Company: NCEL
Filing Date: 2025-07-18
Form Type: F-4/A
Source: 0001213900-25-065783
Chunk: 353

Company: NewcelX Ltd.
Filing Date: 2025-07-18
Form: F-4/A
Chunk 353
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 2 clinical trial in the third quarter of 2021, in adult patients with narcolepsy. NLS published positive interim top -lineresults from its Phase 2 clinical trial in March 2022. As a result, NLS intends to apply for expedited development program(s) facilitated by the FDA, such as Breakthrough Therapy and/or Fast Track designations and by the European Medicines Agency, or EMA, such as PRIME. NLS has completed a Phase 2 clinical trial evaluating the safety and efficacy of Nolazol in adults with ADHD in the U.S. Although further clinical development of Nolazol in ADHD is on hold, given the positive outcome of this trial, NLS may initiate Phase 3 clinical trials after NLS receives approval to commercialize Quilience. NLS also intends to seek FDA and other regulatory approval for Nolazol for use in children with ADHD, which requires additional nonclinical work, as well as staged clinical work in determining safe dosing and monitoring. In addition, following its current focus on the development of Quilience for narcolepsy in adults, and if approved for marketing, NLS intends to seek a label expansion for the treatment of narcolepsy in pediatric patients, which may require additional pre -clinicaland clinical studies. Quilience and Nolazol both contain mazindol as the active ingredient in a proprietary controlled release, or CR, formulation developed for a once -a-daydosing. Mazindol has a well -establishedsafety record from its extended history of clinical use across the United States and several countries in Europe, where mazindol was previously approved in an immediate release formulation for the short -termmanagement of exogenous obesity. It was marketed for nearly 30 years, into the early 2000’s, before being voluntarily withdrawn from the market not for safety nor for efficacy reasons (Docket n° FDA -2007-P-0326) but for commercial. In addition to the 30 -yearperiod in which it was marketed, mazindol was also widely used off -labeland prescribed under compassionate use for the treatment of narcolepsy for approximately four decades, during which time it demonstrated a well -toleratedsafety profile in patients over long -term, chronic use of the drug. NLS has entered into an agreement with Novartis Pharma AG for the exclusive rights to mazindol pre -clinical, non -clinicaland clinical data and to San