Longeveron Inc. published the results of its Phase 2b clinical trial of laromestrocel in patients with age‑related frailty in the journal Cell Stem Cell on February 25 2026. The randomized, dose‑finding study enrolled 148 ambulatory participants and demonstrated a statistically significant improvement in the 6‑minute walk test, with a mean gain of 63.4 meters at nine months (p = 0.0077) and 41.3 meters at six months (p = 0.0635).
The study also reported a positive correlation between the 6‑minute walk test improvement and PROMIS Physical Function scores, and found that higher doses of laromestrocel were associated with decreases in soluble TIE‑2 levels. The trial is registered under NCT03169231.
Chief Science Officer Joshua M. Hare said, "We are highly encouraged by these Phase 2b results that demonstrate the potential of stem cell therapy to improve the condition of patients with aging‑related frailty." He added, "Those with Aging Frailty are disproportionately compromised in their ability to cope with everyday and acute stressors, are at high vulnerability to disease and injury, and are at increased risk for poor outcomes and death after surgery. This development area is at the core of Longeveron's mission – advancing stem cell therapies addressing life‑threatening conditions in the most vulnerable populations – children and the elderly."
The positive data reinforce Longeveron's strategy to advance laromestrocel across multiple indications, including hypoplastic left heart syndrome, Alzheimer’s disease, and pediatric dilated cardiomyopathy. The company has secured Orphan Drug, Fast Track, and RMAT designations for several programs and operates a GMP facility that also offers contract development and manufacturing services, providing an additional revenue stream.
Longeveron remains a clinical‑stage biotech with modest revenue. In 2024 the company generated $2.39 million, a 237 % increase from $709 k in 2023, but reported a net loss of $24.62 million. In Q3 2025 the company posted an EPS of –$0.39 versus an estimate of –$0.25, compared with –$0.34 in the same quarter of 2024. The company is actively seeking additional financing and partnership opportunities to support its pipeline and extend its cash runway.
Analysts have expressed mixed views on Longeveron's prospects. The positive Phase 2b data are likely viewed favorably, but investors are weighing the company’s ongoing financial challenges and the need for further capital to advance later‑stage trials and regulatory submissions.
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