Investing.com -- Adicet Bio shares jumped 6.4% premarket after the company announced that the U.S. Food and Drug Administration (FDA) granted Fast Track Designation to its investigational therapy ADI-001 for the treatment of systemic sclerosis (SSc).
ADI-001 is a CAR T cell therapy that targets CD20 to treat autoimmune diseases.
Fast Track Designation is intended to accelerate the development and regulatory review of drugs aimed at treating serious conditions with unmet medical needs.
The designation provides Adicet Bio with several potential advantages, including more frequent FDA interactions, eligibility for priority review, and the possibility of accelerated approval if clinical data supports it.
This milestone strengthens Adicet Bio’s position in the cell therapy space, particularly in autoimmune diseases and cancer, where the company is focused on developing novel gamma delta T cell-based treatments.
The stock’s premarket jump reflects investor optimism about the regulatory progress of ADI-001 and its potential to address systemic sclerosis.
Related Articles
Adicet Bio shares rise on FDA Fast Track Designation for ADI-001
Target and Warby Parker team up for in-store eyewear shops
Microsoft urges Trump to overhaul Biden's last AI chip export curbs
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。