New Investment Criteria Applied to Late-Stage Pipeline

Sanofi (Sanofi, SNY) has discontinued the development of amlitelimab, itepekimab, and balinatunfib, and appointed Paulo Fontoura as Global Head of Pharmaceutical R&D effective September 1, 2026. Fontoura, a neurologist with prior leadership roles in clinical development at Zyla Therapeutics and Roche, will oversee the integration of research and regulatory functions. With CEO Belén Garijo emphasizing capital allocation based on scientific rationale, unmet medical need, and long-term value, this move reflects a portfolio reset that demands commercial differentiation even in late-stage assets.

Amlitelimab Was Discontinued Despite Phase 3 Success

Unnamed amlitelimab (amlitelimab, SAR445229/KY1005) is a fully human monoclonal antibody targeting OX40 ligand (OX40L), which completed COAST 1, COAST 2, and SHORE Phase 3 trials in moderate-to-severe atopic dermatitis. Although the long-term extension ESTUARY Phase 3 (NCT06407934) showed sustained clinical response, Sanofi halted global regulatory submissions on July 24, 2026, citing insufficient evidence of efficacy and safety improvements over standard-of-care. Dupilumab (dupilumab, IL-4Rα inhibitor) was approved by the FDA on March 28, 2017, in the EU on September 26, 2017, and in Japan on January 19, 2018, with global sales reaching USD 17.8 billion in 2025, setting a high benchmark alongside upadacitinib (JAK1), abrocitinib (JAK1), and lebrikizumab (IL-13).

Itepekimab and Balinatunfib Also Failed to Demonstrate Reproducibility

Unnamed itepekimab is an IL-33 monoclonal antibody co-developed by Sanofi and Regeneron Pharmaceuticals (REGN). While AERIFY-1 Phase 3 showed a 27% reduction in moderate-to-severe exacerbations in COPD patients over 52 weeks, AERIFY-2 did not meet the same primary endpoint. Standard-of-care for COPD includes inhaled LABA/LAMA/ICS combinations, and dupilumab was already approved by the FDA on September 27, 2024, for eosinophilic patients, reducing the incentive to accept regulatory and commercial risks based on a single successful trial. Unnamed balinatunfib (balinatunfib, SAR441566) is an oral TNFR1 signaling inhibitor that failed to achieve statistical significance in PASI75 at 12 weeks in a psoriasis Phase 2 trial and also missed primary endpoints in a rheumatoid arthritis Phase 2 trial, leading to the termination of the entire program.

Securing Growth Beyond Dupilumab Is More Critical Than Cost Savings

Sanofi’s R&D expenses for Q2 2026 reached EUR 2.2 billion, a 17.9% increase year-over-year, including costs from pipeline reprioritization. However, the company maintained its annual guidance and raised revenue growth forecasts to approximately 10% on a constant currency basis. Dupilumab generated EUR 5.2 billion in Q2 2026 revenue, and Sanofi has projected sales of around EUR 25 billion by 2030, ensuring strong near-term cash flow. Nevertheless, the removal of amlitelimab, once projected as a USD 5 billion potential asset, lowers the net present value of the internal immunology pipeline, increasing the importance of late-stage clinical rigor and external in-licensing or acquisitions.