Replimune Shares Take Flight Premarket After FDA Panel Backs RP1

Dow Jones
07/31
 
 

Shares of Replimune Group more than doubled in premarket trading Friday after a Food and Drug Administration advisory committee backed approval of the biotechnology company's proposed RP1 skin cancer drug.

Replimune shares, which fell 38% on Tuesday after briefing materials released ahead of the advisory committee's meeting shows the agency believes the company's data didn't show substantial evidence of the drug's effectiveness, were recently up about 128% premarket at $12.44.

The FDA panel vote marks the latest twist in the saga of Replimune's efforts to win FDA approval of RP1 in combination with Bristol Myers Squibb's blockbuster cancer drug Opdivo for advanced melanoma.

The FDA previously declined to approve Replimune's treatment in July last year and then again in April, but the agency then allowed a third submission in June and set a target action date of Aug. 2, just days after the advisory committee.

The FDA, which often turns to advisory committees to obtain advice from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective, usually follows the advice of the panels but isn't bound by the recommendations.

 
 

應版權方要求,你需要登入查看該內容

免責聲明:投資有風險,本文並非投資建議,以上內容不應被視為任何金融產品的購買或出售要約、建議或邀請,作者或其他用戶的任何相關討論、評論或帖子也不應被視為此類內容。本文僅供一般參考,不考慮您的個人投資目標、財務狀況或需求。TTM對信息的準確性和完整性不承擔任何責任或保證,投資者應自行研究並在投資前尋求專業建議。

熱議股票

  1. 1
     
     
     
     
  2. 2
     
     
     
     
  3. 3
     
     
     
     
  4. 4
     
     
     
     
  5. 5
     
     
     
     
  6. 6
     
     
     
     
  7. 7
     
     
     
     
  8. 8
     
     
     
     
  9. 9
     
     
     
     
  10. 10