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FDA Extends Review Period of Sanofi's Multiple Sclerosis Drug Filing
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Key Takeaways
{\"0\":\"SNY\'s NDA for tolebrutinib in nrSPMS is under FDA priority review with a decision pushed to Dec. 28, 2025.\",\"1\":\"Extension follows submission of new analyses, deemed a major amendment to SNY\'s application by the FDA.\",\"2\":\"In phase III studies, tolebrutinib delayed confirmed disability progression versus placebo and Aubagio.\"}
Sanofi (SNY - Free Report) announced that the FDA has extended the target action date for its new drug application (NDA) for tolebrutinib by three months. The NDA is seeking approval of tolebrutinib, an oral and brain-penetrant investigational Bruton's tyrosine kinase (BTK) inhibitor, to treat non-relapsing, secondary progressive multiple sclerosis (nrSPMS)
The FDA’s decision follows Sanofi’s submission of additional analyses during the review process, which the agency deemed a major amendment to the NDA. As a result, the decision date has been moved to Dec. 28, 2025, from Sept. 28, 2025.
The FDA accepted Sanofi’s tolebrutinib NDA for the nrSPMS indication in March 2025 under its priority review pathway. The 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 HERCULES showed that patients treated with tolebrutinib delayed the time to onset of six-month confirmed disability progression when compared to placebo, and data from GEMINI 1 and 2 showed that patients treated with tolebrutinib delayed the time to onset of six-month confirmed disability worsening when compared to Aubagio (teriflunomide). A similar regulatory filing for the drug is currently under review in the EU.
Year to date, shares of Sanofi have lost 2.5% against the industry’s 0.9% growth.
Image Source: Zacks Investment Research
Per Sanofi, tolebrutinib is the first and only brain-penetrant BTK inhibitor to treat both nrSPMS and RMS. 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.
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.
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 by the end of 2025.
Tolebrutinib was added to Sanofi’s portfolio with the acquisition of Principia in 2020. It enjoys the FDA’s Breakthrough Therapy designation in the United States for the nrSPMS indication.
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.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from $1.10 to $1.52 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.46 to $2.12. Year to date, shares of CRMD have surged 59.7%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Pharming Group’s 2025 loss per share have narrowed from 40 cents to 10 cents. For 2026, PHAR’s earnings per share estimate has improved from 7 cents to 27 cents. PHAR stock has risen 45.8% year to date.
Pharming Group’s earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 39.14%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has surged 87.5% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.
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FDA Extends Review Period of Sanofi's Multiple Sclerosis Drug Filing
Key Takeaways
Sanofi (SNY - Free Report) announced that the FDA has extended the target action date for its new drug application (NDA) for tolebrutinib by three months. The NDA is seeking approval of tolebrutinib, an oral and brain-penetrant investigational Bruton's tyrosine kinase (BTK) inhibitor, to treat non-relapsing, secondary progressive multiple sclerosis (nrSPMS)
The FDA’s decision follows Sanofi’s submission of additional analyses during the review process, which the agency deemed a major amendment to the NDA. As a result, the decision date has been moved to Dec. 28, 2025, from Sept. 28, 2025.
The FDA accepted Sanofi’s tolebrutinib NDA for the nrSPMS indication in March 2025 under its priority review pathway. The 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 HERCULES showed that patients treated with tolebrutinib delayed the time to onset of six-month confirmed disability progression when compared to placebo, and data from GEMINI 1 and 2 showed that patients treated with tolebrutinib delayed the time to onset of six-month confirmed disability worsening when compared to Aubagio (teriflunomide). A similar regulatory filing for the drug is currently under review in the EU.
Year to date, shares of Sanofi have lost 2.5% against the industry’s 0.9% growth.
Image Source: Zacks Investment Research
Per Sanofi, tolebrutinib is the first and only brain-penetrant BTK inhibitor to treat both nrSPMS and RMS. 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.
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.
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 by the end of 2025.
Tolebrutinib was added to Sanofi’s portfolio with the acquisition of Principia in 2020. It enjoys the FDA’s Breakthrough Therapy designation in the United States for the nrSPMS indication.
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.
Sanofi Price and Consensus
Sanofi price-consensus-chart | Sanofi Quote
SNY’s Zacks Rank & Stocks to Consider
Sanofi currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are CorMedix (CRMD - Free Report) , Pharming Group (PHAR - Free Report) and Kiniksa Pharmaceuticals (KNSA - Free Report) , each sporting a Zacks Rank #1 (Strong Buy) at present. You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, estimates for CorMedix’s earnings per share have increased from $1.10 to $1.52 for 2025. During the same time, earnings per share estimates for 2026 have increased from $1.46 to $2.12. Year to date, shares of CRMD have surged 59.7%.
CorMedix’s earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 34.85%.
In the past 60 days, estimates for Pharming Group’s 2025 loss per share have narrowed from 40 cents to 10 cents. For 2026, PHAR’s earnings per share estimate has improved from 7 cents to 27 cents. PHAR stock has risen 45.8% year to date.
Pharming Group’s earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 39.14%.
In the past 60 days, estimates for Kiniksa Pharmaceuticals’ 2025 earnings per share have increased from 74 cents to $1.03. Earnings per share estimate for 2026 has increased from $1.19 to $1.60 during the same period. KNSA stock has surged 87.5% year to date.
Kiniksa Pharmaceuticals’ earnings beat estimates in two of the trailing four quarters and missed on the remaining two occasions, delivering an average negative surprise of 330.56%.