A significant rise in the shares price of NLS Pharmaceutics (NASDAQ: NLSP) began in the early-hours of trades today. In the wake of positive news about licensing agreements around data related to mazindol, the NLSP stock rose 85.16% to $5.24 as of this writing.
What does the agreement say?
An experienced management team, an innovative science, and a track record of producing and repurposing product candidates for treating rare and complex neurological disorders are the foundations of Swiss clinical-stage pharmaceutical company NLS Pharmaceutics Ltd. Quilience is developed through the Company as a proprietary controlled release formulation of mazindol for narcolepsy.
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For years, Mazindol was used to treat patients diagnosed with narcolepsy in compassionate use programs as a triple monoamine reuptake inhibitor and partial orexin receptor 2 agonist. Mazindol CR has been tested extensively in adult subjects with ADHD in phase 2 trials conducted by NLS Pharmaceutics. The study was well tolerated and met all primary and secondary endpoints. As a medicine for the treatment of narcolepsy, Quilience has been granted designation as an orphan drug in the U.S. and Europe.
In an announcement today, NLS said that it entered into a license agreement with Novartis Pharma AG around data related to mazindol.
- According to the contract, the Company is granted exclusive use of all of the available data referenced in the original New Drug Application (NDA) for Sanorex (mazindol).
- The NDA for the drug was submitted to the United States Food and Drug Administration (FDA) in February 1972.
- In accordance with the Agreement, all studies designed to make or develop products containing mazindol as an active substance, manufacturing data and formulations, and know-how are covered.
- All studies and periodic safety reports undertaken following market entry, from 1973 onward, are also included in that agreement.
- Under the Agreement, NLS has acquired the same rights in all territories outside the U.S., except for Japan, on a non-exclusive basis.
- Additionally, the Sanorex NDA can be used to cross-refer to the non-U.S. regulatory agencies in the licensed territories.
- Sublicenses or assignments are permitted under the Agreement, provided that third parties meet certain obligations.
By getting such an essential clinical and regulatory package for mazindol, NLS Pharmaceutics (NLSP) could cut clinical costs, save time, and boost its clinical and regulatory programs. NLSP will ultimately be able to boost its capabilities and growth prospects by creating a competitive advantage in different parts of the world.