Oncopeptides publishes the 2020 Annual Report Regulatory
April 26, 2021
STOCKHOLM — April 26, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today publishes the 2020 Annual Report
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Annual General Meeting in Oncopeptides AB (publ) Regulatory
April 26, 2021
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 Wednesday May 26, 2021. Due to the extraordinary situation resulting from the covid-19 pandemic, Oncopeptides’ Annual General Meeting will be carried out through advance voting (postal voting) pursuant to temporary legislation. No meeting with the possibility to attend in person or to be represented by a proxy will take place. Hence, the Annual General Meeting will be held without physical presence
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Oncopeptides submits application for conditional marketing authorization of melflufen in the EU Regulatory
April 16, 2021
STOCKHOLM — April 16, 2021 — 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 Company has submitted an application to the European Medicines Agency, EMA, for conditional marketing authorization of melflufen (melphalan flufenamide) in the EU, based on the pivotal phase 2 HORIZON study in relapsed refractory multiple myeloma. Pending a positive validation from the EMA, melflufen will be subject to a regulatory assessment according to the standard timelines
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Number of shares and votes in Oncopeptides Regulatory
March 31, 2021
Stockholm — March 31, 2021 — Oncopeptides AB (Nasdaq Stockholm, ONCO) 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 announces that PEPAXTO® is included in new Multiple Myeloma guidelines of National Comprehensive Cancer Network®
March 22, 2021
STOCKHOLM — March 22, 2021 — 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 PEPAXTO[®] (melphalan flufenamide) has been included in the new Multiple Myeloma Clinical Practice Guidelines of the National Comprehensive Cancer Network[®] (NCCN) in Oncology. PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody
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Oncopeptides announces that the first patients in the United States are being treated with PEPAXTO®
March 15, 2021
STOCKHOLM — March 15, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that PEPAXTO[® ](melphalan flufenamide) is now commercially available across the United States and that the first patients are being treated with the drug. PEPAXTO, in combination with dexamethasone, was granted accelerated approval by the FDA on February 26, 2021, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody
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Oncopeptides has completed a directed share issue raising approximately SEK 1,106 million (USD 130 million) Regulatory
March 10, 2021
NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, HONG KONG, ISRAEL, JAPAN, NEW ZEALAND, SOUTH AFRICA, SWITZERLAND OR ANY OTHER JURISDICTION WHERE SUCH PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR OTHER MEASURES
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Oncopeptides intends to carry out a directed share issue Regulatory
March 9, 2021
NOT FOR PUBLICATION, DISTRIBUTION OR RELEASE, DIRECTLY OR INDIRECTLY, IN WHOLE OR IN PART, IN OR INTO THE UNITED STATES OF AMERICA, AUSTRALIA, CANADA, HONG KONG, ISRAEL, JAPAN, NEW ZEALAND, SOUTH AFRICA, SWITZERLAND OR ANY OTHER JURISDICTION WHERE SUCH PUBLICATION, DISTRIBUTION OR RELEASE WOULD BE UNLAWFUL OR REQUIRE REGISTRATION OR OTHER MEASURES
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Oncopeptides strengthens leadership in Europe and opens an Early Access Program in multiple myeloma
March 8, 2021
STOCKHOLM — March 8, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that it strengthens the leadership of the European operations by appointing Andrea Passalacqua as General Manager in Europe, and Pamela Bacon as Head of Medical Affairs Europe. The Company also announced that it opens an Early Access Program across Europe to address the significant need of new treatment alternatives in multiple myeloma. As previously announced, Oncopeptides will also seek a Conditional Marketing Authorization of melphalan flufenamide in triple class refractory multiple myeloma, during second quarter of 2021
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FDA approves Oncopeptides’ PEPAXTO® ( melphalan flufenamide) for patients with relapsed or refractory multiple myeloma Regulatory
February 26, 2021
STOCKHOLM — February 26, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today announced that the U.S. Food and Drug Administration, FDA, has approved PEPAXTO[®] (melphalan flufenamide, also known as melflufen), in combination with dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma, who have received at least four prior lines of therapy and whose disease is refractory to at least one proteasome inhibitor, one immunomodulatory agent, and one CD38-directed monoclonal antibody
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