Oncopeptides focuses clinical development efforts to increase cash runway Regulatory
November 4, 2021
STOCKHOLM — November 4, 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 decided to reduce the activity level in the clinical development program with melflufen (INN melphalan flufenamide) to increase the company´s cash runway and at the same time support the ongoing marketing authorization application process in Europe. This will have implications on the following studies
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Oncopeptides appoints Annika Muskantor as interim CFO
November 1, 2021
STOCKHOLM — November 1, 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 appointed Annika Muskantor as interim Chief Financial Officer, CFO. Annika has an extensive experience as interim CFO from a broad range of industries including the life science industry, and she will assume her position on November 8. The appointment follows the previously announced resignation by CFO Anders Martin-Löf
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Oncopeptides withdraws Pepaxto® in US, scale down organization and focus on R&D Regulatory
October 22, 2021
STOCKHOLM — October 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 the company has decided to withdraw Pepaxto[® ](INN melphalan flufenamide) from the market in the US, following the phase 3 OCEAN study, which showed an overall survival in the ITT population with a HR of 1.104. The decision has been made after interactions and dialogue with the US Food and Drug Administration, FDA. Pepaxto was granted accelerated approval on February 26[th] 2021
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Oncopeptides’ CFO Anders Martin-Löf will leave the company Regulatory
October 15, 2021
STOCKHOLM — October 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 announces that CFO Anders Martin-Löf has informed Oncopeptides that he will leave the company for personal reasons. Anders was appointed CFO in 2018 and has a six-month notice period. He will continue in his current role until a new temporary or permanent CFO takes office. A recruitment process will be initiated immediately
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Oncopeptides presents phase 3 OCEAN study results at the IMW meeting
September 11, 2021
STOCKHOLM — September 11, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, today presents data from the phase 3 OCEAN study, a direct head to head comparison of the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone and pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma, (RRMM), who are refractory to lenalidomide and have received 2-4 prior lines of therapy. The data was presented today by Fredrik Schjesvold, Head of Oslo Myeloma Center, Norway, at the 18[th] International Myeloma Workshop (IMW) in Vienna
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Invitation to webcast for presentation of OCEAN data presented at IMW
September 9, 2021
STOCKHOLM — September 9, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, will present data from the OCEAN study at the 18th International Myeloma Workshop (IMW) on September 11. Investors, financial analysts, and media are invited to participate in a webcast including a Q&A on September 12 at 16:00 CEST. The event will be hosted by CEO, Marty J Duvall, Klaas Bakker, CMO as well as Fredrik Schjesvold, MD, Head of Oslo Myeloma Center. The presentation will be held in English
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Regulatory update from US Food and Drug Administration
September 2, 2021
STOCKHOLM — September 2, 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 US Food and Drug Administration, FDA, has announced a forthcoming public advisory committee meeting of the Oncologic Drugs Advisory Committee, on October 28, 2021 concerning Oncopeptides’ product Pepaxto. The information is in line with the FDA safety alert on July 28, where the FDA stated that a public meeting may be hold to discuss the safety findings from the OCEAN study
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Oncopeptides presents new data from OCEAN and PORT study – abstracts online
August 27, 2021
STOCKHOLM — August 27, 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 data from the phase 3 OCEAN study has been accepted as an oral presentation at the upcoming 18[th] International Myeloma Workshop (IMW), and the abstract is now available online. More comprehensive data will be presented at the IMW-meeting in Vienna on September 11, at 10:00 (CET)
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Oncopeptides publishes report for Q2 2021 Regulatory
August 19, 2021
Launch dynamics encouraging, but US regulatory situation challenging
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Invitation to presentation of the Q2 2021 results
August 12, 2021
STOCKHOLM — August 12, 2021 — Oncopeptides AB (publ) (Nasdaq Stockholm: ONCO), a global biotech company focused on the development of therapies for difficult-to-treat hematological diseases, will publish its report for the second quarter 2021 on August 19. Investors, financial analysts, and media are invited to participate in a webcast with a QnA session on the same day at 12:00 CEST. The event will be hosted by CEO, Marty J Duvall and members of the Oncopeptides’ Leadership team. The presentation will be held in English
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