Brief: FDA Issues Complete Response Letter For Camurus CAM2029 NDA For Acromegaly
BRIEF-FDA Issues Complete Response Letter For Camurus CAM2029 NDA For Acromegaly June 11 (Reuters) - Camurus AB CAMX.ST:
SAID ON WEDNESDAY FDA ISSUES COMPLETE RESPONSE LETTER FOR CAMURUS CAM2029 NDA FOR ACROMEGALY
CRL DOES NOT RELATE TO THE CLINICAL EFFICACY OR SAFETY OF CAM2029
WORKING TOWARD RESUBMISSION OF NDA IN NEAR TERM, WHILE MAINTAINING LAUNCH READINESS AND WITH NO CHANGE TO 2026 FINANCIAL OUTLOOK
Source text for Workspace: nWkr1vT7T
Further company coverage: CAMX.ST
(Gdansk Newsroom)
((gdansk.newsroom@thomsonreuters.com; +48 58 769 66 00;))
Recent news on Camurus AB
See all newsBrief: Camurus Receives Approval In Canada For Oczyesa XR
Brief: Executive Sells About £279,000 Of Camurus Shares
Jefferies cuts Ipsen to 'underperform' on Somatuline competition risk
Brief: Camurus Says NDA Resubmission For CAM2029 In Acromegaly Accepted For Review By FDA
Camurus shares rise after Q2 revenue, operating profit beat