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Tuesday, January 20, 2026

FDA Guidance Boosts Arcellx (ACLX) and Legend

 Shares of Arcellx (ACLX) and Legend Biotech (LEGN) rose following the U.S. FDA's draft guidance on using minimal residual disease (MRD) and complete response as endpoints for accelerated approval in multiple myeloma treatments. Legend Biotech, in collaboration with Johnson & Johnson, is advancing Carvykti, while Arcellx is developing anito-cel with Kite Pharma. Analysts view the guidance as a positive development, particularly for Legend's CARTITUDE-6 trial, which already incorporates MRD negativity as an endpoint.

https://www.gurufocus.com/news/7533428/fda-guidance-boosts-arcellx-aclx-and-legend-biotech-legn-shares

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