Succinylcholine Chloride

VANCOUVER, British Columbia & DALLAS--(BUSINESS WIRE)--Alpha Cognition Inc. (NASDAQ: ACOG) (the “Company” or “Alpha Cognition”) today announced three upcoming presentations at the 2025 Alzheimer’s Association International Conference (the “AAIC”), taking place July 27–31, 2025 in Toronto, Canada. The presentations will highlight clinical studies supporting ZUNVEYL (benzgalantamine), the Company’s lead product and a novel galantamine prodrug approved by the FDA in July 2024 and commercially launched in March 2025. The studies demonstrated bioequivalence to galantamine IR and ER and were integral to the NDA submission and approval. “We’re excited to share data that underscore ZUNVEYL’s potential to deliver meaningful clinical benefit to patients,” said Dr. Denis Kay, Chief Scientific Officer at Alpha Cognition. “We believe ZUNVEYL offers an attractive new option for Alzheimer’s disease patients and caregivers.” Presentation Schedule at AAIC 2025: Bioequivalence to Galantamine ER under Steady State Conditions Poster #107147 | July 27, 2025 Bioequivalence to Galantamine IR under Fed and Fasting Conditions Poster #107030 | July 28, 2025 Dose Proportionality Across 5–15 mg Range under Fasting Conditions Poster #107255 | July 30, 2025 About ZUNVEYL ZUNVEYL is a twice-daily treatment designed to address the cognitive symptoms of mild-to-moderate Alzheimer’s disease. By enhancing cholinergic function in the brain, ZUNVEYL supports memory, learning, and overall cognitive function, offering a meaningful improvement for patients and their caregivers. Targeted for the long-term care market, ZUNVEYL is uniquely positioned to address the needs of a growing patient population in a segment valued at $2 billion annually in the United States. Alpha Cognition is committed to ensuring ZUNVEYL is accessible to patients and caregivers, supported by robust market access strategies and a dedicated commercial team. 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. For more information, please visit www.alphacognition.com. INDICATION ZUNVEYL is a cholinesterase inhibitor indicated for the treatment of mild to moderate dementia of the Alzheimer’s type in adults. IMPORTANT SAFETY INFORMATION Contraindications ZUNVEYL is contraindicated in patients with known hypersensitivity to benzgalantamine, galantamine, or any inactive ingredients in ZUNVEYL. Warnings and Precautions Serious Skin Reactions: 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. Cardiovascular conditions: Cholinesterase inhibitors, including ZUNVEYL, may have vagotonic effects on the sinoatrial and atrioventricular nodes. These effects may manifest as bradycardia or heart block in patients both with and without known underlying cardiac conduction abnormalities. Syncopal episodes have been reported in association with the use of donepezil. Peptic ulcer disease and gastrointestinal bleeding: 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). Genitourinary conditions: Although not observed in clinical trials of ZUNVEYL, bladder outflow obstruction may occur. Pulmonary conditions: Cholinesterase inhibitors, including ZUNVEYL, should be prescribed with care to patients with a history of asthma or obstructive pulmonary disease. Monitor for respiratory adverse effects. Adverse Reactions The most common adverse reactions with galantamine tablets (≥5%) were nausea, vomiting, diarrhea, dizziness, headache, and decreased appetite. Drug Interactions Cholinesterase inhibitors, including galantamine, have the potential to interfere with the activity of anticholinergic medications. A synergistic effect may be expected when cholinesterase inhibitors are given concurrently with succinylcholine, similar neuromuscular blocking agents, or cholinergic agonists such as bethanechol. These are not all of the possible side effects of ZUNVEYL. You can report side effects to the FDA. Visit www.fda.gov/MedWatch or call 1‑800‑FDA‑1088. Please click here for Full Prescribing Information. 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 presentation of ZUNVEYL at the 2025 Alzheimer’s Association International Conference, the contraindications of ZUNVEYL, the warning and precautions of ZUNVEYL, the adverse reactions of ZUNVEYL, the clinical benefits of ZUNVEYL to patients, ZUNVEYL’s efficacy and tolerability, ZUNVEYL’s long-term benefits, the Company’s timing and planned activities to launch ZUNVEYL, potential timing for the availability of ZUNVEYL, potential future developments of ZUNVEYL, the potential market size for ZUNVEYL, the Company’s business strategy, market size, potential growth opportunities, capital requirements, clinical development activities, the timing and results of clinical trials, regulatory submissions, potential regulatory approval and commercialization of the Company’s products. 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 www.sedar.com 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 January 10, 2025 and available at www.sec.gov. 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.

Blujepa is the first in a new class of oral antibiotics for uUTIs in nearly 30 years Over half of all women experience a uUTI in their lifetime, with approximately 30% suffering from a recurrent episode Approval based on data from the pivotal phase III EAGLE-2 and EAGLE-3 trials PHILADELPHIA--(BUSINESS WIRE)--GSK plc (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved Blujepa (gepotidacin) for the treatment of female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with uncomplicated urinary tract infections (uUTIs) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus and Enterococcus faecalis. Discovered by GSK scientists, Blujepa is a first-in-class oral antibiotic with a novel mechanism of action that is part of GSK’s infectious diseases portfolio. Tony Wood, Chief Scientific Officer, GSK, said: “The approval of Blujepa is a crucial milestone with uUTIs among the most common infections in women. We are proud to have developed Blujepa, the first in a new class of oral antibiotics for uUTIs in nearly three decades, and to bring another option to patients given recurrent infections and rising rates of resistance to existing treatments.” uUTIs are the most common infection in women, impacting up to 16 million women in the US annually.1-4 Over half of all women are affected by uUTI in their lifetime,5 with approximately 30% suffering from at least one recurrent episode which can cause significant patient burden, including discomfort and restriction of daily activities.6 New treatments are needed as the number of uUTIs caused by drug-resistant bacteria is increasing which can result in higher treatment failure rates.7 Thomas Hooton, MD, Professor of Clinical Medicine, University of Miami School of Medicine said: “For many, uUTIs can be a burden that severely impacts daily life. With an increasing number of patients experiencing recurrent infections, there remains a clear need for continued research of antimicrobials to help address ongoing patient challenges and the strain on healthcare systems.” The approval is based on positive results from the pivotal phase III EAGLE-2 and EAGLE-3 trials which demonstrated non-inferiority to nitrofurantoin, one of the leading current standard of care options for uUTI, in female adults (≥40 kg) and pediatric patients (≥12 years, ≥40 kg) with a confirmed uUTI. In EAGLE-2, Blujepa demonstrated non-inferiority in therapeutic success which occurred in 50.6% (162/320) of participants compared to 47.0% (135/287) for nitrofurantoin (covariate-adjusted treatment difference 4.3%, 95% CI (-3.6, 12.1)). In EAGLE-3, Blujepa demonstrated statistically significant superiority versus nitrofurantoin (one-sided p-value 0.0003). Therapeutic success occurred in 58.5% (162/277) of participants compared to 43.6% (115/264) for nitrofurantoin (covariate-adjusted treatment difference 14.6%, 95% CI (6.4, 22.8)). The safety and tolerability profile of Blujepa in the EAGLE-2 and EAGLE-3 phase III trials was consistent with previous trials. The most commonly reported adverse events (AEs) in Blujepa participants were gastrointestinal (GI). Diarrhea was the most common (16% of participants), followed by nausea (9%). Of the participants who reported GI AEs in the Blujepa group, the most common maximum severity was mild (69% Grade 1) and moderate (28% Grade 2). Participants with Grade 3 GI events accounted for 3% of all patients with GI events and occurred in <1% of all participants. There was one drug-related serious adverse event in each treatment arm (Blujepa and nitrofurantoin) across the two trials. US commercial launch is planned in 2H 2025. The development of Blujepa (gepotidacin) has been funded in part with federal funds from the US Department of Health and Human Services, Administration for Strategic Preparedness and Response, Biomedical Advanced Research and Development Authority (BARDA), under Other Transaction Agreement number HHSO100201300011C and with federal funds awarded by the Defense Threat Reduction Agency under agreement number HDTRA1-07-9-0002. About Blujepa (gepotidacin) Blujepa, discovered by GSK scientists, is a bactericidal, first-in-class triazaacenaphthylene antibiotic that inhibits bacterial DNA replication by a distinct binding site, a novel mechanism of action and for most pathogens, provides well-balanced inhibition of two different Type II topoisomerase enzymes. This provides activity against most target uropathogens (such as Escherichia coli and Staphylococcus saprophyticus), and Neisseria gonorrhoeae, including isolates resistant to current antibiotics. Due to the well-balanced inhibition for most pathogens, Blujepa target-specific mutations in both enzymes are needed to significantly affect susceptibility to Blujepa. Therefore, a lower potential for resistance development is expected. Efficacy and safety in patients have been demonstrated in uUTI and gonorrhea phase III clinical trials, including in patients with drug-resistant pathogens. Please see full Prescribing Information including Medication Guide, available here. About the EAGLE (Efficacy of Antibacterial Gepotidacin Evaluated) phase III program The global phase III clinical program for Blujepa (gepotidacin) in adults and pediatric patients consists of three trials: EAGLE-2 and EAGLE-3 (non-inferiority uUTI trials) compared the efficacy and safety of Blujepa (1,500mg administered orally twice daily for five days) to nitrofurantoin (100mg administered orally twice daily for five days) with 1531 and 1605 female adults and pediatric patients with uUTIs, respectively. Across both trials, the planned duration of follow-up for participants was approximately 28 days, and the primary endpoint, a stringent composite measure of efficacy, was the combined clinical and microbiological response at the Test-of-Cure (ToC) visit (days 10-13) in patients with qualifying uropathogens susceptible to nitrofurantoin. EAGLE-1 (non-inferiority uncomplicated urogenital gonorrhea trial) compared the efficacy and safety of Blujepa to ceftriaxone plus azithromycin in 628 patients with uncomplicated urogenital gonorrhea caused by N. gonorrhoeae. GSK in infectious diseases GSK has pioneered innovation in infectious diseases for over 70 years, and the Company’s pipeline of medicines and vaccines is one of the largest and most diverse in the industry, with a goal of developing preventive and therapeutic treatments for multiple disease areas or diseases with high unmet needs globally. Our expertise and capabilities in infectious disease strongly position us to help prevent disease and mitigate the challenge of antimicrobial resistance (AMR). In antimicrobials, in addition to gepotidacin, GSK entered into an exclusive license agreement with Spero Therapeutics, Inc. in September 2022 to add tebipenem HBr, a late-stage antibiotic and potential treatment for complicated urinary tract infections (cUTIs), to the pipeline and are currently enrolling for PIVOT-PO, a phase III trial. In March 2023, GSK announced an exclusive license agreement with Scynexis for Brexafemme (ibrexafungerp tablets), a first-in-class antifungal for the treatment of vulvovaginal candidiasis (VVC) and reduction in the incidence of recurrent VVC. BLUJEPA (gepotidacin) tablets, for oral use Indication(s) and Important Safety Information (ISI) INDICATION BLUJEPA is indicated for the treatment of female adult and pediatric patients 12 years of age and older weighing at least 40 kilograms (kg) with uncomplicated urinary tract infections (uUTI) caused by the following susceptible microorganisms: Escherichia coli, Klebsiella pneumoniae, Citrobacter freundii complex, Staphylococcus saprophyticus, and Enterococcus faecalis. Usage to Reduce Development of Drug-Resistant Bacteria To reduce the development of drug-resistant bacteria and maintain the effectiveness of BLUJEPA and other antibacterial drugs, BLUJEPA should be used only to treat infections that are proven or strongly suspected to be caused by bacteria. IMPORTANT SAFETY INFORMATION CONTRAINDICATIONS BLUJEPA is contraindicated in patients with a history of severe hypersensitivity to BLUJEPA WARNINGS AND PRECAUTIONS QTc Prolongation A dose and concentration-dependent prolongation of the QTc interval has been observed with BLUJEPA. Avoid use of BLUJEPA in patients with a history of QTc prolongation or with relevant pre-existing cardiac disease, patients taking antiarrhythmic agents, and in patients receiving drugs that prolong the QT interval. Due to an increase in BLUJEPA exposure, avoid concomitant administration of BLUJEPA with strong CYP3A4 inhibitors, in patients with severe hepatic impairment (Child-Pugh Class C), and in patients with severe renal impairment (estimated glomerular filtration rate [eGFR] < 30 mL/min) Acetylcholinesterase inhibition Dysarthria and other adverse reactions potentially attributed to acetylcholinesterase inhibition have been reported with BLUJEPA, an acetylcholinesterase inhibitor. Increased cholinergic effects can be associated with severe adverse effects including atrioventricular block, bradycardia, bronchospasm, seizures/convulsions, and vasovagal syncope. Monitor patients with underlying medical conditions that may be exacerbated by acetylcholinesterase inhibition and patients receiving succinylcholine-type neuromuscular blocking agents, systemic anticholinergic medications, or non-depolarizing neuromuscular blocking agents Hypersensitivity Reactions Hypersensitivity reactions, including anaphylaxis, have been reported in patients receiving BLUJEPA. If an allergic reaction to BLUJEPA occurs, discontinue the drug and institute appropriate supportive measures. Clostridioides difficile-Associated Diarrhea Clostridioides difficile Infection (CDI) has been reported with nearly all systemic antibacterial agents, including BLUJEPA. Evaluate patients who develop diarrhea ADVERSE REACTIONS The most common adverse reactions occurring in ≥1% of patients are diarrhea, nausea, abdominal pain, flatulence, headache, soft feces, dizziness, vomiting, and vulvovaginal candidiasis DRUG INTERACTIONS CYP3A4 Inhibitors: Avoid coadministration of BLUJEPA with strong CYP3A4 inhibitors due to increased gepotidacin exposure CYP3A4 Inducers: Avoid coadministration of BLUJEPA with strong CYP3A4 inducers due to decreased gepotidacin exposure CYP3A4 Substrates: Avoid coadministration of BLUJEPA with drugs that are extensively metabolized by CYP3A4 and have a narrow therapeutic window Digoxin: Due to an increase in digoxin exposures, consider monitoring digoxin serum concentration, as appropriate, with concomitant administration of BLUJEPA USE IN SPECIFIC POPULATIONS Renal Impairment: Avoid use of BLUJEPA in patients with severe renal impairment with eGFR <30 ml/min, including those receiving dialysis Hepatic Impairment: Avoid use of BLUJEPA in patients with severe hepatic impairment (Child-Pugh Class C) About GSK GSK is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. Find out more at gsk.com. Cautionary statement regarding forward-looking statements GSK cautions investors that any forward-looking statements or projections made by GSK, including those made in this announcement, are subject to risks and uncertainties that may cause actual results to differ materially from those projected. Such factors include, but are not limited to, those described in the “Risk Factors” section in GSK’s Annual Report on Form 20-F for 2024. Registered in England & Wales: No. 3888792 Registered Office: 79 New Oxford Street London WC1A 1DG References ______________________________ 1 Advani SD, et al. Poster presented at: ISPOR 2024; May 5-8, 2024. Presentation EPH17. 2 Foxman B, et al. Urinary tract infection: self-reported incidence and associated costs. Ann Epidemiol. 2000;10(8):509-15. 3 Foxman B. Urinary Tract Infection Syndromes: Occurrence, Recurrence, Bacteriology, Risk Factors, and Disease Burden. Infect Dis Clin North Am. 2014 28(1):1-13. 4 United States Census Bureau. Age and Sex Composition: 2020. [Available from: https://www2.census.gov/library/publications/decennial/2020/census-briefs/c2020br-06.pdf Last accessed March 2025]. 5 Czajkowski, K, et al. Urinary tract infection in women. Prz Menopauzalny. 2021;20(1):40-7. 6 Little P, et al. Presentation, pattern, and natural course of severe symptoms, and role of antibiotics and antibiotic resistance among patients presenting with suspected uncomplicated urinary tract infection in primary care: observational study. BMJ. 2010;340:b5633. 7 Kaye KS, et al. Antimicrobial resistance trends in urine Escherichia coli isolates from adult and adolescent females in the United States from 2011 to 2019: rising ESBL strains and impact on patient management. Clin Infect Dis 2021;73:1992–1999.