Cabaletta Bio Stock Surges To 2-Month High On Autoimmune Therapy Progress; Retail’s Pleased

The company announced the addition of two subtype-specific cohorts to its RESET-Myositis trial and received RMAT designation from the FDA for rese-cel.

Cabaletta Bio shares hit their highest levels in nearly two months on Thursday following an announcement of crucial regulatory and clinical progress for its leading autoimmune therapy, rese-cel.

CABA shares closed up 2.36% at $164.70 on Thursday.

The company said it has expanded its RESET-Myositis trial with two new subtypes-specific patient cohorts containing approximately 15 patients each. 

The expansion followed the U.S. FDA's approval of RMAT designation for rese-cel, which shows its potential treatment for myositis in Americans who have few therapeutic options.

The company plans to submit a Biologics License Application (BLA) for rese-cel in 2027 based on a registrational study design that follows FDA guidelines. 

The RESET clinical development program enrolled 44 patients and administered doses to 23 by May 9.

The RESET trials for myositis, systemic autoimmune diseases, SLE/LN, and systemic sclerosis will reveal new clinical data during the EULAR 2025 Congress in June. 

Cabaletta intends to begin registrational discussions with the FDA regarding SLE and lupus nephritis during Q3 2025, followed by conversations about systemic sclerosis in Q4 2025.

On Stocktwits, retail sentiment was ‘extremely bullish’ amid a 3,500% surge in 24-hour message volume.

Some traders said they reached one of their target prices for CABA and have exited their positions but remain optimistic about a possible upward move tomorrow, keeping an eye out for re-entry opportunities. 

Another user highlighted that after-hours trading already accounted for a third of the daily volume within the first hour, expressing bullish expectations for the stock to open higher and potentially reach $10 within six months.

The stock has declined 55% so far in 2025.

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