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Press releases

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Year

CHMP issues a positive opinion recommending full approval of Oncopeptides Pepaxti in EU for patients with triple class refractory multiple myeloma Regulatory

June 23, 2022
STOCKHOLM — June 23, 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 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. The European Commission (EC) will make a legally binding decision based on the EMA recommendation within 60 days. Once granted by EC, the marketing authorization is valid in all EU member states, as well as in the European Economic Area (EEA) countries Iceland, Lichtenstein, and Norway
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Annual General Meeting in Oncopeptides AB (publ) Regulatory

May 25, 2022
STOCKHOLM — May 25, 2022 — The shareholders in Oncopeptides AB (publ), reg. no. 556596-6438, with registered office in the municipality of Stockholm, (“Oncopeptides” or the “Company”) are hereby given notice to attend the Annual General Meeting to be held on Tuesday 28 June 2022
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Oncopeptides publishes Q1 report 2022 Regulatory

May 4, 2022
STOCKHOLM — May 4, 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 first quarter 2022
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Invitation to presentation of Q1 report

April 27, 2022
STOCKHOLM — April 27, 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 it will present the interim report for the first quarter 2022 on May 4, at 11:00 (CET), and that the Annual General Meeting in Oncopeptides AB (publ) will be held on Tuesday June 28, 2022, (changed from May 19, 2022)
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Oncopeptides publishes the 2021 Annual Report Regulatory

April 21, 2022
STOCKHOLM — April 21, 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 2021 Annual Report has been published
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Number of shares and votes in Oncopeptides Regulatory

March 31, 2022
STOCKHOLM — March 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 due to the exercise of warrants under the company’s incentive program
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Oncopeptides publishes year-end report 2021 Regulatory

February 17, 2022
STOCKHOLM — February 17, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on the development of therapies for difficult-to-treat hematological diseases, has today published the year-end report 2021
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Invitation to presentation of 2021 year-end results

February 14, 2022
STOCKHOLM — February 14, 2022 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a biotech company focused on the development of therapies for difficult-to-treat hematological diseases, will publish its report for the fourth quarter and year-end results 2021 on February 17. Investors, financial analysts, and media are invited to participate in a webcast and a following QnA session at 15:00 CET. The event will be hosted by CEO, Jakob Lindberg and members of Oncopeptides’ Leadership team, and the presentation will be held in English
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Oncopeptides rescinds voluntary withdrawal of Pepaxto in the US – no intent to market in the US at this time Regulatory

January 21, 2022
STOCKHOLM — January 21, 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 contacted the US Food and Drug Administration and rescinded the October 22, 2021, letter requesting voluntary withdrawal of the NDA of Pepaxto[® ](INN melphalan flufenamide, also called melflufen) in the US
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Oncopeptides phase 3 OCEAN study published in the Lancet Haematology

January 13, 2022
STOCKHOLM — January 13, 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 data from the randomized head-to-head phase 3 OCEAN study, evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in lenalidomide refractory patients with relapsed refractory multiple myeloma (RRMM) that have received 2-4 prior lines of therapy, have been published in the Lancet Hematology. The OCEAN study was initiated in 2017 and includes 495 patients from 108 hospitals in 21 countries across Europe, North America, and Asia
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