Sanofi stock falls as amlitelimab Phase III results disappoint

Investing.com - Sanofi (NASDAQ:SNY) reported top-line results for its anti-OX40 ligand antibody amlitelimab in atopic dermatitis from the Phase III COAST 1 trial on Thursday. The results could impact competition with Regeneron (NASDAQ:REGN), a prominent biotechnology player with $14.2 billion in revenue and strong financial health according to InvestingPro data.

While the trial met all primary and key secondary endpoints, the magnitude of benefit fell significantly below investor expectations based on Phase II benchmarks and compared to approved treatments like Dupixent.

On the key EASI-75 score endpoint, amlitelimab showed approximately 20% improvement over placebo with the Q12W regimen, considerably lower than the 39% improvement reported in the previous Phase IIb study.

William Blair noted that these results suggest OX40 or OX40L targeting therapies do not drive deep responses as quickly as IL-13/4 class treatments, potentially relegating them to second-line biologic status for patients not responding to IL-13/4 therapies.

The Phase III OCEANA development program for amlitelimab in atopic dermatitis continues with four additional Phase III studies scheduled to report results in 2026.

In other recent news, Regeneron Pharmaceuticals announced that its investigational drug, cemdisiran, achieved significant results in a Phase 3 trial for generalized myasthenia gravis (gMG). The NIMBLE trial demonstrated that cemdisiran monotherapy led to a 2.3-point improvement in the Myasthenia Gravis Activities of Daily Living score, surpassing the improvements seen with existing C5 inhibitor therapies. Following these positive trial outcomes, Jefferies increased its price target for Regeneron to $831, maintaining a Buy rating, while Bernstein raised its price target to $781, also keeping an Outperform rating.

Raymond James reiterated its Outperform rating for Regeneron, with a price target of $673, expressing continued confidence in the company. UBS maintained a Neutral rating with a $595 price target after the positive trial data. Bernstein noted that the potential addition of the myasthenia gravis treatment could boost Regeneron’s future earnings per share by 7%. These developments reflect the growing optimism among analysts regarding Regeneron’s prospects in the treatment of gMG.

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