Grace Therapeutics Inc Dossier
Qualitative Analysis
Business overview
Grace Therapeutics, Inc. (NASDAQ: GRCE), formerly known as Acasti Pharma Inc. until its name change in October 2024, is a late-stage biopharmaceutical company focused on developing and commercializing innovative therapies for rare and orphan diseases. The company's proprietary drug delivery technologies aim to optimize the performance of established drugs by achieving faster onset of action, enhanced efficacy, and reduced side effects. Grace's lead clinical asset is GTx-104, a novel, clinical-stage, injectable formulation of nimodipine designed for intravenous (IV) infusion to treat patients with aneurysmal Subarachnoid Hemorrhage (aSAH). This life-threatening medical emergency currently relies on oral nimodipine, which is associated with high pharmacokinetic variability and dosing errors. GTx-104 has been granted Orphan Drug Designation by the FDA, providing seven years of marketing exclusivity post-approval.
Research as of 19 Jun 2026
Strategic Initiatives
Growth programs, investments, and their expected impact
Focusing resources on resolving the Chemistry, Manufacturing, and Controls (CMC), leachables data, and contract manufacturing organization (CMO) cGMP deficiencies cited in the FDA's April 2026 Complete Response Letter (CRL) for GTx-104.
Expected impact: Successful resubmission and potential FDA approval of GTx-104 for the treatment of aneurysmal subarachnoid hemorrhage (aSAH).
Halting internal development funding for the GTx-102 (Ataxia-Telangiectasia) and GTx-101 (Postherpetic Neuralgia) programs to conserve capital and focus exclusively on the lead asset GTx-104.
Expected impact: Reduction in ongoing R&D burn rate and concentration of strategic focus on a single late-stage asset, while continuing to seek out-licensing or strategic partnerships for the deferred assets.
Proactively investing in pre-commercial planning, infrastructure buildup, and market readiness in anticipation of potential FDA approval for GTx-104.
Expected impact: Rapid market penetration and commercial readiness upon potential regulatory approval of GTx-104.
Mergers, Acquisitions & Partnerships
Recent deals and strategic collaborations
Recent Acquisitions
Acasti Pharma acquired Grace Therapeutics to transition its business focus toward rare and orphan diseases, acquiring Grace's entire clinical-stage pipeline (including GTx-104, GTx-102, and GTx-101) and drug delivery technologies. The combined entity subsequently returned to the 'Grace Therapeutics, Inc.' name in October 2024.
Financial impact: Allowed the combined company to leverage remaining cash reserves to fund the Phase 3 STRIVE-ON safety trial for GTx-104.