Crinetics Pharmaceuticals (NASDAQ:CRNX) provided a corporate update highlighting early commercial progress for Palsonify in acromegaly and new phase 2 data for atumelnant in congenital adrenal hyperplasia (CAH), along with details on the ongoing phase 3 program.
Palsonify launch: early uptake and fourth-quarter revenue
Chief Executive Officer Scott Struthers said the company is “excited” with the first full quarter of the Palsonify launch following approval in late September, emphasizing that commercial execution is the company’s top priority as it begins 2026.
On launch metrics, Struthers reported:
- More than 200 enrollment forms processed to date.
- More than 125 unique prescribers across all U.S. regions, with about half in smaller community practices and the remainder in pituitary treatment centers.
- All 22 U.S.-based open-label extension patients have switched to commercial supplies.
- Approximately 50% of filled prescriptions are reimbursed quickly without requiring bridging supply through the company’s QuickStart program, with assistance from the Crinetics Care patient support program.
- The “vast majority” of prior authorizations are for 12 months.
Crinetics reported over $5 million in unaudited net Palsonify revenue for the fourth quarter. In response to investor questions about whether the initial enrollment pace could be extrapolated, CFO Toby Schilke said it is “difficult at this point in time to extrapolate going forward,” while adding that the early performance reflects field execution and messaging around efficacy and symptom control.
Payer access: early formulary inclusions and prior authorizations
Management said payer engagement began early and has already produced some formulary inclusions, which the company described as sooner than expected given typical payer update cycles.
Chief Commercial Officer Isabel Kalofonos said more than 80% of prior authorizations are coming through at 12 months, with most of the remainder at six months and a smaller portion at three months. She also said the company has not seen step edits required and has not experienced pushback tied to generic depot injectables, describing early dynamics as positive and consistent with on-label prescribing.
Kalofonos added that Crinetics’ goal is to drive formulary coverage over time, stating the company hopes that after six to nine months “most of the formularies will have been approximately 95%.” She also said Crinetics is working toward being “over 75%” in the next nine months.
Atumelnant phase 2 cohort 4: androgen reduction maintained during steroid tapering
Crinetics also discussed atumelnant, an ACTH receptor antagonist being developed for CAH. Chief Endocrinologist Alan Krasner said atumelnant is the first and only agent tested in humans that selectively blocks the ACTH receptor found only in the adrenal glands, describing the receptor as a “single choke point” that may explain the potency observed to date.
The update focused on top-line results from cohort 4 of the phase 2 Toucan study, which evaluated atumelnant 80 mg daily while requiring glucocorticoid dose reductions to physiologic range if tolerated, and also explored morning versus evening dosing. Ten patients enrolled; two withdrew consent after enrollment, leaving eight completers for the androstenedione (A4) efficacy analysis, while safety included all dosed participants.
Krasner reported that A4 reductions in cohort 4 were similar to prior results at the same 80 mg dose, despite glucocorticoid reductions. He said A4 dropped rapidly—within two weeks—and did not rebound through 12 weeks even as glucocorticoids were reduced, with seven of eight patients reaching physiologic glucocorticoid dosing. He also said there was no discernible impact from morning versus evening dosing in the small dataset.
Management summarized cohort 4 as demonstrating a 67% reduction in A4, sustained alongside glucocorticoid tapering, and said the results strengthen confidence heading into phase 3.
Open-label extension snapshot and safety profile
Krasner also provided an early snapshot from the ongoing open-label extension (OLE). Among seven subjects with at least 13 weeks of OLE treatment at the time of the snapshot, the company reported a median 72% A4 reduction along with glucocorticoid dose reductions across the group. He noted that one patient appeared to show continued A4 decline after week 13, which he described as intriguing but not conclusive. Krasner linked the possibility of improving efficacy over time to previously presented MRI data showing reductions in adrenal gland volume within three months.
On safety, Krasner said the most common adverse events across the phase 2 cohorts included headache and fatigue, which he noted are commonly reported in this patient population. In cohort 4, two cases of glucocorticoid deficiency and one case of adrenal insufficiency were reported in connection with glucocorticoid tapering. He said no adverse events were classified as serious, and there were no discontinuations due to adverse events in the phase 2 core study or OLE to date. Management also said there were no hepatic transaminase adverse events in cohort 4 or in the OLE.
Phase 3 CALM CAH: responder endpoint and dosing strategy
Crinetics said the phase 3 CALM CAH study is a 32-week randomized, double-blind, placebo-controlled trial targeting enrollment of 150 patients. The company described the primary endpoint as a responder analysis: achieving normal A4 levels while being on a physiologic glucocorticoid dose. Global Product Leader Garnet Howells specified the physiologic threshold as below 11 mg/m2/day hydrocortisone-equivalent dosing and A4 below the upper limit of normal.
Howells said the trial is “very highly powered” to detect a difference between placebo and active treatment, and that the study size also accounts for overall safety database requirements. Management said CALM CAH will start at 80 mg once daily with a single-step up-titration to 120 mg once daily for those who need additional A4 control. Participants will take atumelnant in the evening in phase 3 to align drug exposure with the early-morning ACTH surge, though cohort 4 suggested morning dosing also produced similar A4 lowering.
In Q&A, Krasner said glucocorticoid reductions in phase 3 will be guided by protocol instructions and patient tolerance rather than being based on A4 levels, and he suggested the longer trial duration should allow a more gradual taper to avoid withdrawal symptoms.
Struthers closed by positioning 2025 as a “landmark year” marked by the first approval and launch, and said the company is focused on sustaining growth while advancing atumelnant and other pipeline programs.
About Crinetics Pharmaceuticals (NASDAQ:CRNX)
Crinetics Pharmaceuticals, Inc is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of novel therapeutics for rare endocrine diseases. The company’s proprietary platform leverages insights into hormone receptor signaling to design small-molecule candidates that address conditions driven by dysregulated hormone activity. Crinetics’ research efforts center on targeting somatostatin, vasopressin and other GPCR-mediated pathways with orally bioavailable molecules intended to improve patient convenience and adherence.
The company’s lead product candidate, paltusotine (formerly CRN04777), is a selective, non-peptide somatostatin receptor type 2 agonist being evaluated for the treatment of acromegaly and carcinoid syndrome diarrhea.
