Alzheimer’s disease
As the DOJ and SEC look into two of its senior employees, Cassava Sciences’ CEO and one senior vice president have departed the company.
Asceneuron, which develops small molecules targeting tau protein aggregation, plans to use the funds to advance its Alzheimer’s disease asset into Phase II.
After a busy first half of 2024, several companies are expecting key data readouts in the neuropsychiatric and neurodegenerative disease spaces during the next six months.
Two CRLs from the FDA last week cited concerns with third-party manufacturers, while Indian CDMOs may make a bid for U.S. business if there is a decoupling from Chinese companies under the BIOSECURE Act.
Donanemab, which will be marketed as Kisunla, will compete with Biogen and Eisai’s Leqembi.
The FDA’s calendar is relatively light in July, with only five major deadlines, including one for a PD-1 blocker and another for an opioid overdose drug.
The next six months for the FDA are primed to be as groundbreaking as the first six, with Eli Lilly’s donanemab and Lykos Therapeutics’ MDMA-assisted PTSD therapy on the docket, among others.
Accurately diagnosing Alzheimer’s disease pathologies is becoming increasingly important, but the U.S. is facing imaging resource constraints.
Despite concerns raised in FDA briefing documents about Eli Lilly’s Alzheimer’s treatment, donanemab, the committee concluded that the benefits outweighed the risks.
In advance of an advisory committee meeting on Monday, the FDA’s internal reviewers have raised issues regarding Eli Lilly’s Alzheimer’s disease candidate donanemab, flagging problems with its study design and safety outcomes.
PRESS RELEASES