Grace Therapeutics, Inc.

Grace Therapeutics, Inc.

Company overview

Grace Therapeutics, Inc., formerly Acasti Pharma, focuses on developing and commercializing treatments for rare and orphan diseases using novel drug-delivery technologies. The company applies proprietary formulations to existing approved pharmaceutical compounds to improve efficacy, onset of action, safety, dosing convenience, and patient compliance, with potential use of a 505(b)(2) regulatory pathway.

Grace controls a broad intellectual property portfolio and pursues orphan-drug designation to obtain orphan drug exclusivity where applicable. Active pharmaceutical ingredients in development include existing approvals or repurposed compounds for new indications.

Pipeline at a glance

• GTx-104 (nimodipine injectable IV formulation using nanoparticle technology)

  • Indication: aneurysmal subarachnoid hemorrhage (aSAH)
  • Status: Phase 3 safety trial (STRIVE-ON) completed; NDA submitted and accepted for review; FDA PDUFA target date set; Complete Response Letter (April 2026) cited manufacturing and non-clinical deficiencies; planning NDA resubmission after addressing deficiencies
  • Key points: IV nimodipine formulation addresses solubility, bioavailability, food effects, and IV administration challenges of oral nimodipine. STRIVE-ON showed lower incidence of hypotension and favorable pharmacoeconomic signals. More than 200 total administrations in patients and volunteers with lower PK variability versus oral nimodipine.

• GTx-102 (betamethasone concentrated oral-mucosal spray)

  • Indication: ataxia-telangiectasia (A-T), pediatric
  • Status: PK bridging trial completed; development deprioritized in June 2026; company is evaluating out-licensing or partnerships
  • Key points: Licenses data from an Italian trial of oral betamethasone solution; topline PK results met objectives; prior work includes a PK bridging study comparing GTx-102 to oral solution and injectable betamethasone.

• GTx-101 (topical bioadhesive film-forming bupivacaine spray)

  • Indication: postherpetic neuralgia (PHN) and potential non-PHN pain indications
  • Status: Phase 1 PK and tolerability data generated; development deprioritized in 2023; company is evaluating monetization options
  • Key points: Four single-dose Phase 1 trials in healthy volunteers demonstrated favorable PK and minimal systemic absorption; no serious safety signals.

• Strategic focus (2024–2026)

  • Since May 2023 the company realigned to concentrate resources on GTx-104. GTx-102 and GTx-101 are retained for potential out-licensing or partnerships rather than internal development.

Market opportunity and indications

• aSAH (GTx-104): U.S. incidence estimates cited at approximately 42,500 per year, with alternate estimates up to ~70,000; Europe ~60,000; China ~150,000.
• PHN (GTx-101): U.S. PHN incidence about 120,000 patients per year; total addressable market for PHN and related pain indications cited up to approximately $2.5 billion.
• A-T (GTx-102): U.S. addressable population estimated around 4,300 patients per year; U.S. total addressable market about $150 million.
• Orphan drug designation for these programs can provide up to seven years of U.S. exclusivity, plus related tax credits and regulatory incentives.

Intellectual property

• Global IP estate includes 79 granted and pending patents (U.S.: 10 issued; 3 U.S. applications pending), with filings in Europe, Australia, Canada, the U.K., India, Japan, and other jurisdictions.
• Patents cover GTx-104, GTx-101, GTx-102, and related technologies. The company maintains trade secrets and continues to pursue additional patent protection and licenses.
• Orphan drug exclusivity is intended to complement patent protection and extend market exclusivity.

Manufacturing and supply

• The company does not own manufacturing facilities and relies on contract manufacturing organizations (CMOs) for clinical and, if approved, commercial production.
• CMOs are monitored for regulatory compliance and are subject to periodic audits.
• The April 2026 FDA Complete Response Letter identified cGMP deficiencies at the current CMO. Remediation will be required to support an NDA resubmission; risks include delays and potential transfer of manufacturing to an alternative facility.

Commercialization strategy

• Grace holds worldwide rights to its pipeline candidates and plans to commercialize GTx-104 in the U.S. with a focused hospital-based sales force if approved.
• The company seeks partnerships or out-licensing for non-U.S. territories and for GTx-102 and GTx-101 to monetize those programs without internal development.
• Strategic collaborations are part of the plan to access international markets and established commercial capabilities.

Financial and corporate status

• Employees: five full-time employees, all U.S.-based (as of March 31, 2026).
• Cash: approximately $17.0 million in cash and cash equivalents (as of March 31, 2026); $22.1 million as of March 31, 2025.
• Operations: The company has incurred operating losses and negative cash flows since inception and expects ongoing need for additional financing. Planned sources include equity financing and non-dilutive funding such as grants, loans, and strategic alliances.
• Impairments: As of June 2026, remaining carrying values for GTx-102 and GTx-101 in-process R&D assets are considered no longer recoverable on an internal-development basis; impairment charges are expected.
• Regulatory: NDA for GTx-104 was submitted in June 2025, accepted in August 2025 with a PDUFA target of April 23, 2026. A Complete Response Letter was issued in April 2026 citing CMC and non-clinical concerns. A Type A meeting is planned to determine the path forward and resubmission timing.

Corporate history

• Incorporated in Québec in 2002 as 9113-0310 Québec Inc.; renamed Acasti Pharma, Inc. in 2008.
• Merged with Grace Therapeutics in 2021; Grace Therapeutics, Inc. became a wholly owned subsidiary (Grace U.S.).
• In October 2024 the company completed corporate reorganizations including continuance to British Columbia, domestication to Delaware, and a corporate name change to Grace Therapeutics, Inc.; the U.S. subsidiary was renamed Grace Therapeutics U.S., Inc.
• As of the 2026 filing period, the primary focus remains on GTx-104 with GTx-102 and GTx-101 deprioritized.

Current business posture

• GTx-104 is the lead program with active regulatory interactions and a planned NDA resubmission path.
• GTx-102 and GTx-101 have been deprioritized for internal development and are candidates for out-licensing or partnerships.
• Key near-term priorities include responding to the FDA CRL, addressing manufacturing remediation, and securing additional capital for continued development and potential commercialization.