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Legend Biotech Surges on CARVYKTI's Expanded Clinical Success in Multiple Myeloma

Dec 11, 2025 16:26 UTC

Legend Biotech Corporation (LEGN) has gained investor attention following positive data from CARVYKTI's pivotal trials in relapsed or refractory multiple myeloma, with a 78% overall response rate observed in Phase 2 studies. The stock is now rated Outperform amid growing confidence in its commercial potential.

  • 78% overall response rate in CARVYKTI Phase 2 CARTITUDE-2 trial for relapsed/refractory multiple myeloma
  • 67% complete response or better rate, including 49% MRD-negative at 10^-5 sensitivity
  • $124 million in CARVYKTI sales reported in Q3 2025, up 42% YoY
  • Over 3,000 patients enrolled across clinical trials involving CARVYKTI
  • Market cap exceeds $18 billion, with analyst upgrades to Outperform
  • Regulatory submissions for earlier-line indications expected in 2026

Legend Biotech Corporation (LEGN) has seen renewed momentum after data from the Phase 2 CARTITUDE-2 trial demonstrated a 78% overall response rate in patients with relapsed or refractory multiple myeloma treated with CARVYKTI (ciltacabtagene autoleucel). The therapy, co-developed with Janssen Pharmaceuticals, achieved a 67% complete response or better rate, including 49% achieving minimal residual disease (MRD) negativity at 10^-5 sensitivity—a key benchmark for long-term remission. These results strengthen CARVYKTI’s position as a leading CAR-T treatment in the high-growth multiple myeloma market. The clinical data have prompted analysts to upgrade Legend Biotech to Outperform, citing the therapy’s potential to capture a significant share of the $15 billion-plus global multiple myeloma therapeutics market. With over 3,000 patients enrolled in ongoing and completed clinical trials, CARVYKTI’s real-world effectiveness and durability of response are being closely monitored. Regulatory submissions for expanded indications in earlier-line treatment are expected in 2026, which could further accelerate revenue growth. Financially, Legend Biotech reported $124 million in CARVYKTI-related sales in the third quarter of 2025, a 42% increase year-over-year, driven by expanded market access in the U.S., EU, and key Asian markets. The company’s market capitalization now exceeds $18 billion, reflecting investor confidence in the therapy’s long-term commercial viability. Janssen’s global commercialization efforts are also scaling, with distribution in over 60 countries. The broader biotech sector has responded positively, with peer companies in the cell therapy space seeing price increases. Investors are now assessing Legend Biotech’s pipeline expansion, including trials in solid tumors and other hematologic malignancies, which could extend the utility of its CAR-T platform beyond myeloma.

The information presented is derived from publicly available data and disclosures, including clinical trial results, financial reports, and market analyses.