Grace Therapeutics, Inc. (GRCE) Grace Therapeutics, Inc. specializes in the creation and commercialization of pharmaceutical products, primarily targeting uncommon and neglected diseases, with operations centered in Canada. The company's most advanced experimental treatment is GTX-104, an intravenous infusion designed to address subarachnoid hemorrhage. Its development pipeline further includes GTX-102, an oral mucosal betamethasone spray intended for the management of ataxia-telangiectasia, and GTX-101, a topical bioadhesive film-forming bupivacaine spray for postherpetic neuralgia. Established in 2002, the enterprise previously operated under the name Acasti Pharma Inc., before officially adopting Grace Therapeutics, Inc. in October 2024. The company's main offices are located in Princeton, New Jersey.
Sector: Pharmaceutical Preparations
Industry: Biotechnology
Grace Therapeutics, Inc. NASDAQ:GRCE Healthcare · Biotechnology
Mkt Cap $40.81M
Vol 0
$ Vol 0
RVOL 0
Earnings 0
Press Release ⚠ 3
Grace Therapeutics to Participate in the H.C. Wainright 28th Annual Global Investment Conference
Grace Therapeutics announced that CEO Prashant Kohli will present at the H.C. Wainwright 28th Annual Global Investment Conference, held September 14-16, 2026 in New York.
The presentation will be available on demand beginning September 11, and Kohli will be available for one-on-one investor meetings throughout the conference.
Grace's lead asset GTx-104, an IV nimodipine infusion for aneurysmal subarachnoid hemorrhage, holds FDA Orphan Drug Designation; the release's risk language reiterates a prior CRL, pending contract-manufacturing remediation and reinspection, and a potential need for additional capital.
• 1mo ago AI analysis › Press Release ⚠ 2
Grace Therapeutics Announces First Quarter 2027 Financial Results, Provides Business Update
Grace Therapeutics reported a Q1 net loss of $15.8 million, or $0.91 per share, compared to a loss of $3.4 million, or $0.21 per share, in the prior year period, driven primarily by a $13.5 million impairment charge for deprioritized assets GTx-101 and GTx-102.
The company announced a $10 million private placement financing, extending its cash runway through the end of calendar 2028 to fund manufacturing and regulatory work for its lead asset GTx-104.
Management confirmed that the FDA's Complete Response Letter identified no clinical safety or efficacy deficiencies, and the company is advancing a dual-source manufacturing strategy to address the remaining CMC and facility-level compliance items required for NDA resubmission.
• 2mo ago AI analysis › Press Release ⚠ 2
Grace Therapeutics Announces $10 Million Private Placement
Grace Therapeutics secured approximately $10 million in gross proceeds through a private placement of 4.76 million shares at a price of $2.10 per share.
The financing extends the company's cash runway to the end of 2028, providing capital to support manufacturing and regulatory work for its lead asset GTx-104.
To mitigate compliance issues at its current manufacturer, the company has initiated a dual-source manufacturing strategy and a technology transfer to a U.S.-based facility.
• 2mo ago AI analysis › Press Release ⚠ 3
Grace Therapeutics Announces Receipt of Type A Meeting Minutes from U.S. Food and Drug Administration
The FDA confirmed in Type A meeting minutes that GTx-104 has no clinical safety or efficacy deficiencies and did not request additional clinical data. The Complete Response Letter was limited to facility-level cGMP compliance at a contract manufacturer and requests for additional non-clinical data. To address these issues and de-risk the path forward, the company is pursuing a dual-source manufacturing strategy, including technology transfer to a U.S.-based second source. Grace Therapeutics aims to support its NDA resubmission with either the remediated facility or the new partner once compliant.
• 3mo ago AI analysis › Press Release ⚠ 3
Grace Therapeutics Announces 2026 Fiscal Year-End Financial Results, Provides Business Update
Grace Therapeutics reported a fiscal 2026 net loss of $7.8 million, or $0.47 per share, an improvement from the $9.6 million loss reported in the prior year. The company ended the period with $17.0 million in cash, stating it has sufficient runway to fund operations for at least the next 12 months.
Regarding the GTx-104 NDA, the company confirmed that the April FDA Complete Response Letter cited only CMC and non-clinical issues, with no clinical deficiencies identified. A Type A meeting has been scheduled to clarify the path forward for the NDA resubmission.
Business highlights include the presentation of Phase 3 STRIVE-ON safety trial data at multiple medical conferences and the issuance of a new U.S. patent covering the IV dosing regimen, extending protection to 2043.
• 4mo ago AI analysis › Press Release ● Major ⚠ 3
Grace Therapeutics Provides Regulatory Update on New Drug Application for GTx-104
Grace Therapeutics received a Complete Response Letter from the FDA for GTx-104, citing issues related to Chemistry, Manufacturing, and Controls (CMC) as well as non-clinical information.
Notably, the FDA did not request additional clinical data, and the company believes the cited items regarding leachables, toxicology, and manufacturing deficiencies can be addressed in a resubmission.
The company intends to request a Type A meeting to clarify the path forward following the CRL, which impacts the NDA for the treatment of aneurysmal subarachnoid hemorrhage.
• 6mo ago AI analysis › Press Release ● Major
Grace Therapeutics Announces Abstract Highlighting STRIVE-ON Phase 3 Trial Results Accepted for Presentation at AAN 2026
globenewswire.com • 6mo ago Press Release
Grace Therapeutics to Present Data on the Unmet Medical Needs and Potential Benefits of GTx-104 in the Treatment of aSAH at Upcoming Medical Conferences
globenewswire.com • 7mo ago 
