Oncopeptides AB
151 articles about Oncopeptides AB
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Oncopeptides Chief Financial Officer Holger Lembrer takes office today
1/18/2023
Oncopeptides AB announces that Holger Lembrer, who recently was appointed Chief Financial Officer, CFO, takes the office on January 18.
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Oncopeptides appoints Holger Lembrer as Chief Financial Officer
1/11/2023
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 appointed Holger Lembrer as Chief Financial Officer, CFO.
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Monica Shaw appointed CEO of Oncopeptides - Jakob Lindberg assumes position as Chief Scientific Officer
1/4/2023
Oncopeptides AB, a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, announces that the Board of Directors has appointed Dr Monica Shaw as Chief Executive Officer, CEO, of Oncopeptides.
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Oncopeptides has announced the Nomination Committee
12/22/2022
According to the principles for the appointment of the Nomination Committee in Oncopeptides AB, the Nomination Committee for the annual general meeting 2023 shall be composed of members appointed by the three largest shareholders in terms of voting rights as of September 30 who are willing to participate in the Nomination Committee, along with the Chairman of the Board of Directors.
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Oncopeptides presents new scientific data at the Annual American Society of Hematology Meeting ASH
12/12/2022
Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) today announces that the company presents new scientific data including one clinical abstract and three preclinical research posters at the Annual American Society of Hematology Meeting, ASH, in New Orleans, Louisiana, USA, on December 10-13.
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Oncopeptides provides update on Pepaxto US marketing authorization
12/7/2022
Oncopeptides AB today announces that the US Food and Drug Administration, FDA, has requested a withdrawal of the US marketing authorization for Pepaxto ®.
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Oncopeptides enters into a renewed loan facility agreement of up to €30 million with the European Investment Bank
11/25/2022
Oncopeptides AB announced that the company has entered into a renewed unsecured loan facility agreement with the European Investment Bank, granting access to a conditional loan facility of up to €30 million.
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Oncopeptides' Pepaxti has been granted marketing authorization in the UK
11/11/2022
Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO) 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.
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Oncopeptides publishes Q3 report 2022
11/9/2022
Oncopeptides AB, a biotech company focused on research and development of therapies for difficult-to-treat hematological diseases, publishes the report for the third quarter 2022.
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Oncopeptides phase 3 LIGHTHOUSE study further confirms clinical benefit of melflufen
10/26/2022
Oncopeptides AB announces data from the phase 3 LIGHTHOUSE study that further confirms the clinical benefit of melflufen in patients with relapsed refractory multiple myeloma.
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One month after a contentious FDA advisory meeting, Oncopeptides announced positive data from the Phase III LIGHTHOUSE trial of Pepaxto in RRMM patients.
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Issue and re-purchase of class C shares for shareholder program and incentive program - October 20, 2022
10/20/2022
The Board of Directors of Oncopeptides AB has 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.
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Oncopeptides starts commercialization of Pepaxti in Europe - Germany first market
10/3/2022
Oncopeptides AB announces that the Company has submitted the AMNOG dossier to "The Federal Joint Committee" in Germany.
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The FDA’s Oncologic Drugs Advisory Committee (ODAC) voted 14-2 against Oncopeptides’ Pepaxto, a drug that has been on the market since 2021 for multiple myeloma under accelerated approval.
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Oncopeptides provides an update from the meeting with FDAs advisory committee ODAC
9/23/2022
Oncopeptides AB announces that the Oncologic Drugs Advisory Committee, of the US Food and Drug Administration, has finalized the discussion on the benefit-risk profile of Pepaxto®.
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Bulletin from an Extra Ordinary General meeting in Oncopeptides AB (publ)
9/23/2022
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.
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The U.S. FDA had a busy week with a range of drug approvals, advisory committee meetings and classification announcements.
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Briefing Book for ODAC meeting on benefit/risk profile of Pepaxto now published
9/20/2022
Oncopeptides AB announces that the US Food and Drug Administration, has published the Briefing Book for the Oncologic Drugs Advisory Committee meeting on September 22, 2022.
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The FDA has two PDUFA dates on its calendar this week, with two extra days slotted for an advisory committee meeting to evaluate drug applications from three companies.
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European Commission approves Oncopeptides' Pepaxti for the treatment of patients with relapsed refractory multiple myeloma
8/18/2022
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 Commission has granted Pepaxti®.