Camurus slides after FDA rejection of Oclaiz delays launch
BUZZ-Camurus slides after FDA rejection of Oclaiz delays launch ** Shares in Camurus CAMX.ST fall 7% after the U.S. Food and Drug Administration rejected its application for Oclaiz acromegaly, a hormonal disorder, potentially delaying the drug's launch
** The FDA requested a reinspection of the third-party manufacturing facility and a small labelling change to the product packaging
** Assuming the reinspection takes place in H2 2026, approval and launch would shift to H1 2027, Jefferies says
** "While a negative near-term regulatory development, the CRL does not impact our view on Oclaiz's commercial opportunity, representing ~9% of our current valuation," Van Lanschot Kempen says
** The rejection does not relate to the clinical efficacy or safety of the drug and does not change Camurus' 2026 outlook
** Acromegaly is a hormonal disorder that causes abnormal growth of bones and tissues, body parts and inner organs
(Reporting by Vera Dvorakova)
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