NLS Pharma Stock Gains As Its Narcolepsy Candidate To Enter Mid-Stage Study Next Month

The FDA has accepted NLS Pharmaceutics Ltd's NLSP Investigational New Drug application for Quilience (mazindol extended-release (mazindol ER), the Company's lead drug candidate, for the treatment of narcolepsy.
The open IND enables NLS to initiate its Phase 2a clinical trial to assess the safety and efficacy of Quilience.
The proposed multi-center study is expected to enroll 60 patients and commence in August.
The primary endpoint is the change from baseline in excessive daytime sleepiness (EDS) as measured by the Epworth Sleepiness Scale (ESS). A key secondary endpoint is a change from baseline in the mean weekly number of cataplexy attacks in the anticipated subset of patients with cataplexy.
Price Action: NLSP shares are up 21.3% at $3.65 during the premarket session on the last check Thursday.
Related content: Benzinga's Full FDA Calendar.