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VANCOUVER & DALLAS - Alpha Cognition Inc. (NASDAQ:ACOG) announced Tuesday that its Alzheimer’s treatment ZUNVEYL has reached a regulatory milestone in China, with the country’s National Medical Products Administration (NMPA) accepting a New Drug Application for review.
The application, submitted by Alpha Cognition’s partner China Medical System Holdings Limited (CMS), seeks approval for ZUNVEYL to treat mild-to-moderate Alzheimer’s dementia in the Chinese market.
"This acceptance reflects the strength of our partnership with CMS and the dedication of our team," said Michael McFadden, Chief Executive Officer of Alpha Cognition, in a press release statement.
ZUNVEYL (benzgalantamine) is a delayed release oral tablet that received FDA approval in the United States as an acetylcholinesterase inhibitor for Alzheimer’s disease treatment. The company states the drug is designed to have minimal gastrointestinal side effects compared to existing treatments.
According to epidemiological data cited from Lancet Public Health, approximately 7.93 million patients in China suffer from mild-to-moderate Alzheimer’s dementia. This patient population is expected to increase as the country’s aging trend intensifies. InvestingPro data shows Alpha Cognition’s stock has surged over 50% in the past six months, reflecting growing investor confidence in its market potential. Get access to more exclusive insights and 8 additional ProTips with an InvestingPro subscription.
Under the partnership agreement, Alpha Cognition will rely on CMS’s regulatory and commercial expertise in the Chinese market. The company is eligible to receive regulatory and sales milestones, along with royalties if ZUNVEYL receives marketing approval in China and other Asian territories. With a strong current ratio of 17.14 and more cash than debt on its balance sheet, InvestingPro analysis indicates the company is well-positioned to fund its growth initiatives, though analysts anticipate continued losses this year.
ZUNVEYL’s active metabolite binds to neuronal nicotinic receptors, particularly the alpha-7 subtype, which is associated with cognitive benefits. The most common adverse reactions reported with galantamine tablets include nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite.
In other recent news, Alpha Cognition Inc. announced positive preclinical data for its drug candidate ALPHA-1062, which is being developed to treat mild traumatic brain injury (mTBI). The studies, backed by the US Department of Defense and conducted in collaboration with the US Department of Veterans Affairs and the Seattle Institute of Biomedical and Clinical Research, demonstrated that the drug reduced several markers of brain injury following blast-induced mTBI. This development is particularly relevant for military settings where repetitive blast trauma is common. Additionally, H.C. Wainwright has reiterated its Buy rating for Alpha Cognition, maintaining a $20.00 price target. The firm cites the promising data for ALPHA-1062 as a key reason for its positive outlook. These recent developments highlight the continued progress in Alpha Cognition’s drug pipeline, particularly in addressing brain injuries.
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