Oncopeptides hosts a virtual capital markets day on November 30
November 5, 2020
STOCKHOLM — November 5, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the company will arrange a virtual capital markets day for investors, analysts and journalists on November 30[th], 2020. The program will be published on the company´s website during the week of November 23 at: www.oncopeptides.com/en/calendar/ (https://oncopeptides.se/en/calendar/)
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Oncopeptides Announces that New Data for Melflufen is Accepted for Presentation at the Annual American Society of Hematology Meeting
November 4, 2020
STOCKHOLM — November 4, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a pharmaceutical company focusing on the development of targeted therapies for difficult-to-treat hematological diseases, today announced that twelve abstracts, including one oral presentation, have been accepted for the upcoming virtual American Society of Hematology (ASH) meeting on December 5-8, 2020. Key clinical abstracts focus on data from the ongoing phase 1/2 ANCHOR combination study and the pivotal phase 2 HORIZON study. The preclinical abstracts further explore the mechanism of action of the proprietary peptide-drug conjugate platform in multidrug resistant models of multiple myeloma. The abstracts are published online today at https://www.hematology.org/meetings/annual-meeting/abstracts
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Extraordinary General Meeting in Oncopeptides AB (publ) Regulatory
November 3, 2020
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 Extraordinary General Meeting on Friday 4 December 2020
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Nomination committee in Oncopeptides established
October 21, 2020
STOCKHOLM — October 21, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), today announced that the composition of the Nomination Committee for the Annual General Meeting 2021 has been established. The Nomination Committee consists of the following persons who together represent approximately 34 percent of the number of shares and votes in the company, based on the shareholder information by the end of September
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Oncopeptides has submitted an Investigational New Drug application to FDA for the second drug candidate from the PDC platform
October 19, 2020
STOCKHOLM — October 19, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has submitted an Investigational New Drug (IND) application to the U.S. Food and Drug Administration (FDA), for OPD5 - a second drug candidate based on the proprietary Peptide Drug Conjugate platform (PDC)
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Oncopeptides signs € 40 million loan agreement with the EIB Regulatory
October 14, 2020
STOCKHOLM — October 14, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the company has entered into a loan agreement with the European Investment Bank (EIB), granting the company access to an unsecured loan facility of up to €40 M. The loan may be used to further support the clinical development of melflufen, and the company’s transition from a R&D company into a fully integrated global biopharmaceutical 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
October 12, 2020
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)
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Oncopeptides initiates U.S. Expanded Access Program with melflufen in triple-class refractory multiple myeloma
October 1, 2020
STOCKHOLM — October 1, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) announced today that the open-label Expanded Access Program, sEAPort (https://oncopeptides-us.com/en/expanded-access-program/), for eligible U.S. patients, is formally open. Melflufen (INN melphalan flufenamide), is currently being evaluated in several clinical studies as a treatment for patients with triple-class refractory multiple myeloma. The sEAPort program is available to adults, age 18 and older, who have received at least two prior lines of therapy and whose multiple myeloma is refractory to at least one proteasome inhibitor, one immunomodulatory drug and one anti-CD38 monoclonal antibody, (i.e., triple-class refractory multiple myeloma patients)
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Oncopeptides further aligns the US and global organizational structure and appoints Mohamed Ladha as General Manager of the US Business Unit
September 8, 2020
STOCKHOLM — September 8, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the Company has eliminated an organizational layer to shorten the decision-making process in the US operations and to create closer collaboration between global and local functions. The role as CEO of Oncopeptides, Inc. will no longer be a designated Company function and as a consequence, Joseph Horvat, President of North America and CEO of Oncopeptides Inc., will leave the Company. Mohamed Ladha, current Head of US Commercial Operations, will become General Manager of the US Business Unit and a member of the global Leadership Team of Oncopeptides AB (publ)
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Oncopeptides completes the extended enrollment for the pivotal phase 3 OCEAN study in relapsed refractory multiple myeloma – 495 patients included
September 4, 2020
STOCKHOLM — September 4, 2020 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the last patient has been successfully enrolled in the pivotal phase 3 study OCEAN in relapsed refractory multiple myeloma (RRMM). The original enrollment target of 450 patients was reached in May 2020, but an analysis indicated that patients were staying longer on treatment than initially estimated. Thus, a decision was made to leave recruitment open to ensure that the number of disease progression events needed to complete the study would be reached within a reasonable timeframe. An additional 45 patients have now been recruited. The company has closed enrollment and reiterates that the topline results will be available in the first half of 2021
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