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.