Welcome to our dedicated page for Nls Pharmaceutics news (Ticker: NLSP), a resource for investors and traders seeking the latest updates and insights on Nls Pharmaceutics stock.
NLS Pharmaceutics Ltd (NLSP) delivers cutting-edge therapies for central nervous system disorders through innovative platforms like its dual orexin receptor agonist (DOXA) technology. This page provides essential updates for stakeholders tracking clinical developments, strategic partnerships, and regulatory milestones in neuropharmaceutical research.
Access verified press releases and analysis on NLSP's progress in addressing narcolepsy, neurodegenerative diseases, and cognitive disorders. Our curated news collection covers clinical trial results, intellectual property developments, and financial performance updates critical for informed decision-making.
Key content includes updates on the Kadimastem merger's therapeutic pipeline expansion, DOXA platform validation studies, and collaborative research initiatives. Investors will find timely reports on funding rounds, patent approvals, and preclinical data disclosures.
Bookmark this page for consolidated access to NLSP's latest advancements in CNS therapy development. Regularly updated to reflect material events and scientific breakthroughs, it serves as your primary resource for understanding the company's position in competitive biopharmaceutical markets.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) has completed the six-month Open Label Extension (OLE) study for Mazindol ER, a treatment for narcolepsy. The study included patients who previously participated in the POLARIS Phase 2 study. Notably, 87% of the patients opted to continue Mazindol ER treatment rather than switch therapies. The OLE aims to assess long-term safety, tolerability, and efficacy for Excessive Daytime Sleepiness (EDS) and cataplexy, showing promising results in interim data. Full results are expected in Q1 2023 and will be presented at a scientific meeting.
NLS Pharmaceutics Ltd. (NASDAQ: NLSP, NLSPW) announced on January 25, 2023, that it has regained compliance with Nasdaq Listing Rule 5550(b)(1), which requires companies to maintain a minimum stockholders' equity of $2,500,000. This follows a notification letter from the Nasdaq Hearings Panel confirming the company's adherence to the rule. NLS was first notified of its non-compliance on April 1, 2022, but through an appeal process, it received approval to continue its Nasdaq listing. The Panel's recent confirmation resolves all outstanding compliance issues.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) announced new in vitro study results showing that mazindol ER exhibits significant agonist activity at the Orexin-2 receptor, which is crucial for treating narcolepsy. The Phase 2 trials for Quilience (mazindol ER) met primary endpoints with high statistical significance, indicating its potential as a dual mechanism treatment for narcolepsy. The drug offers a unique profile as it targets orexin loss rather than merely treating symptoms. The Phase 3 program is set to begin mid-2023, with additional studies planned to further confirm efficacy and safety.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced an upcoming R&D Day on January 31, 2023, at 10:00 am EST to discuss its strategic pipeline for 2023, focusing on innovative therapies for rare CNS disorders. Key programs include NLS-13 for idiopathic hypersomnia, NLS-3 targeting ADHD, NLS-4 for chronic fatigue syndrome, NLS-8 addressing Alzheimer's amnesia, NLS-11 for Kleine-Levin Syndrome, and NLS-12 for Lewy body dementia. Promising preclinical results and orphan drug designations highlight the company's commitment to meeting unmet medical needs in CNS disorders.
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announced compliance with Nasdaq's minimum bid price requirement after a notification letter from Nasdaq on January 10, 2023. The company had initially been notified on June 10, 2022, of its non-compliance due to a share price falling below $1.00 for 30 consecutive business days. With a bid price meeting the requirement for 10 consecutive business days from December 20, 2022, to January 9, 2023, Nasdaq confirmed that NLS has regained compliance with Listing Rule 5550(a)(2).
NLS Pharmaceutics Ltd. (Nasdaq: NLSP, NLSPW) announces its participation in key upcoming investor conferences. CEO Alex Zwyer will provide a company update at the 2023 BIO CEO & Investor Conference on March 12-14, 2023, and will be available for one-on-one meetings. Additionally, he will participate in the 35th Annual Roth Conference during the same dates. NLS focuses on developing innovative therapies for rare and complex central nervous system disorders.
NLS Pharmaceutics Ltd. announced the grant of a patent for Mazindol ER in Hong Kong, covering its use for ADHD treatment. This patent is key to NLS's global strategy, enhancing its proprietary position in major markets like the U.S., Europe, and Canada. The company is advancing its lead product, Quilience® (Mazindol ER), aimed at treating narcolepsy and potentially ADHD, with Phase 2 clinical trials showing positive results. The ADHD market is projected to increase from $29 billion to nearly $45 billion by 2037.
NLS Pharmaceutics Ltd. (NASDAQ:NLSP, NLSPW) announced significant progress in its clinical pipeline focused on rare CNS disorders in a letter from CEO Alex Zwyer to shareholders. Key achievements for 2022 include successfully completing the Phase 2a clinical program for Quilience (Mazindol ER) in narcolepsy, securing up to $30 million in funding, and launching a Named Patient Program for idiopathic hypersomnia. The company established a strong leadership team and anticipates a fruitful 2023 with ongoing developments in its product pipeline and regulatory efforts.
NLS Pharmaceutics Ltd. has received an Israeli patent for Mazindol, which is recognized as a treatment for Attention Deficit/Hyperactivity Disorder (ADHD) and various sleep disorders, including narcolepsy. The patent is effective until at least 2037. NLS is advancing the clinical development of its lead product, Mazindol ER, with expected funding through 2025, anticipating a new drug application submission in late 2024 or early 2025. The ADHD therapeutics market is currently valued at over $29 billion and expected to increase to nearly $45 billion by 2037.
NLS Pharmaceutics Ltd. announced the closing of an initial $10 million tranche with BVF Partners, securing cash runway beyond pivotal studies for Quilience (Mazindol ER) in narcolepsy. BVF may invest up to $30 million based on meeting conditions, including an FDA phase 2 meeting. The funding aims to accelerate clinical development and business activities, with operations supported until 2025. Quilience has met primary endpoints in clinical trials and received Orphan Drug Designation.
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