Crinetics Pharmaceuticals (CRNX) investor relations material

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.