Neurocrine’s lead neuroendocrinology program has passed its first Phase III test, setting up a potential FDA filing in 2024.
The San Diego biotech saw its shares $NBIX go up almost 7% to $117.10 Tuesday on the heels of the announcement that crinecerfont met primary and key secondary endpoints in the Phase III CAHtalyst trial. The trial enrolled 182 adults with classic congenital adrenal hyperplasia (CAH) due to 21-hydroxylase deficiency (21-OHD) — making it the largest ever interventional trial conducted in this rare disease, according to the principal investigator.
CEO Kevin Gorman told investors at a healthcare conference that “the study had a very high bar for efficacy, which was met and answered in the clinic,” William Blair analysts wrote in a note. Neurocrine is expecting data from a similar study involving children and adolescents…
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