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About us

Bringing hope through science

Oncopeptides is a science-driven biotech company developing targeted therapies for hard-to-treat cancers. We combine cutting-edge research, entrepreneurial spirit, and a deep commitment to improving patients’ lives.

Headquartered in Stockholm, Sweden, with operations also in Germany, Italy, Spain and Austria, Oncopeptides is listed on Nasdaq Stockholm (ticker: ONCO). Our diverse team of 70 people is united by one goal: bringing groundbreaking treatments to patients who need it the most.

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Going beyond Myeloma

  • In February, following up on the presentation during the Capital Market Update in November 2025, the company detailed its new ambitions for its pipeline assets in new indications, with a Window-of-Opportunity study for a PDC in glioblastoma during 2026 as a first step.
  • Oncopeptides carries out a partially guaranteed rights issue of approx. SEK 200 million.

Ciao Italia!

  • Oncopeptides’ flagship drug, Pepaxti, received formal approval for full reimbursement in Italy, marking the final regulatory step for its commercialization in the country.
  • The company successfully transitioned to the commercial phase in Italy by securing its first hospital order for Pepaxti in March.
  • The U.S. Food and Drug Administration lifted the clinical hold on Oncopeptides’ next-generation pipeline drug, OPD5, allowing for the progression of its clinical development.
  • Pepaxti was included in the new EHA-EMN clinical practice guidelines for relapsed and refractory multiple myeloma with the highest level of evidence for non-CAR T therapies.
  • Oncopeptides carries out a partially guaranteed rights issue of approx. SEK 150 million.
  • A peer-reviewed study published in the European Journal of Haematology by researchers at the Dana-Farber Cancer Institute validated Pepaxti’s efficacy and safety in a real-world clinical setting.
  • Real-world evidence from Spanish and Italian clinical centers was accepted for presentation at the International Myeloma Society (IMS) Annual Meeting in Toronto, providing global scientific recognition.
  • Clinical data presented from the University of Catania further supported the effectiveness of Pepaxti in treating heavily pretreated, high-risk multiple myeloma patients.
  • The company progressed into contracting discussions with a major Japanese pharmaceutical company for the licensing of Pepaxti in the Japanese market.
  • Oncopeptides initiated a strategic review to explore alternative funding options and potential licensing partnerships for its pipeline assets.
    In november, the company hosted a Capital Market Update, which included the first presentation of the new strategic path for its pipeline.

Hola Espana!

  • In april 2024, Oncopeptides obtains marketing authorization from the Spanish Agency for  Medicines and Health Products and launches its product.
  • Just a month later the first patient in Spain is treated with Pepaxti in May, ahead of the company´s plan.
  • Later that year, the company reaches an agreement with the Italian Medicines Agency (AIFA) on pricing and reimbursement, paving the way for a launch in 2025.
  • Oncopeptides signs license agreement with SCBIO for commercialization in South Korea.
  • First patient enters Oncopeptides study aiming to gain real-world insights from Pepaxti in Germany
  • Oncopeptides selects first candidate drug, OPSP1, from its SPiKE platform.
  • Oncopeptides carries out a fully guaranteed rights issue of approximately SEK 300 million.

Commercialization in Europe

  • German sales initiated while a full marketing team is built and fully recruited by the end of the year
  • First sales of Pepaxti in Greece
  • In July, the FDA reiterates its request that Oncopeptides withdraw Pepaxto in the US, a decision that the company chooses to appeal. A decision is expected in the second half of 2023
  • Sofia Heigis, former CCO, becomes CEO of the company in August, and Henrik Bergentoft takes over as CFO towards the end of the year
  • Oncopeptides publishes two articles with results from the ANCHOR and LIGHTHOUSE studies in Haematologica
  • Successful price negotiations between Oncopeptides and German payment authorities lead to a German price for Pepaxti of €7,058
  • The medicines agency EMA recommends that Pepaxti be approved for use in earlier lines of therapy, which would increase its potential use but at a lower price, later prompting the company to withdraw its application
  • Article with exploratory alkylator-refractory subgroup analysis from Oncopeptides OCEAN study observing longer PFS and OS in melflufen compared to pomalidomide is published in the European Journal of Hematology
  • Oncopeptides are selected to present additional data from the OCEAN study at the American Society of Hematology congress

A transformative year

  • Phase 3 study OCEAN is published in The Lancet Haematology
  • Oncopeptides rescinds the voluntary withdrawal of Pepaxto in the US, based on additional analyses of survival data from OCEAN and other relevant studies
  • The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommends a full approval of Pepaxti in combination with dexamethasone in Europe for the treatment of triple-class refractory multiple myeloma
  • The European Commission grants marketing authorization for Pepaxti in combination with dexamethasone in the EU, as well as in the EEA countries Iceland, Lichtenstein and Norway
  • Commercialization in Europe begins, with Germany as the first market
  • The clinical benefit of melflufen is further confirmed in the phase 3 LIGHTHOUSE study
  • Pepaxti receives market authorization from the MHRA in the UK
  • The company enters into a renewed loan agreement of up to EUR 30 million with the European Investment Bank
  • At the end of the year, the FDA requests the withdrawal of the marketing authorization for Pepaxto in the US

Science shows the way

  • On February 26, the FDA grants conditional approval to Pepaxto plus dexamethasone for the treatment of adult patients with relapsed, refractory multiple myeloma who have received at least four prior lines of therapy and whose disease is resistant to at least one proteasome inhibitor, one immunomodulatory drug and one monoclonal antibody drug targeting CD38
  • A European business unit is formed to prepare the commercialization of melflufen in the EU. In addition, a so-called Early Access program was initiated to provide early access to melflufen for patients with no or few treatment options
  • Oncopeptides submits an application to the European Medicines Agency (EMA) for conditional approval of melflufen plus dexamethasone in the EU based on the phase 2 HORIZON study
  • Results from the phase 3 OCEAN study are published. Melflufen met the primary endpoint of progression-free survival (PFS) in a direct comparison with pomalidomide. However, the overall survival in the so-called Intention to Treat population, showed a hazard ratio of 1.10 in favor of pomalidomide
  • Based on unsatisfactory survival data, the FDA requests that enrollment of new patients in all clinical trials be stopped. The FDA also issues a safety alert for Pepaxto and calls for an expert public advisory committee (ODAC) meeting to discuss the future of Pepaxto
  • On October 22, Oncopeptides decides to withdraw Pepaxto from the US market and return to being a Sweden-based research and development company, focused on further developing the proprietary PDC platform
  • The application process to the European Medicines Agency, EMA, for a potential market authorization continues

A commercial stage biotech company

  • The organization is strengthened to prepare for the commercial launch of melflufen in the US
  • An application for conditional approval of melflufen in combination with dexamethasone for the treatment of multiple myeloma is submitted to the FDA
  • Oncopeptides develops into a fully integrated global biotech company
  • The FDA approves the application to start clinical studies in the US for OPD5, the second drug candidate based on the proprietary PDC platform
  • Enrollment to the phase 3 OCEAN study is completed. The first results are expected in the first half of 2021
  • First patient enrolled in phase 1/2 study with AL amyloidosis, the first study to investigate the effect of melflufen outside of multiple myeloma
  • A lab in Solna for pre-clinical drug development is established
  • Final data from the pivotal phase 2 study HORIZON is presented at the virtual European Hematology Congress, EHA

US application and additional research data

  • New interim data from the Phase 2 HORIZON study presented at the International Myeloma Workshop
  • Decision to apply for conditional approval in the US is made
  • Updated data from the clinical studies O-12-M1, HORIZON and ANCHOR are presented at several congresses, including ASCO, EHA and SOHO

Organization expands and raises ambitions

  • Phase 1/2 combination study ANCHOR with melflufen is initiated
  • First interim data from the ongoing Phase 2 combination study ANCHOR and updated interim data from HORIZON presented at the American Society of Hematology, ASH
  • First patient enrolled in the phase 2 BRIDGE study in patients with relapsed refractory multiple myeloma with renal impairment
  • Updated interim data from the ongoing phase 2 HORIZON study with melflufen is presented at the European Hematology Meeting, EHA

Oncopeptides becomes a public company

  • The phase 2 study HORIZON is initiated
  • Overall survival data from the phase 2 study and interim data from the ongoing phase 2 HORIZON study are presented at the American Society of Hematology, ASH
  • The phase 3 OCEAN study with melflufen in patients with relapsed refractory multiple myeloma is initiated
  • Melflufen is granted additional patent protection in Europe until 2032
  • Oncopeptides is listed on Nasdaq Stockholm in February 2017

Expanded dialog with regulatory authorities

  • Scientific meetings with European authorities and FDA regarding the design of a phase 3 study
  • Meeting with the FDA regarding the completed phase 2 study in late-stage multiple myeloma patients
  • The phase 2 of the phase 1/2 study presented to the European Hematology Association

Orphan Drug Designation and promising phase 1 data

  • Melflufen is granted Orphan Drug Designation in the EU and US
  • The phase 1 part of the phase 1/2 study in patients with late-stage multiple myeloma is presented at the American Society of Hematology’s annual meeting

Important investments in the future

  • Phase 1/2 study initiated in multiple myeloma patients, the study was led by Harvard Medical School – Dana-Farber Cancer Institute
  • HealthCap and Industrifonden, together with a number of key individuals in the company, provide funding for the Phase 1/2 clinical program in late-stage multiple myeloma patients
  • Industrifonden acquires Karolinska Development’s shares in Oncopeptides
  • HealthCap becomes a shareholder

First clinical studies and research collaboration in the US

  • Phase 1 study in solid tumors conducted at Uppsala University Hospital, Sweden
  • Research collaboration established with Harvard Medical School – Dana-Farber Cancer Institute
  • New freeze-dried drug formulation of melflufen is developed and patented

Research & development phase

  • Preclinical development phase, financed by Industrifonden and Karolinska Development AB

Oncopeptides is founded

  • Oncopeptides AB is founded to further develop drugs candidates, including melflufen
  • Melflufen becomes patent protected

The Oncopeptides way

Breakthrough science starts with passionate people. Our inclusive culture empowers our team to challenge conventions, embrace new ideas, and transform cancer care.

Science

Data-driven, curious, innovative.

Passion

Dedicated to making a difference for patients.

Collaboration

Working across functions and borders to achieve results.

Courage

Supporting bold thinking and new ideas.

Trust

Acting with integrity and mutual respect.

Our Strategy:
Grow Geographically, Partner Smartly, Innovate Purposefully

Commercial Execution: The Engine
  • Maximize European Value: We are driving rapid growth for our fully approved multiple myeloma asset, Pepaxti, targeting a SEK 1.5 billion annual market potential.
  • Path to Profitability: Fueled by strong peer-to-peer recommendations and disciplined operational focus, our commercial engine is structured to carry Oncopeptides to positive cash flow in 2027.
  • Smart Partnering: We scale our reach beyond Europe through high-margin strategic alliances.
  • Unlocking Asia: We are advancing formal licensing negotiations for the Japanese market—structured to secure non-dilutive capital through upfront payments, milestones, and royalties—while leveraging existing partnerships in markets like South Korea.
  • Capital-Efficient R&D: We are executing a strategic shift from internal pre-clinical research to external clinical collaborations to advance our proprietary PDC and SPiKE platforms.
  • The Glioblastoma Leap: We are deploying our clinically validated PDC technology into the $8 billion glioblastoma market.
  • De-Risking Tomorrow: Through a low-cost, focused “Window of Opportunity” study, we will confirm our platform crosses the blood-brain barrier in humans, immediately de-risking our next-generation asset (OPD5) and transforming our long-term trajectory.

Financial discipline

We aspire to ensure that the company has a long-term, sustainable cash and equity position until the company becomes financially self-sufficient. In addition to sales, we are heavily focused on optimizing cost by focusing on activities that maximize patient and shareholder value.

We aspire to ensure that physicians and payors prefer Pepaxti in elderly patients with relapsed, refractory multiple myeloma. We are launching Pepaxti with a patient-focused team, determined to bring new science to the benefit of the right patients. The team is well networked, has in-depth scientific knowledge, strong business acumen and drives scientific share of voice and advocacy.

We continuously analyze the market situation and develop our strategy market access strategy based on it. Outside of Europe, China and Japan are currently the most viable markets and the company is currently looking at opportunities to either license Pepaxti or form a partnership there.

We aspire to progress the development of drug candidates for difficult to treat cancer diseases with significant unmet medical needs.

The drug candidates are based on the proprietary Peptide Drug Conjugate platform, PDC, and the SPiKEs platform (Small Polypeptide based Killer Engagers). For SPiKE, the first candidate selection will take place early in 2024 and for PDC, the first drug Pepaxti is already commercialized while next generation PDC development is in an early stage

We aspire to build company engagement and attraction through our vision and values. We act with an enterprise spirit and believe that the journey to becoming a strong company brand starts internally. We strive to attract, retain and develop key talents in the industry.

Latest company news

View all
March 23, 2026

CEO Sofia Heigis presented at Redeye event Commercialization in Life Science

Investor
March 20, 2026

Sofia Heigis presented and interviewed at Stockholm Corporate Finance Life Science Days

Investor
March 16, 2026

Oncopeptides initiates MARINA study to strengthen real-world evidence for Pepaxti in Germany

Science
March 13, 2026

European Journal of Haematology: Real-World Data reinforces Pepaxti’s role in treatment sequencing for multiple myeloma

Science
March 11, 2026

CEO Sofia Heigis presents Oncopeptides at Aktiespararna

Investor
March 9, 2026

Oncopeptides secures fast-track designation for Window-of-Opportunity study in glioblastoma

Science
March 5, 2026

Biostock: presentation and interview with Sofia Heigis

Investor
February 20, 2026

Oncopeptides CEO Sofia Heigis interviewed by Redeye about Q4 and the new share issue

Investor

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