Sanofi NASDAQ:SNY Price, Chart, News & Insight

Regeneron and Sanofi Expand Immunology Alliance in Deal Worth Up to $8 Billion

Regeneron and Sanofi expanded their long-running immunology collaboration to include four next-generation, long-acting antibody programs targeting key pathways involved in type 2 inflammation.

The expanded alliance includes REGN20423, a long-acting IL-13 monoclonal antibody currently in Phase 1 development for atopic dermatitis, along with a long-acting IL-4xIL-13 bispecific antibody and two additional antibodies targeting IL-4 and IL-4Rα. The latter three programs are expected to enter clinical development in 2027.

Under the agreement, Regeneron will receive $1 billion upfront and could earn up to an additional $7 billion in development, regulatory and commercial milestone payments. The companies will share development and commercialization costs and split future global profits 50:50.

Regeneron will lead research and development, while Sanofi will lead global commercialization. The existing profit-sharing arrangement for Dupixent will remain unchanged.

The companies said the expanded collaboration builds on more than two decades of joint work that helped establish Dupixent as a major treatment across multiple type 2 inflammatory diseases, with more than 1.5 million active patients worldwide.

The deal strengthens both companies’ immunology pipelines and gives them a broader set of long-acting therapies that could potentially extend beyond Dupixent into the next generation of treatments for inflammatory diseases.

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WS Investor 10-01-26

Sanofi Stock Falls Despite Strong Q2 Growth and Higher 2026 Guidance

Sanofi (NASDAQ: SNY) shares fell 6.7% on Thursday despite reporting another strong quarter of double-digit sales and earnings growth while upgrading its full-year 2026 outlook. Investors appeared to focus on strategic pipeline changes and the sharp decline in IFRS earnings caused by one-off items.

Second-quarter net sales increased 17.8% at constant exchange rates (CER) to €11.6 billion, while business EPS rose 33.3% at CER to €2.09. Business operating income climbed 35.8% at CER, supported by strong commercial execution and disciplined cost management. However, IFRS EPS fell sharply to €0.29 due to non-recurring items.

Dupixent and New Launches Fuel Growth

Sanofi's growth continued to be led by its pharmaceutical business. Dupixent generated €5.2 billion in quarterly sales, increasing 37.6% year over year and surpassing the €5 billion quarterly mark for the first time.

The company's recently launched medicines also continued to gain momentum, with launch-product sales rising 48.3% to €1.3 billion, driven primarily by Ayvakit, ALTUVIIIO and Sarclisa. While vaccine sales declined 4.7% because of a difficult comparison in influenza vaccines, the strength of the broader pharmaceutical portfolio more than offset the weakness.

Pipeline Progress and Higher Outlook

Sanofi reported seven regulatory approvals and two positive Phase 3 trial readouts during the quarter while also accepting several regulatory submissions. At the same time, management discontinued the development of amlitelimab for global regulatory submission, itepekimab and balinatunfib as part of a broader pipeline prioritization strategy.

Reflecting the strong first-half performance, the company upgraded its 2026 outlook and now expects sales to grow around 10% at constant exchange rates, with business EPS projected to increase slightly faster than revenue. Sanofi also completed its €1 billion share buyback program during the quarter.

What to Watch

Despite the stronger guidance, investors appeared concerned about the company's strategic pipeline restructuring and normalization of growth expected in the second half of the year. Going forward, markets will closely monitor continued Dupixent expansion, the commercial performance of Sanofi's recent product launches and progress in strengthening its late-stage pipeline while delivering sustainable earnings growth.

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WS Investor 07-30-26

Sanofi’s experimental drug Cenrifki (tolebrutinib) has been recommended for approval in the European Union by the European Medicines Agency’s CHMP for treating secondary progressive multiple sclerosis (SPMS) without relapses. A final regulatory decision is expected in the coming months.

The recommendation is based on phase 3 trial results showing the drug significantly delayed disability progression in patients, addressing a major unmet need in MS treatment. Cenrifki targets underlying neuroinflammation, a key driver of disease progression.

Sanofi highlighted that the therapy could potentially transform care for patients with limited treatment options, while noting safety considerations including infection risks and liver-related side effects requiring monitoring.

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The Investor 04-26-26

Sanofi announced that the U.S. Food and Drug Administration has approved an expanded use of Tzield to delay the onset of stage 3 type 1 diabetes in children as young as one year old with stage 2 disease.

The approval extends the previous indication, which covered patients aged eight and older, and is based on data from the Phase 4 PETITE-T1D study. Tzield is the first disease-modifying therapy for type 1 diabetes in this young patient group, targeting the autoimmune process early to slow disease progression.

The decision marks a significant advancement in early intervention for type 1 diabetes, particularly for high-risk children, where delaying the need for insulin therapy could have meaningful clinical and quality-of-life benefits.

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The Investor 04-22-26

Sanofi announced that the U.S. Food and Drug Administration has extended the review period for its subcutaneous formulation of Sarclisa by up to three months, setting a new target decision date of July 23, 2026.

The application covers the use of Sarclisa SC in combination with standard treatments for multiple myeloma across all currently approved indications of its intravenous version. If approved, the therapy would become the first anticancer treatment delivered via an on-body injector, potentially improving patient convenience and administration efficiency.

Meanwhile, the European Medicines Agency has already issued a positive opinion for the subcutaneous version, with a final decision in the European Union expected in the coming months.

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The Investor 04-22-26

Sanofi announced that its protein-based COVID-19 vaccine Nuvaxovid demonstrated significantly better tolerability than Moderna’s mNEXSPIKE in a head-to-head Phase 4 study. The randomized trial, involving 1,000 adults in the United States, showed lower rates and severity of side effects for Nuvaxovid across all key endpoints.

Results presented at the ESCMID Global Congress indicated that severe systemic reactions were more than 50% less frequent with Nuvaxovid, while moderate-to-severe symptoms were also notably lower compared to the mRNA-based comparator. Participants receiving Nuvaxovid reported less disruption to daily activities and a higher willingness to choose the same vaccine again.

The findings suggest that improved tolerability could help address vaccine hesitancy and support broader uptake of routine COVID-19 vaccination as the disease transitions to an endemic phase.

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The Investor 04-19-26

Sanofi and Regeneron Pharmaceuticals announced that the European Commission has approved Dupixent (dupilumab) for treating children aged 2 to 11 with chronic spontaneous urticaria (CSU), marking the first targeted therapy for this age group in the EU.

The approval expands Dupixent’s indication beyond adults and adolescents, offering a new option for young patients whose condition remains uncontrolled with standard antihistamine treatments. CSU is a chronic inflammatory skin disease characterized by severe itching and recurrent hives, significantly affecting quality of life.

The decision is based on results from the LIBERTY-CUPID clinical program, which showed that Dupixent significantly reduced disease activity compared with placebo and improved symptom control. Safety outcomes were consistent with the drug’s established profile across other indications.

With this latest authorization, Dupixent is now approved in the EU for children under 12 across multiple diseases linked to type 2 inflammation, further strengthening its position as a leading biologic therapy in immunology.

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Global Finance News 04-13-26

Sanofi S.A. announced positive Phase 2 results for its experimental drug lunsekimig in respiratory diseases, meeting primary and key secondary endpoints in studies on asthma and chronic rhinosinusitis with nasal polyps (CRSwNP).

The AIRCULES study showed significant reductions in asthma exacerbations and improvements in lung function, while the DUET study demonstrated meaningful improvements in nasal polyp scores and patient symptoms. The drug was generally well tolerated across trials.

However, a separate Phase 2 study in atopic dermatitis did not meet its primary endpoint, although some secondary measures showed improvement.

Sanofi said the results support lunsekimig’s potential as a novel treatment targeting multiple inflammatory pathways, with further development ongoing in late-stage trials.

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The Investor 04-07-26

Sanofi announced that the European Commission has granted conditional approval for its drug Rezurock (belumosudil) to treat chronic graft-versus-host disease (GVHD) in patients aged 12 and older.

The treatment is intended for patients with limited options after previous therapies have failed, addressing a serious and potentially life-threatening condition following stem cell transplantation.

The approval is based on clinical studies, including the ROCKstar trial, which demonstrated a strong response rate and durable benefits, with the therapy generally well tolerated.

Rezurock is already approved in multiple markets, including the U.S., UK, and Canada, and the EU authorization is conditional on further confirmatory studies, reflecting ongoing clinical evaluation.

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The Investor 03-31-26

Sanofi announced that its cancer therapy Sarclisa in a subcutaneous formulation has received a positive recommendation from the European Medicines Agency’s CHMP for the treatment of multiple myeloma.

The recommendation is based on clinical data showing comparable efficacy, safety, and pharmacokinetics between the new subcutaneous version and the existing intravenous formulation. If approved, Sarclisa would become the first anticancer treatment delivered via an on-body injector in the EU, offering greater flexibility and convenience for patients and healthcare providers.

Studies also indicated higher patient and provider preference for the subcutaneous administration method, which uses a wearable injector designed to improve comfort and simplify treatment delivery.

A final regulatory decision is expected in the coming months, with the new formulation potentially expanding treatment options for patients with multiple myeloma across Europe.

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Global Finance News 03-27-26

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