Company: CRNX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001658247-25-000019
Chunk: 95

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 2
Chunk 95
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 chemical entities that target peptide GPCRs to address unmet needs for people with endocrine diseases and related tumors. 

Our first approved therapy is PALSONIFY™ (paltusotine), which has been approved by the U.S. Food and Drug Administration, or FDA, in the United States for the treatment of acromegaly. Additionally, PALSONIFY is under review by regulatory agencies in Europe for the treatment of acromegaly.  Paltusotine is also in clinical development for treatment of carcinoid syndrome associated with neuroendocrine tumors. Atumelnant is in clinical development for congenital adrenal hyperplasia, or CAH, and ACTH-Dependent Cushing’s Syndrome, or ADCS. We are advancing additional product candidates through preclinical discovery and development studies in indications such as neuroendocrine tumors, Graves’ disease (including Graves’ hyperthyroidism and Graves’ orbitopathy, or thyroid eye disease), polycystic kidney disease, hyperparathyroidism, diabetes, obesity, and GPCR-targeted oncology indications. Our vision is to build the premier, endocrine-rooted global pharmaceutical company dedicated to improving the lives of patients.

Key Pipeline Updates

The following represents a summary of notable business updates and events:

Paltusotine

•On September 25, 2025, the FDA approved PALSONIFY for the first-line treatment of adults with acromegaly who had an inadequate response to surgery and/or for whom surgery is not an option.

•Our research suggests that there are approximately 36,000 people living with acromegaly in the United States, of which 17,000 or more are undiagnosed, 7,500 are not in active follow-up for treatment, and 11,500 are actively managed. Our research further suggests that of the 11,500 actively managed patients in the United States, 40% are treatment naïve, 25% are on injectable somatostatin receptor ligands, 20% are on other therapies, and 15% have discontinued treatment. Our research also indicates that there are approximately 1,500 newly diagnosed patients per year, 500 of which are candidates to initiate pharmaceutical treatment.

•Our marketing authorization application, or MAA, was validated by the European Medicines Agency, or EMA, for paltusotine for the treatment of acromegaly, consistent with a timeline for a 

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potential EMA decision in the first