FDA grants breakthrough therapy status to Adaptimmune's cancer treatment

Published 13/01/2025, 14:14
FDA grants breakthrough therapy status to Adaptimmune's cancer treatment

This news is based on a press release statement and contains forward-looking statements that involve risks and uncertainties. These statements reflect the company's current expectations, but actual results could differ materially. InvestingPro subscribers have access to additional insights, including 10 ProTips and comprehensive analysis showing the company is currently trading below its Fair Value. With analysts setting price targets ranging from $1.00 to $3.50, investors seeking detailed financial analysis can access the full Pro Research Report, available exclusively to subscribers. InvestingPro subscribers have access to additional insights, including 10 ProTips and comprehensive analysis showing the company is currently trading below its Fair Value. With analysts setting price targets ranging from $1.00 to $3.50, investors seeking detailed financial analysis can access the full Pro Research Report, available exclusively to subscribers. This designation is for patients with unresectable or metastatic myxoid/round cell liposarcoma (MRCLS) who have previously undergone anthracycline-based chemotherapy and meet specific genetic criteria.

This news is based on a press release statement and contains forward-looking statements that involve risks and uncertainties. These statements reflect the company's current expectations, but actual results could differ materially. InvestingPro subscribers have access to additional insights, including 10 ProTips and comprehensive analysis showing the company is currently trading below its Fair Value. With analysts setting price targets ranging from $1.00 to $3.50, investors seeking detailed financial analysis can access the full Pro Research Report, available exclusively to subscribers.

Adaptimmune plans to provide more details about its sarcoma franchise and the clinical program for lete-cel during its presentation at the Annual J.P. Morgan Healthcare Conference in San Francisco, California, scheduled for Tuesday afternoon.

The breakthrough therapy designation is intended to accelerate the development and review of drugs that show potential for significant improvement over existing therapies on at least one clinically significant endpoint. With this status, lete-cel may benefit from more frequent interactions with the FDA, a rolling submission of the biologics license application, and possibly a priority review.

In addition to the FDA designation, Adaptimmune is also spotlighting its Allo-T program at the Biotech ShowCase™ and the Wuxi Global Forum 2025 Investor Roundtable. The company aims to initiate a rolling Biologics License Application for lete-cel later this year for the treatment of both sarcoma indications, with a market launch anticipated in 2026.

Adaptimmune's CEO, Adrian Rawcliffe, commented on the breakthrough status, emphasizing the potential of lete-cel to meet the critical need for new treatments in the sarcoma patient population.

This news is based on a press release statement and contains forward-looking statements that involve risks and uncertainties. These statements reflect the company's current expectations, but actual results could differ materially.

In other recent news, Adaptimmune Therapeutics (NASDAQ:ADAP) has undergone significant strategic shifts following its third-quarter results. The biopharmaceutical company maintained its Outperform rating, but Mizuho (NYSE:MFG) reduced its price target by 50% due to changes in its pipeline and plans for cost reduction. A pivotal Phase 2 IGNYTE-ESO study data for lete-cel, Adaptimmune's second-most advanced program, showed promising results, leading the company to anticipate submitting a biologics license application by 2025 end.

In a move to streamline operations, Adaptimmune announced a workforce reduction of 33% and a 25% cut in operating expenses in 2025. This is part of the company's strategy to reach a break-even financial position by 2027. Despite the restructuring, Mizuho remains optimistic about Adaptimmune's future, partly due to an increased revenue projection for Tecelra, the company's leading product candidate, in 2025.

Adaptimmune also reported a successful launch of its engineered cell therapy, Tecelra, and plans to expand authorized treatment centers. The company anticipates modest Tecelra revenues starting Q4 2024, with significant growth expected in 2025. These are among the recent developments that have led to a cautiously optimistic outlook from Mizuho.

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