Camurus Shares Fall 7% After FDA Rejection

Camurus Shares Fall 7% After FDA Rejection

Camurus AB (ST:CAMX) saw its share price decline by approximately 7% on Thursday following a U.S. Food and Drug Administration (FDA) decision to reject the company's application for Oclaiz, a proposed treatment for acromegaly. The FDA’s refusal was based on a request for a re‑inspection of a third‑party manufacturing facility and a minor change to the product’s labeling; the agency did not raise any concerns regarding the drug’s clinical efficacy or safety. Jefferies indicated that if the required re‑inspection is completed in the second half of 2026, regulatory approval and commercial launch could be pushed to the first half of 2027. Van Lanschot Kempen commented that, although the regulatory setback is negative in the near term, it does not alter its view of Oclaiz’s commercial opportunity, which it estimates represents roughly 9% of Camurus’s current valuation. The company’s 2026 outlook remains unchanged despite the FDA action.