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Crinetics Pharmaceuticals (CRNX) investor relations material
Crinetics Pharmaceuticals FDA Announcement summary
Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
Introduction and purpose
FDA approved PALSONIFY (paltusotine) as the first once-daily oral therapy for adults with acromegaly who had inadequate response to surgery or are ineligible for surgery, marking a significant milestone in patient care and treatment advancement.
The approval reflects extensive engagement with the acromegaly community and a mission to pioneer new endocrine therapeutics to improve patient quality of life.
Details of approval or decision
PALSONIFY is approved as a first-line treatment for adults with acromegaly not adequately managed by surgery, with broad patient eligibility and no requirement for prior therapies.
Approval is based on two pivotal Phase 3 trials (PATHFNDR-1 and PATHFNDR-2) demonstrating rapid, durable, and consistent biochemical control and symptom reduction.
Initial U.S. approval granted in 2025, with product availability expected in early October.
PALSONIFY is the first and only once-daily oral SSP-2 selective agonist for acromegaly.
Impact on industry and stakeholders
The approval introduces a transformative oral option, addressing long-standing gaps in acromegaly management and representing a new standard of care.
Addresses a significant unmet need for 36,000 people living with acromegaly in the U.S., with 11,500 actively managed and 17,000+ undiagnosed.
Broad access initiatives include collaboration with payers, providers, advocacy groups, and launch of support programs for education, financial assistance, and nurse support.
Commercial launch strategy includes education, patient support, and payer engagement to ensure access and adherence.
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