Legend Biotech reported third-quarter 2025 results anchored by accelerating commercial momentum for Carvykti, including estimated net trade sales of approximately $524 million, regulatory label expansions in the U.S. and EU to include an overall survival benefit over standard regimens, and a manufacturing scale-up with commercial production initiated at its Tech Lane facility in Ghent, Belgium. The company has now supported treatment for more than 9,000 patients across clinical and commercial settings, posted a sharp year-over-year increase in collaboration revenue tied to Carvykti sales, and narrowed its quarterly net loss to $39.7 million. With cash, cash equivalents, and time deposits of roughly $1.0 billion, Legend is guiding to product-level profitability for Carvykti by year-end and company-wide profitability in 2026.

The strategic question now is whether Legend and its partner Janssen can convert a clinical win into durable commercial leadership as second-line adoption ramps. The addition of overall survival data from CARTITUDE-4 materially strengthens the value narrative with payers. It reinforces positioning as the only approved CAR-T in multiple myeloma at this line of therapy. Yet success will hinge on execution across three pressure points: manufacturing throughput and vein-to-vein time; site capacity and care coordination; and safety management after the label update, including the risk of immune effector cell-associated enterocolitis. The new EU manufacturing node should shorten supply chains and support incremental demand from the first half of 2026, while a pending U.S. capacity expansion in Raritan is designed to ease bottlenecks. Whether these steps translate into faster time-to-treatment and predictable slot availability will decide how much of the second-line opportunity Carvykti can capture.

For patients, the survival label crystallizes a shift in the treatment algorithm: definitive, one-time cellular therapy is moving earlier, potentially displacing chronic triplet and quadruplet regimens and altering the role of transplant. For payers, the combination of OS data and earlier-line use reframes value from cost-per-response to total cost-of-care and durability, increasing the relevance of outcomes-based arrangements and episode-based payment. Medical Affairs teams will need to expand education around recognizing and managing IEC-associated enterocolitis and other immune effector toxicities, update care pathways across inpatient and outpatient settings, and generate decision-grade real-world evidence on utilization, quality of life, and resource intensity in second-line practice.

Competitionally, Carvykti’s survival advantage raises the bar for both BCMA CAR-T rivals and BCMAxCD3 bispecific antibodies that trade off one-time treatment for dosing flexibility. Bispecifics retain an access edge in community settings, but they must now contend with an OS-certified benchmark in a pivotal line of therapy. Looking ahead, Legend’s initiation of CARTITUDE-10 in newly diagnosed multiple myeloma signals an intent to push CAR-T further upstream, where efficacy expectations, durability requirements, and budget-impact scrutiny intensify. The ability to demonstrate operational reliability at scale will be as determinative as incremental efficacy gains.

The following year will test whether Carvykti can translate its label into real-world advantage: faster EU and U.S. throughput from new capacity, tighter safety governance that preserves confidence across centers, and payer frameworks that monetize survival without clogging access. If Legend and Janssen thread that needle before bispecifics broaden their labels and next-generation, potentially off-the-shelf cell therapies arrive, Carvykti could become the template for profitable, scaled cell therapy. If not, will manufacturing and toxicity management be the ceiling that caps market share just as the second-line window opens widest?

Source link: https://www.globenewswire.com/news-release/2025/11/12/3186056/0/en/Legend-Biotech-Reports-Third-Quarter-2025-Results-and-Recent-Highlights.html

Jon Napitupulu
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Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.