Skip to content

NLS Pharmaceutics (NLSP) Stock Surges After FDA Accepts IND Application

Sam Boughedda
Sam Boughedda trader
Updated 15 Jul 2021

Practice Stock Trading Your Capitals Is At Risk
NLSP Pharmaceutics

Shares of NLS Pharmaceutics (NASDAQ: NLSP) are rallying premarket after the company announced that the US Food and Drug Administration (FDA) has accepted its Investigational New Drug application (IND) for Quilience.


Quilience is the company‘s lead drug candidate and is used to treat narcolepsy.

The open IND enables NLS to initiate its Phase 2a clinical trial to assess the safety and efficacy of Quilience in patients diagnosed with narcolepsy.

The multi-centre study will take place in the US and Europe and is expected to enrol 60 patients.

The primary endpoint of the trial, which is due to start in August, is the change from baseline in excessive daytime sleepiness as measured by the Epworth Sleepiness Scale, and a key secondary endpoint is a change from baseline in the mean weekly number of cataplexy attacks in the subset of patients with cataplexy.

“We are pleased to now have an open IND so that we can initiate our clinical program with Quilience®, our novel formulation of mazindol ER, for the treatment of narcolepsy,” said Alex Zwyer, CEO of NLS.

“We remain on track to commence our prospective Phase 2a clinical trial for Quilience next month as we focus on bringing this treatment option to patients suffering from narcolepsy as soon as possible.”

NLS Pharmaceutics’ share price is trading at $3.65, up 21.26% premarket on Thursday.

Should You Invest in NLS Pharmaceutics Shares?

One of the most frequently asked questions we receive is, “what stocks are best to buy right now?” It’s a wide-ranging question, but one that we have answered… Our AskTraders stock analysts regularly review the market and compile a list of which companies you should be adding to your portfolio, including short and longer-term positions. Here are the best stocks to buy right now

Sam Boughedda
Sam is a trader and lead stock market writer at AskTraders. After starting his career in the forex market, Sam now focuses on stocks, specifically consumer staples.