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Grace Therapeutics (GRCE) investor relations material
Grace Therapeutics Q3 Investor Summit Group Virtual Conference 2025 earnings summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Key product and clinical insights
Developed a novel IV formulation of amlodipine (GTX-104) for subarachnoid hemorrhage, addressing limitations of oral forms and improving dose compliance and hypotension management.
Pivotal phase III STRIVE-ON trial met primary endpoint, showing fewer hypotensive events, higher dose compliance, and better recovery rates compared to oral.
Pharmaco-economic data showed reduced ICU stay, fewer ventilation days, and lower readmission rates for IV arm.
No new safety signals observed; safety profile comparable to oral and existing IV forms outside the U.S.
Strong patent protection through 2042 and seven years of market exclusivity via orphan drug status.
Regulatory and commercialization plans
NDA submitted and accepted by FDA, with PDUFA goal date set for April 23, 2026.
Regulatory pathway aligned with FDA, utilizing 505(b)(2) approach, minimizing risk and not requiring an advisory committee.
Targeted commercial strategy focused on 250 U.S. hospitals, requiring a small, specialized sales force.
Market research indicates strong clinician and hospital administrator support for IV formulation due to clinical and economic benefits.
Cash runway extends past PDUFA date, with additional potential funding from warrant exercises supporting commercialization into 2027.
Market and investment outlook
Subarachnoid hemorrhage is a rare, high-morbidity disease affecting a younger population, with significant unmet clinical need.
GTX-104 positioned to become new standard of care, with no direct competitors in the clinic.
Strong management team with experience in acute and chronic care drug launches.
Anticipated major inflection point within 12 months, with clear investment thesis and attractive market opportunity.
Commercial launch expected to be efficient and cost-effective due to concentrated hospital market.
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