US/UK/Canada

Share

Pick a time period -
Tags ( Active)

Oncopeptides announces the market potential for Pepaxti in Europe

STOCKHOLM — November 9, 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 the estimated market potential for Pepaxti[®] in Europe. The potential assumes that the Company´s pending type 2 variation submission to the European Medicines Agency based on OCEAN data, will be approved by the agency, and enable patients with relapsed refractory multiple myeloma access to the drug in an earlier treatment line. Furthermore, the market potential assumes that price

Oncopeptides phase 3 OCEAN study published in the Lancet Haematology

STOCKHOLM — January 13, 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 data from the randomized head-to-head phase 3 OCEAN study, evaluating the efficacy and safety of melflufen (INN melphalan flufenamide) plus dexamethasone versus pomalidomide plus dexamethasone in lenalidomide refractory patients with relapsed refractory multiple myeloma (RRMM) that have received 2-4 prior lines of therapy, have been published in the Lancet Hematology. The OCEAN

Oncopeptides focuses clinical development efforts to increase cash runway

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:· OCEAN study will continue with long-term follow-up and

Oncopeptides presents phase 3 OCEAN study results at the IMW meeting

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,

Invitation to webcast for presentation of OCEAN data presented at IMW

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.

Regulatory update from US Food and Drug Administration

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.

Oncopeptides presents new data from OCEAN and PORT study - abstracts online

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).The phase 3 OCEAN study is a head-to-head comparison evaluating the efficacy and safety of melflufen (

Updated results from phase 3 OCEAN study shows melflufen met primary endpoint of superior PFS – Overall Survival data lead to partial clinical hold

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

Phase 3 OCEAN study demonstrates that melflufen is at least as efficacious as pomalidomide, the most used medicine in relapsed refractory multiple myeloma

· 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

Oncopeptides completes the extended enrollment for the pivotal phase 3 OCEAN study in relapsed refractory multiple myeloma – 495 patients included

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

New analysis confirms that multiple myeloma patients in the OCEAN study stay on treatment longer than previously estimated - results expected H1-2021

STOCKHOLM — June 1, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announces that patients in the OCEAN study stay on treatment longer than previously estimated. As a consequence, top-line results are estimated for H1 2021 instead of previously communicated Q4 2020. Patient recruitment in OCEAN will remain open to ensure that the 339 disease progression events needed to complete the study can be reached within a reasonable timeframe.OCEAN is a randomized, comparative study between melflufen and pomalidomide in patients with relapsed refractory multiple myeloma (RRMM). The patients enrolled

Oncopeptides provides update regarding COVID-19 impact on the melflufen clinical program

STOCKHOLM — March 20, 2020 — Oncopeptides AB (Nasdaq Stockholm: ONCO) announced today measures the company is taking in response to the global spread of the novel coronavirus (COVID-19) pandemic. Most importantly, the pivotal phase 2 HORIZON study will not be affected and FDA submission plans are on track for a filing late Q2. The phase 3 OCEAN study with 423 out of 450 planned patients enrolled will remain open for patient enrolment. Topline results are expected to be only slightly delayed. Recruitment for other ongoing clinical studies will be put on temporary pause for patient safety

Oncopeptides provides new guidance on the patient recruitment in the OCEAN study and a clinical program update in a webcast at 10:00 (CET)

Stockholm – 24 April 2019 - Oncopeptides AB (Nasdaq Stockholm: ONCO) announces today that the company will provide an update on patient recruitment in the ongoing phase 3 study OCEAN, as well as a general update from all the company's clinical studies in a webcast at 10.00am (CET) today.Conference call for investors, analysts and the media, Wednesday, 24 April 2019, at 10 am (CET). CEO Jakob Lindberg will provide an overview of ongoing clinical studies and activities in connection with these. Phone numbers for participants from:Sweden: +46850558357Europe: +443333009030USA:

There are no items matching the current filter
There are no more items matching the current filter
Back to top

Subscribe

Media