Amryt Shares Fall After Oleogel-S10 EMA Regulatory Update

The European Medicines Agency plans to seek external independent Epidermolysis Bullosa (EB) specific expertise and advice on assessing Amryt Pharma Plc's AMYT Oleogel-S10.

  • Oleogel-S10 is under development for cutaneous manifestations of Junctional and Dystrophic EB, a rare genetic skin disorder.
  • The European Medicines Agency (EMA) review process for Oleogel-S10 in EB is ongoing, and Amryt has responded to outstanding questions. 
  • Related: Amryt's Skin Disorder Drug Application Review With FDA Extended By Three Months.
  • Given the rarity of the disease without any approved therapies, the EMA has proposed that an Ad-Hoc Expert Group, comprised of both EB clinical experts and patients with EB, be consulted to provide external and independent EB-specific advice.  
  • The Committee for Medicinal Products for Human Use (CHMP) opinion is anticipated in March 2022.
  • Price Action: AMYT shares are down 5.55% at $10.05 during the market session on the last check Friday.
Market News and Data brought to you by Benzinga APIs
Comments
Loading...
Posted In: BiotechNewsHealth CareSmall CapMoversTrading IdeasGeneralBriefs
Benzinga simplifies the market for smarter investing

Trade confidently with insights and alerts from analyst ratings, free reports and breaking news that affects the stocks you care about.

Join Now: Free!