Regeneron Gains As New Data Favors Higher Dose Of Flagship Eye Disease Drug

  • Regeneron Pharmaceuticals Inc's REGN two pivotal trials evaluating aflibercept 8 mg with 12- and 16-week dosing regimens met the primary endpoints in diabetic macular edema (DME) and wet age-related macular degeneration (wAMD). 
  • The PHOTON trial in DME and the PULSAR trial in wAMD achieved non-inferiority in vision gains compared to the currently-approved 2 mg Eylea 8-week dosing regimen. 
  • Also Read: Regeneron's Price Target Cut On Dim Prospects For Its Flagship Eye Product.
  • 91% and 89% of DME patients were rapidly initiated and maintained on 12- and 16-week dosing intervals (without the need for regimen modification) through week 48, respectively.
  • 79% and 77% of wAMD patients were rapidly initiated and maintained on 12- and 16-week dosing intervals.
  • The safety of aflibercept 8 mg was similar to Eylea and consistent with the well-established safety profile of Eylea from previous clinical trials.
  • Aflibercept 8 mg is being jointly developed by Regeneron and Bayer AG BAYRY. In the U.S., Regeneron maintains exclusive rights to Eylea and aflibercept 8 mg. Bayer has licensed the exclusive marketing rights outside of the U.S., where the companies share equally the profits from sales of Eylea.
  • Price Action: REGN shares traded higher by 13.30% at $675.77 on the last check Thursday.
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