Yes, Besao, I saw part of Cramer's pitch on Lilly, and he attributed part of the recent strong movement in LLY to the anticipation of FDA approval for its new Alzheimer's drug, donanedab. I believe the company suggested that approved was expected in the next week or two. Like the Biogen/Eisai drug, lecanemab (LEQEMBI), as well as its now defunct predecessor, aducanemab (ADUHELM), donanemab is a monoclonal antibody (mAb) treatment that reduces the quantity of amyloid plaque in the brain and therefore hopefully retards the development of Alzheimer's. After decades of work in pursuit of that theory, the results from the mAb's have been disappointing to put it mildly. Donanemab might be somewhat better than LEQEMBI, but it certainly seems a huge stretch to call it a game changer. Like the others it requires infusions at a medical facility. The side effects can be quite serious, particularly cerebral edema potentially leading to life threatening brain bleeds. The latter possibility requires patients to receive regular brain scans. In addition, like its mAb predecessors, it accelerates brain shrinkage. Also a significant number of patients in the trials apparently dropped out because of nausea.
If you indeed read this board regularly, you know that blarcamesine, Anavex' current entry in the Alzheimer's field, does not have the serious safety issues common to the mAb's. There is no cerebral edema and therefore no need for ongoing brain scans. As I recall, there was no issue with nausea, as seemed to plague the donanemab trials. Some patients reported mild to moderate dizziness, and the company now recommending an evening dosing protocol. As you mentioned, it is a small molecule oral drug, in contrast to the mAb infusions (which may evolve into injections). As to efficacy, I would refer you to page 19 of the new (2024) Anavex Corporate Presentation on the company website. No longer does Anavex need to compare itself to ADUHELM, so now we see a chart of ADAS-COG showing that blarcamesine slows the cognitive decline vs. placebo by 28% over 48 weeks. That is a faster and stronger response than donanemab, which slows the cognitive decline vs. placebo by 19% over 76 weeks, as noted in the sidebar. I am sure that Missling won't fail to highlight this at the TD Cowen presentation on Monday.
So, of the two which is more likely to be the game changer? The stock price of AVXL should take care of itself after an MAA is filed and accepted at the EMA and and/or after the peer reviewed article is published.
