Company: CRNX
Filing Date: 2025-11-06
Form Type: 10-Q
Source: 0001658247-25-000019
Chunk: 75

Company: Crinetics Pharmaceuticals, Inc.
Filing Date: 2025-11-06
Form: 10-Q
Item: Part I, Item 8
Chunk 75
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romegaly 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 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

•In January 2025, we reported positive results from the Phase 2 TouCAHn open-label study of atumelnant in CAH. 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.

•Continued progress on the development program for atumelnant across multiple trials, including enrollment completion of Cohort 4 of the adult Phase 2 study with data expected early in 2026.

•In May 2025, we  revealed the design of our Phase 3 CALM-CAH study with an uncompromising primary endpoint to demonstrate atumelnant’s potential ability to normalize A4 levels with physiological glucocorticoid, or GC, replacement. 

•Announced our pediatric trial design in CAH, BALANCE-CAH. BALANCE-CAH is designed as an operationally seamless three-part