Brief: Camurus AB Says FDA Issues A Crl For Cam2029 Pending FDA's Assessment Of Responses From A Third-Party Manufacturer

Camurus AB

22/10/2024 24:03

Oct 21 (Reuters) - Camurus AB  CAMX.ST :
    * CAMURUS AB - FDA ISSUES A CRL FOR CAM2029 PENDING FDA'S
ASSESSMENT OF RESPONSES FROM A THIRD-PARTY MANUFACTURER
    * CAMURUS AB - WILL WORK WITH FDA AND MANUFACTURER TO
RESOLVE ANY
POTENTIAL OUTSTANDING OBSERVATIONS
    * CAMURUS AB - CRL DID NOT STATE ANY OTHER CONCERNS,
INCLUDING
RELATED TO CLINICAL EFFICACY OR SAFETY OF CAM2029.
    * CAMURUS AB - CRL DOES NOT IMPACT ON ADVANCEMENT OF THESE
PROGRAMS
    * CAMURUS AB - LABELLING DISCUSSIONS WITH FDA WERE HELD
DURING
FINAL STAGE OF NDA REVIEW AND PRESCRIBING INFORMATION FOR
CAM2029 IS WELL ADVANCED
    * CAMURUS AB - 2 DEVELOPMENT PROGRAMS FOR CAM2029 FOR
TREATMENT OF
GASTROENTEROPANCREATIC NEUROENDOCRINE TUMORS, POLYCYSTIC LIVER
DISEASE PROGRESSING

Source text for Eikon:  ID:nWkr5VxCq4 
Further company coverage:  CAMX.ST 

 ((Reuters.Briefs@thomsonreuters.com;))