Cartesian Therapeutics Climbs on FDA Nod for New Autoimmune Drug Trial
FDA accepts Investigational New Drug application for RNA cell therapy Descartes-08 in myositis, a key validation for the company's expanding pipeline.
Shares of Cartesian Therapeutics (NASDAQ: RNAC) are in the spotlight after the company announced a significant regulatory milestone, securing the U.S. Food and Drug Administration’s acceptance of its Investigational New Drug (IND) application for Descartes-08, a novel RNA cell therapy candidate for the treatment of myositis.
The announcement, made on Tuesday, marks a critical step forward for the clinical-stage biotechnology firm, allowing it to proceed with a planned adaptive Phase 2 trial. The news comes amid a period of positive momentum for the company's stock, which had already posted gains for four consecutive days leading up to the announcement, closing Monday's session up 4.6%.
Descartes-08 is designed as a next-generation, autologous anti-BCMA CAR T-cell therapy. Unlike conventional DNA-based CAR-T, Cartesian’s therapies are engineered with RNA, which the company believes could result in better safety by avoiding the risks of genomic integration. This IND opens a second front for the therapy, which is also being evaluated for the autoimmune condition myasthenia gravis in the company's ongoing Phase 3 AURORA trial. In its update, Cartesian confirmed that enrollment for the AURORA study remains on track.
Myositis is a group of debilitating chronic inflammatory diseases that affect the muscles, for which new and more effective treatment options are sorely needed. The FDA's decision to allow clinical studies to proceed for Descartes-08 in this indication represents a significant de-risking event for Cartesian’s technology platform and a validation of its potential to address a wider range of autoimmune disorders.
Wall Street has been monitoring the company’s pipeline closely, with a strong consensus of analysts rating the stock as a “Buy” or “Strong Buy” ahead of the news. According to StockAnalysis.com, five analysts have a consensus "Strong Buy" rating with an average price target of $38.40, suggesting substantial upside from its recent close around $8.13. This sentiment was echoed in a November 2025 note from BTIG, which assigned a $44 price target while highlighting the potential expansion of Descartes-08 into myositis as a key value driver.
The move into myositis diversifies Cartesian's clinical portfolio and provides another pathway to potential commercialization. The company, which has a market capitalization of approximately $202 million, is operating in the rapidly growing RNA-based therapeutics sector. Recent data has projected the market for such therapies to surpass $200 billion by 2033, fueled by technological advancements and significant investments across the industry.
In its press release, Cartesian outlined its outlook for 2026, signaling its intent to initiate a single, pivotal trial for Descartes-08 in myositis during the first half of the year. This aggressive timeline underscores management's confidence in the therapy's profile and the streamlined clinical path enabled by the adaptive trial design.
For investors, the FDA's acceptance serves as a crucial piece of positive data, affirming the scientific rationale behind Cartesian’s RNA-based cell therapy approach. As the company prepares to advance two distinct programs into later-stage clinical evaluation, the focus will now shift to trial execution and the initial data readouts from the newly approved myositis study.