Shares in Dutch RNA editing specialist Proqr Therapeutics NV (NASDAQ:PRQR) surged by as much as 88% Dec. 22 news that Eli Lilly and Co. is substantially expanding an existing preclinical alliance. It is paying Proqr an initial $75 million, which consists of an up-front payment and equity investment, a potential $50 million option fee should it decide to widen the scope of the partnership even further, and up to $2.5 billion in new research, development, and commercialization milestones. Proqr would also receive royalties on any resulting product sales.
Investigators at Relmada Therapeutics Inc. believe the same problem that plagued an earlier phase III effort called Reliance-3 – an “implausibly” high placebo response at certain sites – also foiled the latest phase III study (conducted at overlapping sites) known as Reliance-1, testing REL-1017 (esmethadone), meant as an adjunctive treatment for major depressive disorder.
Following the tone set in an October U.S. FDA Oncologic Drugs Advisory Committee meeting, the agency has issued a complete response letter (CRL) to Y-mabs Therapeutics Inc.’s BLA for Omblastys (131I-omburtamab) to treat central nervous system/leptomeningeal metastasis arising from neuroblastoma.
Anavex Life Sciences Corp. posted positive top-line data from its phase IIb/III study of ANAVEX 2-73-AD-004 (blarcamesine) in treating mild cognitive impairment due to Alzheimer’s disease (AD) and mild AD. The oral small-molecule activator of the sigma-1 receptor (SIGMAR1) met the study’s primary endpoints and key secondary endpoint with statistically significant results.
Eisai Co. Ltd. and Biogen Inc. presented the full data set for the Clarity Alzheimer’s disease trial of lecanemab at the 2022 Clinical Trials on Alzheimer’s Disease, which was simultaneously published in the New England Journal of Medicine. The data supported the top-line results released in September 2022.
Researchers have identified a link between amyloid plaques and dysfunctional neuronal conduction in animal models of Alzheimer’s disease (AD). Their study, which was published in the Dec. 1, 2022, issue of Nature, suggests new ways to think about AD, as well as badly needed potential alternatives to plaque removal to fight the disease.
The shadow of two reported patients’ deaths hovers over Eisai Co Ltd. and Biogen Inc.’s Alzheimer’s disease treatment, lecanemab, as the companies prepare to present phase III study data on the drug later today at the 15th Clinical Trials on Alzheimer's Disease conference.
Rgenta Therapeutics Inc.’s $52 million in a series A money will let the RNA-focused firm pursue its small-molecule drug efforts “for the next two or three years,” as candidates in cancer and neurology make their ways toward the clinic, said co-founder and CEO Simon Xi. “We’ll go where the science leads us,” he told BioWorld, adding that the cash on hand is sufficient to complete a phase I study.
Cajal Neuroscience Inc., a startup seeking new targets to use in medicines for neurodegeneration, has launched with the completion of a $96 million series A financing led by The Column Group and Lux Capital. The company, inspired by the pioneering work of Santiago Ramón y Cajal, is focused on the "mechanistic, spatial and temporal complexity of neurodegeneration" to determine "how, where and when different mechanisms contribute to disease."
Axsome Therapeutics Inc.’s AXS-05 (dextromethorphan + bupropion) has notched another success by hitting its phase III primary endpoint in treating a notoriously difficult Alzheimer’s disease (AD) indication when compared to placebo. Newly released data from the Accord study showed AXS-05, an oral, NMDA receptor antagonist with multimodal activity, statistically significantly delayed time to relapse of AD agitation vs. placebo (p=0.014), which was the primary endpoint.
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