Sesen BioAktie
ISIN: US8177631053 | WKN: A2JL47 | Symbol: SESN
Bladder cancer is the single most expensive ($4 billion/year) cancer to treat in the US
Bisher wurden nur 3 Medikamente seit 1959 zugelassen
Vicinium is Highly Differentiated and has a Dual Mechanism of Action
2019 - FDA Type C CMC Meeting
Type B Clinical pre-BLA Meeting
Type C Confirmatory Trial Meeting
Type B CMC pre-BLA Meeting
(Dec 4, 2019) Initiation of BLA Submission
(Dec 2019)2020 - FDA CMC Module 3 Submission
Completion of BLA Submission Oncologic Drugs Advisory Committee Meeting
2020 - EMA Feedback from EMA on regulatory pathway for marketing authorization application
Regulatory Designations -
FDAFast Track
Accelerated Approval Pathway
Rolling Review
Priority Review Anticipated Upon BLA filing