Legend Biotech Charts a Course Toward Profitability Amid Share Price Challenges

Legend Biotech Corp US52490G1022

Following a period of significant stock price declines, Legend Biotech Corp is strategically focusing its efforts on achieving operational profitability by fiscal year 2026. The biotech specialist is aiming to restore investor confidence through a major expansion of manufacturing capacity for its CAR-T cell therapy, CARVYKTI, and by targeting near-term profitability for the product. The central question is whether the company can successfully convert its clinical achievements into sustained financial growth.

Despite operational progress, Legend Biotech's shares continue to face substantial headwinds in the market. The stock closed at €14.90 on Thursday, marking a new 52-week low. Year-to-date, the share price reflects a decline of more than 58%. Management is countering this trend with clear financial expectations, projecting that the CARVYKTI division will reach profitability as early as fiscal year 2025. The broader corporate goal is to achieve operational profitability for the entire company in 2026.

Key financial metrics as of the latest close:
* Closing Price (Thursday): €14.90
* 52-Week Low: €14.90 (reached on January 29, 2026)
* Distance from 52-Week High: -60.79%

Investors are anticipating the next significant update with the release of quarterly results in mid-March 2026. Beyond financials, the latter half of the year will bring a focus on initial data from the new in vivo pipeline program, which is designed to pioneer the next technological phase of cell therapies.

Capacity Expansion and Strengthened Clinical Data

The company is reporting substantial advances for its core product, CARVYKTI, a treatment for multiple myeloma. To date, more than 10,000 patients globally have been treated with the therapy, and its availability has been extended to over 279 sites across 14 markets.

A pivotal element for targeted growth is the completion of the manufacturing facility in Raritan, USA. As one of the largest plants of its kind, it is intended to secure production capacity for up to 10,000 patients annually. This expansion is supported by bolstered clinical evidence. Both the U.S. Food and Drug Administration (FDA) and the European Commission have updated the therapy's label to include data demonstrating an improved survival benefit over standard treatment options.

Regulatory Shifts Provide Potential Tailwinds

The landscape for future drug approvals may also be becoming more favorable. New draft guidance from the FDA suggests that certain surrogate endpoints, such as minimal residual disease (MRD), could be recognized for accelerated approval pathways in multiple myeloma. Market observers interpret this as a signal that timelines for highly active therapies could be meaningfully shortened. Such a development would directly benefit Legend Biotech, particularly regarding its ongoing Phase 3 trial, CARTITUDE-6.