(CercleFinance.com) – The UCB share fell by more than 15% on Friday after the negative opinion of the American drug agency (FDA) on the approval of bimekizumab, its new treatment against psoriasis.
In a press release published this morning, the Belgian laboratory indicates that it has received a complete response letter concerning its application for a license for biological products on this drug project intended for adult patients with moderate to severe plaque psoriasis.
For the record, receipt of a complete response letter means that the FDA is unable to approve the application in the current form of the dossier.
According to UCB, the FDA has determined that some of its observations made following an inspection must be corrected for possible approval of the product.
Following this setback, UCB said it had to revise its earnings forecast for the 2022 financial year.
In a reaction note, analysts at Berenberg recall that they forecast annual sales of 32 million euros for bimekizumab in the United States in 2022 alone, and then 150 million next year.
The design office argues that the drug candidate alone represents 12 euros per title, or 9% of the theoretical value of the action.
Berenberg nevertheless thinks that bimekizumab could be authorized during the second half of 2023.
Around 2:20 p.m., the UCB title dropped 15.2%. Its performance since the beginning of the year is now negative, with a decline of more than 13%.
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