Sanofi (SASY.PA) Amlitelimab discontinued in AD, despite positive ESTURY data first move under the new CEO
Equity Research 24 July 2026 | 8:02AM BST
Sanofi (SASY.PA): Amlitelimab discontinued in AD, despite positive ESTURY data - first move under the new CEO
This morning, Sanofi announced that, as part of an ongoing R&D review, amlitelimab James Quigley | will be discontinued in Atopic Dermatitis despite positive results from the ESTURY Goldman Sachs International trial, as the data were not seen as sufficient to represent a meaningful improvement Shyam Kotadia over the standard of care for patients with Atopic Dermatitis. The Phase 2 trial in | Celiac Disease is ongoing and is expected to read out in the second half of 2026. As Goldman Sachs International
previously noted, towards the end of 2025, Sanofi engaged external consultants to Kaaviya Ganesan | review its pipeline opportunities and make recommendations. Given that efficacy Goldman Sachs India SPL was broadly in line with Dupixent, together with competitors’ decisions to discontinue OX40-targeting programmes (although Sanofi has always maintained Max Da, Ph.D. | that the risk of Kaposi sarcoma was low and manageable with amlitelimab), this Goldman Sachs International
outcome is unlikely to come as a surprise to the market. Therefore, while the timing Theodora Rowe Beadle | may look somewhat odd given that new Head of R&D Paulo Fontoura is not due to Goldman Sachs International start until September 2026, the decision appears to have been made on the basis of the external recommendations provided to the CEO and Board.
Given that the external review appears to have been completed, and with next week marking the first time new CEO Belen Garijo will address the market, we could see some updates on other pipeline projects, particularly those where we have seen mixed data including; (1.) itepekimab (IL-33) and the decision on whether to move forward in COPD (given no itepekimab discontinuation PR, we expect the programme could now move forward to another Phase 3, although this could be commercially challenging given the all-comers win for AstraZeneca’s tozorakimab - see here), (2.) balinatunfib (oral TNF), where we would expect the asset to move forward in combination with other psoriasis and RA agents, and (3.) brivekimig (OX40xTNF bispecific nanobody), which shares part of its mechanism of action with amlitelimab.
In our model, we had included peak sales of €1.7bn for amlitelimab in Atopic Dermatitis (included at a 67% PoS), assuming some disease-modifying activity of the drug that could potentially offset some rare safety concerns. Mechanically removing the asset from our model would therefore imply c.4% downside to our DCF (all else equal), although there could likely be some modest offset from lower SG&A that could also be removed. Sanofi paid $1.1bn upfront for Kymab in January 2021; therefore, we expect an impairment charge for the majority of this amount to be recognised in the IFRS P&L in 2Q26 (non-cash impact). As Bus. EPS guidance was reiterated, we expect limited impact from wind-down costs of the clinical programme.
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Goldman Sachs Sanofi (SASY.PA)
Overall, the market is unlikely to be surprised by the decision to discontinue amlitelimab. While it implies a negative impact on our DCF (which currently stands at €83), at current levels, this is likely already reflected in the share price. This is the first move under the new CEO and could reflect an appetite to make tough portfolio decisions to help reshape the pipeline, and reallocate resources for the long term. We recently could not find reasons to become more positive, and commentary at the results next week will be key to lay the foundations, but we await the start of the new Head of R&D to get…
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