Sanofi (SNY) Skin Disorder Drug Misses Goal in Phase III Study


Sanofi (SNY Quick QuoteSNY ) announced that a phase III study evaluating its BTK inhibitor, rilzabrutinib, to treat pemphigus, a rare skin disorder that causes lesions in the skin and mucous membranes, failed to meet its primary or key secondary endpoints.

Data from the study (PEGASUS) showed that the proportion of patients meeting the primary endpoint (complete remission from weeks 29 to 37 with minimal doses of corticosteroids) in the rilzabrutinib arm was not significantly different from placebo. In the study, rilzabrutinib’s safety profile was similar to the previous study results. At present, systemic corticosteroid is the standard-of-care treatment for this potentially life-threatening disorder.

So far this year, Sanofi’s shares have risen 3.2% compared with the industry’s 14.1% increase.

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Rilzabrutinib was added to Sanofi’s pipeline with last year’s acquisition of Principia Biopharma and is being developed for some immune-mediated diseases.

A phase III study is also ongoing on rilzabrutinib for immune thrombocytopenia (ITP), a blood disorder that causes a high risk of bleeding events. The candidate is also in a phase II study for IgG4-Related Disease (IgG4-RD), a rheumatologic disease driven by chronic inflammation, immune cell infiltration, and fibrosis within organs. Sanofi plans to begin phase II studies in asthma, atopic dermatitis, chronic spontaneous urticaria, and warm autoimmune hemolytic anemia later this year.

The Principia deal also added another BTK inhibitor, tolebrutinib to Sanofi’s pipeline, which isin late-stage development for relapsing multiple sclerosis.

Sanofi has significantly stepped up its acquisition and alliance activity over the past few years. On Wednesday, Sep 7, it announced a definitive agreement to acquire New York-based biopharma company, Kadmon Holdings (KDMN Quick QuoteKDMN ) for $1.9 billion. The acquisition, if successfully closed, will add Rezurock (belumosudil), Kadmon’s newly FDA-approved treatment for chronic graft-versus-host disease (cGVHD), to Sanofi’s portfolio.

In August, Sanofi announced a definitive agreement to acquire its current partner for some pipeline candidates, Translate Bio (TBIO Quick QuoteTBIO ) for approximately $3.2 billion. The acquisition, if successfully closed, will allow Sanofi to leverage Translate Bio’s mRNA technology platform to develop therapeutics and vaccines and also accelerate the development of their existing partnered pipeline programs

Sanofi currently has a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

A better-ranked stock from the biotech sector is Regeneron (REGN Quick QuoteREGN ) , which sports a Zacks Rank #1.

Regeneron’s earnings per share estimates have moved north from $49.53 to $54.15 for 2021 and from $41.35 to $44.11 for 2022 in the past 30 days. The stock has risen 38.5% so far this year.

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