Successful U.S. Commercial Launch of PALSONIFY
PALSONIFY (paltusotine) launched in 2025 with Q4 net product revenue of $5.4M and total Q4 net revenue of $6.2M (including $0.8M licensing revenue from SKK). The launch generated >200 enrollment forms in Q4 and adoption by >125 unique prescribers across community and pituitary centers. Early payer momentum includes wins with top plans adding PALSONIFY to formularies with label-consistent prior authorization and no step edits.
Strong Balance Sheet and Extended Runway
Crinetics ended 2025 with >$1.0B in cash, cash equivalents and investments and, after a January 2026 public offering ($380M net proceeds), held ~ $1.4B. Management expects existing cash to fund operations into 2030, providing multi-year runway for commercialization and multiple pivotal readouts.
Promising Clinical Data for Atumelnant and Development Progress
Atumelnant (ACTH receptor antagonist) showed rapid, large biomarker responses in NIH Phase Ib/IIa ADCS data with UFC responses within days and all patients achieving serum cortisol <5 µg/dL. Global, operationally seamless Phase II/III (EQUILIBRIUM ADCS) initiated (Phase II dose range 20–80 mg/day) with Phase III powered for normalization of 24-hour urine-free cortisol; open-label extension included.
Pipeline Expansion: CRN09682 Phase I/II Initiation
First candidate from non-peptide drug conjugate program (CRN09682) entered dose escalation in a Phase I/II basket trial (BRAVESST) targeting SST2-expressing tumors. Broad tumor eligibility (NETs, meningioma, others) with clear PET-based SST2 selection criteria and encouraging preclinical signals (including small cell lung carcinoma models).
Regulatory Progress in Europe
Received a positive CHMP opinion for PALSONIFY in the EU for acromegaly, representing an important regulatory milestone supporting global commercialization plans.
Disciplined 2025 Cash Usage vs Guidance
Used $326.2M of total net cash in 2025, favorable to guidance of $340M–$370M (management attributed the variance to working capital timing and higher employee option proceeds), demonstrating execution in line with financial planning.