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Concopeptides Stockholm , Sweden Press release October 22 , 2021 Oncopeptides withdraws Pepaxto® in US , scale down organization and focus on R & D STOCKHOLM October 22 , 2021 Oncopeptides AB ( publ ) ( Nasdaq Stockholm : ONCO ) , a global biotech company focused on the development of therapies for difficult - to - treat hematological diseases , today announces that the company has decided to withdraw Pepaxto ( INN melphalan flufenamide ) from the market in the US , following the phase 3 OCEAN study , which showed an overall survival in the ITT population with a HR of 1.104 . The decision has been made after interactions and dialogue with the US Food and Drug Administration , FDA . Pepaxto was granted accelerated approval on February 26th 2021 . During our dialogue with FDA it has become evident that the FDA does not consider that the phase 3 OCEAN study meets the criteria of a confirmatory study . Oncopeptides believes that the OCEAN data are scientifically meaningful and that the findings warrant further evaluation . As a consequence Oncopeptides will immediately refocus the company and return to being a Sweden based R & D company , dedicated to further develop our proprietary Peptide Drug Conjugate ( PDC ) platform including the next generation of drug candidates including OPD5 and OPDC3 . The organization will be scaled down to increase our cash runway and focus on building a platform for longer term development and growth . The commercial business units in the US and Europe will be closed down and the Stockholm based organization will be significantly reduced . The application to the European Medicines Agency , EMA , for a potential Conditional Marketing Authorization of melflufen ( melphalan flufenamide ) in the EU , based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma , remains pending . The company expects to receive a CHMP opinion in Q2 , 2022 . " The decision to withdraw Pepaxto from the market has been a difficult decision , that has been made with great consideration and with the best intentions for patients and shareholders , " says Marty J Duvall , Chief Executive Officer at Oncopeptides . " The Company now needs to refocus its resources and energy on R & D and remain true to its mission of bringing hope to patients through science . We believe that this is the only viable path forward to accomplish this goal . " " We remain confident in our scientific platform , despite the fact that the OCEAN data didn't pass the regulatory hurdle to confirm the accelerated approval in the US , " says Jakob Lindberg , CSO at Oncopeptides . " Going forward we will further explore our PDC - platform , to develop drugs that potentially can make a significant difference for patients . Oncopeptides is committed to work closely with the regulatory authorities to evaluate the most appropriate possibilities for our pipeline products . " Oncopeptides will work together with the FDA to continue to make the drug available for patients currently treated with Pepaxto . Based on the above news Oncopetides has decided to postpone the Q3 report until November 24 .