- Sanofi-Regeneron stocks are trading higher today after their blockbuster drug aced the pivotal COPD trial.
- Sanofi SA (NASDAQ:SNY) and Regeneron Pharmaceuticals Inc’s (NASDAQ:REGN) Phase 3 trial of Dupixent (dupilumab) for uncontrolled chronic obstructive pulmonary disease (COPD) met its primary and secondary endpoints.
- Dupixent exhibited a 30% reduction in moderate or severe acute exacerbations compared to the placebo.
- The Phase 3 trial involving 939 current or former smokers also showed improvements in lung function, quality of life, and COPD respiratory symptoms.
- Overall rates of adverse events in the trial reporting results were 77% for Dupixent and 76% for placebo.
- Sanofi’s “bold” decision to go without earlier-stage clinical COPD trials had shaved years off the development time, Reuters reported.
- “We see Dupixent data in COPD exceeding any expectations in the market for benefit,” the JP Morgan analyst said in a Reuters report.
- Jefferies analysts said the update yielded “perhaps best case efficacy” to treat the disease.
- The drug could be the first new COPD treatment in over a decade.
- The companies said full efficacy and safety results would be presented in a future scientific forum.
- The companies said a second, replicate Phase 3 trial of Dupixent in COPD (NOTUS) is ongoing, with data expected in 2024.
- The broader Sanofi and Regeneron COPD clinical research program includes Phase 3 trials with itepekimab.
- Itepekimab received FDA Fast Track Designation in January 2023 for COPD in patients who do not currently smoke. Data from this program is expected in 2025.
- Price Action: SNY shares are up 6.46% at $51.94, and REGN stock is up 6.48% at $800.00 during the premarket session on the last check Thursday.
U.S. FDA Broadens Indication For Verzenio In HR+, HER2-, Node-Positive, High Risk Early Breast Cancer
High risk patients eligible for Verzenio can now be identified solely based on nodal status, tumor size, and tumor grade, regardless of Ki-67 score
Approval supported by four-year data
