Company: CRNX
Filing Date: 2025-08-07
Form Type: 10-Q
Source: 0001193125-25-175498
Chunk: 5

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-08-07
Form: 10-Q
Item: Part I, Item 2
Chunk 5
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 product candidate is paltusotine, which is under review by the U.S. Food and Drug Administration, or FDA,  in the United States, or U.S., for the treatment of acromegaly as PALSONIFYTM, under review by regulatory agencies in Europe for the treatment of acromegaly, and in clinical development for treatment of carcinoid syndrome associated with neuroendocrine tumors. Our second product candidate is atumelnant, which 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. 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

•U.S. Food and Drug Administration review of PALSONIFY for the treatment and maintenance of acromegaly continues as expected.

•Shared additional detail on the patient population with acromegaly that could be a candidate for chronic pharmacological intervention with Palsonify.  Our research suggests that there are approximately 11,000 addressable patients, approximately 500 newly diagnosed addressable patients each year and at least 17,000 undiagnosed patients in the U.S.

•Marketing authorization application, or MAA, validated by the European Medicines Agency, or EMA, for paltusotine for the treatment of acromegaly, consistent with a timeline for a potential EMA decision in the first half of 2026.  The EMA also granted Orphan Drug Designation, or ODD, for paltusotine for the treatment of acromegaly, further highlighting the level of unmet need and the potential for paltusotine to offer significant benefit to patients. 

Atumelnant

•Phase 2 TouCAHn open-label study of atumelnant in CAH reported positive results. Atumelnant administration was shown to result in rapid, substantial and sustained statistically significant reduction in androstenedione, or A4, levels, the key biomarker for disease control. Atumelnant was well-tolerated and demonstrated significant clinical improvements. We have also initiated an open-label extension study.

•Phase 3 CALM-CAH study is designed with an uncompromising primary endpoint to demonstrate atumelnant’s potential ability to normalize A4 levels