Refile: BUZZ-Mabion shares rise after FDA submission for MabionCD20
REFILE-BUZZ-Mabion shares rise after FDA submission for MabionCD20 Refiles to add dropped word 'after' in headline, no changes to text.
** Shares in Polish biotech developer Mabion MABP.WA rise around 4% as plans for its autoimmune blood disorder treatment (ITP) become more tangible
** Oddifact, Mabion's partner, files with FDA documents on the planned development of MabionCD20, treatment against immune thrombocytopenia (ITP)
** The submission includes a request for a pre-IND Type B meeting, where the FDA gives early feedback before formal drug trials begin
** "The filing marks a shift from declarations and analyses to a concrete regulatory process," Trigon says
** The broker adds the critical test ahead will be FDA feedback on whether it accepts the proposed ITP development plan, what scope of preclinical and clinical data it will require, and whether Mabion can leverage its earlier work on MabionCD20
** MabionCD20 was originally developed as a biosimilar copy of a cancer and arthritis drug but never won approval
(Reporting by Rafal Nowak)
((RafalWojciech.Nowak@thomsonreuters.com; +48 58 769 66 63;))
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