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NLS Pharmaceutics Ltd. (Nasdaq: NLSP) is a Swiss clinical-stage biopharmaceutical company focused on the discovery and development of innovative therapies for patients with rare and complex central nervous system (CNS) disorders. Founded in 2015 and headquartered in Zurich, Switzerland, NLS Pharmaceutics is committed to designing affordable, safe, and effective therapeutics aimed at safeguarding and empowering the brain throughout all stages of life.
The company's core mission is to serve patients by developing life-improving drug therapies, particularly targeting rare and complex neurobehavioral and neurocognitive conditions. NLS Pharmaceutics' leading products include Quilience, which is being developed for the treatment of narcolepsy, and Nolazol, aimed at treating ADHD.
Recent Achievements:
- Positive results from Phase 2 clinical trials (NLS-1021) demonstrating the efficacy, tolerability, and safety of Quilience (Mazindol ER) in treating narcolepsy.
- Initiation of a Phase 3 clinical trial program (AMAZE) for Mazindol ER in patients with narcolepsy type 1, following IRB and FDA green light.
- Exclusive worldwide option agreement with Aexon Labs to acquire global development and commercialization rights for Dual Orexin Receptor Agonists, with potential applications in treating narcolepsy, idiopathic hypersomnia, and neurodegenerative disorders like Parkinson’s and Alzheimer’s disease.
- Secured a definitive agreement for the issuance and sale of common shares to generate $1.75 million for working capital and general corporate purposes.
- Publication of a new patent application (PCT/WO2024115797) by Aexon Labs covering dual orexin receptor agonists targeting narcolepsy and neurodegenerative conditions.
- Appointment of Elena Thyen-Pighin as Chief Financial Officer to further strengthen the company's leadership team.
Financial Condition and Market Position:
NLS Pharmaceutics operates in a challenging financial environment but continues to demonstrate resilience through strategic partnerships, clinical trial successes, and innovative research. Despite facing compliance issues with Nasdaq's minimum stockholders' equity requirement, the company has submitted and received approval for a compliance plan to regain its standing.
Leadership and Vision:
The company is led by an experienced management team with a proven track record in developing and commercializing therapeutic products. CEO Alex Zwyer emphasizes a patient-first approach, valuing partnership, integrity, and innovation. NLS Pharmaceutics remains committed to advancing its pipeline and maximizing shareholder value through strategic actions and partnerships aligned with its core mission.
For more information, please visit NLS Pharmaceutics.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) announced that the FDA has accepted its Investigational New Drug application for Quilience (mazindol ER), the lead candidate for treating narcolepsy. The company plans to launch a Phase 2a clinical trial in August 2021 across the U.S. and Europe, enrolling about 60 patients. The primary objective is to assess changes in excessive daytime sleepiness using the Epworth Sleepiness Scale, with secondary endpoints related to cataplexy attacks. This milestone emphasizes NLS's commitment to developing treatments for central nervous system disorders.
STANS, SWITZERLAND / ACCESSWIRE / July 9, 2021 / NLS Pharmaceutics Ltd. (NASDAQ:NLSP)(NASDAQ:NLSPW) announced that CEO Alex Zwyer will present a corporate overview at the First Annual Access to Giving Virtual Investor Conference from July 13-15, 2021. The presentation is scheduled for July 15th at 9:00 am ET, followed by a Q&A session. NLS focuses on innovative therapies for rare central nervous system disorders, with its lead candidate, Quilience®, aimed at treating narcolepsy, receiving Orphan Drug Designations in the U.S. and Europe.
NLS Pharmaceutics Ltd. (NASDAQ: NLSP) will present a corporate overview at the LD Micro Virtual Invitational Conference from June 8-10, 2021. CEO Alex Zwyer is set to deliver the presentation on June 10 at 11:30 AM ET on Track 2. The company's lead product, Quilience®, a controlled-release formulation of mazindol, is designed to treat narcolepsy and has received Orphan Drug Designations in both the U.S. and Europe. NLS completed a successful Phase 2 study on mazindol CR for ADHD, meeting all study endpoints.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP) is set to present a corporate overview at the MicroCap Rodeo 2021 Summer Solstice Conference from June 1-4, 2021. CEO Alex Zwyer will deliver the presentation on June 2 at 8:30 AM ET and will engage in one-on-one meetings throughout the event. The presentation will be webcast live, with a replay available for later viewing. NLS is focused on developing therapies for rare central nervous system disorders, with its lead product candidate, Quilience®, targeting narcolepsy. For more details and to register, visit the company’s website.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP) announced new study data confirming mazindol's mechanism of action as an Orexin-2 receptor (OX2R) agonist, essential for treating narcolepsy. In a pre-clinical study, genetically modified mice demonstrated significantly reduced sensitivity to mazindol, reinforcing its potent neurochemical activity. Ongoing studies aim to expand on these findings, emphasizing mazindol's potential dual mechanism of action in addressing narcolepsy's core symptoms. The company remains committed to developing Quilience®, a controlled-release formulation of mazindol, with hopes of improving treatment efficacy.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP) has appointed Dr. Silvia Panigone as Chief Operating Officer, effective immediately. Dr. Panigone brings over 25 years of experience in healthcare, having previously led ADYA Consulting and served in various roles within international pharmaceutical companies. Her expertise will be pivotal as NLS advances its lead drug, Quilience®, designed for treating narcolepsy. The company aims to secure IND approval in the U.S. and move Quilience into clinical stages, addressing significant unmet medical needs in CNS disorders.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP) announced the issuance of Canadian Patent No. 3016852 for its controlled-release mazindol formulation aimed at treating ADHD and related disorders. This patent provides intellectual property protection for a multilayer tablet combining immediate and sustained-release properties. CEO Alex Zwyer emphasized the potential of Quilience® to address unmet needs in narcolepsy treatment. NLS's European patent application is also progressing, with a Phase 2 clinical study for Quilience planned. The company holds Orphan Drug Designations for this drug in the U.S. and Europe.
NLS Pharmaceutics Ltd. (NLSP) has entered a License Agreement with Novartis Pharma AG, securing exclusive rights in the U.S. for all data related to the NDA for Sanorex® (mazindol). This agreement also extends non-exclusively outside the U.S., excluding Japan. The CEO stated this acquisition may streamline clinical processes and reduce costs, enhancing the development of Quilience®, a controlled release formulation of mazindol aimed at treating narcolepsy and related sleep disorders. Quilience has received Orphan Drug Designation in the U.S. and Europe.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW), a clinical-stage biopharmaceutical company, announced CEO Alex Zwyer will present at key investor conferences. The events include the Livingston Securities Healthcare and Emerging Growth CEO Series on February 25, 2021, at 11:30 AM ET and the Maxim 2021 Emerging Growth Virtual Conference on March 17, 2021. NLS is focused on developing treatments for rare central nervous system disorders, with its lead candidate Quilience®, a formulation of mazindol, targeting narcolepsy. The company has successfully completed a Phase 2 study for ADHD and holds Orphan Drug Designations in the U.S. and Europe.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP) announced the closing of its initial public offering, raising approximately $20.0 million by selling 4,819,277 units at $4.15 per unit. Each unit consists of one common share and one warrant, both of which began trading on the Nasdaq Capital Market on January 29, 2021. The warrants are exercisable immediately at the same price and expire in five years. NLS also granted underwriters a 45-day option to purchase additional shares and warrants. The funds will support the development of their lead product candidate, Quilience®, for treating narcolepsy.
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