Oncopeptides AB

Oncopeptides AB
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Oncopeptides is a global biotech company focused on the development of targeted therapies for difficult-to-treat hematological diseases. The company uses its proprietary peptide-drug conjugate (PDC) platform to develop compounds that rapidly and selectively deliver cytotoxic agents into cancer cells. The first drug coming from PDC platform, PEPAXTO®(melphalan flufenamide), has been launched in the U.S., for the treatment of adult patients with relapsed or refractory multiple myeloma. Melphalan flufenamide is evaluated in a comprehensive clinical study program including the global phase 3 studies OCEAN and LIGHTHOUSE. Oncopeptides is developing several new compounds based on the PDC platform. The first one is expected to enter into clinical development in 2021.Oncopeptides has approximately 300 coworkers. The global Headquarters is based in Stockholm, Sweden and the U.S. Headquarters is situated in Boston, Mass. The company is listed in the Mid Cap segment on Nasdaq Stockholm with the ticker ONCO. More information is available on www.oncopeptides.com.

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With the priority review underway at FDA, Oncopeptides moves forward with intent to file for conditional approval of melflufen with EMA

Mon, Oct 12, 2020 08:00 CET

STOCKHOLM — October 12, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has informed the European Medicines Agency, EMA, about its intention to submit an application for a conditional marketing authorization of melflufen (INN melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma (RRMM).The decision to submit an application for conditional approval has been grounded on an in-depth analysis of the regulatory environment and is endorsed by key opinion leaders in the EU. Previously the Company

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With the priority review underway at FDA, Oncopeptides moves forward with intent to file for conditional approval of melflufen with EMA

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