RNAC

Wedbush initiated coverage of Cartesian Therapeutics with an Outperform rating and $38 price target.

As previously reported, Wedbush initiated coverage of Cartesian Therapeutics with an Outperform rating and $38 price target. With no conditioning requirement, re-dosing capabilities, and an ongoing Phase 3 trial, the firm believes Cartesian Therapeutics could be the first cell therapy company to achieve widespread use in autoimmune diseases. Wedbush notes that a Phase 2 trial in myasthenia gravis yielded deeper responses than benchmarks for approved biologics, and a registrational Phase 3 trial is enrolling. Further upside is possible from expansion into other autoimmune indications. A Phase 2 trial in lupus will have initial data in the second half of 2025, while a Phase 2 pediatric basket trial is enrolling across multiple indications.

Mizuho reiterates an Outperform rating on Cartesian Therapeutics with a $40 price target following the Q1 report. The quarter was "straightforward" with the company continuing to execute as planned, the analyst tells investors in a research note. The firm believes Cartesian shares have been "unduly punished" with other cell therapy companies due to concerns about potential changes in regulatory standards under new Center for Biologics Evaluation and Research, director Dr. Vinay Prasad. Cartesian has limited near-term FDA exposure, as the company already has a Special Protocol Assessment agreement on the registrational Phase 3 AURORA trial, Mizuho points out. Further, the firm believes the Phase 3 design should meet Dr. Prasad's more rigorous standards, given it is a placebo-controlled trial. Thus, it sees an "attractive buying opportunity" with Cartesian trading below $10 given Descartes-08's "potential blockbuster opportunity" in myasthenia gravis.

Cartesian Therapeutics announced 12-month efficacy and safety data from the Phase 2b trial of Descartes-08 in participants with generalized myasthenia gravis. Participants dosed with a single six-week course of treatment of Descartes-08 were observed to continue to experience a sustained benefit in symptoms of MG at the 12-month assessment. The data will be discussed by management at the 24th Annual Needham Virtual Healthcare Conference today, April 8, 2025 at the 2025 American Academy of Neurology Annual Meeting being held in San Diego. 12-Month Efficacy Results: Participants treated with Descartes-08 were observed to have deep responses following initial treatment and sustained symptom improvement, with an average MG-ADL reduction of 5.5 at Month 4 and 4.8 at Month 12. Participants treated with Descartes-08 were observed to have an average Quantitative Myasthenia Gravis Score reduction of 4.8 points at Month 4, which deepened through Month 12. 33% of participants achieved minimum symptom expression, defined as an MG-ADL score of 0 or 1, at Month 6, all of whom maintained MSE through Month 12. 83% of evaluable participants maintained a clinically meaningful response through Month 12. Clinically meaningful response is defined as a reduction in MG-ADL score of at least 2 points. The subset of participants who did not have exposure to prior biologic therapies, including complement or neonatal fragment crystallizable receptor inhibitors, were observed to exhibit a deepening of responses throughout the year, with an average MG-ADL reduction of 6.6 (+/-1.5) at Month 4 and 7.1 at Month 12. The participants treated with Descartes-08 without exposure to prior biologic therapies were observed to have an average QMG reduction of 5.9points at Month 4, which deepened through Month 12. 57% of these participants were observed to achieve MSE at Month 6 which was maintained through Month 12. 100% of these participants were observed to maintain at least a clinically meaningful response through Month 12.