaths attributed to the severity of underlying conditions, which may still impact the FDA's safety assessment of the drug.
- Next Steps: The company intends to resubmit the application after addressing the FDA's concerns and plans to request a Type A meeting with the FDA to clarify the path forward, demonstrating its ongoing commitment to drug development.
See More
Grace Therapeutics Reports FY 2026 Financial Results and NDA Update
- Financial Performance: Grace Therapeutics reported a net loss of $7.8 million for FY 2026, translating to a loss of $0.47 per share, which is an improvement from the $9.6 million loss in the previous year, indicating effective cost management efforts by the company.
- R&D Expense Reduction: The company’s R&D expenses dropped to $2.4 million in FY 2026 from $9.5 million in 2025, primarily due to the completion of the Phase 3 STRIVE-ON trial for GT-104, reflecting enhanced efficiency in research and development.
- NDA Progress: After submitting the NDA for GTx-104 in June 2025, the company received a complete response letter from the FDA in April 2026 regarding CMC issues, but plans to address these concerns promptly for resubmission, with potential approval marking the first new standard of care for aSAH in over 40 years.
- Clinical Trial Success: The STRIVE-ON study successfully met its primary endpoint, showing a 19% reduction in hypotension among patients treated with IV nimodipine, which strongly supports the market potential of GTx-104 and could significantly enhance treatment outcomes for aSAH patients.
See More
Grace Therapeutics Under Investigation for Securities Violations
- Investigation Launched: The Schall Law Firm has announced an investigation into Grace Therapeutics (NASDAQ:GRCE) for potential violations of securities laws, focusing on whether the company issued false or misleading statements and failed to disclose material information to investors.
- FDA Response: On April 23, 2026, Grace announced that the U.S. FDA issued a Complete Response Letter (CRL) regarding its New Drug Application (NDA), highlighting issues in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections related to leachables data and manufacturing deficiencies.
- Stock Price Plunge: Following the FDA's negative feedback, Grace's shares plummeted nearly 45.5% on the same day, indicating extreme market pessimism about the company's future prospects, which may undermine investor confidence significantly.
- Investor Rights: The Schall Law Firm encourages affected investors to reach out for discussions about their rights, showcasing the firm's expertise in securities class action lawsuits and shareholder rights litigation, potentially providing legal support for investors.
See More
Pomerantz LLP Investigates Claims for Grace Therapeutics Investors
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of investors in Grace Therapeutics, focusing on whether the company and its executives have engaged in securities fraud or other unlawful business practices, which could severely impact investor rights.
- FDA Response Letter: On April 23, 2026, Grace announced that its New Drug Application for GTx-104 received a Complete Response Letter from the FDA, citing issues related to leachables data and manufacturing deficiencies, indicating significant compliance challenges in drug development.
- Stock Price Plunge: Following the FDA's negative feedback, Grace's stock price fell by $1.96, a 45.48% drop, closing at $2.35 per share, reflecting market pessimism regarding the company's future prospects.
- Potential Legal Consequences: The investigation by Pomerantz LLP could lead to a class action lawsuit, and if fraud is confirmed, Grace may face substantial damages, further affecting its market reputation and investor confidence.
See More
Pomerantz LLP Investigates Grace Therapeutics for Securities Fraud
- Securities Fraud Investigation: Pomerantz LLP is investigating claims on behalf of investors in Grace Therapeutics, focusing on whether the company and its executives engaged in securities fraud or other unlawful business practices, which could undermine investor confidence and the company's reputation.
- FDA Response Letter: On April 23, 2026, Grace announced that the FDA issued a Complete Response Letter for its New Drug Application for GTx-104, citing issues in the Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections, potentially delaying the product's market entry.
- Stock Price Plunge: Following the FDA announcement, Grace's stock price fell by $1.96, a 45.48% drop, closing at $2.35 per share, indicating a severe market reaction and pessimism regarding the company's future prospects.
- Potential Legal Consequences: The investigation by Pomerantz LLP could lead to a class action lawsuit, and if fraud is confirmed, it may have significant implications for Grace's financial health and shareholder equity, further exacerbating investor losses.
See More
Grace's Drug FDA Rejection Leads to Stock Plunge
- FDA Rejection: Grace Therapeutics' application for GTx-104 to treat aneurysmal subarachnoid hemorrhage was rejected by the FDA due to issues in Chemistry, Manufacturing, and Controls (CMC) and Non-Clinical sections, resulting in a 49% drop in stock price this week, marking its worst performance since September 2020.
- Analyst Downgrades: Craig-Hallum cut its price target for Grace from $11 to $4 while maintaining a 'Buy' rating, believing the company has enough runway to address the FDA's deficiencies, although shares are unlikely to recover until more visibility is provided.
- Management's Response: CEO Prashant Kohli expressed confidence in the robust data package supporting their NDA submission and stated that the CMC issues identified by the FDA can be successfully addressed in a resubmission, with plans to meet with the FDA to clarify resubmission timelines.
- Retail Investor Sentiment: Despite the stock's decline, retail sentiment on Stocktwits remained 'bullish', with users highlighting that the FDA's cited issues are fixable and expecting a rebound, indicating market confidence in the company's future prospects.
See More
Grace Therapeutics Faces FDA Rejection for New Drug Application
- FDA Complete Response Letter: Grace Therapeutics' New Drug Application for GTx-104 was rejected by the FDA due to issues in chemistry, manufacturing, and controls (CMC) and non-clinical sections, hindering progress in treating aneurysmal Subarachnoid Hemorrhage (aSAH).
- Clinical Trial Data: GTx-104 demonstrated clinical benefits in the Phase 3 STRIVE-ON trial, showing a 19% reduction in the incidence of clinically significant hypotension compared to oral Nimodipine, providing supportive data for future applications.
- Death Event Analysis: The GTx-104 group reported 8 deaths compared to 4 in the oral Nimodipine group, with all deaths attributed to the severity of underlying conditions, which may still impact the FDA's safety assessment of the drug.
- Next Steps: The company intends to resubmit the application after addressing the FDA's concerns and plans to request a Type A meeting with the FDA to clarify the path forward, demonstrating its ongoing commitment to drug development.
See More
