Australia’s Therapeutic Goods Administration (TGA) has once again decided against approving Eisai Australia Pty Ltd.’s amyloid beta binder, Leqembi (lecanemab), for treating patients with mild cognitive impairment due to Alzheimer's disease and mild Alzheimer's dementia.
The EMA’s Committee for Medicinal products for Human Use (CHMP) is standing by its opinion on Leqembi (lecanemab) after the European .mission pushed back against a recommendation in November 2024 that the Alzheimer’s disease drug be approved
Researchers from the Centre for Addiction and Mental Health (CAMH) and affiliated organizations presented preclinical data for the α5-GABA-A receptor (α5-GABAAR) positive allosteric modulator GL-II-73 (DPX-101), which is being developed by Damona Pharmaceuticals Inc. for the treatment of Alzheimer’s disease and other cognitive and neurological disorders.
Cognition Therapeutics Inc. evolved from the work of a neuroscientist and a chemist working in the San Francisco Bay area, seeking out targets to block the effects of Alzheimer’s disease. Since the company’s 2007 inception, it has received close to $200 million in U.S. NIH grant funding. Investors often tell CEO Lisa Ricciardi, who joined the company in 2020: “’That’s because you have a relationship with the FDA.’ Well, no. It’s because it’s competitive” and the company’s research has met the muster. “You have to apply two or three times. … It’s with rigor that these results are generated and that we’re able to get more funding.”
EMA approval of the Alzheimer’s disease therapy Leqembi (lecanemab) has stalled once again, after the European Commission did not as usual nod through the agency’s recommendation, but told it to examine safety data that have recently become available.
Lantheus Holdings Inc. is making waves in M&A with its second big deal of the month – and year – the acquisition of Evergreen Theragnostics Inc. for $250 million in cash up front and up to an additional $752.5 million in contingent payments. The transaction follows announcement of a definitive agreement to acquire Life Molecular Imaging Ltd., a subsidiary of Life Healthcare Group Holdings Ltd., on Jan. 13 for $350 million in cash at closing and a further $400 million in milestone payments.
Icelandic genomics company Arctic Therapeutics has closed a €26.5 million (US$27.6 million) series A, enabling it to assess if its lead drug AT-001, designed to treat a rare inherited amyloid disease, also could be used to treat more common forms of dementia, including Alzheimer’s disease. The program is currently in a phase IIb/III European trial in cystatin C amyloid angiopathy, an ultra-rare disease found only in Iceland that is caused by the L68Q mutation in the cystatin C gene.
Gemvax & Kael Co. Ltd. has identified peptides reported to be useful for the treatment of age-related macular degeneration (AMD), cerebral amyloid angiopathy and Alzheimer’s disease.
Universitat de Barcelona has identified histone-lysine N-methyltransferase EHMT2 (H3-K9-HMTase 3; G9a) inhibitors reported to be useful for the treatment of Alzheimer’s disease among others.
Among the companies to provide updates at the J.P. Morgan Healthcare Conference in San Francisco was Vigil Neuroscience Inc., which has intrigued Wall Street more since the deal signed in December by Muna Therapeutics ApS, of Copenhagen, Denmark, with London-based GSK plc.
