Cabaletta Bio Announces 2027 BLA Plans for Rese-cel

Cabaletta Bio ( (CABA) ) has issued an update.

On May 15, 2025, Cabaletta Bio announced plans for a 2027 Biologics License Application (BLA) submission for rese-cel in myositis, following FDA alignment on registrational cohorts. The RESET-Myositis trial will include two subtype-specific cohorts, each with approximately 15 patients, and aims to address the unmet needs of around 80,000 myositis patients in the U.S. The FDA granted RMAT designation to rese-cel, facilitating expedited review and development. Cabaletta is also advancing its manufacturing strategy to support commercial supply readiness, with new clinical data to be presented at the EULAR 2025 Congress.

The most recent analyst rating on (CABA) stock is a Buy with a $26.00 price target. To see the full list of analyst forecasts on Cabaletta Bio stock, see the CABA Stock Forecast page.

Spark’s Take on CABA Stock

According to Spark, TipRanks’ AI Analyst, CABA is a Underperform.

Cabaletta Bio’s overall score is low primarily due to its financial performance, marked by no revenue and increasing losses. The technical analysis indicates a bearish trend, further impacting the score. However, the recent positive clinical trial data provides a glimmer of hope, slightly improving future outlook. Despite this, the stock’s valuation remains a concern, making it a risky investment at this stage.

To see Spark’s full report on CABA stock, click here.

More about Cabaletta Bio

Cabaletta Bio is a clinical-stage biotechnology company focused on developing curative targeted cell therapies specifically for patients with autoimmune diseases. The company is advancing the CABA platform, which includes engineered T cell therapies aimed at offering deep and durable treatments across multiple therapeutic areas such as rheumatology, neurology, and dermatology. Its lead investigational therapy, rese-cel, is part of the RESET clinical development program.

Average Trading Volume: 933,396

Technical Sentiment Signal: Sell

Current Market Cap: $66.98M

See more insights into CABA stock on TipRanks’ Stock Analysis page.