Crinetics Pharmaceuticals, Inc. 8-K

What Happened
Crinetics Pharmaceuticals (CRNX) filed an 8-K on January 5, 2026 announcing preliminary, unaudited results for the quarter ended December 31, 2025 and clinical updates. The company expects to report net product revenue from PALSONIFY (paltusotine) of greater than $5.0 million for Q4 2025. Crinetics also released topline data from the fourth cohort of its Phase 2 study of atumelnant (an ACTH antagonist) in congenital adrenal hyperplasia (CAH) and updated open‑label extension results.

Key Details

• Preliminary, unaudited PALSONIFY net product revenue: > $5.0 million for the three months ended Dec 31, 2025 (subject to final audit and close procedures).
• Commercial uptake metrics: >200 enrollment forms received (including 22 from U.S. open‑label extension participants); >125 unique prescribers (≈50% community, 50% pituitary centers).
• Reimbursement/access: about half of newly filled bottles reimbursed without Quickstart bridge supplies; most prior authorizations have 12‑month duration.
• Atumelnant Phase 2 (Cohort 4): n=10 (12‑week); 8 completed cohort with rapid, sustained reductions in androstenedione (A4); 7 of 8 maintained lower A4 after glucocorticoid doses were reduced to physiologic levels. No serious adverse events, no treatment‑related severe adverse events, and no hepatic transaminase issues reported. Open‑label extension: 25 enrolled, 7 patients with ≥13 weeks of data (data consistent with cohort 4), 7 with >20 weeks.

Why It Matters
For investors, the preliminary >$5.0M Q4 PALSONIFY revenue indicates early commercial traction, but the figure is unaudited and may change after the company completes its financial close. The reimbursement and prescriber metrics suggest initial market access and adoption trends that could affect future sales if sustained. Positive Phase 2 atumelnant data with consistent biomarker reductions and favorable tolerability may support further clinical development plans, though the company explicitly cautions these are early results and subject to the usual development and regulatory risks. The company furnished (not filed) a press release and investor presentation with these updates.