NASDAQ:LEGN

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Legend Biotech Falls 13% Despite CARVYKTI Growth and First Quarterly Profit

Legend Biotech (NASDAQ: LEGN) shares fell about 13% on Tuesday despite strong CARVYKTI sales growth, a swing to profitability and encouraging long-term clinical data.

CARVYKTI net trade sales increased 36% year over year to approximately $710 million in the third quarter, including 19% growth in the U.S. and 86% growth outside the U.S. The therapy is now available at 373 treatment sites across 20 markets.

Legend also reported a major financial improvement. Collaboration revenue increased to $353.2 million from $261.8 million, while operating income reached $46.8 million versus a $43.3 million operating loss a year earlier. Net income was $51.7 million compared with a $39.6 million loss, and adjusted net income improved to $55.6 million from an $18.7 million loss.

Clinical and regulatory developments were also positive. Five-year CARTITUDE-2 Cohort A data showed that 50% of patients remained alive and progression-free without additional anti-myeloma therapy after a single CARVYKTI infusion. Updated NCCN guidelines also favor referral to T-cell therapy-capable centers at first relapse and prefer CAR-T over T-cell engagers when both are viable.

The company also received FDA IND clearance for LB2501, its investigational dual-targeting in vivo CAR-T therapy, while ending the quarter with approximately $853 million in cash, cash equivalents and time deposits.

Given the strong operating and clinical update, the 13% decline appears more likely to reflect elevated expectations, valuation pressure or investor concerns not directly evident in the reported quarter, rather than deterioration in CARVYKTI demand or Legend’s underlying financial performance.
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Author
WS Investor 11-10-26
Legend Biotech Stock Rises 5% as CARVYKTI Sales Jump and Company Turns Profitable

Legend Biotech (NASDAQ: LEGN) shares rose about 5% on Tuesday after the company reported strong second-quarter results, driven by continued growth of its CARVYKTI cell therapy and improving profitability.

CARVYKTI net trade sales increased 50% year-over-year to approximately $657 million, including 32% growth in the U.S. and 128% growth outside the U.S. The treatment is now available across 348 sites in 19 markets.

Legend reported collaboration revenue of $326.1 million, up from $219.7 million a year earlier. More importantly, operating performance swung sharply into positive territory, with operating income of $57.7 million versus a $21.9 million loss last year. Net income reached $33.2 million compared with a $125.4 million loss in Q2 2025.

Clinical developments also supported sentiment. Legend reported a 100% overall response rate and 83.3% complete response rate at the higher dose level in an early study of its investigational LB2501 in vivo CAR-T therapy.

The combination of rapid CARVYKTI growth, the transition to quarterly profitability and encouraging pipeline data appears to be driving the positive reaction in LEGN shares.
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Author
The Investor 08-11-26
Legend Biotech Soars 39% as Early In Vivo CAR-T Data Impress Investors

Shares of Legend Biotech (NASDAQ: LEGN) surged 39% after the company reported promising early clinical data for LB2501, its investigational in vivo CAR-T therapy for relapsed or refractory non-Hodgkin lymphoma (NHL).

The Phase 1 study showed particularly strong efficacy in the higher-dose cohort. Among six patients treated at dose level 2, the objective response rate was 100%, while 83.3% achieved a complete response. Importantly, all responses remained ongoing at the time of the data cutoff.

Investors were also encouraged by the therapy's safety profile. The company reported no dose-limiting toxicities, no serious adverse events, no deaths, and no cases of immune effector cell-associated neurotoxicity syndrome (ICANS). All observed cytokine release syndrome (CRS) events were mild, with no cases above Grade 2.

LB2501 is designed to generate CAR-T cells directly inside the patient following a single infusion, potentially eliminating the need for complex cell manufacturing and lymphodepleting chemotherapy. The treatment targets both CD19 and CD20 and could represent a significant advance in making CAR-T therapies more accessible and scalable.

The data will be presented in a late-breaking oral session at the European Hematology Association (EHA) Congress later this month, further highlighting the significance of the results.

The sharp rally reflects investor enthusiasm for what could become a first-in-class in vivo CAR-T platform, with the early data suggesting the potential to combine strong efficacy, favorable safety, and a much simpler treatment process than traditional CAR-T therapies.
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Author
European Investor 06-02-26