Andrea Lobo,  —

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…

A U.S. Food and Drug Administration (FDA) advisory committee is expected to meet to discuss data from a Phase 3 trial of the anti-amyloid therapy donanemab in people with early Alzheimer’s disease. Developer Eli Lilly asked the FDA last year to approve donanemab, based on the…

AriBio will soon start recruiting participants in the U.K. for the Phase 3 trial of AR1001 (mirodenafil), an investigational oral therapy for early Alzheimer’s disease. This follows a positive opinion of the U.K. Medicines and Healthcare Products Regulatory Agency. The Polaris-AD trial (NCT05531526), which is enrolling patients…

Health Canada has approved Rexulti (brexpiprazole) for agitation associated with Alzheimer’s disease-related dementia in patients with aggressive behavior. The treatment, co-developed by Otsuka Pharmaceuticals and Lundbeck, was recently approved by the U.S. Food and Drug Administration (FDA) for the same indication. “Today marks a major milestone…

Dosing has begun in a first group of healthy adults in a Phase 1a clinical trial of OLX-07010, Oligomerix’s lead treatment candidate for Alzheimer’s disease and other neurodegenerative disorders. OLX-07010 is an oral small molecule inhibitor of tau self-association — one of the initial steps leading to tau…