Press releases

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

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

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

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

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

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)

Launch dynamics encouraging, but US regulatory situation challenging

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

STOCKHOLM — July 28, 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 issued a safety alert to patients and health care professionals, regarding an increased risk of death associated with Pepaxto[® ](melphalan flufenamide), in the OCEAN study

STOCKHOLM — July 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 announces updated results and safety measures based on the head-to-head phase 3 OCEAN study evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in patients with relapsed refractory multiple myeloma who have received 2 – 4 prior lines of therapy. The randomized study was initiated in 2017 and includes 495 patients from more than 100 hospitals in 21 countries around the world. The topline results were announced on May 25[th]