- 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.
Genprex Inc. Receives Orphan Drug Designation For Immunogene Therapy For Treatment Of SCLC
Globe Newswire
NEW YORK, Sept. 21, 2023 (GLOBE NEWSWIRE) -- via InvestorWire — Genprex Inc. (NASDAQ:GNPX) today announces its placement in an editorial published
