Regeneron (NASDAQ:REGN) and Sanofi (NASDAQ:SNY) 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:NOVN) 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 InvestingPro website.
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