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

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

新數據支持更高劑量的眼科旗艦藥物,Regeneron收益
Benzinga Real-time News ·  2022/09/08 10:13
  • Regeneron Pharmaceuticals Inc's (NASDAQ: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 (OTC: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.
  • Regeneron製藥公司的納斯達克代碼:REGN)兩項評估afLibercept 8毫克、12周和16周給藥方案的關鍵試驗達到了治療糖尿病黃斑水腫和濕性年齡相關性黃斑變性的主要終點。
  • 與目前批准的2 mg Eylea 8周給藥方案相比,在DME進行的光子試驗和在wAMD進行的脈衝星試驗在視力改善方面取得了不遜色的效果。
  • 另請閲讀: Regeneron下調其旗艦眼科產品前景黯淡的目標價格.
  • 分別有91%和89%的DME患者在12周和16周的給藥間隔(不需要修改方案)中快速啟動和維持到48周。
  • 79%和77%的wAMD患者分別在12周和16周的給藥間隔內快速啟動和維持。
  • AfLibercept 8 mg的安全性與Eylea相似,與Eylea在以前的臨牀試驗中公認的安全性一致。
  • AfLibercept 8 mg由Regeneron和拜耳股份公司(場外交易:BAYRY)。在美國,Regeneron保留了Eylea和afLibercept 8 mg的獨家權利。拜耳已經授權了在美國以外的獨家營銷權,在美國,兩家公司平均分享Eylea的銷售利潤。
  • 價格行動:在週四的最後一次檢查中,雷根的股價上漲了13.30%,達到675.77美元。
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