Sanofi SNY announced that a phase III study evaluating its investigational oral BTK inhibitor, tolebrutinib, demonstrated clinically meaningful benefit in disability accumulation in patients with non-relapsing secondary progressive multiple sclerosis (nrSPMS).
The HERCULES phase III study met the primary endpoint by showing an improvement over placebo in delaying time to onset of confirmed disability progression.
There are no approved therapies to treat nrSPMS at present. Multiple sclerosis (MS) is a chronic neurodegenerative disease that causes disability accumulation over time, which is not properly addressed by the currently available therapies and remains a significant unmet need in MS treatment. By showing a clinically meaningful benefit in disability accumulation, tolebrutinib holds the potential to address this significant unmet need in MS.
Sanofi plans to discuss the phase III data with regulatory bodies to get approval for the candidate.
Sanofi’s stock has risen 13.2% so far this year against the industry’s rise of 28.6%.
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Two other phase III studies evaluating tolebrutinib in people with relapsing multiple sclerosis (RMS), GEMINI 1 and 2, failed to show significance in the primary endpoint of reducing an annualized relapse rate over another Sanofi MS drug, Aubagio. However, when a key secondary endpoint of pooled 6-month confirmed disability worsening was analyzed, data showed a considerable delay in time to onset, in line with data from the HERCULES phase III study.
Another phase III study PERSEUS, evaluating tolebrutinib in primary progressive MS, is currently ongoing. Data from this study is expected to be released in 2025.
Tolebrutinib was added to Sanofi’s portfolio with the Principia acquisition in 2020. In 2022, the FDA had placed a partial clinical hold on Sanofi’s phase III studies on tolebrutinib in MS and MG (myasthenia gravis) indications after the regulatory agency identified cases of drug-induced liver injury in some study participants who were administered with tolebrutinib. The MG studies on tolebrutinib were eventually discontinued in 2022 after careful evaluation of the emerging competitive treatment landscape.
SNY's Zacks Rank
Sanofi currently has a Zacks Rank #3 (Hold). Some better-ranked drug/biotech companies are Roche RHHBY, Arcturus Therapeutics Holdings ARCT and Eli Lilly LLY. While Roche and Arcturus Therapeutics Holdings sport a Zacks Rank #1 (Strong Buy) each, Lilly carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Sanofi Price and Consensus
Sanofi price-consensus-chart | Sanofi Quote
In the past 30 days, 2024 earnings estimates for Roche have improved from $2.59 per share to $2.68 per share. For 2025, earnings estimates have improved from $2.79 per share to $2.87 per share over the same timeframe. Roche’s shares have risen 16.9% year to date.
In the past 30 days, loss estimates for 2024 for Arcturus Therapeutics have improved from $4.39 per share to $2.60 per share. Estimates for 2025 have improved from a loss of 45 cents per share to earnings of 21 cents per share. Year to date, shares of Arcturus Therapeutics have declined 33.1%.
Earnings of Arcturus Therapeutics beat estimates in each of the last four quarters. ARCT delivered a four-quarter average earnings surprise of 56.73%
Estimates for Lilly’s 2024 earnings have risen from $13.79 to $16.23 per share over the past 30 days. For 2025, earnings estimates have risen from $19.44 to $23.45 per share over the same timeframe. Year to date, Lilly’s stock has risen 64.7 %.
Lilly beat estimates in each of the last four quarters, delivering a four-quarter average earnings surprise of 69.07%.
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