Oncopeptides plummets after FDA ODAC votes against Pepaxto

Oncopeptides AB

23/09/2022 08:58

** Shares of Swedish biotechnology company Oncopeptides
 ONCO.ST  plunge 16% after Oncologic Drugs Advisory Committee
(ODAC) of U.S. Food and Drug Administration (FDA) voted against
the benefit/risk profile of Pepaxto  urn:newsml:reuters.com:*:nFWN30T2RX
    ** The company said the panel considered that OCEAN trial
did not confirm Pepaxto's favorable benefit-risk profile in the
current indicated patient population
    ** According to Kempen Life Sciences Research the voting is
firmly closing the U.S. door for Pepaxto
    ** Kempen adds, though, its valuation (PT of SEK
35)conservatively only included Europe and hence even after the
stock's negative reaction from Monday (-62%) and the downtick on
Friday, it fundamentally does see upside to the valuation even
without the U.S. opportunity
    ** Oncopeptides started its dialogue with FDA to review new
data on Pepaxto in January 2022 after it had voluntarily
withdraw Pepaxto in the U.S. in October 2021  urn:newsml:reuters.com:*:nFWN2RI0RE  
    ** Pepaxto, Oncopeptides' treatment for multiple myeloma,
was granted marketing authorization in Europe in August 2022 
    ** Oncopeptides stock is down 66% since Monday when the
company published Briefing Book for the ODAC meeting, with
shares now trading at June price level of about SEK 11
 (Reporting by Agnieszka Gosciak-Rabalska)
 ((agnieszka.gosciak@thomsonreuters.com))