Ipsen Withdraws Drug from Market After Potential Risks Outweigh Benefits
Ipsen announces the voluntary and immediate withdrawal of Tazverik (tazemetostat) from all markets where it is sold, across all indications. This decision follows emerging data from the SYMPHONY-1 phase Ib/III trial, which revealed a less favorable safety profile than expected.
The Independent Data Monitoring Committee (IDMC) of the SYMPHONY-1 trial indicated that, based on adverse events related to secondary hematologic malignancies, the risks could outweigh the potential benefits for patients in the therapeutic regimen evaluating tazemetostat in combination with lenalidomide and rituximab (R²) compared to R² alone in follicular lymphoma. The withdrawal affects both follicular lymphoma (FL) and epithelioid sarcoma (ES). Tazverik had received accelerated approval from the U.S. FDA in 2020 for these two indications.
Immediate Actions Taken in Clinical Trials
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Ipsen has taken immediate action to discontinue treatment with tazemetostat for all patients currently enrolled in the SYMPHONY-1 trial. All participants will receive the standard treatment, namely lenalidomide plus rituximab only. The study will remain open, without new inclusions, to continue long-term safety follow-up of all participants. Ipsen is also discontinuing all active clinical trials and expanded access programs involving tazemetostat. The company is collaborating with the U.S. FDA to determine the next steps for the withdrawal and to provide all necessary information to finalize this process.
Financial Outlook Remains Unchanged
Ipsen states that the withdrawal should not impact the company's financial forecasts.
SectorPharmacie et biotechnologies›Vaccins et laboratoires de recherche
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Context
Period
Period: S1 2026
Key reported figures
Revenue: 2 190 millions d'euros
Quarterly revenue: 2 190 millions d'euros
Revenue growth: 20,4 %
EBITDA: 733,9 millions d'euros
EBITDA margin: 40,7 %
Net income: 403,1 millions d'euros
Free cash flow: 651,7 millions d'euros
-1 005 millions d'euros
Guidance from the release
Cette dynamique nous permet de relever nos objectifs financiers pour 2026
Risks mentioned
Arrivée potentielle de génériques du lanréotide, concurrençant les ventes de Somatuline
Effet défavorable des devises d'environ 1 % anticipé sur l'exercice 2026
Impact dilutif des acquisitions de Memo Therapeutics AG et de Kartos Therapeutics sur la marge
Opportunities identified
Plusieurs lancements attendus à court terme d'actifs à potentiel de blockbuster dans les trois aires thérapeutiques
Résultats positifs de Phase III de Dysport dans la migraine épisodique et chronique
Résultats positifs de Phase IIIb ELSPIRE d'Iqirvo dans la cholangite biliaire primitive
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Investments in the stock market involve risks, including the risk of capital loss. Past performance of an asset or market is no guarantee of future results. Any investment decision should be made taking into account your personal financial situation, objectives and risk tolerance.
