Sanofi Shares Plunge 2.56% Midday After Regulatory Setbacks
Sanofi's stock fell 2.56% to 81.19 euros this Monday midday, following a close at 83.32 euros on Friday. The pharmaceutical company announced that the U.S. regulatory review process for tolebrutinib in non-recurring secondary progressive multiple sclerosis will extend beyond the targeted U.S. action date of December 28, 2025, with further FDA guidance expected by the end of the first quarter of 2026. This news comes after the failure of the phase 3 Perseus study of the same treatment in another form of the disease, primary progressive multiple sclerosis, where the primary endpoint of disability progression delay was not met. Trading volumes remain low with only 0.08% of capital traded during the session. Over the last seven days, the stock has declined by 4.48%, while it has slightly increased by 0.61% over three months. The annual performance remains decidedly negative at minus 8.95%, reflecting the stock's difficulty in convincing in an unfavorable market environment. The stock is currently trading between a support at 82.68 euros and a resistance at 90.44 euros, framing a relatively narrow technical corridor.
Technical Analysis and Market Response
Technically, the RSI stands at 33, a level approaching the oversold zone, reflecting increased selling pressure on the stock. The current price is now significantly below the 50-day moving average, set at 86.15 euros, and the 200-day moving average, established at 87.87 euros. This gap between the price and these long averages underscores the bearish trend that has been in place for several weeks. According to Oddo BHF, there is currently no approved treatment for this form of multiple sclerosis, and two hypotheses could explain this regulatory delay: either the FDA has safety concerns about the product, or the recent U.S. government shutdown could be another explanation. The MACD shows a line at minus 1.10 and a signal at minus 0.84, generating a negative histogram of minus 0.26, confirming the weakening of the current momentum. The Chaikin Money Flow, at minus 0.20, indicates a capital outflow from the stock, reinforcing the bearish scenario in the short term. The Bollinger Bands, ranging from 82.20 to 88.77 euros, frame the current price which is located in the lower part of this channel, indicating moderate volatility but a degraded sentiment.
Operational Strength Amid Regulatory Challenges
Despite these regulatory setbacks, the third-quarter 2025 results, published on October 24, demonstrate the operational strength of the group. The quarterly revenue stood at 12.43 billion euros, up 7% at constant exchange rates, exceeding consensus expectations. The flagship drug Dupixent crossed the 4 billion euros quarterly sales threshold for the first time, with a 26.2% increase, confirming its role as a growth driver. The group maintains its annual targets with expected revenue growth between 7 and 9% and a double-digit increase in earnings per share. In response to a request from the FDA, Sanofi submitted an expanded access protocol for tolebrutinib in non-recurring secondary progressive multiple sclerosis, highlighting its commitment to providing eligible patients access to this experimental treatment. On the analyst recommendation front, HSBC confirmed an 'buy' rating early December with a price target of 100 euros, while JPMorgan recently downgraded the stock to 'neutral' with a target of 95 euros. BNP Paribas, on the other hand, lowered its target from 115 to 112 euros while maintaining an 'outperform' recommendation. These adjustments reflect market concerns about the pipeline's ability to offset short-term regulatory disappointments.
