Welcome to our dedicated page for NLS Pharmaceutics Ltd. Ordinary Shares news (Ticker: NLSP), a resource for investors and traders seeking the latest updates and insights on NLS Pharmaceutics Ltd. Ordinary Shares stock.
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. has engaged LifeSci Partners as a financial advisor to explore strategic partnership opportunities to advance its lead drug candidate, Quilience® (Mazindol ER), which is being developed for narcolepsy and other sleep-wake disorders. Following positive interim Phase 2a results presented at the World Sleep Congress, the company received interest from multiple third parties for potential collaborations. This move aims to accelerate bringing innovative therapies to market and enhance shareholder value. No assurances of successful transactions are provided.
NLS Pharmaceutics has launched a Named Patient Program (NPP) allowing European patients with Idiopathic Hypersomnia (IH) to access the Mazindol Extended-Release (ER) formulation. This initiative is anticipated to generate revenue and provide crucial treatment options for patients who have not responded to approved therapies. Sales from the NPP are projected to yield mid-to-high single-digit million dollars over the next 36 months, providing additional funding for continued clinical development.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced that CEO Alex Zwyer will participate in a fireside chat at the Maxim Group 2022 Virtual Growth Conference on March 30, 2022, at 2:00 p.m. ET. The company is focused on developing therapies for rare central nervous system disorders, notably narcolepsy. Its leading candidate, Quilience, an extended-release formulation of mazindol, is currently in a Phase 2a trial in the United States, having received Orphan Drug Designation. Registration for the event is available at m-vest.com.
NLS Pharmaceutics announced positive interim top-line data from its Phase 2a clinical trial of Quilience (Mazindol ER) for narcolepsy, demonstrating a 39% reduction in the Epworth Sleepiness Scale (ESS) from baseline. The trial confirmed its statistical power and safety, with no serious adverse events (SAEs) reported. Additionally, 82% of patients opted to continue in the open-label extension study, indicating strong interest in the treatment. The results were presented at the World Sleep Congress, highlighting Mazindol ER's potential to be an effective therapy for narcolepsy.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW), a Swiss biopharmaceutical company focused on rare CNS disorders, announces CEO Alex Zwyer will meet with attendees at the SACHS 15th Annual European Life Sciences Virtual CEO Forum on March 1-2, 2022. Additionally, he will participate in an interview with Maxim Group's Jason McCarthy on March 3, 2022. The lead product, Quilience, is in a Phase 2a trial for narcolepsy. The company has received Orphan Drug Designations in both the U.S. and Europe for this treatment.
NLS Pharmaceutics Ltd. (NASDAQ: NLSP, NLSPW) announces CEO Alex Zwyer will hold one-on-one meetings at the 2022 BIO CEO & Investor Conference. The company focuses on innovative therapies for rare CNS disorders, with its lead product candidate, Quilience, an extended-release formulation of mazindol, targeting narcolepsy. NLS has received Orphan Drug Designations for Quilience in both the U.S. and Europe. A Phase 2a clinical trial for Quilience is ongoing, following a successful Phase 2 study for its ADHD treatment, Nolazol.
NLS Pharmaceutics Ltd. (NASDAQ: NLSP, NLSPW) has successfully achieved its enrollment target for a Phase 2a clinical trial, with over 50% of participants enrolled. The trial, which focuses on Quilience® (Mazindol ER) for narcolepsy treatment, includes 21 clinical sites across the U.S. Notably, nearly 90% of patients have opted into an Open Label Extension study. Interim data will be presented at the World Sleep Congress in Rome, Italy, from March 11-16, 2022, detailing safety, efficacy, and patient outcomes as the company aims to finalize enrollment by Q2 2022.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has announced its participation in the upcoming International Narcolepsy Webinar hosted by Wake Up Narcolepsy on January 20-21, 2022. The webinar aims to educate patients and caregivers about narcolepsy treatments and features a presentation on mazindol, NLS's potential treatment under study in a phase 2 trial. Interested participants can join the event online. Quilience (mazindol ER) has received Orphan Drug Designations in the U.S. and Europe for narcolepsy treatment.
NLS Pharmaceutics Ltd. announces the grant of U.S. Patent No. 11207271 for its lead product candidate, Quilience® (mazindol ER), effective January 4, 2022. This patent covers the use of Quilience® for treating ADHD and narcolepsy, bolstering NLS's intellectual property in key markets including the U.S., Europe, Canada, and South Korea. The company anticipates reporting Phase 2a results for Quilience® in treating narcolepsy in the first quarter of 2022, emphasizing the drug's potential to address significant unmet medical needs.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has released final results from a preclinical study on NLS-4 (Lauflumide), highlighting its potential as a treatment for chronic fatigue associated with Long-Covid. The study indicates that NLS-4 significantly outperformed modafinil in improving circadian rhythm and chronic fatigue syndrome in animal models, at doses four times lower than modafinil. Notably, NLS-4 did not induce weight loss or hepatic toxicity. The company aims to advance NLS-4's development amidst rising demand for effective treatments for Long-Covid fatigue.
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