Crinetics Pharmaceuticals Inc shares jumped over 60% in pre-market trading on Monday after the clinical-stage pharmaceutical company announced that its experimental treatment for a rare hormonal disorder exceeded analyst forecasts in a Phase 3 trial.
Crinetics said 83% of patients on its experimental drug paltusotine were able to maintain growth-factor levels, compared to 4% who were receiving the placebo.
At least three analysts, on the other hand, had been expecting about 70% of patients to maintain growth-factor levels.
The Phase 3 PATHFNDR-1 study was a randomized, double-blind, placebo-controlled 36-week treatment period followed by an optional open-label extension study evaluating paltusotine in participants with acromegaly, in which the body produces an excess of growth hormone.
"We could not be more excited by the results from PATHFNDR-1, which further reinforce our conviction that, if approved, paltusotine could address patients’ unmet need for a simple, oral, once-daily therapy," Crinetics Pharmaceuticals CEO Scott Struthers said in a statement.
"These data showed that upon switching from injected standard of care, paltusotine provided reliable, durable control of their disease," he added.
Analysts at Oppenheimer, meanwhile, called the data "picture perfect" and noted the daily oral drug could become the preferred therapy for acromegaly.
Crinetics stated that pending successful findings from the PATHFNDR-2 study, in which topline data is expected in the first quarter of 2024, it plans to submit a new drug application to the US Food and Drug Administration (FDA) in 2024 seeking regulatory approval for all acromegaly patients who require pharmacotherapy.
Shares of Crinetics Pharmaceuticals have fallen 12% year to date.
Contact Sean at sean@proactiveinvestors.com