Bringing hope through science

Tyska lanseringen av Pepaxti - presentation

Fredagen den 21 oktober kl.14.00, 2022, håller Oncopeptides en presskonferens för att prata om den tyska lanseringen av Pepaxti^®.

Se presentationen i PDF här

Link to Sep 22 ODAC meeting and Briefing Book

The US Food and Drug Administration (FDA) has published the Briefing Book for the Oncologic Drugs Advisory Committee (ODAC) meeting on September 22, 2022. The purpose of the meeting is to obtain the advisory committee's input regarding the benefit/risk of Pepaxto^® (melphalan flufenamide, also called melflufen) for the currently indicated patient population.

Link to the Briefing Book

Link to the public ODAC meeting (starts 19:50 CET, Sep 22)

Read the press release about the Briefing Book

Webcast - update from the ODAC meeting

September 23, 2022, the Oncologic Drugs Advisory Committee (ODAC), of the US Food and Drug Administration (FDA), has finalized the discussion on the benefit-risk profile of Pepaxto^® (melphalan flufenamide, also called melflufen). A majority of the panel considered that OCEAN did not confirm a favorable benefit-risk profile in the current indicated patient population.

Investors, analysts and media were invited to listen to a webcast presentation and participate in a following Q&A session on September 26, at 14:00 (CET). The webcast was recorded.

Link to the webcast and phone numbers

Webcast - CHMP issues a positive opinion recommending full approval of Oncopeptides Pepaxti in EU

June 23, 2022, the European Medicines Agency´s (EMA) Committee for Medicinal Products for Human Use (CHMP), has unanimously adopted a positive opinion recommending a full marketing authorization approval (MAA) of Pepaxti® (melphalan flufenamide, also called melflufen) in EU. 

Investors, financial analysts, and media were invited to participate in a webcast with a Q&A session on June 27, 2022, at 11:00 (CET). The event was hosted by CEO Jakob Lindberg, CMO Klaas Bakker and CFO Annika Muskantor. 

More info, presentation and the webcast link

Webcast - Oncopeptides rescinds voluntary withdrawal of Pepaxto in the US

January 21, 2022, Oncopeptides announced that the Company has contacted the US Food and Drug Administration and rescinded the October 22, 2021, letter requesting voluntary withdrawal of the NDA of Pepaxto^® in the US.

Investors, financial analysts and media are invited to participate in a webcast with a Q&A session on January 24, 2022, at 09:00 (CET).

The event will be hosted by CEO, Jakob Lindberg and CMO, Klaas Bakker. The presentation will be held in English.

More info, dial in numbers and the webcast link