Although amyloid-lowering agents still represent the lion’s share of late-stage candidates for Alzheimer’s disease, they account for less than 20% of compounds across all clinical stages. Tau inhibition, modulation of neurotransmitter signaling, and quelling of...

Orna emerged from stealth Wednesday with an $80 million A round to develop circular RNA therapies for cancer and genetic diseases that could be easier to manufacture than linear RNAs and immune cell therapies. MPM Capital,...

Alzheimer’s disease immunotherapy reduces β-amyloid without increasing brain bleedingPublished in Science Translational Medicine, Denali Therapeutics Inc. (NASDAQ:DNLI) and Washington University School of Medicine in St. Louis researchers led by David Holtzman found that an anti-APOE...

It’s unclear whether FDA is calling for more data from Biogen because it is looking for a rationale to approve aducanumab against the recommendation of its advisers, or whether it’s primarily stalling for time, avoiding...

With a portfolio of three gene therapy programs from Weill Cornell, two of which have already reached the clinic, start-up Lexeo has drawn $85 million in series A funding from a syndicate led by Longitude Capital...

For almost any other compound, the nearly unanimous advisory committee vote that Biogen’s Alzheimer’s therapy aducanumab suffered would make its chances of approval vanishingly small. But this mAb...

COVID-19 vaccine data from Pfizer and BioNTech have set a high bar for what could be a rapid wave of readouts from other companies developing vaccines accelerated by surges in case counts. In the latest...

FDA’s advisers not only roundly rebuffed Biogen’s Alzheimer’s candidate aducanumab, tanking its odds of approval, they also lambasted the agency for bias in its presentation of the analyses. In Friday’s meeting of the Peripheral and...

FDA appears to be leaning toward approval of the first theoretically disease-modifying therapy for Alzheimer’s disease, or any neurodegenerative disorder, based on two incomplete Phase III trials, one...