Company news

Oncopeptides has, as reported in the media, decided to not pursue an appraisal with the National Institute for Health And Care Excellence (NICE) in the United Kingdom at this time. On Thursday morning, the company clarified this decision in an interview with the news agency Direkt.

Oncopeptides AB announces the approval of price and reimbursement allowing Oncopeptides to start commercializing its flagship drug Pepaxti in Spain as early as in 2024. Preparations ongoing with full launch expected to commence after summer.

Sofia Heigis, CEO discusses recent news in the latest edition of Oncopeptalks.

Oncopeptides AB and Vector Pharma FZCO (“Vector”) today announced a collaboration to commercialize Oncopeptides’ flagship drug Pepaxti (melphalan flufenamide) in the Middle East and North Africa (“MENA”).

Oncopeptides AB (publ) today announces that the U.S. Food and Drug Administration (FDA) has made a decision regarding the withdrawal of Pepaxto, which Oncopeptides had appealed.

Oncopeptides AB (publ), a biotech company focused on difficult-to-treat cancers, today announces that the Spanish Drug Pricing Authority (CIPM) has published a positive recommendation for the pricing of melflufen, branded in Europe as Pepaxti.

Oncopeptides AB today announces that it will receive an extension of a key patent ensuring market exclusivity for melflufen, marketed in Europe as Pepaxti, in Europe until 2037, an extension of five years.

February 9, 2024 - Oncopeptides was recently ranked in the top 10 in the Nordic Business Diversity Index’s Sweden small-cap category.

January 8, 2024 - Oncopeptides has not yet received any notification from the US Food and Drug Administration (FDA) regarding the company's appeal of the authority's request to withdraw Pepaxto's approval in the US. Oncopeptides has not received any time indication for when an announcement may come. 

December 15, 2023 - Oncopeptides announces that the European Commission has decided to formally approve the company’s application to the European Medicines Agency (EMA) for an extended indication for Pepaxti into earlier lines. The previously communicated decision by Oncopeptides to opt out of the process to extend the indication remains.

November 13, 2023 - Henrik brings 20+ years of experience from leading finance roles at both medical and non-medical, publicly listed organizations.

Oncopeptides recently successfully agreed on a reimbursed price for Pepaxti in Germany that in the company´s view reflects the innovation of the drug and is in line with the company´s financial projections.

On Monday, October 2, Oncopeptides participated in a joint meeting with the Center for Drug Evaluation and Research’s (CDER’s) hosted by Dr. Peter Marks. The meeting presented an opportunity for both parties to present their view on the issue. The materials used, including meeting notes, will be posted in the public docket in the future, we don´t have information on when.

The decision does not impact the company´s financial projections or the estimated market potential of Pepaxti negatively.

Oncopeptides announces that following negotiations between Oncopeptides and the German Federal Joint Committee National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), a reimbursed price for Pepaxti has been agreed on in Germany. The negotiated reimbursed price in Germany, which will also guide negotiations in other European markets, is reflective of the innovation Pepaxti brings to the market, and in line with the company´s financial projections.

We are very proud and happy to share that Oncopeptide's founders, Professor Rolf Larsson, Professor Peter Nygren and Associate Professor Joachim Gullbo, were today awarded the Uppsala University Award Hjärnäpplet (Brain apple) for their successful work to improving drug treatment in cancer.