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Sanofi (SNY) NextGen Multiple Sclerosis Drug Meets Phase II Goal

Sanofi SNY announced positive data from a phase II study, which showed that its novel investigational anti-CD40L antibody, frexalimab, significantly reduced disease activity in patients with relapsing multiple sclerosis.

The data was presented at the annual meeting of the 2023 Consortium of Multiple Sclerosis Centers (CMSC).

The study met the primary endpoint by showing that a higher dose of frexalimab led to an 89% reduction in the number of new gadolinium-enhancing (GdE) T1-lesions after 12 weeks of treatment, compared with placebo. A reduction of 79% in GdE T1-lesions was observed in the lower-dose treatment arm compared with placebo. Additionally, reductions were also observed in   new or enlarging T2-lesions and total GdE T1-lesions in both the treatment arms. Frexalimab was well tolerated in the study.

Sanofi’s stock has risen 4.1% this year so far against the industry’s decline of 0.8%.

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Zacks Investment Research

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Based on positive data from the phase II study, Sanofi plans to begin pivotal late-stage studies on frexalimab in multiple sclerosis in early 2024.

Though the multiple sclerosis market is crowded, there is a constant need for new medicines with unique mechanisms, which can provide a sustainable control of disease activity and slow or halt disability while reducing risks. Sanofi claims frexalimab has a unique mechanism of action as it blocks the CD40/CD40L costimulatory pathway to control MS disease activity without lymphocyte depletion.

Sanofi has a strong portfolio of multiple sclerosis medicines. However, sales of its key drug, Aubagio, approved for relapsing-remitting multiple sclerosis, are expected to decline as generics were launched in the United States in March 2023. In Europe, generics are expected to be launched in the fourth quarter.

Zacks Rank

Sanofi currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Some other top-ranked stocks are Novartis NVS, Allogene Therapeutics ALLO and Roche RHHBY all with a Zacks Rank of 2.

The Zacks Consensus Estimate for Novartis’ 2023 EPS has risen from $6.56 per share to $6.67 while that for 2024 has jumped from $7.05 per share to $7.22 over the past 60 days. This Swiss drugmaker’s stock has risen 6.4% this year so far.

Novartis beat earnings expectations in each of the trailing four quarters. The company delivered a four-quarter earnings surprise of 5.15%, on average.

Loss per share estimates for Allogene have narrowed from $2.45 to $2.31 for 2023 and from $2.48 per share to $2.21 per share for 2024 in the past 60 days.

Shares of ALLO have plunged 17.5% this year so far. Allogene’s earnings beat estimates in three of the last four quarters, the average surprise being 5.08%.

The Zacks Consensus Estimate for Roche’s 2023 EPS has risen from $2.61 per share to $2.67 while that for 2024 has jumped from $2.83 per share to $2.89 over the past 60 days. RHHBY stock has risen 1.8% this year so far.

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