Press releases

STOCKHOLM — December 07, 2022 — 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 US Food and Drug Administration, FDA, has requested a withdrawal of the US marketing authorization for Pepaxto[® ](melphalan flufenamide, also called melflufen). The request is based on the outcome of the confirmatory phase 3 OCEAN study, which demonstrated an ITT overall survival HR of 1.1, but with significant survival result differences for both melflufen and the comparator drug pomalidomide for large relevant patient groups

STOCKHOLM — November 25, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announced that the company has entered into a renewed unsecured loan facility agreement with the European Investment Bank (EIB), granting access to a conditional loan facility of up to €30 million

STOCKHOLM — November 11, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that Pepaxti[®] (melphalan flufenamide, also called melflufen) has been granted marketing authorization in combination with dexamethasone, by the Medicines & Healthcare products Regulatory Agency, MHRA, in UK

STOCKHOLM — November 9, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today publishes the report for the third quarter 2022

STOCKHOLM — November 9, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces the estimated market potential for Pepaxti[®] in Europe. The potential assumes that the Company´s pending type 2 variation submission to the European Medicines Agency based on OCEAN data, will be approved by the agency, and enable patients with relapsed refractory multiple myeloma access to the drug in an earlier treatment line. Furthermore, the market potential assumes that price negotiations will reflect the degree of innovation of the drug and the clinical benefit to the patients

STOCKHOLM — October 31, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the number of shares and votes in Oncopeptides has changed as a result of the company’s issue of 3,940,607 new class C shares in accordance with the shareholder program Board SHP 2022 and the incentive program Co-worker LTIP 2022 adopted by the annual general meeting on June 28, 2022. Before the share issue, the total number of outstanding shares and votes in Oncopeptides amounted to 90,368,660. As a result of the share issue, the number of outstanding shares in Oncopeptides has increased by 3,940,607 shares, corresponding to 394,060.7 votes. As of today, the total number of outstanding shares in Oncopeptides amounts to 94,309,267 shares, of which 90,368,660 are ordinary shares and 3,940,607 are class C shares. The number of votes in Oncopeptides as of today amounts to 90,762,720.7. The share capital has increased by approximately SEK 437,845.24 from approximately SEK 10,040,962.63 to approximately SEK 10,478,807.87

STOCKHOLM — October 26, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces data from the phase 3 LIGHTHOUSE study that further confirms the clinical benefit of melflufen in patients with relapsed refractory multiple myeloma (RRMM). The LIGHTHOUSE study investigated the efficacy and safety of the combination of melflufen plus daratumumab subcutaneous (sc) plus dexamethasone in comparison with daratumumab sc. (with supportive dexamethasone) in patients who were refractory to at least an immunomodulatory agent and a proteasome inhibitor or have received at least three prior lines of therapy including a proteasome inhibitor and an immunomodulatory agent

STOCKHOLM — October 20, 2022 — The Board of Directors of Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) (“Oncopeptides”), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, has today resolved, by virtue of the authorization by the Annual General Meeting held on June 28, 2022, to issue and immediately thereafter re-purchase a total of 3,940,607 class C shares. The shares are issued and re-purchased in accordance with the shareholder program and the incentive program which were adopted by the Annual General Meeting held on June 28, 2022 (“Board SHP 2022” and “Co-worker LTIP 2022” respectively)

STOCKHOLM — October 3, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, today announces that the Company has submitted the AMNOG dossier to “The Federal Joint Committee” (G-BA) in Germany. This initiates the commercial launch of Pepaxti[®] (melphalan flufenamide) and thus Germany will be the first market in Europe where the drug is launched

Stockholm, Sweden – An Extraordinary General Meeting in Oncopeptides AB (publ) (ONCO) was held on Friday, 23 September 2022. At the Extraordinary General Meeting, the following principal resolution was passed