Zunveyl (benzgalantamine) / Alpha Cognition - LARVOL DELTA

Benzgalantamine (Zunveyl) for Alzheimer's disease. (PubMed, Med Lett Drugs Ther) - No abstract available

Journal • Alzheimer's Disease • CNS Disorders

Alpha Cognition Announces the Commercial Launch of ZUNVEYL (Benzgalantamine) for the Treatment of Mild to Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition Inc...announced the official commercial launch of ZUNVEYL, a new treatment for mild to moderate Alzheimer’s disease....ZUNVEYL is designed to provide a differentiated treatment option for patients with mild to moderate Alzheimer’s disease, offering an alternative for those who may have limited options. With the commercial launch now underway, Alpha Cognition is engaging with healthcare providers, payers, and caregivers to support patient access and education. Patients can now access ZUNVEYL in three doses (5 mg, 10 mg, and 15 mg) through a prescription that can be filled at pharmacies nationwide."

Launch US • Alzheimer's Disease

Alpha Cognition Secures Additional U.S. Patent for ZUNVEYL (benzgalantamine) in the Treatment of Mild to Moderate Alzheimer’s disease (Businesswire) - "Alpha Cognition Inc...today announced that the United States Patent and Trademark Office (USPTO) has granted a new patent titled 'Coated Tablets for pH-Dependent Release of Benzgalantamine.'....With this approval, ZUNVEYL has patent protection in the United States through 2044, supporting the Company’s long-term growth strategy as it prepares for commercialization....ZUNVEYL will be available by prescription in pharmacies nationwide in Q1 2025."

Launch US • Patent • Alzheimer's Disease

Alpha Cognition Announces a $44 Million Exclusive Licensing Agreement for the Development and Commercialization of ZUNVEYL (benzgalantamine), an FDA-Approved Treatment for Mild-to-Moderate Alzheimer’s Disease, in China (Businesswire) - "Alpha Cognition, Inc...and China Medical System Holdings Limited...today announced an exclusive licensing agreement for the development, manufacturing and commercialization of ZUNVEYL (benzgalantamine) in Asia (excluding Japan), Australia and New Zealand. ZUNVEYL is a next generation acetylcholinesterase inhibitor approved in the US for the treatment of mild-to-moderate Alzheimer’s disease. Terms of the agreement total $44 million, which includes $6 million in total upfront payments split into tranches and development and commercial milestone payments. Additionally, ACI is eligible to receive royalties on net sales of ZUNVEYL in Asia (excluding Japan), Australia and New Zealand."

Commercial • Alzheimer's Disease • CNS Disorders

Alpha Cognition to Present Q1 2025 ZUNVEYL (benzgalantamine) Launch Strategy Targeting the $2 Billion U.S. Alzheimer’s Long-Term Care Market During Investor Update Call (Businesswire) - "Alpha Cognition Inc...today announced it will host an investor update call on Tuesday, January 28th, 2025 at 4pm EST to present its commercial launch strategy for ZUNVEYL (benzgalantamine), an FDA-approved treatment for mild-to-moderate Alzheimer’s disease (AD). The call will focus on the company’s plans to address the needs of a growing patient population within the $2 billion long-term care market in the U.S...Alpha Cognition’s leadership team will provide key updates on the Q1 2025 commercial launch strategy, including market positioning, launch strategy, and long-term growth objectives."

Commercial • Launch US • Alzheimer's Disease • CNS Disorders

Alpha Cognition Announces Partial Exercise of Over-allotment Option (Businesswire) - "Alpha Cognition Inc...today announced that the underwriters of its underwritten U.S. public offering (the 'Offering') have partially exercised their over-allotment option to purchase an additional 488,506 common shares at the public offering price of US$5.75 per share for an additional US$2.8 million in gross proceeds....The Company intends to use the proceeds towards the commercialization and launch of ZUNVEYL in Alzheimer’s Disease, further research and development of its pipeline product candidates, continued commercial CMC activities (chemistry, manufacturing, and controls), and for working capital and general corporate purposes."

Financing • Alzheimer's Disease • CNS Disorders

Alpha Cognition Receives Notice of Allowance for Composition-of-Matter Patent for ZUNVEYL for Mild to Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition Inc...is pleased to announce that the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No. 18/434,155, entitled 'Coated Tablets for pH-Dependent Release of benzgalantamine,' which includes claims covering tablet forms of benzgalantamine (ZUNVEYL). This composition of matter patent, once issued, provides protection for the current formulation of ZUNVEYL and complements other patents that the company holds for benzgalantamine and provides protection in the United States through 2044."

Patent • Alzheimer's Disease • CNS Disorders

Alpha Cognition Receives Notice of Allowance for Composition-of-Matter Patent for ZUNVEYL for Mild to Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition Inc...is pleased to announced the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No. 18/463,157, entitled 'Solid Forms of ALPHA-1062 Gluconate,' which includes claims covering an additional novel crystalline solid form of ZUNVEYL and complements existing patents that the Company holds for ZUNVEYL. The patent provides protection for a second commercially viable form of the drug. A Notice of Allowance is issued after the USPTO makes the determination that the claimed invention is patentable, and a patent should be granted from an application."

Patent • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies

Alpha Cognition Announces Financial Results for the Second Quarter and Six Months Ended June 2024 and Provides Corporate Update (Businesswire) - "Research and development (R&D) expenses were $0.9 million for the three months ended June 30, 2024, and $1.9 million for the six months ended June 30, 2024, compared to $1.3 million and $2.4 million in the same periods in 2023, respectively. R&D expenses decreased from the prior year primarily due to the completion of the main clinical trails for ZUNVEYL in AD and the majority of the NDA filing expenditures having been incurred during 2023."

Commercial • Alzheimer's Disease • CNS Disorders

Alpha Cognition’s Oral Therapy ZUNVEYL Receives FDA Approval to Treat Alzheimer's Disease (Businesswire) - "Alpha Cognition...announces that the U.S. Food and Drug Administration (FDA) has granted approval for ZUNVEYL (benzgalantamine) previously known as ALPHA-1062, for the treatment of mild-to-moderate Alzheimer's disease. Alzheimer’s disease (AD) is a progressive brain disorder that slowly destroys memory, thinking skills, and eventually the ability to do simple tasks, like carry on a conversation. AD is the most common form of dementia affecting nearly 7 million people, and is the leading cause of nursing home admissions and deaths, with 70% of all nursing home residents suffering with AD."

FDA approval • Alzheimer's Disease • CNS Disorders

Alpha Cognition Files U.S. Patent Application Covering an ALPHA-1062 Oral Formulation to Treat Mild to Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition...is pleased to announce that it has filed a new composition-of-matter patent that secures broad protection for its lead asset, ALPHA-1062, currently under review by the FDA for mild-to-moderate Alzheimer’s Disease. The present composition-of-matter patent application is filed for approval with the USPTO and may be extended to pursue protection throughout the world and, if approved, will secure composition-of-matter protection for an oral formulation of ALPHA-1062....If approved, the patent will provide protection for ALPHA-1062 into 2044, adding to other patent protection that currently protect ALPHA-1062 through 2042."

Patent • Alzheimer's Disease

Alpha Cognition Announces FDA Acceptance of New Drug Application for ALPHA-1062 for Mild-to-Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition...is pleased to announce that the U.S. Food and Drug Administration (FDA) has completed its filing review and has accepted the company’s New Drug Application (NDA) for ALPHA-1062, a proprietary, patented, delayed release oral tablet formulation in development for the treatment of mild-to-moderate Alzheimer’s Disease. The NDA has been granted a Prescription Drug User Fee Act (PDUFA) goal date of July 27th, 2024. The NDA submission is based on results from four studies the Company conducted demonstrating bioequivalence for ALPHA-1062 to galantamine and galantamine ER."

NDA • PDUFA date • Alzheimer's Disease

Alpha Cognition Announces Third Quarter and Nine Months Ended September 30, 2023, Results and Provides Corporate Update (Businesswire) - "Research and development (R&D) expenses were $1.5 million for the three months ended September 30, 2023, and $3.9 million for the nine months ended September 30, 2023, compared to $1.6 million and $6.4 million in the same periods in 2022, respectively. R&D expenses decreased from the prior year primarily due to the completion during 2022 of the main clinical trails for ALPHA-1062."

Commercial • Alzheimer's Disease • CNS Disorders

Atypical hypertrophy of retinal pigment epithelium manifesting as the first sign of familial adenomatous polyposis. (PubMed, BMJ Case Rep) - "Pathology did not reveal submucosal invasion. Genetic testing detected an adenomatous polyposis coli mutation (heterozygotic variant c.3183_3187delACAAA p.(Gln1062*))."

Journal • Colon Cancer • Colonic Polyps • Colorectal Cancer • Gastroenterology • Gastrointestinal Cancer • Genetic Disorders • Oncology • Ophthalmology • Solid Tumor

Alpha Cognition Announces Submission of New Drug Application to the FDA for ALPHA-1062 for Mild-to-Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition...is pleased to announce the submission of a New Drug Application ('NDA') to the U.S. Food and Drug Administration ('FDA') for ALPHA-1062, a proprietary, patented, delayed release oral tablet formulation in development for the treatment of mild-to-moderate Alzheimer’s Disease....The NDA submission is based on results from four studies the Company conducted demonstrating bioequivalence for ALPHA-1062 to galantamine and galantamine ER. Adverse events documented across all studies for ALPHA-1062 were less than 2% and no insomnia was observed. The Company expects to receive FDA acceptance of the NDA in Q4 2023."

NDA • Alzheimer's Disease

Alpha Cognition Announces Second Quarter and Six Months Ended 2023 Results and Provides Corporate Update (Businesswire) - "Alpha Cognition continues progress its new drug application (NDA) for ALPHA-1062 in mild-to-moderate Alzheimer’s disease ('AD') which it expects to submit to FDA in September 2023. If the NDA file is accepted by the FDA, it would put Alpha Cognition on track for product approval during the third quarter of-2024....Research and development (R&D) expenses were $1.3 million for the three months ended June 30, 2023, and $2.4 million for the six months ended June 30, 2023, compared to $3.0 million and $4.8 million in the same periods in 2022, respectively. R&D expenses for decreased from the prior year primarily due to the completion during 2022 of the main clinical trails for ALPHA-1062 in AD and overall lower costs associated with advancing clinical development of ALPHA-1062."

Commercial • NDA • Alzheimer's Disease • CNS Disorders

Alpha Cognition Receives Notice of Allowance for U.S. Patent Application covering use of ALPHA-1062 for Mild to Moderate Alzheimer’s Disease (Businesswire) - "Alpha Cognition...is pleased to announced the United States Patent and Trademark Office (USPTO) has issued a Notice of Allowance for patent application No. 17/575,025, titled 'Solid Forms of ALPHA-1062 Gluconate,' which includes claims covering protection for crystalline solid forms of ALPHA-1062 and will bolster existing patents that the company holds....'This patent will provide protection through 2042 in the United States and will allow our team to continue to build on the immense potential that ALPHA-1062 holds for patients and healthcare providers'..."

Patent • Alzheimer's Disease • CNS Disorders • Tauopathies And Synucleinopathies

Alpha Cognition Receives Army Medical Research Grant for Study on Mild Traumatic Brain Injury (mTBI) from Blast Induced Functional Deficit and Brain Pathology (Businesswire) - "Alpha Cognition Inc...is pleased to announce the that it has been awarded a $750,000 grant from the Army Medical Research and Material Command (AMRMC) for a pre-clinical study on the use of ALPHA-1062 Intranasal (IN) to reduce blast mTBI induced functional deficit and brain abnormalities...The study grant will be issued by AMRMC and conducted in collaboration with the Seattle Institute for Biomedical and Clinical Research (SIBCR) and is endorsed by Department of Defense (DOD). The aim of the study is to evaluate the efficacy of ALPHA-1062IN in reducing the adverse effects of repetitive blast induced-mTBI in pre-clinical models....The pre-clinical study is expected to begin in early Q4 of 2023 and continue for a period of 16 months."

Financing • Preclinical • CNS Disorders

Alpha Cognition Announces First Quarter 2023 Results and Provides Corporate Update (Businesswire) - "The Company’s principal 2023 business objectives are to: file an NDA for ALPHA-1062 in mild-to-moderate Alzheimer’s disease during the third quarter of 2023, with possible FDA approval for the U.S. market by Q3 2024; continue to advance its development and commercialization activities for ALPHA-1062 in mild-to-moderate Alzheimer’s disease, including program development and clinical manufacturing for ALPHA-1062; meet with FDA on the Company’s R&D program for Cognitive Impairment with Mild Traumatic Brain Injury ('mTBI') at a pre-IND meeting; and Pursue the out-licensing of its TBI indication to the TBI Company (as defined below), a newly formed and funded company, where the TBI indication can be further developed."

Commercial • FDA event • Licensing / partnership • NDA • Alzheimer's Disease • CNS Disorders

Alpha Cognition Closes Private Placement (Businesswire) - "Alpha Cognition Inc...is pleased to announce that it has closed a second tranche of its previously announced private placement (the 'Offering') of units (the 'Units'). Pursuant to the second tranche, the Company issued 6,952,427 Units of the Company at a price of $0.255 per Unit, for gross proceeds of $1,772,869....Combined with the first tranche the Company issued an aggregate of 23,747,648 Units for total gross proceeds of $6,055,650. The net proceeds from the Offering are expected to be used for the advancement of the Company’s clinical development programs, to complete and file a New Drug Application for ALPHA-1062, and for general corporate purposes."

Commercial • Alzheimer's Disease • CNS Disorders

Alpha Cognition Closes First Tranche of Private Placement (Businesswire) - “Alpha Cognition Inc…is pleased to announce that it has closed the first tranche of its previously announced private placement (the ‘Offering’). Pursuant to the Offering, the Company issued 16,795,221 units of the Company (the ‘Units’) at a price of $0.255 per Unit, for gross proceeds of $4,282,781….As of the date of this news release the Company has also received subscription agreements towards a second tranche closing for an additional 6.48 million shares or $1.65M under the Offering. The second tranche is expected to close around the end of February 2023….The Company expects to use the net proceeds from the Offering…for the advancement of the Company’s clinical development programs, complete and file a New Drug Application for ALPHA-1062, and for working capital and other general corporate purposes.”

Commercial • Alzheimer's Disease • CNS Disorders

Alpha Cognition Announces Marketed Offering (GlobeNewswire) - "Alpha Cognition Inc...is pleased to announce it has commenced a marketed public offering (the 'Offering') of units (the 'Units') for up to $10 million....The Over-Allotment Option may be exercised in whole or in part to purchase Common Shares, Warrants or Units as determined by the Agents upon written notice to the Company at any time up to 30 days following the closing date of the Offering. The Offering will be conducted pursuant to the Company’s Canadian base shelf prospectus dated February 24, 2022 (the 'Base Shelf Prospectus')....The Company intends to use the net proceeds of the Offering towards clinical development and marketing of its Alpha-1062 and Alpha-0602 formulations and for working capital and general corporate purposes."

Commercial • Alzheimer's Disease • Amyotrophic Lateral Sclerosis • CNS Disorders

Alpha Cognition Announces Positive Topline Results from Bioequivalence Study with ALPHA-1062 in Development for Alzheimer’s Disease (Businesswire) - P=N/A | N=N/A | “Alpha Cognition Inc…announced positive results from a bioequivalence study with ALPHA-1062…for the treatment of mild to moderate Alzheimer’s Disease (AD)….These data, coupled with the positive pivotal data released in June, establish bioequivalence to both formulations of galantamine hydrobromide and strengthen the NDA application for ALPHA-1062 in mild-to-moderate AD, planned for Q2 2023….In the pre-specified primary analysis, ALPHA-1062 achieved area-under-the-curve and peak exposures of approximately 107% and 127%, respectively, compared to those generated by galantamine hydrobromide ER. As expected, Cmax results for ALPHA-1062 is bracketed between galantamine hydrobromide IR and ER (lower than IR, higher than ER) providing a robust and enhanced data set for the NDA filing.”

Clinical data • NDA • PK/PD data • Alzheimer's Disease • CNS Disorders

A Quantitative-EEG Assessment of Alpha-1062, a Novel Pro-Drug of Galantamine for the Treatment of Mild to Moderate Dementia Associated with Alzheimer’s Disease. (AAIC 2022) - No abstract available

Alzheimer's Disease • CNS Disorders • Dementia

Alpha Cognition Announces Positive Results from Pivotal Study with ALPHA-1062 in Development for Alzheimer’s Disease (Businesswire) - P2 | N=N/A | “Topline results confirmed in fed and fasted bioequivalence studies that ALPHA-1062 achieved bioequivalent area-under-the-curve and peak exposures relative to galantamine hydrobromide IR. Data were within the required pharmacokinetic range of prior data demonstrated with galantamine hydrobromide ER. There were no adverse events reported for ALPHA-1062 during these studies. With these positive pivotal study results, Alpha Cognition plans to file an NDA for ALPHA-1062 in mild to moderate AD in Q2 2023….‘If approved by the FDA, ALPHA-1062 could provide an exciting next-generation treatment option for patients living with Alzheimer’s Disease.’”

NDA • P2 data • Alzheimer's Disease • CNS Disorders