Filsuvez's European Approval Adds Growth Driver For Amryt Pharma

Yesterday, Amryt Pharma plc AMYT received European approval for Filsuvez for partial thickness wounds associated with dystrophic and junctional Epidermolysis Bullosa (EB) in patients six months and older.
Filsuvez becomes the first approved treatment for EB.
HC Wainwright notes that the Medicines and Healthcare products Regulatory Agency in the U.K. is expected to grant authorization sometime soon.
He hopes that Amryt can get an FDA nod for Filsuvez sometime in the next 12-18 months after receiving a rejection in March.
Related: FDA Rejects Amryt Pharma's Oleogel-S10 Application For Skin Blistering Disorder.
The analyst anticipates Filsuvez's launch in Germany in September and expects to seek reimbursement in the other key European markets this year.
HC Wainwright models peak sales of over $140 million in the EU market for Filsuvez.
The analyst sees the approval add a new growth driver alongside Mycapssa, which should address investor concerns regarding the durability of the company's legacy products.
The analyst keeps a Buy rating on the stock with a price target of $18.00
Price Action: AMYT shares are down 1.09% at $7.28 during the market session on the last check Friday.