NASDAQ:REGN

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.
Regeneron Stock Rises After Strong Q2 Results and Improved 2026 Outlook

Regeneron Pharmaceuticals (NASDAQ: REGN) shares rose 1% after the biotechnology company reported strong second-quarter results, driven by continued growth from Dupixent, EYLEA HD and Libtayo, while updating its full-year financial guidance.

Second-quarter revenue increased 17% year over year to $4.3 billion, while non-GAAP earnings per share rose 11% to $14.29. Although GAAP EPS declined to $12.23 due to acquired in-process research and development (IPR&D) charges, the company's underlying operating performance remained strong.

Flagship Medicines Continue to Deliver

Regeneron's commercial portfolio continued to post robust growth during the quarter. Global Dupixent sales, recorded by partner Sanofi, climbed 38% to a record $6.0 billion, while U.S. sales of EYLEA HD surged 52% to a record $596 million. Global Libtayo sales also reached a new high, increasing 30% to $489 million. Higher Dupixent sales lifted collaboration revenue from Sanofi by 51%, helping drive overall revenue growth.

The company also announced that the Sanofi Development Balance was fully repaid by the end of the second quarter, a milestone expected to increase collaboration profits beginning in the third quarter.

Pipeline Advances and Guidance Update

Regeneron reported multiple regulatory and clinical milestones during the quarter, including accepted FDA and EMA submissions for cemdisiran in generalized myasthenia gravis and several approvals and label expansions across its portfolio. Management also updated its 2026 financial guidance, including higher expected gross margins and lower projected SG&A and capital expenditures, reflecting confidence in the business outlook.

What to Watch

The modest share gain reflects investor confidence in Regeneron's expanding commercial portfolio and improving profitability. Going forward, investors will monitor continued adoption of EYLEA HD, sustained Dupixent growth, upcoming regulatory decisions for cemdisiran and the anticipated increase in collaboration profits following the repayment of the Sanofi Development Balance.
Regeneron Pharmaceuticals reported strong first-quarter 2026 results, driven by robust product growth and continued pipeline expansion.

Revenue increased 19% year-over-year to $3.6 billion, reflecting solid demand across key therapies. Non-GAAP EPS reached $9.47, while GAAP EPS was $6.75, impacted by charges related to in-process R&D.

Growth was supported by Dupixent, whose global sales (reported by partner Sanofi) surged 33% to $4.9 billion. Meanwhile, EYLEA HD U.S. sales jumped 52% to $468 million, although combined EYLEA franchise sales declined 10%, reflecting product transition dynamics.

On the regulatory front, the company secured multiple approvals, including expanded indications for Dupixent and the approval of Otarmeni, a first-in-class gene therapy for genetic hearing loss.

Regeneron also announced a new $3 billion share buyback program, underscoring confidence in its long-term growth outlook.

Source: GlobeNewswire
Regeneron Pharmaceuticals announced an agreement with the U.S. government to lower drug costs and expand access to treatments, including providing its newly approved gene therapy Otarmeni for free in the United States. The therapy targets a rare genetic form of hearing loss and marks a significant step in improving patient access to advanced medicines.

Under the agreement, the company will align U.S. drug prices with those in other developed countries and reduce Medicaid pricing accordingly. It will also enable direct patient purchases of its cardiovascular drug Praluent through a government platform.

Regeneron said the initiative supports broader affordability while maintaining investment in domestic research, development, and manufacturing.

Source: GlobeNewswire
Regeneron reported positive Phase 3 results for its investigational therapy cemdisiran in patients with generalized myasthenia gravis (gMG), demonstrating rapid, deep, and sustained disease control. The NIMBLE trial met both its primary and key secondary endpoints at 24 weeks, showing significant improvements in daily functioning and muscle strength compared to placebo.

Patients receiving cemdisiran experienced clinically meaningful benefits within two weeks, with effects sustained throughout the study period. The therapy, administered subcutaneously every 12 weeks, also offers a reduced treatment burden compared to existing options.

The safety profile was generally consistent, with most adverse events mild to moderate and no new major safety concerns identified.

Regeneron has already submitted a U.S. regulatory application and plans additional filings in other regions, positioning cemdisiran as a potential first siRNA-based treatment for gMG.
Globe Newswire
Regeneron Pharmaceuticals and Telix Pharmaceuticals have entered into a strategic collaboration to develop and commercialize next-generation radiopharmaceutical therapies for cancer.

The partnership combines Regeneron’s antibody discovery and oncology expertise with Telix’s radiopharmaceutical development and manufacturing capabilities, targeting multiple solid tumor indications. The companies will jointly fund development and share profits under a 50/50 model, while also working on diagnostic tools to support patient selection and treatment monitoring.

Under the agreement, Telix will receive an upfront payment of $40 million, with potential additional milestone payments of up to $2.1 billion depending on development and commercialization outcomes.

The collaboration reflects growing industry interest in targeted radiopharmaceuticals as a promising approach in precision oncology, particularly for hard-to-treat cancers.
Globe Newswire
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.
Regeneron Pharmaceuticals announced a strategic collaboration with TriNetX to access de-identified electronic health records from approximately 300 million patients worldwide.

The partnership will allow Regeneron to integrate TriNetX’s large-scale clinical data with its own genomic and proteomic datasets, significantly expanding its research database. The combined data is expected to accelerate drug discovery, improve clinical development, and support the training of AI-driven healthcare solutions.

As part of the agreement, Regeneron will invest up to $200 million in TriNetX, while ensuring compliance with global data privacy regulations such as HIPAA and GDPR.

The companies said the collaboration aims to advance precision medicine and enable new digital health innovations by leveraging one of the largest integrated health data ecosystems in the industry.
Globe Newswire
Sanofi and Regeneron announced that Japan has approved Dupixent (dupilumab) as the first targeted treatment for adults with moderate-to-severe bullous pemphigoid, a chronic inflammatory skin disease.

The approval is based on clinical trial data showing that patients receiving Dupixent were more than four times as likely to achieve sustained disease remission at 36 weeks compared with placebo (18% vs. 4%).

Dupixent, already approved in Japan for multiple inflammatory conditions, marks its seventh indication in the country, expanding its role in treating type 2 inflammatory diseases.
Regeneron announced positive Phase 3 results for the obesity treatment olatorepatide in a clinical trial conducted in China by Hansoh Pharmaceutical.

In the 48-week randomized, placebo-controlled study involving 604 adults with obesity or overweight, patients receiving once-weekly olatorepatide achieved up to 19% average body-weight loss, with as many as 97% of participants losing at least 5% of their body weight. The drug also showed favorable gastrointestinal tolerability, with relatively low rates of nausea and vomiting.

Olatorepatide is a dual GLP-1/GIP receptor agonist, and Regeneron holds development and commercialization rights outside Greater China. The company plans to launch a global Phase 3 registrational program later in 2026 as it advances the treatment in the competitive obesity-drug market.
Source: Global Newswire
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