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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.FDA Announcement summary25 Sep, 2025
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.
PALSONIFY payer access strategy details?
Paltusotine global expansion and pipeline plans?
Impact of PALSONIFY approval on pipeline prioritization?
Strategy for 7,500 lapsed acromegaly patients?
Payer step-edit experience post-launch?
Key drivers for new standard of care timeline?
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Next Crinetics Pharmaceuticals earnings date
Q3 20256 Nov, 2025
Next Crinetics Pharmaceuticals earnings date
Q3 20256 Nov, 2025
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Frequently asked questions
Crinetics Pharmaceuticals Inc. is a clinical-stage pharmaceutical company that specializes in the development of novel therapeutics targeting peptide hormone receptors. Their focus is on the treatment of rare endocrine disorders and endocrine-related tumors. The company’s leading product candidate is Paltusotine, an oral selective nonpeptide somatostatin receptor type 2 agonist. It is in advanced clinical trials for conditions such as acromegaly, carcinoid syndrome, and nonfunctional neuroendocrine tumors. Additionally, Crinetics Pharmaceuticals is developing other drug candidates for conditions like congenital hyperinsulinism and Cushing's disease. The company is headquartered in San Diego, California, and its shares are listed on the NASDAQ.
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