Crinetics will get more time after FDA setback for Camurus' rival drug, Piper Sandler says

Camurus AB

11/06/2026 14:48

** Brokerage Piper Sandler says the FDA’s refusal to approve Swedish drugmaker Camurus’ CAMX.ST Oclaiz for a rare hormone disorder is likely to give Crinetics CRNX.O more time to build out Palsonify’s U.S. launch
** Palsonify was approved by the FDA to treat acromegaly in September last year 
** Acromegaly is a rare condition in which the pituitary gland in the brain produces excess growth hormone, causing abnormal organ, bone and tissue growth
** Camurus' drug is approved in the UK and EU under the brand name Oczyesa
** The FDA declined to approve the drug citing unresolved issues at a third-party manufacturing site, rather than safety or efficacy concerns
** Piper says resolving the manufacturing deficiencies should enable a straightforward path to refiling the marketing application
** "We continue to think Palsonify is instilled with clear blockbuster potential as it continues to mature into launch through 2026" - Piper Sandler
** As of last close, CRNX stock was down 26.3% YTD 

 (Reporting by Padmanabhan Ananthan)
 ((Padmanabhan.Ananthan@thomsonreuters.com))