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Cartesian Therapeutics, Inc. (RNAC) announced the FDA has granted Regenerative Medicine Advanced Therapy designation for Descartes-08 for the treatment of myasthenia gravis. Descartes-08 was previously granted Orphan Drug Designation for the treatment of MG. The company said it remains on track to report topline data from Phase 2b randomized, double-blind, placebo-controlled trial of Descartes-08 in patients with MG in mid-2024.Carsten Brunn, CEO of Cartesian, said: 'We look forward to working closely with the FDA to efficiently advance the development of Descartes-08 for this underserved population.'Shares of Cartesian are up 4% in pre-market trade on Wednesday.For More Such Health News, visit rttnews.com.
Cartesian Therapeutics,Inc.(RNAC)宣布,FDA已批准Descartes-08用于治疗重症肌无力的再生医学高级疗法。Descartes-08之前被授予用于治疗MG的孤儿药称号。该公司表示,它仍将在2024年年中报告Descartes-08在MG患者中的2b期随机,双盲,安慰剂对照试验的基线数据。Cartesian首席执行官Carsten Brunn说:“我们期待着与FDA密切合作,为这一服务不足的人群有效推进Descartes-08的开发。”在周三的上市前交易中,Cartesian的股价上涨了4%。欲了解更多此类健康新闻,请访问rttnews.com。
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Cartesian Therapeutics
药物研发商