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Regeneron and Sanofi advance Dupixent program after FDA seeks more efficacy data

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Regeneron (NASDAQ:) and Sanofi (NASDAQ:) are making headway with the LIBERTY-CUPID program, including Study C, following the FDA’s request for additional efficacy data for Dupixent’s sBLA for Chronic Spontaneous Urticaria (CSU), a malady affecting patients resistant to antihistamines. The FDA had previously rejected their initial application via a Complete Response Letter (CRL), asking for more effectiveness data while not identifying any manufacturing or safety issues.

Dupixent, an IL-4 and IL-13 pathway inhibitor, has demonstrated significant benefits in phase 3 trials and is approved for a variety of diseases driven by type 2 inflammation, such as atopic dermatitis and CRSwNP. The drug has been developed under a global collaboration between Regeneron, a leading biotech company, and Sanofi, and has been approved in over 60 countries, treating more than 750,000 patients worldwide. According to InvestingPro Tips, Regeneron is a prominent player in the Biotechnology industry and operates with a high return on assets, while Sanofi is a prominent player in the Pharmaceuticals industry, consistently increasing its earnings per share.

The LIBERTY-CUPID C trial is currently underway with results anticipated by the end of next year. The earlier LIBERTY-CUPID A study achieved its objectives, but the LIBERTY-CUPID B program was discontinued due to inadequate symptom reduction despite numerical improvements.

The drug has already generated $5.3 billion in sales for Regeneron and Sanofi during the first half of this year. As competition heats up in the market for CSU treatment, Novartis (SIX:) and Roche are preparing their TK inhibitor remibrutinib for approval following two successful phase 3 trials. Sanofi suggests there is room for another biologic in the market as only a small fraction of eligible patients were using Xolair, which was approved for CSU in 2014 and made $4 billion in sales last year.

InvestingPro Data indicates that Regeneron has a market cap of 85.66B USD and a P/E Ratio of 19.87, while Sanofi’s market cap is substantially higher at 130960.0M USD with a lower P/E Ratio of 14.27. Both companies have demonstrated growth, but Sanofi has the edge with a revenue growth of 9.53% compared to Regeneron’s -10.94%. Furthermore, Sanofi has been able to maintain dividend payments for 24 consecutive years, providing an added incentive for investors. For more tips and insights, visit the website.

This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.

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