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Sanofi Says Primary Progressive Multiple Sclerosis Drug did not Meet Main Goal in a Phase 3 Trial

Sanofi Says Primary Progressive Multiple Sclerosis Drug did not Meet Main Goal in a Phase 3 Trial

marketscreener·
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+1.29%
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-0.37%
marketscreener·
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SNYNF
+1.29%
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-0.37%

Sanofi: Buy Rating Maintained Amid Attractive Valuation and Long-Term Growth Potential Despite Pipeline Setbacks

Analyst Sachin Jain from Bank of America Securities maintained a Buy rating on Sanofi with a €102.00 price target, citing attractive valuation and long-term growth potential despite recent pipeline setbacks. Jain highlights the potential for future catalysts like amlitelimab data and believes risks associated with tolebrutinib approval are manageable. Jefferies also maintained a Buy rating with a €100.00 price target.

Tip Ranks·
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-0.37%
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SNYNF
+1.29%
Tip Ranks·
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-0.37%
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SNYNF
+1.29%

Sanofi Dips as Multiple Sclerosis Treatment Misses in Late-stage Trial, Faces US Regulatory Delay

Sanofi Dips as Multiple Sclerosis Treatment Misses in Late-stage Trial, Faces US Regulatory Delay

marketscreener·
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+1.29%
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-0.37%
marketscreener·
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Sanofi Shares Slip After Tolebrutinib Misses Key Milestone in MS Trial

Sanofi shares fell 4.4% after its Phase 3 PERSEUS trial showed that tolebrutinib failed to delay disability progression in primary progressive multiple sclerosis (PPMS) patients. The company will not seek regulatory approval for PPMS but remains hopeful for other indications. Tolebrutinib has provisional approval in the UAE for non-relapsing secondary progressive multiple sclerosis (nrSPMS) and is under review in the EU and other regions. The FDA's decision on nrSPMS is delayed to Q1 2026. Financial impacts will be disclosed in January, with no change to 2025 earnings forecasts.

Stock Invest·
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+1.29%
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-0.37%
Stock Invest·
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Sanofi Says It Will Not Pursue Regulatory Registration For PPMS

Sanofi announced it will not pursue regulatory registration for its drug, Tolebrutinib, in treating Primary Progressive Multiple Sclerosis (PPMS) after failing to meet primary endpoints. PPMS accounts for 10% of MS patients. Sanofi will conduct an impairment test on Tolebrutinib's intangible asset value, with results expected in January 2026. This decision will not affect business net income or EPS, nor change financial guidance for 2025.

Reuters·
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+1.29%
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Reuters·
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