Sanofi SNY and partner Regeneron REGN announced that the FDA approved Dupixent (dupilumab) for the treatment of chronic spontaneous urticaria (“CSU”) in adults and adolescents aged 12 years and above, who remain symptomatic despite histamine-1 (H1) antihistamine treatment.

Following the latest FDA nod, Dupixent became the first new targeted therapy to be approved for CSU in more than a decade. The drug is now approved for seven type II inflammatory diseases in the United States.

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.

CSU is an inflammatory skin condition, primarily occurring due to type 2 inflammation. This causes sudden and debilitating hives and swelling on the skin, which is mostly inadequately controlled by antihistamine treatment.

Year to date, shares of Sanofi have risen 5.6% against the industry’s decline of 3.3%.

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FDA Nod for Dupixent in CSU, a Big Win for SNY & REGN

The latest FDA approval for Dupixent was based on data from two phase III studies, which evaluated it as an add-on therapy to standard-of-care antihistamines compared with antihistamines alone in the given patient population.

Both studies met their primary and secondary endpoints, wherein treatment with Dupixent significantly reduced itch and hives versus placebo at 24 weeks. Treatment with Dupixent also increased the likelihood of well-controlled disease or complete response versus placebo at 24 weeks.

Another study, Study B, provided additional safety data on treatment with Dupixent.

Importantly, safety data from Study A, Study B and Study C was similar to the known safety profile of Dupixent in its approved indications.

Please note that the FDA issued a complete response letter to SNY and REGN’s first supplemental biologics license application (sBLA), seeking approval of Dupixent for CSU in October 2023, citing the need for more efficacy data.

In November 2024, the FDA accepted the companies’ resubmitted sBLA seeking approval of Dupixent for the treatment of CSU.

Dupixent is already approved for the CSU indication in Japan, while it is under review in the European Union.

Dupixent – Key Top-Line Driver for SNY & REGN

Dupixent is being jointly marketed by Regeneron and Sanofi 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 2024, Dupixent generated global product sales of €13.07 billion, which were recorded by Sanofi, representing growth of 23.1% at a constant exchange rate. Sanofi expects Dupixent to achieve around €22 billion in sales in 2030.

For Regeneron, Dupixent generated collaboration revenues of $4.53 billion in 2024, up 19% year over year.

An sBLA seeking approval of Dupixent for treating bullous pemphigoid (“BP”) is currently under priority review in the United States. A decision from the FDA is expected on June 20, 2025.

If approved for BP, Dupixent will become the first medicine approved for this chronic and relapsing skin disease in the United States.

SNY's Zacks Rank & Stocks to Consider

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

Some better-ranked stocks in the biotech sector are Jazz Pharmaceuticals, Inc. JAZZ and Krystal Biotech, Inc. KRYS, 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 Jazz Pharmaceuticals’ earnings per share have increased from $22.11 to $23.33 for 2025. During the same time, earnings per share estimates for 2026 have increased from $23.23 to $23.34. Year to date, shares of JAZZ have lost 16.5%.

JAZZ’s earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.20%.

In the past 60 days, estimates for Krystal Biotech’s earnings per share have increased from $5.52 to $7.00 for 2025. During the same time, earnings per share estimates for 2026 have increased from $9.15 to $10.84. Year to date, shares of KRYS have gained 7.6%.

KRYS’ earnings beat estimates in three of the trailing four quarters while missing the same on the remaining occasion, the average surprise being 3.29%.

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