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Tag: NASDAQ:NLSP

  • After-Hour Surge For NLS Pharmaceutics (NLSP) Stock

    After-Hour Surge For NLS Pharmaceutics (NLSP) Stock

    On Tuesday, NLS Pharmaceutics AG (NASDAQ: NLSP) shares increased 10.58% after-hours to $2.30. Following a 12.43% spike during the regular session, this after-hours rise closed at $2.08. The company’s most recent preclinical data release at the 2025 Annual Meeting of the American Society of Clinical Psychopharmacology (ASCP), which is taking place this week from Tuesday to Friday at the Fairmont Scottsdale Princess in Arizona, was the main driver of the strong momentum.

    Mazindol ER Shows Potential Against Fentanyl Dependence

    NLS Pharmaceutics unveiled a study titled “Evaluating the Effects of Mazindol on Fentanyl Reward and Dependence in C57BL/6J Mice and Sprague-Dawley Rats (Study KO-943)” during a poster session scheduled for Thursday. Conducted in collaboration with Key-Obs SAS and several European academic partners, the study focused on the efficacy of Mazindol ER in preclinical models of opioid addiction.

    The capacity of Mazindol to considerably lower fentanyl-induced conditioned place preference (CPP) in C57BL/6J mice at a dosage of 0.5 mg/kg was one of the main results. When tested by the Gellert-Holtzman scale, the same medication at 0.5 and 1.0 mg/kg significantly decreased opioid withdrawal symptoms in Sprague-Dawley rats, including agitation, salivation, and motor disruption.

    A Novel Multi-Target Mechanism

    The data suggest Mazindol’s effectiveness may stem from its unique multi-receptor activity. By partially agonizing the mu-opioid receptor, acting strongly on the 5-HT1A receptor, and modulating orexin-2 receptors, Mazindol offers a distinct pharmacological approach to combating opioid dependence. These properties make it a promising non-opioid alternative in addressing both reward and withdrawal dimensions of fentanyl addiction.

    Implications Beyond Addiction

    The treatment of illnesses of the central nervous system (CNS), especially ADHD, is affected by the study’s wider implications. Mazindol exhibits a dual impact in lowering opioid reward and withdrawal symptoms, in contrast to conventional stimulant and non-stimulant therapy.

    This further differentiates Mazindol’s therapeutic profile and is consistent with earlier CNS studies, including data presented by Wigal et al. (2018). Clinical validation through forthcoming trials, including the planned NLS-6002 study, will be pivotal in advancing its development.

  • NLS Pharmaceutics (NLSP) Shares Surge As Market Reacts To Potential Merger

    NLS Pharmaceutics (NLSP) Shares Surge As Market Reacts To Potential Merger

    As of the most recent check today, NLS Pharmaceutics AG’s (NASDAQ: NLSP) shares have had a notable upward trend, climbing 37.97% to $2.58. NLSP’s strategic stance ahead of an expected merger with Kadimastem Ltd., a clinical-stage biotechnology company that specializes in allogeneic cell treatments for diabetes and neurological illnesses, is primarily responsible for the spike.

    A Strategic Partnership for the Treatment of Advanced Diabetes

    The goal of NLS Pharmaceutics (NLSP) and Kadimastem proposed merger is to transform the way complicated illnesses, especially diabetes, are treated. The two businesses want to provide complete therapeutic solutions that treat diabetes beyond traditional glucose management by combining their individual strengths in pharmaceutical discovery and regenerative medicine.

    GLP-1 receptor agonists have helped treat diabetes by helping with weight reduction and glucose control, but they are ineffective in reducing immune system interactions, metabolic disturbances, and neurological problems. Furthermore, the need for alternative medicines that provide more extensive systemic advantages is highlighted by worries about long-term safety and negative gastrointestinal consequences.

    Introducing DOXA: A Multi-Pathway Approach

    NLS Pharmaceutics is spearheading a next-generation treatment strategy known as DOXA (Dual Orexin and Multi-Pathway Modulation). This novel approach integrates orexin receptor agonism, neuroprotection, and metabolic regulation to provide a holistic solution for diabetes and its associated complications. Unlike conventional incretin-based therapies, DOXA synchronizes metabolic and neurological pathways, offering a more comprehensive treatment model.

    DOXA may greatly improve insulin sensitivity and metabolic control in conjunction with islet transplantation. By addressing the disease’s wider physiological effects and enhancing long-term treatment results, this combination therapy has the potential to establish a new benchmark in the treatment of diabetes.

    Increasing Innovation in Neurodegenerative and Metabolic Disorders

    A strategic integration of complementary platform technologies is represented by the merging of Kadimastem and NLS Pharmaceutics. It is anticipated that NLSP’s pharmaceutical inventions and Kadimastem’s cell treatment breakthroughs would strengthen their combined standing in the biotechnology industry. By merging knowledge of metabolic and neurodegenerative diseases, the combined organization hopes to lead the changing therapeutic market and spur innovation in diabetes treatment and beyond.

  • What Lead The NLSP Stock To Rise 13% Premarket?

    The shares of NLS Pharmaceutics AG (NLSP) rose 12.62 percent to $3.39 in pre-market trading. Last session, NLSP stock closed at $3.01, down -2.59% or $0.08. Over the course of the day, NLSP’s shares fluctuated between $2.99 and $3.1083 each. The trading volume of NLSP stock was 80530 shares, lower than its average daily volume of 233K over the past 50 days.  In response to the approval of its application by the drug authorities, NLSP stock is rising.

    Which NLSP application has been accepted?

    The Swiss biopharmaceutical company, NLS Pharmaceutics, is leading the development and repurposing of therapeutic product candidates for the treatment of rare and complex central nervous system disorders with experience in developing and repurposing drugs. A lead narcolepsy product candidate being developed by NLSP, Quilience, will be an extended-release formulation of mazindol (mazindol ER).

    NLSP conducted a phase 2 study in the US to evaluate the effects of Nolazol, a mazindol-based drug candidate that is designed to treat ADHD in adults. All primary and secondary endpoints of NLSP’s study were met, and the drug was well tolerated. For the treatment of narcolepsy, NLSP’s Quilience has been designated an orphan drug in both the US and Europe.

    In a press release today, NLSP announced that the U.S. Food and Drug Administration (FDA) has accepted its Investigational New Drug application (IND) for Quilience.

    • Due to an open IND, NLSP will be able to evaluate the safety and effectiveness of Quilience in narcolepsy patients in Phase 2a clinical trials.
    • Study enrolling 60 patients and scheduled for August 2021 in both North America and Europe is NLSP’s proposed multi-center study.
    • As measured by the Epworth Sleepiness Scale (ESS), the primary endpoint is the change from baseline in excessive daytime sleepiness (EDS).
    • NLSP’s study includes a secondary endpoint that measures how often patients with cataplexy attacks change from baseline.
    • In order to bring this treatment option as soon as possible to patients suffering from narcolepsy, NLSP plans to commence its Phase 2a clinical trial for Quilience next month.

    NLSP CEO will discuss business overview today:

    NLSP’s Chief Executive Officer and Co-Founder, Alex Zwyer, will be attending a health conference to speak on the company’s corporate overview today.

    The CEO of NLSP will present at the First Annual Access to Giving Virtual Investor Conference, which began on July 13 and ends today, July 15, 2021. A keynote address will be delivered by Mr. Zwyer today at 9:00 ET.  The presentation will be followed by a Q&A session with the NLSP.