June 6 Company Quick Takes: Take two for Celgene's ozanimod; plus Protalix, ABPI, Axovant and Mylan

Celgene resubmits NDA for ozanimod
FDA and EMA accepted submissions from Celgene Corp. (NASDAQ:CELG) for ozanimod to treat multiple sclerosis. The PDUFA date for the selective S1PR1 and S1PR5 modulator is March 25, 2020, and Celgene expects a decision from EMA in 1H20. FDA had issued a refusal-to-file letter for a prior NDA in February 2018 (see "Celgene Resubmits NDA for MS Candidate Ozanimod").

Protalix, Chiesi eyeing accelerated approval for Fabry disease therapy next year
Protalix BioTherapeutics Inc. (NYSE-A:PLX; Tel Aviv:PLX) and Chiesi Farmaceutici S.p.A. (Parma, Italy) said they plan to submit a BLA via FDA's accelerated approval pathway for pegunigalsidase alfa to treat Fabry disease in 1Q20. The candidate is a plant cell-expressed recombinant form of human alpha galactosidase A...