Nls Pharmaceutic Stock Price, News & Analysis

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. (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. 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.

NLS Pharmaceutics Ltd. received a notification from Nasdaq stating it failed to meet the minimum bid price of $1.00, a requirement for continued listing. The company has 180 days to regain compliance, but by December 6, 2022, it received a notice indicating potential delisting. NLS has presented its plan to the Nasdaq Hearings Panel and has been granted until February 28, 2023, to rectify the issue. NLS is a clinical-stage biopharmaceutical company focused on therapies for complex CNS disorders, notably its product Quilience for narcolepsy.

NLS Pharmaceutics Ltd. has entered a definitive agreement with BVF Partners L.P. to raise up to $30 million through a private placement. The initial closing of $10 million will provide 11,494,253 common shares at $0.87 per share, with an option for an additional $20 million following a successful end of phase 2 meeting with the FDA. The funds will support the clinical development of Quilience for narcolepsy and other business activities, ensuring operational funding through 2025.

NLS Pharmaceutics Ltd. (NASDAQ NLSP, NLSPW) has received a Notice of Allowance from the USPTO for a patent covering Mazindol as a treatment for opioid dependence and substance use disorders. This patent could be issued within months and will expire no earlier than 2038. The opioid market is projected to grow to nearly $5 billion by 2028, with over 100,000 overdose deaths annually in the U.S. Mazindol, classified as a Schedule IV controlled substance, presents a non-addictive alternative to current treatments like methadone.