Crinetics Pharmaceuticals Inc. (CRNX) has begun its pivotal Phase 3 trial of Paltusotine in adults with carcinoid syndrome, dubbed CAREFNDR.
Carcinoid syndrome affects about 20% of patients with neuroendocrine tumors, typically arising when tumors spread to the liver. Symptoms, such as flushing and diarrhea, can severely disrupt quality of life, and current monthly injectable therapies often provide incomplete relief.
The Phase 3 CAREFNDR study is a multicenter, randomized, double-blind, placebo-controlled trial designed to enroll 141 adults. Participants will receive either paltusotine 80 mg once daily or a placebo for 16 weeks. The primary endpoint will measure the change in flushing episodes per day from baseline to week 12, with bowel movement frequency as a key secondary endpoint. Following the controlled period, patients will enter a 104-week open-label extension to assess long-term efficacy, safety, and tumor control.
In earlier Phase 2 studies, the drug showed rapid and sustained reductions in flushing episodes and bowel movement frequency, offering hope for patients who struggle with the limitations of injections.
Paltusotine, a once-daily, oral therapy that selectively targets somatostatin receptor type 2 (SST2), is already approved for the treatment of adults with acromegaly who have had an inadequate response to surgery and/or for whom surgery is not an option and is marketed under the brand name PALSONIFY.
The CAREFNDR trial represents the latest step in Crinetics' goal of expanding the value of PALSONIFY beyond its lead indication for the treatment of acromegaly. PALSONIFY was approved by the U.S. FDA in September 2025 for adults with acromegaly who had an inadequate response to surgery or for whom surgery was not an option.
Upcoming milestones:
Crinetics is also advancing its Phase 1/2 study, CRN09682, an investigational anti-tumor candidate targeting SST2-expressing neuroendocrine and other solid tumors.
The company anticipates enrolment to begin in the CALM-CAH Phase 3 study of Atumelnant in adults with congenital adrenal hyperplasia and the BALANCE-CAH Phase 2/3 study in pediatric patients in the fourth quarter of 2025.
Glucocorticoid reduction data from Cohort 4 of the Phase 2 study and 13-week results from the Phase 2 open-label extension study of Atumelnant are expected in early 2026.
Planning is underway for a Phase 2/3 study of Atumelnant in ACTH-dependent Cushing's syndrome, with initiation targeted for the first half of 2026.
The company ended September 30, 2025, with a cash balance of $1.1 billion, sufficient to fund its current operating plan into 2029.
CRNX has traded in the range of $24.10 to $60.34 over the past year. The stock closed yesterday's trading at $41.97, down 2.17%, but during the after-hours, the stock rose to $41.98, up 0.02%.
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