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What's Going On With Cadrenal Therapeutics Stock Today

What's Going On With Cadrenal Therapeutics Stock Today

今天的 Cadrenal Therapeutics 股票怎么了
Benzinga Real-time News ·  2023/01/24 00:41
  • The FDA has granted a Fast Track designation to Cadrenal Therapeutics Inc's (NASDAQ:CVKD) tecarfarin for the prevention of systemic thromboembolism, more commonly referred to as blood clots, of cardiac origin in patients with end-stage renal disease (ESRD) and atrial fibrillation (AFib).
  • Fast Track is a process designed to facilitate the development and expediting of the review of drugs to treat serious conditions. Fast Track aims to get important new drugs to the patient earlier.
  • The FDA had previously granted an Orphan Drug Designation (ODD) for tecarfarin. The FDA grants orphan status to drugs targeting rare diseases or disorders that affect fewer than 200,000 people in the U.S.
  • The ODD program provides certain benefits and incentives, including seven years of U.S. marketing exclusivity, waiver of FDA user fees, and tax credits for clinical research.
  • Tecarfarin is a Vitamin K antagonist oral anticoagulant designed to target a different pathway than the most commonly prescribed drugs used to treat thrombosis and AFib. Tecarfarin has been evaluated in eleven human clinical trials and more than 1,000 individuals.
  • The stock went up by 44% today and has been volatile and given up gains since.
  • Price Action: CVKD shares are up 0.61% at $4.15 on the last check Monday.
  • 美国食品和药物管理局已授予快速通道称号 Cadenaral Therapeut (纳斯达克股票代码:CVKD)替卡法林用于预防终末期肾脏病(ESRD)和心房颤动(AFiB)患者心源性全身性血栓栓塞,通常称为血块。
  • Fast Track是一个旨在促进开发和加快治疗严重疾病的药物审查的过程。Fast Track旨在尽早为患者提供重要的新药。
  • 美国食品药品管理局此前曾为替卡法林授予孤儿药称号(ODD)。美国食品药品管理局向针对罕见疾病或影响少于20万人的疾病的药物授予孤儿地位。
  • ODD计划提供某些好处和激励措施,包括七年的美国市场独家经营权、FDA用户费减免以及临床研究的税收抵免。
  • Tecarfarin是一种维生素K拮抗剂口服抗凝剂,旨在靶向与用于治疗血栓形成和心房颤动的最常用处方药物不同的途径。Tecarfarin已在11项人体临床试验和1,000多人中进行了评估。
  • 该股今天上涨了44%,一直波动不定,此后放弃了涨势。
  • 价格走势: 周一的最后一张支票中,CVKD股价上涨0.61%,至4.15美元。

译文内容由第三方软件翻译。


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