Crinetics Announces Strong PALSONIFY Launch Execution and Positive Results for Concurrent Androstenedione Lowering and Glucocorticoid Dose Reduction in Phase 2 Trial of Atumelnant for Congenital Adrenal Hyperplasia
Strong PALSONIFY U.S. Launch Execution Resulted in Unaudited and Preliminary Net Product Revenue of >$5 Million for Fourth-Quarter 2025, with >200 Enrollment Forms at the End of December
Atumelnant (80 mg) Achieved a 67% Mean Reduction in Androstenedione Levels While Simultaneously Enabling 88% of Participants Completing 12 Weeks of Treatment to Successfully Reduce Glucocorticoid Dose to Physiologic Replacement Levels
Atumelnant's Favorable Benefit/Risk Profile Was Maintained in Cohort 4 and Open-Label Extension of Phase 2 CAH Study With No Hepatic Transaminase Adverse Events
Management to Host Investor Conference Call Today at 8:30 AM ET
SAN DIEGO, Jan. 05, 2026 (GLOBE NEWSWIRE) -- Crinetics Pharmaceuticals, Inc. (Nasdaq: CRNX) today announced PALSONIFY U.S. unaudited and preliminary net product revenue of over $5 million for fourth-quarter 2025. Crinetics also announced positive topline results from the fourth cohort of its Phase 2 congenital adrenal hyperplasia (CAH) study of investigational atumelnant, a novel, once-daily oral adrenocorticotropic hormone (ACTH) receptor antagonist candidate being developed for the treatment of classic CAH and ACTH-dependent Cushing’s syndrome.
"I’m very proud of our team’s strong execution of Palsonify's launch in acromegaly. We are delivering impressive results, highlighted by over 200 enrollment forms in the first three months after FDA approval, a broad prescriber base, and continued momentum toward favorable payer coverage,” said Scott Struthers, Ph.D., founder and chief executive officer of Crinetics. "Further, we are excited to announce additional positive atumelnant clinical data which reinforces its potential to become an uncompromising, highly differentiated treatment for people struggling with CAH. Today’s launch update and clinical results mark two major steps forward for becoming the premier global endocrine company and to advance our unique portfolio that has been purposefully built to redefine the standard of care for people struggling with endocrine and endocrine-related diseases."
Highlights from Launch of PALSONIFYCrinetics is highly encouraged by early results from the launch of PALSONIFY, which was approved by the U.S. Food and Drug Administration (FDA) on September 25, 2025 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. Crinetics recognized over $5 million of revenue from PALSONIFY during the fourth quarter of 2025. Feedback from patients, physicians, and payers has been very positive thus far. Notably, Crinetics’ continued engagement with payers has resulted in early formulary inclusions, reflecting payers’ appreciation of PALSONIFY’s value proposition.
As of December 31, 2025, after a full quarter on the market, launch performance of PALSONIFY can be characterized as below:
- >200 enrollment forms1 received
- >125 unique prescribers
- Approximately half of newly filled bottles were reimbursed without need for Quickstart bridge supplies
- 12-month duration of most prior authorizations
Highlights from Cohort 4 of Phase 2 TouCAHn TrialThe TouCAHn trial is an open-label, global, Phase 2 study designed to evaluate the efficacy, safety, and pharmacokinetics of atumelnant when administered for 12 weeks in people with CAH caused by 21-hydroxylase deficiency. The fourth cohort of the study enrolled 10 patients with classic CAH on a stable dose of glucocorticoid replacement; two patients withdrew consent. The participants received atumelnant (80 mg) once daily in the morning and underwent glucocorticoid (GC) dose reduction toward physiologic levels (
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