Crinetics Pharmaceuticals Highlights Early PALSONIFY Sales, EU Milestone, and GPCR Pipeline at TD Cowen Conf.

Executives from Crinetics Pharmaceuticals (NASDAQ:CRNX) used an investor discussion at TD Cowen’s 46th Annual Healthcare Conference to highlight early U.S. commercial progress for its newly launched acromegaly drug, outline upcoming regulatory and clinical milestones, and describe how its pipeline is built around novel small-molecule therapies targeting G protein-coupled receptors (GPCRs).

PALSONIFY launch: early demand, reimbursement work underway

Chief Financial Officer Tobin Schilke said the company’s transition from an R&D-focused organization to an “R&D commercial company” was a core management focus, pointing to the 2025 launch of PALSONIFY (paltusotine) in acromegaly as a key step. Schilke reported $5.4 million in first-quarter revenue, along with “over 200” patient start/enrollment forms. He added that the company raised additional capital earlier in the year and said Crinetics is “well funded into 2030.”

Schilke characterized early prescribing as broad, citing “over 125 unique prescribers” split between academic/pituitary treatment centers and community settings. He also described how enrollment forms are processed through the company’s hub and specialty pharmacy, and how reimbursement is pursued through payer submissions.

On payer access, Schilke said more than half of patients have been “quickly reimbursed” through medical exception forms, while others are supported via a Quick Start program that provides a month of PALSONIFY while paperwork is completed. He said the company’s goal is to convert Quick Start patients to reimbursed therapy in roughly a couple of months, noting that payer feedback has generally centered on completing forms and providing supporting information rather than requiring step edits. He added that prior authorizations granted so far average about 12 months in duration.

• U.S. list price disclosed at launch: $290,000 per year of therapy
• Early access mix discussed: roughly 10% Medicaid, 30% Medicare, 60% commercial (based on claims data for other acromegaly products)
• Company expectation: about three-quarters of covered lives within nine months of launch
• Formulary update highlighted: CVS Caremark added PALSONIFY to formulary earlier in the year, according to Schilke

Schilke said it was “premature” to provide specific gross-to-net guidance, citing uncertainty around the evolving patient mix, including the proportion of patients dispensed through 340B hospitals. He noted the company does not plan to broadly discount to commercial payers, while government reimbursement would typically involve larger discounts.

Positioning: oral therapy intended to simplify acromegaly care

Chief Endocrinologist Alan Krasner emphasized that paltusotine is a once-daily oral therapy intended to simplify care for patients with rare endocrine diseases. He contrasted the oral approach with established somatostatin receptor ligand (SRL) therapies that are administered as monthly injections, which he described as painful and requiring healthcare-provider administration.

During Q&A, Schilke said Crinetics aspires for PALSONIFY to become the standard of care in acromegaly. He also noted the company believes the total addressable market could expand if patients stay on therapy longer, citing published data that 80% of patients on an SRL discontinue or switch within five years for reasons other than cure.

In a discussion of market size, Schilke said global SRL sales were “roughly $2.5 billion,” with $800 million to $900 million attributed to acromegaly, though he cautioned that SRLs are also used in other indications and off-label settings. He added that, directionally, about two-thirds of the acromegaly-related market is in the U.S., citing differences in pricing across regions.

Europe: positive CHMP recommendation and a country-by-country approach

Krasner said Crinetics had received a positive recommendation from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for paltusotine, with a potential European approval “hopefully in May.”

Schilke said Crinetics wants to “keep the asset whole,” arguing it preserves optionality amid uncertainty in the U.S. pricing landscape. For Europe, he said the company expects to proceed pragmatically on a country-by-country basis and suggested the orphan nature of acromegaly could allow a more focused launch approach without a “large lift.”

Pipeline focus: GPCR targets, including first-in-class receptor antagonists

Krasner said Crinetics’ pipeline centers on novel small molecules designed to therapeutically interact with GPCRs, including targets not previously addressed with approved medicines. He described atumelnant as an ACTH receptor antagonist and said it represents the first time such an antagonist has been tested in humans.

He said paltusotine is also being developed for carcinoid syndrome, a condition affecting an estimated 20% of patients with neuroendocrine tumors and marked by diarrhea and flushing. Krasner noted that Crinetics has announced Phase 2 data and has advanced paltusotine into Phase 3 for carcinoid syndrome. He explained that the Phase 3 program is placebo-controlled, with flushing frequency as the primary endpoint and bowel movement frequency as a key secondary endpoint, and said both endpoints are independently powered.

Atumelnant: Phase 3 approach in CAH and additional Cushing’s data expected

Discussing congenital adrenal hyperplasia (CAH), Krasner said Crinetics’ Phase 3 plan for atumelnant uses a composite primary endpoint intended to address two goals simultaneously: normalizing elevated adrenal androgens and reducing glucocorticoid dosing into the low physiologic replacement range. He contrasted this with crinecerfont’s Phase 3 results, which he described as demonstrating steroid-sparing without showing meaningful androgen reductions.

Krasner said the company expects additional data from an ongoing open-label extension study in CAH patients and suggested longer treatment could further reduce adrenal androgen levels and potentially reduce adrenal size, based on observations from earlier trial periods.

In Cushing’s, Krasner said the NIH is testing multiple doses of atumelnant in active patients. He reported that an 80 mg dose “pretty much normalized” urine free cortisol in study patients within a 10-day treatment period and said additional dose data could be reported later in the year, potentially around the Endocrine Society meeting.

Krasner also highlighted CRN09682, a small-molecule approach targeting SST2 with a cytotoxic payload for neuroendocrine tumors and related tumors. He said the program is in a first-in-human Phase 1 dose escalation trial (the BRAVESST2 study), with any timing for sharing clinical data dependent on the pace and results of dose escalation and the decision to move into expansion cohorts. He added that progress continues in preclinical programs, including TSH receptor and PTH receptor antagonists, with the goal of entering the clinic next year and the possibility of new INDs this year.

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.