Latest news with #ALPHA-1062
Business Wire
7 days ago
- Business
- Business Wire
Alpha Cognition to Report Second Quarter 2025 Financial Results and Operating Overview
VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)--Alpha Cognition Inc. (Nasdaq: ACOG), a biopharmaceutical company dedicated to advancing treatments for neurodegenerative diseases, today announced that it will release financial results for the second quarter on August 14, 2025 after close of market. Following the release, management will host a conference call to review financial and operating results. Conference Call Information: To participate in the conference call, please use the dial-in information below: Participant Listening: 1-877-407-9039 or 1-201-689-8470 or - Participants can use Guest dial-in #s above and be answered by an operator OR click the Call me™ link for instant telephone access to the event. Call me™ link will be made active 15 minutes prior to scheduled start time. The live audio webcast will be accessible here: A replay of the earnings call is available after the conference call has ended. Replay Dial-In: 1-844-512-2921 or 1-412-317-6671 Access ID: 13754595 Replay webcast: About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options. ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as an intranasal formulation for Cognitive Impairment with mTBI.] Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's [ Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at ] These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.
National Post
29-07-2025
- Business
- National Post
Alpha Cognition Announces Partner China Medical System Has NDA Accepted in China for the Review of ZUNVEYL® (Benzgalantamine) for Alzheimer's Disease
Article content VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' [ACI], or the 'Company'), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced China Medical System Holdings Limited (CMS) New Drug Application (NDA) for ZUNVEYL has been accepted by the National Medical Products Administration of China (NMPA) for review for the treatment of mild-to-moderate Alzheimer's dementia. Article content 'We are pleased to announce the NMPA acceptance of the ZUNVEYL New Drug Application, marking a significant milestone in our mission to bring innovative treatments to patients in need,' said Michael McFadden, Chief Executive Officer of Alpha Cognition. 'This acceptance reflects the strength of our partnership with CMS and the dedication of our team. We look forward to working closely with our partner throughout this important review process as we move one step closer to potentially delivering this important therapy to the Asia market.' Article content Alpha Cognition will rely on successful regulatory and commercial expertise of CMS in the Chinese market and will benefit financially from advances in China and other Asia territories. The Company is eligible to receive regulatory, sales milestones, and royalties should ZUNVEYL be approved for marketing in China and other Asia territories. Article content According to the epidemiological study results published in the Lancet Public Health, there are about 7.93 million patients with mild-to-moderate Alzheimer dementia in China. With the intensifying aging trend, the number of patients and the consequent disease burden will further increase in the future. The Company anticipates additional progress across other countries with regulatory advancement and ZUNVEYL commercial approvals. Article content About Alpha Cognition Inc. Article content Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options. Article content ALPHA-1062 (benzgalantamine) formulated as a delayed release oral tablet (ZUNVEYL ®), is FDA approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as a sublingual formulation for cognitive Impairment with mTBI. Article content ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer's type in adults. Article content IMPORTANT SAFETY INFORMATION Article content CONTRAINDICATIONS Article content ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or to any inactive ingredients in ZUNVEYL. Serious skin reactions have occurred. Article content WARNINGS AND PRECAUTIONS Article content Serious Skin Reactions Article content : Serious skin reactions (Stevens-Johnson syndrome and acute generalized exanthematous pustulosis) have been reported in patients receiving galantamine (the active metabolite of ZUNVEYL tablets). If signs or symptoms suggest a serious skin reaction, use of this drug should not be resumed, and alternative therapy should be considered. Article content Anesthesia Article content : See Drug Interactions Section Article content Cardiovascular Conditions: Article content Cholinesterase inhibitors, including ZUNVEYL, have vagotonic effects on the sinoatrial and atrioventricular nodes, leading to bradycardia and AV block. Bradycardia and all types of heart block have been reported in patients taking cholinesterase inhibitors, both with and without known underlying cardiac conduction abnormalities. Therefore, all patients should be considered at risk for adverse effects on cardiac conduction. Article content Patients treated with galantamine up to 24 mg/day using the recommended dosing schedule showed a dose-related increase in risk of syncope. Article content Gastrointestinal Conditions Article content : Cholinesterase inhibitors, including ZUNVEYL, may increase gastric acid secretion. Patients should be monitored closely for active or occult gastrointestinal bleeding, especially those with a history of ulcer disease or those receiving concurrent nonsteroidal anti-inflammatory drugs (NSAIDs). Clinical studies of galantamine have shown no increase, relative to placebo, in the incidence of either peptic ulcer disease or gastrointestinal bleeding. Article content Galantamine has been shown to produce nausea, vomiting, diarrhea, anorexia, and weight loss. Monitor the patient's weight during therapy with ZUNVEYL. Article content Genitourinary Conditions: Article content Although this was not observed in clinical trials with galantamine, cholinesterase inhibitors, including ZUNVEYL, may cause bladder outflow obstruction. Article content Neurological Conditions: Article content Cholinesterase inhibitors are believed to have some potential to cause generalized convulsions. Seizure activity may also be a manifestation of Alzheimer's disease. Patients with Alzheimer's disease should be monitored closely for seizures while taking ZUNVEYL. Article content Pulmonary Conditions: Article content Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of severe asthma or obstructive pulmonary disease. Monitor for respiratory adverse reactions. Article content ADVERSE REACTIONS Article content The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Article content DRUG INTERACTIONS Article content Use with Anticholinergics: Article content Galantamine has the potential to interfere with the activity of anticholinergic medications. Article content Use with Cholinomimetics and Other Cholinesterase Inhibitors: Article content A synergistic effect is expected when cholinesterase inhibitors are given concurrently with succinylcholine, other cholinesterase inhibitors, similar neuromuscular blocking agents or cholinergic agonists such as bethanechol. Article content USE IN SPECIFIC POPULATIONS Article content Pregnancy: Article content Based on animal data may cause fetal harm. Article content Hepatic Impairment: Article content In patients with moderate hepatic impairment, a decrease in clearance of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with severe hepatic impairment is not recommended. Article content Renal Impairment: Article content In patients with a creatinine clearance of 9 to 59 mL/min, an increase in exposure of galantamine was observed; therefore, a dosage adjustment is recommended. Use of ZUNVEYL in patients with creatinine clearance less than 9 mL/min is not recommended. Article content These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. Article content Forward-looking Statements Article content This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company's timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company's planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company's business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company's potential growth opportunities in China, the timing and results of the Company's milestone payments for China, the Company's regulatory submissions in China, and the potential regulatory approval and commercialization of the Company's products in China. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law. 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Business Insider
02-07-2025
- Health
- Business Insider
Alpha Cognition shares preclinical data for TBI drug ALPHA-1062
Alpha Cognition (ACOG) announced preclinical data supporting the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury, or mTBI. The study, supported by the U.S. Department of Defense and conducted with VA investigators, demonstrated that ALPHA-1062 administration following blast-induced mTBI resulted in a notable reduction in indices of TBI-associated neuropathology, including toxic forms of brain protein Tau. These changes suggest a potential role for ALPHA-1062 in treating TBI and possibly reducing the risk of later Alzheimer's disease. Next steps include formulation for sublingual administration and a bridging pharmacokinetic study. Don't Miss TipRanks' Half-Year Sale Take advantage of TipRanks Premium at 50% off! Unlock powerful investing tools, advanced data, and expert analyst insights to help you invest with confidence. Make smarter investment decisions with TipRanks' Smart Investor Picks, delivered to your inbox every week.
Business Wire
01-07-2025
- Health
- Business Wire
Alpha Cognition Announces Positive Pre-Clinical Data for ALPHA-1062 Use in a Military Relevant Model of Repetitive Mild Traumatic Brain Injury
VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)--Alpha Cognition Inc. (Nasdaq: ACOG) ('Alpha Cognition' [ACI], or the 'Company'), a biopharmaceutical company developing novel therapies for debilitating neurodegenerative disorders, today announced preclinical data supporting the continued development of ALPHA-1062 for the treatment of mild traumatic brain injury (mTBI). The data provides additional evidence of benefits of ALPHA-1062, in the treatment of mTBI resulting from repetitive blast trauma, a highly relevant military injury. Service related mTBI results in a high incidence of persistent physical and emotional challenges for patients, impacting their quality of life and that of their families. Additionally, a history of mTBI increases the risk of dementia diagnosis later in life. Data analysis for this study, supported by the US Department of Defense and conducted in collaboration with US Department of Veterans Affairs investigators and the Seattle Institute of Biomedical and Clinical Research, has been concluded, demonstrating that ALPHA-1062 administration following blast induced mTBI, results in a notable reduction in indices of TBI associated neuropathology. ALPHA-1062 administration reduced the brain levels of three toxic forms of a brain protein Tau. One of these forms (pTau 217) has been suggested to identify TBI patients at greater risk of long-term cognitive decline. It is also one of the earliest emerging biomarkers in Alzheimer's disease. A second form of toxic Tau (pTau-S202/T205) can be found in very early-stage pathology in the brains of Alzheimer's patients before the appearance plaques and tangles. The third form (pTau 231) is elevated in early Alzheimer's disease and TBI. Taken together, reduction of these toxic forms of pTau suggests a potential role for ALPHA-1062 in the treatment of TBI and that this may additionally positively impact the risk of later developing Alzheimer's disease. Additional benefits of ALPHA-1062 were observed following blast trauma. High dose ALPHA-1062 reduced the numbers of myeloid cells which play a critical role in neuroinflammation and tissue repair, as well as the number of astrocytes, which regulate neurotransmitters like glutamate and GABA to support neuronal health. These changes are consistent with reduced neuroinflammation following ALPHA-1062 administration. Finally, nerve growth factor receptor expression, which plays an important role in neuronal survival, was increased in an ALPHA-1062 dose-dependent manner. 'These outcomes are in agreement with those of an earlier pre-clinical study in a moderate TBI animal model, both studies demonstrated protective effects of ALPHA-1062, providing support for the continued development of ALPHA-1062 for the treatment of traumatic brain injury,' said Denis Kay, ACI's Chief Scientific Officer. Alpha Cognition's next steps in this program will be to complete formulation of ALPHA-1062 for sublingual administration and conduct a bridging pharmacokinetic study vs. ZUNVEYL® (Benzgalantamine) and an existing intranasal formulation of ALPHA-1062. About Alpha Cognition Inc. Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options. ALPHA-1062 formulated as a delayed release oral tablet ZUNVEYL (Benzgalantamine) is FDA approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as a sublingual formulation for cognitive Impairment with mTBI. Forward-looking Statements This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Forward‐looking statements may include statements regarding the potential benefits of the licensing agreement for the development and commercialization of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand, the Company's timing and planned activities to launch ZUNVEYL in the U.S. and China, the timing for the Company's planned corporate update call, the potential timing for the availability of ZUNVEYL in the U.S. and China, the potential future developments of ZUNVEYL in China, the potential market size for ZUNVEYL in China, the Company's business strategy for the launch of ZUNVEYL in China, the market size and demand for ZUNVEYL in China, the Company's potential growth opportunities in China, the timing and results of the Company's milestone payments for China, the Company's regulatory submissions in China, and the potential regulatory approval and commercialization of the Company's products in China. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law.
National Post
01-05-2025
- Business
- National Post
Alpha Cognition to Report First Quarter 2025 Financial Results and Operating Overview
Article content VANCOUVER, British Columbia & DALLAS — Alpha Cognition Inc. (Nasdaq: ACOG), a biopharmaceutical company dedicated to advancing treatments for neurodegenerative diseases, today will announce financial results for the first quarter ended March 31, 2025 on May 15, 2025 after close of market. Article content Following the release, management will host a conference call to review financial and operating results. Article content Conference Call Information: Article content To participate in the conference call, please use the dial-in information below: Article content 1-877-407-9039 or 1-201-689-8470 Article content Note, you can avoid long wait times for the operator by using the Call me™ feature and clicking the link below 15 minutes prior to the scheduled call start time: Article content The live audio webcast will be accessible here: Article content For a replay of the audio webcast: Article content About Alpha Cognition Inc. Article content Alpha Cognition Inc. is a commercial stage, biopharmaceutical company dedicated to developing treatments for patients suffering from neurodegenerative diseases, such as Alzheimer's disease and Cognitive Impairment with mild Traumatic Brain Injury ('mTBI'), for which there are currently no approved treatment options. Article content ZUNVEYL is a patented drug approved as a new generation acetylcholinesterase inhibitor for the treatment of Alzheimer's disease, with expected minimal gastrointestinal side effects. ZUNVEYL's active metabolite is differentiated from donepezil and rivastigmine in that it binds neuronal nicotinic receptors, most notably the alpha-7 subtype, which is known to have a positive effect on cognition. ALPHA-1062 is also being developed in combination with memantine to treat moderate to severe Alzheimer's dementia, and as an intranasal formulation for Cognitive Impairment with mTBI. Article content Forward-looking Statements Article content This news release includes forward-looking statements within the meaning of applicable securities laws. Except for statements of historical fact, any information contained in this news release may be a forward‐looking statement that reflects the Company's current views about future events and are subject to known and unknown risks, uncertainties, assumptions and other factors that may cause the actual results, levels of activity, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. In some cases, you can identify forward‐looking statements by the words 'may,' 'might,' 'will,' 'could,' 'would,' 'should,' 'expect,' 'intend,' 'plan,' 'objective,' 'anticipate,' 'believe,' 'estimate,' 'predict,' 'project,' 'potential,' 'target,' 'seek,' 'contemplate,' 'continue' and 'ongoing,' or the negative of these terms, or other comparable terminology intended to identify statements about the future. Although the Company believes to have a reasonable basis for each forward-looking statement, we caution you that these statements are based on a combination of facts and factors currently known by us and our expectations of the future, about which we cannot be certain. The Company cannot assure that the actual results will be consistent with these forward-looking statements. These forward-looking statements are subject to certain risks, including risks regarding our ability to raise sufficient capital to implement our plans to commercialize ZUNVEYL, risks regarding the efficacy and tolerability of ZUNVEYL, risks related to ongoing regulatory oversight on the safety of ZUNVEYL, risk related to market adoption of ZUNVEYL, risks related to the Company's intellectual property in relation to ZUNVEYL, risks related to the commercial manufacturing, distribution, marketing and sale of ZUNVEYL, risks related to product liability and other risks as described in the Company's filings with Canadian securities regulatory authorities and available at and the Company's filings with the United States Securities and Exchange Commission (the 'SEC'), including those risk factors under the heading 'Risk Factors' in the Company's Form S-1/A registration statement as filed with the SEC on November 6, 2024 and available at These forward‐looking statements speak only as of the date of this news release and the Company undertakes no obligation to revise or update any forward‐looking statements for any reason, even if new information becomes available in the future, except as required by law. Article content Article content Article content Article content Article content
