Cabaletta Bio (CABA) shares extended gains in recent premarket activity Friday after the company said it anticipates a 2027 biologics license application submission on a proposed registrational cohort design for a trial of resecabtagene autoleucel to treat myositis.
"Based on the minutes from our recent [Food and Drug Administration] meeting, we are proceeding with a registrational study design that includes two independent, subtype specific cohorts, each with approximately 15 patients and a primary endpoint within 26 weeks of rese-cel infusion," Chief Medical Officer David Chang said.
The company said the FDA granted regenerative medicine advanced therapy designation to rese-cel to treat myositis, a disabling, multi-system autoimmune disease.
Cabaletta also said it had cash and cash equivalents of $131.8 million as of March 31, expected to fund operating plan into H1 2026.
The company's shares closed 39% higher Thursday and were up 18% pre-bell Friday.
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。