Latest news

• FDA approves Sarepta rival NS Pharma’s Duchenne drug

  Drug approved for patients with exon 53 mutation. Japanese pharma Nippon Shinyaku (NS Pharma) has scored US Food and Drug Administration (FDA) approval for its Duchenne muscular dystrophy drug viltolarsen, now

• FDA sets Q3 decision date for NS Pharma’s DMD drug

  Viltolarsen has been granted a priority review, as well as fast track, orphan drug and rare disease designations. ... Viltolarsen is an antisense oligonucleotide that promotes the production of functional dystrophin by masking exon 53 in the dystrophin

• Wave’s challenge to Sarepta in Duchenne falls flat

  It’s exon 53 skipping drug  viltolarsen was filed for approval in October and could be approved in the middle of next year.

• FDA grants surprise OK to Sarepta’s DMD therapy after earlier rejection

  It could face its first competition fairly soon however after rival NS Pharma filed for approval of its exon 53 skipping drug  viltolarsen in October.

• Solid Bio falls as FDA halts DMD trial over safety concerns

  In the meantime, rival candidate viltolarsen from Japanese pharma Nippon Shinyaku (NS Pharma) has been  filed with the FDA for the treatment of DMD. ... Although the FDA has not yet set an approval decision date, if there are no significant issues