Sanofi & Regeneron's Dupixent Gets FDA Nod for Bullous Pemphigoid

Sanofi SNY and its partner, Regeneron REGN, announced that the FDA has approved their blockbuster medicine, Dupixent (dupilumab), for the treatment of adult patients with bullous pemphigoid (BP), a rare skin disease.

Following the latest FDA nod, Dupixent became the first and only targeted therapy to be approved for BP in the United States. The drug is now approved for eight type II inflammatory diseases in the United States.

BP is a chronic and relapsing skin disease that causes pain and affects around 27,000 adults in the United States, whose condition doesn’t improve with steroid treatment.

Dupixent is already approved in several countries, including the United States and the European Union, for treating severe chronic rhinosinusitis with nasal polyposis, severe asthma, moderate-to-severe atopic dermatitis, eosinophilic esophagitis, prurigo nodularis and chronic obstructive pulmonary disease.

Dupixent was approved for its seventh indication, chronic spontaneous urticaria, in the United States in April 2025.

Year to date, shares of Sanofi have lost 1.2% compared with the industry’s decline of 1.7%.

Continuous Label Expansion of Dupixent Bodes Well for SNY & REGN

The latest FDA approval was based on data from the pivotal phase II/III ADEPT study, which evaluated the safety and efficacy of Dupixent versus placebo in adults with moderate-to-severe BP.

Data from the same showed that treatment with Dupixent led to significant improvements in sustained disease remission while reducing itch and oral corticosteroid use compared to placebo in the given patient population.

The latest approval reinforces Dupixent’s ability as a key therapeutic option in the management of multiple conditions driven by type II inflammation, highlighting its clinical utility and potential to shift standard-of-care practices.

Regulatory applications seeking approval for Dupixent in BP are currently under review in the European Union, Japan and China.

Dupixent – Key Top-Line Driver for SNY & REGN

Dupixent is being jointly marketed by Sanofi and Regeneron under a global collaboration agreement. Sanofi records global net product sales of Dupixent, while Regeneron records its share of profits or losses in connection with the global sales of the drug.

In the first quarter of 2025, Dupixent generated global product sales of €3.48 billion, which were recorded by Sanofi, representing growth of 20.3% at a constant exchange rate. Sanofi expects Dupixent to achieve around €22 billion in sales in 2030.

Regeneron recorded collaboration revenues of $1.18 billion from Sanofi during the first quarter of 2025, up 30% year over year.

SNY's Zacks Rank & Stocks to Consider

Sanofi currently carries a Zacks Rank #3 (Hold).

Some better-ranked stocks in the biotech sector are Exelixis EXEL and Amarin Corporation AMRN, each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

In the past 60 days, estimates for Exelixis’ earnings per share have increased from $2.31 to $2.61 for 2025. During the same time, earnings per share estimates for 2026 have increased from $2.83 to $3.03. Year to date, shares of EXEL have increased 22.4%.

EXEL’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 48.60%.

In the past 60 days, estimates for Amarin’s loss per share have narrowed from $5.00 to $2.50 for 2025. During the same time, loss per share estimates for 2026 have narrowed from $3.87 to $1.78. Year to date, shares of AMRN have surged 37.4%.

AMRN’s earnings beat estimates in two of the trailing four quarters, met the same once and missed the same on the remaining occasion, the average surprise being 29.11%.

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This article originally published on Zacks Investment Research (zacks.com).

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