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BRIEF-Tigenix says remains on track to receive a MA decision for Cx601 in 2017
May 31, 2017 / 5:23 AM / 6 months ago

BRIEF-Tigenix says remains on track to receive a MA decision for Cx601 in 2017

May 31 (Reuters) - TIGENIX NV

* REG-TIGENIX PROVIDES REGULATORY UPDATE ON CX601 EU MARKETING AUTHORIZATION APPLICATION PROCEDURE

* REMAINS ON TRACK TO RECEIVE A MARKETING AUTHORIZATION (MA) DECISION FOR CX601 IN 2017

* CX601 HAS BEEN DEVELOPED FOR TREATMENT OF COMPLEX PERIANAL FISTULAS IN CROHN‘S DISEASE PATIENTS AS A FIRST INDICATION.

* RECEIPT OF MA IN EUROPE WILL TRIGGER A MILESTONE PAYMENT FROM TAKEDA TO TIGENIX OF EURO 15 MILLION AS WELL AS EUROPEAN LAUNCH OF CX601

* MARKETING AUTHORIZATION (MA) APPLICATION TO EMA, WHICH IS SUPPORTED BY POSITIVE 24 AND 52 WEEK PHASE III DATA AND IS NOW EXPECTING A DECISION ON EUROPEAN APPROVAL OF PRODUCT

* GLOBAL PHASE III TRIAL OF CX601 INTENDED TO SUPPORT A FUTURE U.S. BIOLOGIC LICENSE APPLICATION (BLA) IS EXPECTED TO START IN 2017

* ENTERED INTO LICENSING AGREEMENT WITH TAKEDA, UNDER WHICH TAKEDA ACQUIRED EXCLUSIVE RIGHT TO DEVELOP AND COMMERCIALIZE CX601 FOR COMPLEX PERIANAL FISTULAS OUTSIDE US

* SECOND ADIPOSE-DERIVED PRODUCT, CX611, IS UNDERGOING A PHASE I/II TRIAL IN SEVERE SEPSIS

* ALLOCSC-01, TARGETING ACUTE ISCHEMIC HEART DISEASE, HAS DEMONSTRATED POSITIVE RESULTS IN A PHASE I/II TRIAL IN ACUTE MYOCARDIAL INFARCTION (AMI) Source text for Eikon: See also: Further company coverage: (Gdynia Newsroom)

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