The Alzheimer’s disease (AD) space took another blow along with the shares of Cassava Sciences Inc. (NASDAQ:SAVA), which plummeted by 83.8%, or $22.19, to end Nov. 25 at $4.30 after the firm unveiled top-line data from the phase III Rethink-Alz study with simufilam. The study tested simufilam in mild to moderate AD, where results fell short of each of the prespecified co-primary, secondary and exploratory biomarker endpoints.
Voyager Therapeutics Inc. has selected a lead development candidate, VY-1706, for its tau silencing gene therapy program in Alzheimer’s disease. The company anticipates filing an IND application with the FDA and a clinical trial application (CTA) with Health Canada for VY-1706 in 2026.
The bad news keeps piling up for Sage Therapeutics Inc. Having absorbed other study stumbles in the past few months, the company now has halted development of dalzanemdor in treating Huntington’s disease after top-line phase II data showed it missed a statistically significant difference compared to placebo on the primary endpoint.
The EMA has changed its mind about an earlier decision that the risks of Leqembi (lecanemab) outweigh the benefits and is now recommending the Alzheimer’s disease drug is approved for a subgroup of patients. That follows an appeal by Eisai Co. Ltd. and a re-examination of the data, after details relating to 274 patients with two copies of the ApoE4 gene were removed from the file.
At the BioFuture 2024 conference held in New York in November, Seema Kumar, the CEO of Cure, described women’s health as something that has been directed at the “bikini area.” That “bikini” bias extended to both diseases and their causes – women’s health covered the breasts and reproductive system, and its causes were hormonal. Both concepts are far too narrow.
It’s difficult to fathom that the health of half the world’s population is underserved. But it’s a hard truth. There are many conditions that disproportionately impact women. Other conditions and diseases affect women in different ways than men. Decades of research excluding women from clinical trials and investment decisions in male-dominated board rooms have ignored these facts. Though an increasing number of women are now managing investments and driving the research, it’s all still woefully behind. In BioWorld’s new report, Healing the health divide, we’ve highlighted the disparities.
Radiopharmaceutical biotech and contract development and organization firm Duchembio Co. Ltd. filed a securities report to South Korea’s Financial Services Commission Nov. 11, kickstarting the IPO process to list on the Korea Exchange.
Radiopharmaceutical biotech and contract development and organization firm Duchembio Co. Ltd. filed a securities report to South Korea’s Financial Services Commission Nov. 11, kickstarting the IPO process to list on the Korea Exchange.
Reducing microglial activity in the presence of apolipoprotein E4 (APOE4) has uncovered a mechanism associated with the deposition of misfolded amyloid and tau in a novel mouse model of Alzheimer’s disease. By transplanting human neurons into the mouse brain and eliminating the mouse microglia, scientists at the Gladstone Institutes in San Francisco observed that amyloid and tau deposition was reduced. These results support therapeutic strategies that target APOE4 and microglia.
Data from two Alzheimer’s tests being developed by Roche Holding AG showed high accuracy in detecting the disease in patients being tested for the condition. The tests measure biomarkers in the blood linked to Alzheimer’s and will help provide desperately needed information by letting patients know whether they have the disease or not, Margherita Carboni, Neurology Indication Lead at Roche Diagnostics told BioWorld.