Camurus AB (CAMX.ST) has announced on Friday that the U.S. Food and Drug Administration has accepted to review their resubmission of New Drug Application for Oclaiz, an extended-release octreotide injection intended for treating acromegaly.
The FDA has set a Prescription Drug User Fee Act or PDUFA target action date of June 10, 2026. They submitted the updated filing on December 10, 2025, after receiving a Complete Response Letter that was focused only on issues from a cGMP inspection at a third-party manufacturing facility.
The NDA is backed by data from seven clinical studies, which include two Phase 3 trials from the ACROINNOVA program.
CAMX.ST closed Friday's trading at SEK 665.00 up SEK 26.50 or 4.15 percent on the Nasdaq Stockholm.
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