Crinetics Pharmaceuticals Inc. (CRNX) has dosed the first patient in its pivotal Phase 3 CALM-CAH trial of Atumelnant, a novel ACTH receptor antagonist being developed for the treatment of classic congenital adrenal hyperplasia (CAH).
CAH is a rare genetic disorder that disrupts adrenal hormone production, often requiring lifelong glucocorticoid therapy. Current treatments can lead to significant side effects, including growth impairment, metabolic complications, and reduced quality of life.
Atumelnant aims to normalize adrenal androgen levels and reduce glucocorticoid dependence, addressing a major unmet need for patients.
The CALM-CAH study builds on positive Phase 2 results, which showed rapid and sustained reductions in key disease biomarkers and clinical measures of CAH.
The Phase 3 trial is designed to evaluate Atumelnant's efficacy and safety in adults with classic CAH, with endpoints focused on adrenal hormone control and clinical outcomes.
Atumelnant has already demonstrated promise in earlier studies, where patients experienced meaningful improvements in disease markers and reduced reliance on high-dose steroids. The drug's once-daily oral formulation offers a potential advantage over current regimens, which often involve complex dosing and incomplete symptom control.
Crinetics recently received Orphan Drug Designation from the U.S. FDA for Atumelnant in the treatment of classic CAH, further underscoring the potential of the program.
Upcoming milestones for Crinetics include:
-BALANCE-CAH Phase 2/3 trial of Atumelnant in pediatric patients, expected to begin enrolment in Q4 2025.
-Glucocorticoid reduction data from Cohort 4 of the Phase 2 study and 13-week results from the open-label extension, anticipated in early 2026.
-Planning for a Phase 2/3 study in ACTH-dependent Cushing's syndrome, targeted for initiation in the first half of 2026.
Crinetics is also advancing other pipeline programs, including CRN09682, a Phase 1/2 investigational candidate for SST2-expressing neuroendocrine and solid tumors. The first patient was dosed in December 2025.
The company ended September 30, 2025, with a cash balance of $1.1 billion, which Crinetics stated is sufficient to fund its current operating plan into 2029.
CRNX has traded in a range of $24.10 to $56.53. The stock closed yesterday's trading at $49.31, up 2.60%, and declined in overnight trading to $48.20, down 2.52%.
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