Article with exploratory alkylator-refractory subgroup analysis from Oncopeptides’ OCEAN study observing longer PFS and OS in melflufen vs. pomalidomide published in European Journal of Haematology
A new article analyzing scientific data on melflufen, marketed in Europe as Pepaxti, has been published in the European Journal of Haematology, an international journal for communication of research in hematology. The results further demonstrate efficacy and consistent safety profile in patients with alkylator-refractory disease.
Company news
German price of Pepaxti published
Oncopeptides recently successfully agreed on a reimbursed price for Pepaxti in Germany that in the company´s view reflects the innovation of the drug and is in line with the company´s financial projections.
Read moreUpdate on Oncopeptides’ appeal of U.S. withdrawal
On Monday, October 2, Oncopeptides participated in a joint meeting with the Center for Drug Evaluation and Research’s (CDER’s) hosted by Dr. Peter Marks. The meeting presented an opportunity for both parties to present their view on the issue. The materials used, including meeting notes, will be posted in the public docket in the future, we don´t have information on when.
Read moreScience news
Article with exploratory alkylator-refractory subgroup analysis from Oncopeptides’ OCEAN study observing longer PFS and OS in melflufen vs. pomalidomide published in European Journal of Haematology
Read moreOncopeptides selected to present additional data from OCEAN study at the American Society of Hematology meeting
Long-term outcomes from its Phase 3 OCEAN study has been accepted as a poster and will be presented at ASH in San Diego, December 9-12.
Read moreOncopeptides publishes article in the Journal of Clinical Pharmacology
A new article on the Phamacokinetics and metabolism of melflufen, marketed in Europe as Pepaxti, in patients with Relapsed Refractory Multiple Myeloma.
Read moreInvestor news
The Q3 Earnings episode of Oncopeptalks
David Augustsson, Director, Corporate Affairs, and CEO Sofia Heigis are leading this edition of Oncopeptalks.
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The third episode of Oncopeptalks - Industry Congresses
Join David Augustsson, Director of Corporate Affairs at Oncopeptides, for the third episode of Oncopeptalks together with CEO Sofia Heigis.
Read moreOncopeptides opts to abandon Type II variation process for Pepaxti to optimize patient and shareholder value
The decision does not impact the company´s financial projections or the estimated market potential of Pepaxti negatively.
Read more
Released November 8, 2023
Oncopeptides publishes Q3 report 2023
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“Providing clinical benefit to patients”
CEO Sofia Heigis
See the Webcast
For further information, please contact:
David Augustsson
Director Corporate Affairs
david.augustsson@oncopeptides.com
+46 762 29 38 68
Oncopeptides AB Year-end report 2023 will be published February 27, 2024
Press release - November 17, 2023
Article with exploratory alkylator-refractory subgroup analysis from Oncopeptides’ OCEAN study observing longer PFS and OS in melflufen vs. pomalidomide published in European Journal of Haematology
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Upcoming events
2023-12-09 - 2023-12-12
65th ASH Annual Meeting in San Diego, US
Meeting
2024-01-28 - 2024-02-23
Silent Period
Other
2024-02-27
Year-end report 2023
Report
Update on Oncopeptides’ appeal of U.S. withdrawal
On Monday, October 2, Oncopeptides participated in a joint meeting with the Center for Drug Evaluation and Research’s (CDER’s) hosted by Dr. Peter Marks. The meeting presented an opportunity for both parties to present their view on the issue.
Oncopeptides opts to abandon Type II variation process for Pepaxti to optimize patient and shareholder value
More information, Q&A for investors and Oncopeptalks with CEO Sofia Heigis
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.
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.
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.
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).
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.
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
Download
Annual Report 2022
Letter from the CEO – Providing clinical benefit to patients
For further information, please contact:
David Augustsson
Director Corporate Affairs
david.augustsson@oncopeptides.com
+46 762 29 38 68
Vision of Oncopeptides
”Oncopeptides brings hope to patients through passionate people, innovative science and transformative medicines”
Cultures & Values
We are a science driven, entrepreneurial company, committed to bringing innovation to patients with an unmet medical need, and improving their lives.
Journey of innovation
Oncopeptides was formed in 2000 to develop anti-cancer drugs based on research by some of Sweden’s leading cancer researchers and cancer research institutions.