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Sanofi's stock plummets over 10% as Amlitelimab's Phase III trial results raise concerns about the company's future pipeline and Dupixent's patent expiration.
The Phase III trial data disappointed Wall Street, resulting in the significant drop in value.
Sanofi’s shares fell upwards of 10% today (totaling around $13 billion in market value) following its Phase III trial results data for Amlitelimab, due to Wall Street’s growing concerns over the company’s future pipeline. With share reportedly being down as much as 10.3%, Sanofi saw the biggest drop on Europe’s blue-chip Stoxx index.
Barclays analyst Emily Field commented on the sudden fluctuation to Reuters, saying, “Investors had viewed Amlitelimab as Sanofi's lead pipeline asset to follow on from that drug ahead of the data release. That's why we're seeing a big reaction in the stock, because of the concern that Sanofi is not going to have enough in its pipeline to replace Dupixent after patent expiry. This is increasingly looked at as a cliff stock."1
Amlitelimab, which is currently in development for the treatment of atopic dermatitis (a severe form of eczema), met all main goals in the Phase III study, displaying statistically significant improvements in skin clearance and disease severity compared with placebo after 24 weeks.1 However, when comparing the results of Amlitelimab to Dupixent (a Sanofi owned medicine treating the same condition), the results were weak.
The Phase III trial investigated two dosing regimens: once every four weeks and once every 12 weeks. In the four-weekly dosing group, approximately 21.1% achieved clear or almost clear skin, per the Validated Investigator Global Assessment scale for Atopic Dermatitis. In patients administered for 12-weeks, the endpoint was achieved in 22.5% of participants. When compared to the placebo, which achieved 9.2% endpoint, Amlitelimab’s results seem promising.
According to JPMorgan, data from the trial results confirmed that Amlitelima is less effective than Dupixent, along with analysts from Jefferies claiming the Phase III results fell short of earlier trial and its rival’s results.1 Additionally, UBS referred to the drug's efficacy as “solid,” despite evidence suggesting it’s weaker than Dupixent. UBS also believes the strength can be countered, through Amlitelimab's advantage of less frequent dosing, noting that injection-averse patients may prefer the least number of injections.
William Blair analyst, Matt Phipps, touched on the results, saying, “Overall, the results add to the evidence suggesting OX40 or OX40L targeting therapies do not drive deep responses as fast as the IL-13/4 class, and therefore may relegate the class to second-line biologic for patients not responding to IL-13/4 therapies.”2
Dupixent, Sanofi’s best-selling medication, is due to lose its patent protect in 2030 and Sanofi anticipated Amlitelimab to become its successor. Investors also believed in Amlitelimab’s potential, with many viewing Amlitelima as the company’s leading pipeline candidate. Dupixent helped generate Sanofi $15.2 billion in sales in 2024, with an estimated total reaching $25.3 billion in 2030, when its patent is set to expire.2
Regeneron, co-owners of Dupixent assisted in its development, along with supporting its process to get approved for eczema, as well as other immune-related conditions such as severe asthma. With the clock ticking on Dupixent’s patent, Sanofi elected to double down on immunology research and development, aiming to make Amlitelimab its main priority.
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