Andrea Lobo,  —

The U.S. Food and Drug Administration (FDA) has approved monthly maintenance dosing for Leqembi (lecanemab), a treatment for early Alzheimer’s disease. The decision follows a supplemental application from Eisai, which is codeveloping Leqembi with Biogen, based on the modeling of data from the Phase…

After completing a third review of interim safety data, an independent safety monitoring board has recommended the continuation — without modifications — of two ongoing Phase 3 clinical trials testing the oral therapy simufilam in people with Alzheimer’s disease. The board’s findings were announced by therapy developer…

Fujirebio Diagnostics asked the U.S. Food and Drug Administration (FDA) to approve its Alzheimer’s disease diagnostic blood test,  Lumipulse G pTau 217/β [beta]-Amyloid 1-42 Plasma Ratio. If approved, the test would be the first commercially available blood-based in vitro test in the U.S. to aid in diagnosing…

Alzamend Neuro is partnering with Massachusetts General Hospital to conduct a Phase 2 clinical trial of AL001, an oral therapy being developed for dementia related to Alzheimer’s disease. The trial will compare the brain levels of AL001, a novel lithium-delivery system, with those of marketed lithium, in healthy…

The use of Montelukast oral film, an experimental therapy being repurposed by Intelgenx to treat mild to moderate Alzheimer’s disease, led to significant improvements in patients’ cognition versus a placebo in a Phase 2 clinical trial. That’s according to the findings of a top-line analysis of efficacy data…

The U.S. Food and Drug Administration (FDA) has granted regenerative medicine advanced therapy (RMAT) designation to Longeveron’s experimental cell therapy Lomecel-B for mild Alzheimer’s disease. The designation is designed to accelerate the development and review processes for regenerative medicine candidates, including cell therapies, intended to treat, modify, reverse,…

Note: This story was updated June 21, 2024, to correct that SNK01 was given approval by NKGen Biotech’s Safety Review Committee. SNK01, a natural killer (NK) cell therapy being developed by NKGen Biotech, has received clearance from its Safety Review Committee to advance into the Phase 2 part of a…

Otsuka Pharmaceutical has stopped the development of AVP-786, an investigational oral therapy to treat agitation in people with Alzheimer’s disease. The decision comes after the company’s recent announcement that the treatment failed to meet its primary efficacy goal of lowering agitation in ALS patients after 12…

BioXcel Therapeutics plans to launch a pivotal Phase 3 in-care trial — one involving patients in nursing or assisted living facilities — to continue to evaluate BXCL501 (dexmedetomidine sublingual film) for the acute treatment of agitation in patients with Alzheimer’s disease dementia. BXCL501 is an experimental orally dissolving…

Eisai is seeking approval in the U.S. of Leqembi (lecanemab)’s monthly maintenance dosing for people with early Alzheimer’s disease. The supplemental biologics license application with the U.S. Food and Drug Administration (FDA), recently announced by the company, is backed by modeling of observed data from the…