- 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.
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