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Regeneron Pharmaceuticals (NASDAQ:REGN) shares witnessed a notable 19% decline on Friday, May 30, in the wake of the unexpected failure of itepekimab, its chronic obstructive pulmonary disease (COPD) treatment in conjunction with Sanofi, during a late-stage clinical trial. One of the two trials did not achieve its primary endpoint, which is a significant setback considering that itepekimab was anticipated to become a blockbuster drug, with peak sales projections from Sanofi estimated between $2 billion and $6 billion.
Its dermatitis drug could win at least 10% of annual sales in dermatitis by 2030—or about $3 billion.
Regeneron Pharmaceuticals said on Monday its experimental weight-loss drug combination helped preserve muscle mass in a mid-stage study.
New licensing agreement with Hansoh Pharma provides Regeneron with HS-20094, a GLP-1/GIP receptor agonist in advanced stages of clinical development in China
Libtayo demonstrated a 68% reduction in the risk of disease recurrence or death, the primary endpoint of the trial (p
Major U.S. equities indexes were mixed in the final session of the holiday-shortened trading week as President Donald Trump reverted to an antagonistic tone on trade with China and the latest Personal Consumption Expenditures data showed that inflation fell more than expected in April.
Regeneron's stock is having its worst day in 14 years after the failure of late-stage trial of its COPD treatment, after analysts had just placed a high probability of a positive result.
Itepekimab's inconsistent phase 3 results represent a setback for Regeneron Pharmaceuticals and Sanofi. The results do not support regulatory submissions and a 3-4 year approval delay, and lower peak sales potential looks like a best-case scenario for itepekimab. Regeneron faces a greater impact, as it is losing an important growth driver in the second half of the decade.
U.S. equities were lower at midday as the market focused on the future of U.S.-China trade. The Dow Jones Industrial Average, S&P 500, and Nasdaq all lost ground.
Shares of Regeneron Pharmaceuticals Inc (NASDAQ:REGN) sank nearly 19% on Friday after the company's experimental COPD drug, developed with partner Sanofi SA (ADR) (NYSE:SNY), posted mixed results in two Phase 3 trials—casting doubt on its regulatory path and delaying hopes for a major new revenue stream. The drug, itepekimab, reduced moderate or severe flare-ups by 27% compared to placebo over 52 weeks in the AERIFY-1 study, which enrolled 1,127 former smokers with chronic obstructive pulmonary disease (COPD).