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
Free · Every morning
Technical market signals, before the opening bell.
Bullish and bearish momentum, analyst changes, stocks to watch — automatically computed from Euronext data.
✓ Before 9 AM every morning✓ Euronext data✓ AI-powered analysis
Almost there! Check your inbox.
A confirmation email has been sent. Click the link to confirm your subscription.
An error occurred.
Indicative data. No investment advice. Unsubscribe at any time.
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.
"En 2025, Ipsen a enregistré une croissance solide de son chiffre d'affaires et de son résultat opérationnel."
Ipsen a publié ses résultats 2025 et T4 2025: chiffre d'affaires de 3 675,9 millions d'euros, croissance YoY de 8,1%; Résultat opérationnel des activités de 1 294,1 millions d'euros, marge de 35,2%; Résultat net consolidé IFRS de 444,5 millions d'euros; Bénéfice dilué par action IFRS de 5,32 euros; Cash-flow libre de 1 000,6 millions d'euros; Dividende par action de 1,40 euro.
Outlook / guidance
Expected revenue: Une croissance des ventes totales supérieure à 13,0 % à taux de change constant en 2026
Management commentary: Ipsen prévoit en 2026 une croissance des ventes totales supérieure à 13,0% à taux de change constant et une marge opérationnelle des activités supérieure à 35,0%.
The information presented in this article is provided for informational purposes only and does not constitute an investment recommendation, an incentive to buy or sell a financial asset, or investment advice. Readers are invited to conduct their own research before making any decision.
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.
