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Oncopeptides intends to submit type II variation to expand Pepaxti label to include third line treatment
Prenumeration
Beskrivning
| Land | Sverige |
|---|---|
| Lista | Small Cap Stockholm |
| Sektor | Hälsovård |
| Industri | Bioteknik |
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STOCKHOLM — May 11, 2026 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on difficult-to-treat cancers, today announces its intention to submit a Type II variation application to the European Medicines Agency (EMA). The submission follows an updated assessment of the evolving therapeutic and regulatory landscape in Europe. An approved application for a broader indication would significantly expand the potential addressable market for Pepaxti.
A broader indication including third line patients would double the addressable patient population for Pepaxti in Europe. In addition, third line patients are also estimated to undergo, on average, double the number of treatment cycles compared to the current label. Oncopeptides has previously communicated a SEK 1.5 billion potential for Pepaxti in the European market, reflecting the current indication (fourth treatment cycle and onwards). Oncopeptides assesses that the potential regulatory approval followed by subsequent market access could unlock significant added potential for sales of Pepaxti in Europe.
“As more drugs have entered the markets across Europe, the treatment landscape has developed and now allows us to pursue an indication in earlier lines of therapy giving access to a broader population,” says Sofia Heigis, CEO of Oncopeptides. “Market experience from the use of Pepaxti has generated positive clinical experience confirming the unmet need for a PDC as a complement to immunotherapy.”
The submission is supported by clinical data from the Phase 3 study OCEAN and seeks to expand the therapeutic indication of Pepaxti (melflufen) to include adult patients with multiple myeloma who have received at least two prior lines of therapies (3L+), and whose disease is refractory to lenalidomide and the last line of therapy.
Oncopeptides intends to submit the application during the coming months and expects first regulatory feedback before end of this year with a subsequent final decision by the European Commission in H1 2027.
For more information, including questions and answers for investors, please visit www.oncopeptides.com
Webcast for investors
The company will host a webcast and Q&A session aimed at investors, analysts and media on May 11 at 12:00 CET.
If you wish to participate via webcast, please use the link below.
https://oncopeptides.events.inderes.com/investor-call-2026
If you wish to participate via teleconference, please register on the link below. After registration you will be provided phone numbers and a conference ID to access the conference. You can ask questions verbally via the teleconference.
https://events.inderes.com/oncopeptides/investor-call-2026/dial-in