Crinetics Advances Key Treatment For Adult Congenital Adrenal Hyperplasia Patients With Phase 3 Enrollment Milestone

Crinetics Pharmaceuticals Inc. (CRNX) has enrolled its first participant in the CALM-CAH Phase 3 study—a pivotal investigation into Atumelnant, an investigational ACTH receptor antagonist targeting classic congenital adrenal hyperplasia (CAH) in adults. The milestone represents significant progress for a rare genetic disorder that disrupts normal adrenal function and typically demands lifelong glucocorticoid replacement therapy.

The Clinical Burden and Unmet Need

CAH remains a challenging disease landscape. Current standard-of-care regimens frequently produce substantial side effects—including stunted growth, metabolic dysfunction, and compromised quality of life—while delivering incomplete disease control. Atumelnant’s mechanism aims to normalize excessive adrenal androgens and reduce patients’ dependence on high-dose steroids. By restoring hormonal balance through once-daily oral dosing, the therapy addresses a critical gap in treatment options where existing approaches fail to adequately manage disease manifestations.

Building on Earlier Success

The Phase 3 trial is grounded in encouraging Phase 2 data, demonstrating rapid and sustained improvements in disease biomarkers alongside clinical benefit measures. These earlier-stage findings showed meaningful reductions in adrenal hormone excess and decreased reliance on glucocorticoid therapy. The CALM-CAH study now expands this evaluation to a broader adult congenital adrenal hyperplasia population, with efficacy and safety endpoints centered on hormonal control and clinical outcomes.

Regulatory Recognition and Pipeline Expansion

Crinetics’ program received Orphan Drug Designation from the FDA, reinforcing the significant unmet medical need and commercial potential. Looking ahead, the company’s development roadmap includes:

• Enrollment initiation for BALANCE-CAH, a Phase 2/3 trial in pediatric patients, anticipated in Q4 2025
• Glucocorticoid reduction and 13-week extension data expected in early 2026
• A Phase 2/3 study in ACTH-dependent Cushing’s syndrome targeted for launch in H1 2026

Financial Position and Stock Performance

Crinetics ended Q3 2025 with $1.1 billion in cash, providing runway to support operations through 2029. CRNX shares have traded between $24.10 and $56.53 over the period. The stock closed its most recent session at $49.31 (up 2.60%), though it declined overnight to $48.20 (down 2.52%). The company is also progressing CRN09682, a Phase 1/2 candidate for certain neuroendocrine and solid tumors.

The first patient enrollment occurred in December 2025, marking the transition from promising early-stage evidence to confirmatory Phase 3 testing for adult congenital adrenal hyperplasia therapy.