Oncopeptides announces successful price negotiations for Pepaxti in Germany
Oncopeptides today announces that following negotiations with the German Federal Joint Committee National Association of Statutory Health Insurance Funds (GKV-Spitzenverband), a reimbursed price for Pepaxti has been agreed on in Germany.
New information regarding Oncopeptides’ appeal of U.S. withdrawal published
Additional information regarding the formal request from the U.S. Food and Drug Administration (FDA) to voluntarily withdraw Pepaxto´s approval in the U.S has been made available in the public docket.
Oncopeptides launches “Oncopeptalks” with a fireside chat featuring CEO Sofia Heigis
Join for the first edition of Oncopeptalks – a short company update aimed at investors.
CEO Sofia Heigis presented to Aktiespararna at Aktiedagen in Stockholm
On September 19, Sofia Heigis presented to Aktiespararna at Aktiedagen in Stockholm. During her presentation, followed by a question and answer session, Sofia reviewed some current events including the CHMP’s decision to recommend an approval for Pepaxti for earlier lines.
CHMP issues positive opinion on Type II variation to extend the therapeutic indication of Pepaxti based on OCEAN trial results
On September 14, Oncopeptides announced that the CHMP has, following their scientific assessment, adopted a positive opinion on Oncopeptides’ application for earlier lines of treatment for patients with relapsed, refractory multiple myeloma (RRMM). The opinion from the CHMP will now be sent to the European Commission for a final decision.
Oncopeptides publishes article on NK cell engagers in New Biotechnology
A new article, describing a set of affibody-based NK cell engagers using B cell maturation antigen (BCMA) as a model antigen for targeting of multiple myeloma, has been published online ahead of the November issue of New Biotechnology, the official journal of the European Federation of Biotechnology (EFB). Among the highlights of the article, dual engagers are found effective in activating resting NK cells and inducing a BCMA-dependent killing of MM cells.
Oncopeptides publishes two articles with results from ANCHOR and LIGHTHOUSE studies in Haematologica
Oncopeptides today, September 4, 2023, announces that two new articles with scientific data on melflufen, marketed in Europe as Pepaxti, has been published in Haematologica, a publication reporting on important findings in basic, clinical and translational research within hematology. The published data from two studies, ANCHOR and LIGHTHOUSE, provides additional scientific support for the clinical benefit of melflufen and dexamethasone in combination with daratumumab or bortezomib in relapsed refractory multiple myeloma (RRMM).
Press release - September 26, 2023
Oncopeptides announces successful price negotiations for Pepaxti in GermanyRead press release
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Stefan Norin named Chief Medical Officer at Oncopeptides
Oncopeptides today announces that Stefan Norin has been promoted to new Chief Medical Officer (CMO) at Oncopeptides, effective immediately. Stefan joined Oncopeptides in March 2019, as Clinical Study Physician, appointed Global Clinical Lead in 2020, Head of Clinical Development in 2022 and Head of Clinical Science in 2023.
Information regarding Oncopeptides’ appeal of U.S. withdrawal published
On August 25, 2023, more information regarding the formal request from the U.S. Food and Drug Administration (FDA) to voluntarily withdraw Pepaxto’s approval in the U.S has been made available by the FDA.
The public docket contains, among other documents, a detailed appeal document outlining Oncopeptides’ arguments for why Pepaxto should remain on the U.S. market as an important treatment option for multiple myeloma patients in later lines of treatment.
Released August 10, 2023
Oncopeptides publishes Q2 report 2023
Presentation of the Q2 Interim Report 2023
Oncopeptides will publish the report for the second quarter 2023, at 08.00 (CET) on Thursday August 10, 2023, and will host a webcast on the same day at 09:00 (CET).
Investors, financial analysts, and media are invited to participate in the webcast and following Q&A. The presentation will be hosted by Sofia Heigis, CEO, together with Holger Lembrér, CFO. It will be held in English.
Sofia Heigis appointed CEO
On August 7, 2023, Oncopeptides announced that the Board of Directors has appointed Sofia Heigis as Chief Executive Officer, CEO, of Oncopeptides and replaces Monica Shaw. These changes are effective immediately.
Update following CHMP meeting
Following the June 19-22 CHMP meeting, Oncopeptides would like to clarify that the type II variation submission is running according to plan, and we are currently responding to the last couple of questions from the European Medicines Agency, EMA. We expect an opinion in Q3 2023.
Oncopeptides complete first sales of Pepaxti in Greece
Oncopeptides today announced its first named patient sales of its flagship drug Pepaxti in Greece. The sales were made possible through Oncopeptides’ partnership with Ariti S.A., a company specialized on medical and pharmaceutical supply in Greece.
Holger Lembrér will leave his role as Chief Financial Officer at Oncopeptides
On June 14th, Oncopeptides announced that Holger Lembrér, Chief Financial Officer (CFO) has decided to leave Oncopeptides to pursue a new role in another company. Holger was appointed CFO in January 2023. He will continue in his current role until December or until a new CFO takes office. A recruitment process will be initiated immediately.
Oncopeptides appoints David Augustsson as Director of Corporate Affairs
Oncopeptides AB today announced that David Augustsson has been appointed Director of Corporate Affairs. As part of the company leadership team, David will be responsible for corporate communications, including strengthening the relationship with its broad investor base, and also drive the effort to reshape the corporate strategy of the company and enable the execution of it.
Annual General Meeting on May 25
On Thursday, May 25, Oncopeptides hosted its 2023 Annual General Meeting. Be sure to watch the presentation held by Oncopeptides CEO Monica Shaw, or follow this link to find more information, including the bulletin from the meeting and the filmed Q&A session.
Released April 25, 2023
Oncopeptides publishes the 2022 Annual Report
Annual Report 2022
For further information, please contact:
Director Corporate Affairs
+46 762 29 38 68
Vision of Oncopeptides
”Oncopeptides brings hope to patients through passionate people, innovative science and transformative medicines”