TD Cowen analyst Tyler Van Buren notes that Regeneron (REGN) and Sanofi (SNY) announced that the FDA issued a Complete Response Letter, or CRL, for Dupixent’s sBLA in chronic spontaneous urticaria, or CSU, ahead of the October 22 PDUFA date, which the analyst calls “unfortunate, but not terribly surprising” given that one of the two studies used to support the filing did not succeed. The firm sees a path forward, however, as the ongoing Study C, which is similar to the successful Study A, will have to be used to support refiling of the application, assuming the topline data in Q4 of 2024 are successful. The firm, which thinks Dupixent should eventually be approved and used in CSU, has an Outperform rating and $885 price target on Regeneron shares.
Published first on TheFly – the ultimate source for real-time, market-moving breaking financial news. Try Now>>
See the top stocks recommended by analysts >>
Read More on REGN:
- Regeneron, Sanofi announce results from Phase 3 trial evaluating Dupixent
- Dupixent® (dupilumab) Phase 3 Results Show Sustained Efficacy for Up to One Year in Children 1 to 11 Years of Age with Eosinophilic Esophagitis (EoE)
- Regeneron presents secondary endpoints for PD-1 inhibitor Libtayo regimen
- Libtayo® (cemiplimab) Neoadjuvant Treatment Demonstrates Encouraging Event-Free Survival in Patients with Resectable Cutaneous Squamous Cell Carcinoma (CSCC)
- Regeneron and Sanofi Provide Update on Dupixent® (dupilumab) sBLA for Chronic Spontaneous Urticaria