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Wednesday, 25 December 2024


Regeneron Achieves Breakthroughs in Multiple Therapeutic Areas, Strengthening Leadership in Biotech Innovation

02 September 2024 | Analysis

Dupixent® Expands Across New Indications, Oncology Therapies Gain Ground, and Strategic Collaborations Propel Regeneron’s Growth in H1 2024

With significant achievements across various therapeutic areas. The company’s progress included robust clinical results, critical regulatory approvals, and strategic partnerships that underscore its commitment to advancing innovative treatments for complex diseases.

Dupixent® (dupilumab) Expands Its Impact Across Multiple Indications
A standout performer in Regeneron’s portfolio, Dupixent® (dupilumab), continued to demonstrate its versatility and efficacy in multiple therapeutic areas. In June 2024, Dupixent showed promising Phase 3 results in treating eosinophilic esophagitis (EoE) in children aged 1 to 11, achieving histologic remission in a majority of patients. This success adds to Dupixent’s growing reputation as a critical treatment in pediatric care.

The momentum for Dupixent didn’t stop there. The drug was recommended for European approval for chronic obstructive pulmonary disease (COPD), a significant milestone that could reshape COPD treatment standards in the region. Additionally, the FDA accepted a supplemental Biologics License Application (sBLA) for Dupixent to treat chronic rhinosinusitis with nasal polyposis (CRSwNP) in adolescents, granting it priority review status. With another priority review underway for COPD, Dupixent is poised to make a profound impact on respiratory care, especially as late-breaking data from the NOTUS Phase 3 trial reinforced its efficacy in reducing COPD exacerbations and improving lung function.

Oncology Breakthroughs and Strategic Collaborations
Regeneron also made critical strides in oncology, a therapeutic area that continues to be a focal point of its research efforts. Odronextamab, a novel treatment for relapsed/refractory follicular lymphoma and diffuse large B-cell lymphoma, received a positive opinion from the European Medicines Agency’s CHMP in June 2024. Despite the FDA issuing Complete Response Letters earlier in the year requesting the completion of confirmatory trials, the positive EMA opinion positions Odronextamab as a promising candidate for future cancer therapies.

Meanwhile, Linvoseltamab continued to show deepening responses in heavily pre-treated multiple myeloma patients, achieving a 71% overall response rate as of June 2024. This significant efficacy underscores the drug’s potential as a breakthrough therapy, with both the FDA and EMA currently reviewing it under priority status.

In addition to its oncology advancements, Regeneron expanded its gene editing capabilities through a strategic collaboration with Mammoth Biosciences. This partnership aims to leverage in vivo CRISPR-based therapies to develop treatments for a range of diseases beyond liver tissues, marking a forward-thinking move into next-generation genetic medicine.

Financial Performance and Strategic Investments
Regeneron’s financial performance in the first half of 2024 reflected both challenges and opportunities. The company reported a slight decline in total revenues for Q1, primarily due to decreased sales of Ronapreve. However, when excluding Ronapreve, revenues grew by 7%, driven by strong performances from Dupixent and EYLEA®. This growth reaffirms the resilience and potential of Regeneron’s core products.

Signaling confidence in its future, Regeneron authorized a new $3 billion share repurchase program in April 2024. This move demonstrates the company’s commitment to returning value to shareholders while maintaining a strong financial foundation for continued investment in research and development.


The first half of 2024 was a period of strategic growth and clinical success for Regeneron Pharmaceuticals. With key regulatory milestones achieved and a strong pipeline of innovative therapies, the company is well-positioned to continue its momentum into the second half of the year. As Regeneron advances its drug pipeline and expands its research collaborations, it remains at the forefront of biotechnology, dedicated to delivering transformative therapies to patients worldwide.

 

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