Brief: Mabion Partner Submits FDA Documentation For MabionCD20 In ITP
12/08/2026 07:09
BRIEF-Mabion Partner Submits FDA Documentation For MabionCD20 In ITP Aug 12 (Reuters) - Mabion SA MABP.WA:
SAID ON TUESDAY THAT IT HAD RECEIVED CONFIRMATION FROM ITS PARTNER ODDIFACT CONCERNING SUCCESSFUL SUBMISSION OF DOCUMENTATION TO U.S. FOOD AND DRUG ADMINISTRATION (FDA) ON PLANNED DEVELOPMENT OF MABIONCD20 IN IMMUNE THROMBOCYTOPENIA (ITP), INCLUDING REQUEST FOR PRE-IND TYPE B MEETING
ESTIMATES POTENTIAL ANNUAL US MARKET VALUE OF CD20 MONOCLONAL ANTIBODY TREATMENT FOR ITP AT ABOUT $100 MLN
TARGETS GLOBAL MARKET LAUNCH OF PRODUCT IN NEXT 4 TO 5 YEARS UPON SUCCESSFUL COMPLETION OF THE SUBSEQUENT STAGES OF DEVELOPMENT AND OBTAINING REGULATORY APPROVALS
Source text: nEMmrDZqa
Further company coverage: MABP.WA
(Gdansk Newsroom)
((gdansk.newsroom@thomsonreuters.com; +48 58 769 66 00;))
Recent news on Mabion SA
See all newsBrief: Mabion Partner Oddifact Says FDA Consultations Allow MabionCD20 To Be Used As First-Line Therapy For ITP
Brief: Mabion Holds Pre-IND Type B Meeting With FDA On MabionCD20 Development For ITP
Brief: Mabion Signs LoI With WPD Pharmaceuticals On Extension Of Cooperation
Brief: Mabion Q2 Net Loss At 15 Mln Zlotys
Brief: Mabion Signs Deal With Novavax Expanding Cooperation To Analytical Services For Early-Stage Pipeline Projects