Press releases

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]

Stockholm — June 30, 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

Stockholm, Sweden – The Annual General Meeting in Oncopeptides AB (publ) (ONCO) was held on Wednesday, 26 May 2021. At the Annual General Meeting, the following principal resolutions were passed

A strong start for PEPAXTO in the US

· According to the Independent Review Committee Assessment, melflufen was non-inferior to pomalidomide on the primary endpoint of Progression Free Survival (PFS) with a Hazard Ratio favoring melflufen of 0.817 and the median PFS for melflufen was 41% higher than for pomalidomide · According to the Investigator Assessment, melflufen was superior to pomalidomide on PFS with a Hazard ratio favoring melflufen of 0.790 and median PFS for melflufen was 42% higher than for pomalidomide · The Overall Response Rate (ORR) was 32.1% for melflufen, compared to 26.5% for pomalidomide · Melflufen and pomalidomide had similar discontinuation rates for adverse events, and the safety profile of melflufen was in line with previous studies