Sanofi SNY announced that the FDA has accepted its regulatory filing seeking approval for its investigational BTK inhibitor tolebrutinib to treat non-relapsing secondary progressive multiple sclerosis (nrSPMS) and slow disability accumulation independent of relapse activity in adults.
The filing has been granted priority review by the FDA, bringing down the review period by four months. A final decision is expected by Sept. 28, 2025.
The FDA filing is supported by data from three late-stage studies — one (HERCULES) in nrSPMS and two (GEMINI 1 and 2) in relapsing MS (RMS). Data from these studies showed that patients treated with tolebrutinib delayed the time to onset of six-month confirmed disability progression when compared to placebo. A similar regulatory filing for the drug is currently under review by the EMA, which is also supported by data from these studies.
Per Sanofi, the above results make tolebrutinib the first and the only brain-penetrant BTK inhibitor to treat both the above MS indications. If approved, tolebrutinib will also be the first therapy designed to target smoldering neuroinflammation, a key driver of disability accumulation in MS. By showing a clinically meaningful benefit in disability accumulation, tolebrutinib holds the potential to address a significant unmet need in MS.
MS is a chronic neurodegenerative disease that causes disability accumulation over time, which is not properly addressed by the currently available therapies that are designed to primarily address peripheral inflammation. There are no approved therapies to treat nrSPMS at present.
SNY Stock Price Performance
Year to date, Sanofi’s shares have risen 16% compared with the industry’s 6% growth.
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More on SNY's Tolebrutinib
Besides nrSPMS and RMS, Sanofi is also evaluating the drug in the phase III PERSEUS study in patients with primary progressive MS. Data from this study is expected to be released in the second half of 2025.
Tolebrutinib was added to Sanofi’s portfolio with the acquisition of Principia in 2020.
In 2022, the FDA placed a partial clinical hold on Sanofi’s phase III studies on tolebrutinib in MS and myasthenia gravis (MG) indications after the regulatory agency identified cases of drug-induced liver injury in some study participants who were administered the drug.
The MG studies on tolebrutinib were eventually discontinued in 2022 after careful evaluation of the emerging competitive treatment landscape.
SNY’s Zacks Ranks
Sanofi currently carries a Zacks Rank #3 (Hold).
Sanofi Price
Key Picks Among Biotech Stocks
Some better-ranked stocks from the sector are ANI Pharmaceuticals ANIP, CytomX Therapeutics CTMX and 89bio ETNB. While ANIP and CTMX sport a Zacks Rank #1 (Strong Buy) each at present, ETNB carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for ANI Pharmaceuticals’ 2025 earnings per share (EPS) have risen from $5.54 to $6.35. EPS estimates for 2026 have increased from $6.75 to $7.21 during the same period. Year to date, shares of ANIP have risen over 19%.
ANIP’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 17.32%.
In the past 60 days, estimates for CytomX Therapeutics’ 2025 EPS have improved from a loss of 31 cents to earnings of 25 cents. During the same timeframe, estimates for loss per share for 2026 have narrowed from 65 cents to 31 cents. Year to date, shares of CytomX have lost 35%.
CTMX’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 180.70%.
Estimates for 89bio’s loss per share have narrowed from $3.19 to $1.98 for 2025 in the past 60 days. During the same time frame, the loss per share estimates for 2026 have improved from $2.49 to $2.15. ETNB’s shares have risen 17% year to date.
89bio’s earnings missed estimates in three of the trailing four quarters and beat the mark on one occasion, delivering an average negative surprise of 46.18%.
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Sanofi (SNY) : Free Stock Analysis Report
ANI Pharmaceuticals, Inc. (ANIP) : Free Stock Analysis Report
CytomX Therapeutics, Inc. (CTMX) : Free Stock Analysis Report
89BIO (ETNB) : Free Stock Analysis Report
This article originally published on Zacks Investment Research (zacks.com).
The views and opinions expressed herein are the views and opinions of the author and do not necessarily reflect those of Nasdaq, Inc.
