Regulatory Shift Could Catalyze Legend Biotech’s CAR-T Therapy

Legend Biotech Corp US52490G1022

Legend Biotech Corp's shares are trading near their 52-week lows, hovering around $19. This price level brings renewed focus to a recent draft guidance from the U.S. Food and Drug Administration (FDA) concerning accelerated approvals for multiple myeloma treatments. The agency has proposed recognizing Minimal Residual Disease (MRD) negativity as a valid endpoint in this process. This development raises a critical question for investors: could this regulatory move help pave the way for expanding the use of Legend's key therapy, CARVYKTI (ciltacabtagene autoleucel), into earlier lines of treatment?

Financial and Event Snapshot
* Current Share Price: Approximately $19.00
* 52-Week Trading Range: $18.99 to $45.30
* Key Upcoming Catalyst: Presentations at the ASTCT/CIBMTR Tandem Meetings (February 4–7)
* Latest Quarterly Revenue (Q3 2025): $272.33 million, representing a 70% year-over-year increase
* Flagship Asset: CARVYKTI, a CAR-T cell therapy

The core of the recent regulatory news is an FDA draft document that identifies MRD negativity as a potential surrogate endpoint for accelerated approval pathways in multiple myeloma. This holds particular significance for Legend Biotech and its commercial partner, Johnson & Johnson. Their ongoing CARTITUDE-6 clinical trial is already using MRD negativity as its primary endpoint. Consequently, this regulatory clarification could serve to validate the study's design and potentially streamline the path toward regulatory submissions for earlier-line use of CARVYKTI.

Divergent Analyst Views and Market Pressure

Market experts currently display a split in their outlook for the company. A notable downgrade occurred on January 22, when TD Cowen shifted its rating from 'Buy' to 'Hold' and slashed its price target from $62 to $21. On the same day, H.C. Wainwright also reduced its target, moving from $60 to $50, though it concurrently raised its 2025 earnings per share estimate slightly. These actions contrast with earlier reaffirmations of bullish stances. Deutsche Bank maintained a 'Buy' rating with a $60 target on January 15, and RBC Capital Markets kept its 'Outperform' rating with a $66 target on January 20. Against this backdrop of mixed sentiment, the stock has recently tested its lowest levels over the past year.

The Path Forward: Clinical Data Takes Center Stage

Attention now turns to imminent clinical data presentations. From February 4 to 7, Legend is scheduled to present six scientific posters at the Tandem Meetings in Salt Lake City. These updates are anticipated to provide further insights into the long-term efficacy and safety profile of CARVYKTI. Clear positive data regarding MRD and safety would significantly bolster the case for label expansions. Conversely, ambiguous or disappointing results would likely maintain downward pressure on the stock. The company's management, alongside its partner, continues to target a path to profitability by 2026, a goal heavily dependent on the successful commercial rollout of CARVYKTI.