BUZZ-Disc Medicine drops on report of FDA skepticism over rare blood disorder drug

Reuters
2025/12/20
BUZZ-<a href="https://laohu8.com/S/IRON">Disc Medicine</a> drops on report of FDA skepticism over rare blood disorder drug

** Shares of drug developer Disc Medicine IRON.O fall 13% to $78.86

** FDA official Vinay Prasad is questioning the effectiveness of Disc Medicine's experimental drug, bitopertin, for treating a rare blood disorder, brokerage Truist Securities said in a note, quoting a report in STAT News

** IRON's bitopertin for porphyria is one of the nine products under FDA Commissioner's National Priority Voucher program announced in October

** Truist says "we note that Prasad does not oversee the FDA Division that would typically conduct the filing review, however, he is part of the committee that chooses which products to award the CNPV vouchers"

** Vinay Prasad was recently appointed as director at FDA's Center for Biologics Evaluation and Research

** Brokerage adds that the IRON stock "is trading as if accelerated approval is no longer viable"; however, the existing data still supports a pathway for accelerated approval

** "Even if the CNPV committee ultimately declines to grant approval by the end of January 2026, we think a traditional accelerated approval should still remain an option, implying a modest shift in launch timing to the late May - September window" Truist adds

** Including session's move, stock up ~28% YTD

(Reporting by Sahil Pandey and Siddhi Mahatole in Bengaluru)

((Sahil.Pandey@thomsonreuters.com))

应版权方要求,你需要登录查看该内容

免责声明:投资有风险,本文并非投资建议,以上内容不应被视为任何金融产品的购买或出售要约、建议或邀请,作者或其他用户的任何相关讨论、评论或帖子也不应被视为此类内容。本文仅供一般参考,不考虑您的个人投资目标、财务状况或需求。TTM对信息的准确性和完整性不承担任何责任或保证,投资者应自行研究并在投资前寻求专业建议。

热议股票

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