Oncopeptides tumbles as FDA withdraws U.S. marketing authorization for Pepaxto

Oncopeptides AB

07/12/2022 14:17

** Shares of Swedish biotechnology company Oncopeptides
 ONCO.ST  plunge around 28% after U.S. Food and Drug
Administration (FDA) requested a withdrawal of U.S. marketing
authorization for its drug Pepaxto
    ** The request is based on the outcome of the confirmatory
phase 3 OCEAN study, which in Oct. 2021 led to Oncopeptides
withdrawing the drug in the U.S. 
        ** The stock reaction is purely sentimental, Kempen
analyst Suzanne van Voorthuizen says 
  
        ** She points out it was already well known that Pepaxto
was slammed down by the FDA earlier in September, adding that
the withdrawal from the U.S. market is "more a formality than
anything else"
        ** Pepaxto, Oncopeptides' treatment for multiple
myeloma, was granted marketing authorization in Europe in August
2022
    ** Oncopeptides is the biggest faller among Swedish stocks
 (Reporting by Agata Rybska)
 ((agata.rybska@thomsonreuters.com))