• Late 2017/early 2018: Expected FDA approval of NVS/MNTA’s 40mg-Copaxone ANDA. (On 2/17/17, MNTA reported that the ANDA approval was held up due to an FDA compliance issue at PFE’s fill/finish facility at McPherson, KS, which NVS/MNTA are using for Glatopa. Approval of the ANDA can’t happen until PFE fixes the compliance issue at this site.)
FoB program
• Soon (overdue): Submit 351(k) FDA application for M923, MNTA’s wholly owned Humira FoB.
• Timing unknown: M923 commercial partnership or out-license.
• Late 2017/early 2018: File IND for M710 (the second FoB compound in the MYL-MNTA partnership) and formally disclose what the compound is (likely Xolair [#msg-135286163]).
• 2018: Report reason for inability of M834 (MNTA-MYL Orencia FoB) to meet its phase-1 pharmacokinetic endpoint, and start phase-1 do-over.
Proprietary autoimmune program
• 4Q17: Report data from SAD and MAD portions of phase-1 trial of M281, an anti-FcRn mAb wholly owned by MNTA.
• 4Q17: Start phase-1 trial of M230, an Fc-receptor compound partnered with CSL (#msg-127656306).
• 2018 Start phase-1 trial of M254, a hyper-sialylated IVIG.
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