Lumosa Therapeutics today (Feb. 20, 2026) announced that its novel therapy for acute ischemic stroke, LT3001, has successfully cleared the US FDA's 30-day review period for an exploratory clinical trial evaluating multiple-dose administration.  

The clinical trial now cleared by the FDA is an open-label, single-arm, exploratory Phase II study formally titled:
"An Open-Label, Single-Arm, Exploratory Study to Evaluate Intracranial Arterial Recanalization with Multiple Doses of LT3001 Drug Product in Participants with Acute Ischemic Stroke (AIS)"
Primary Scientific Objective: To establish the rate of successful intracranial arterial recanalization achieved through multiple doses of LT3001 in patients presenting with acute ischemic stroke.
Key Efficacy Endpoint: Intracranial arterial recanalization rate measured at 24 hours following the first dose of LT3001.
Trial Enrollment: Ten evaluable subjects in this exploratory phase.

LT3001 was presented as a late-breaker at the 2026 International Stroke Conference (ISC), held February 5-7 in New Orleans, Louisiana, the data was from Study 202 and Study 205, two double-blind, placebo-controlled trials that spanned across China, the US, EU, and Taiwan. The drug is safe for patients with disabling strokes, and led to clinically meaningful improvements at day 90. Despite the limitations of the studies, the investigators concluded that the findings support advancement into a global phase 3 trial, which is currently being planned.