FDA approves Crinetics Pharmaceuticals’ first drug

Crinetics Pharmaceuticals just won its first Food and Drug Administration approval with Palsonify, a once-daily pill for adults with acromegaly, a rare and debilitating hormonal disorder, who cannot undergo surgery or did not respond to it.

Backed by two late-stage trials showing significant drops in growth hormone and improved symptoms, the small-molecule drug offers patients an oral alternative to injectable or restrictive oral therapies from Novartis, Ipsen, and the Italian firm Chiesi, STAT’s Jonathan Wosen writes.

Analysts see blockbuster potential if the drug is later approved to treat related disorders, though competition will be fierce.

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