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Cabaletta Bio Sets 2026 Strategy for Rese-cel Expansion

Story Highlights
  • Cabaletta is advancing rese-cel toward myositis registration, expanding into lupus and scleroderma.
  • The company is automating rese-cel manufacturing and broadening no-preconditioning trials to support scalable commercialization.
  • Looking for the best stocks to buy? Follow the recommendations of top-performing analysts.
Cabaletta Bio Sets 2026 Strategy for Rese-cel Expansion

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

On January 12, 2026, Cabaletta Bio outlined its 2026 strategic priorities centered on advancing rese-cel toward registration in myositis and broadening its autoimmune pipeline. The company is actively enrolling a 17‑patient FDA-aligned registrational cohort in dermatomyositis and antisynthetase syndrome, building on 2025 Phase 1/2 data and targeting its first biologics license application for rese-cel in myositis next year, while also securing FDA alignment on small single‑arm registrational cohorts in systemic lupus erythematosus and lupus nephritis and obtaining RMAT designation in systemic sclerosis as it works toward additional registrational designs in scleroderma and myasthenia gravis. Operationally, Cabaletta has gained clearance to use Cellares’ fully automated Cell Shuttle platform to manufacture rese-cel—described as a first for an autologous CAR T program—with clinical manufacturing data expected in the first half of 2026 to confirm GMP and supply chain readiness, a move that could materially lower costs and support global scale if the therapy is approved. Clinically, the company is pushing to expand rese-cel’s use without preconditioning, escalating doses in pemphigus vulgaris and adding a no‑preconditioning cohort in lupus, and expects complete Phase 1/2 data in lupus, systemic sclerosis and myasthenia gravis in the first half of 2026, milestones that will be closely watched by regulators, investors and potential commercial partners as Cabaletta positions rese-cel as a potentially outpatient, industry‑leading cell therapy for autoimmune disease.

The most recent analyst rating on (CABA) stock is a Buy with a $14.00 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 Neutral.

Score is held back primarily by weak financial performance (no revenue, widening losses, and significant cash burn that increases funding/runway risk). Technicals are mixed with soft near-term momentum, while recent positive clinical/program updates provide some offset but do not fully counterbalance the current financial profile. Valuation remains challenging to assess given negative earnings.

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

More about Cabaletta Bio

Cabaletta Bio (Nasdaq: CABA) is a late-stage clinical biotechnology company based in Philadelphia that is focused on developing and launching curative targeted cell therapies for autoimmune diseases. Its lead candidate, rese-cel (resecabtagene autoleucel), is an investigational autologous CD19-directed CAR T cell therapy being advanced through the RESET clinical program across multiple therapeutic areas, including rheumatology, neurology and dermatology, with a platform aimed at scalable, potentially durable treatments for a broad range of autoimmune indications.

Average Trading Volume: 3,304,824

Technical Sentiment Signal: Sell

Current Market Cap: $208.9M

For a thorough assessment of CABA stock, go to TipRanks’ Stock Analysis page.

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