Latest news

• FDA approves Sarepta rival NS Pharma’s Duchenne drug

  Following the approval, NS Pharma is required to conduct a confirmatory clinical trial to demonstrate the drug’s clinical benefit. ... Like NS Pharma, Sarepta is conducting a confirmatory trial of Vyondys 53 after winning initial approval to determine

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

  NS Pharma’s drug is designed to treat DMD patients with exon 53 mutations – the exact same mutation which rival Sarepta’s Vyondys 53 targets. ... NS Pharma and its parent company Nippon Shinyaku are currently enrolling patients for a phase 3 study

• 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.

• Sarepta bounces back with new gene therapy data

  Sarepta has been down-on-luck since then, facing another blow earlier this month when NS Pharma filed a rival Duchenne drug with the FDA.