Cabaletta Bio (CABA, Financial) is preparing for a Biologics License Application (BLA) submission for rese-cel, targeting an anticipated timeline of 2027. This decision comes after a recent meeting with the U.S. Food and Drug Administration (FDA) regarding the proposed design of the registrational cohorts for the RESET-Myositis trial. The company received the meeting minutes in April 2025 and intends to proceed with establishing two single-arm, disease-specific registrational cohorts. Success in either could facilitate a future BLA submission for rese-cel in myositis treatment.
Additionally, the FDA has granted Regenerative Medicine Advanced Therapy designation to rese-cel, specifically for addressing myositis, potentially expediting its development and review processes. Cabaletta Bio's strategic plan highlights a significant step forward in its efforts to bring this innovative treatment to patients affected by myositis.
Wall Street Analysts Forecast
Based on the one-year price targets offered by 9 analysts, the average target price for Cabaletta Bio Inc (CABA, Financial) is $16.22 with a high estimate of $28.00 and a low estimate of $3.00. The average target implies an upside of 1,147.86% from the current price of $1.30. More detailed estimate data can be found on the Cabaletta Bio Inc (CABA) Forecast page.
Based on the consensus recommendation from 11 brokerage firms, Cabaletta Bio Inc's (CABA, Financial) average brokerage recommendation is currently 1.8, indicating "Outperform" status. The rating scale ranges from 1 to 5, where 1 signifies Strong Buy, and 5 denotes Sell.
