NVS Novartis AG

By Chris Wack

NLS Pharmaceutics Ltd. shares doubled to $6.35 after the company said it entered into a license agreement with Novartis Pharma AG to obtain, on an exclusive basis in the U.S., all of the available data referred to and included in the original NDA for Sanorex mazindol submitted to the Food and Drug Administration in 1972.

Volume for the stock was 54 million shares at 10 a.m. ET, compared to its 65-day average volume of 375,000 shares. The stock, which has 12 million shares outstanding, hit its 52-week high of $7.20 early in the session.

The clinical-stage pharmaceutical company said the agreement encompasses all preclinical and clinical studies, data used for manufacturing including stability and other chemistry manufacturing and controls data, formulation data and know-how for all products containing mazindol as an active substance, and all post-marketing clinical studies and periodic safety reports from 1973 forward.

NLS has obtained the same rights on an non-exclusive basis in all territories outside of the U.S, except for Japan, with the right to cross-reference the Sanorex NDA with non-U.S. regulatory agencies in the licensed territories. The agreement includes the right to sublicense or assign the license to third parties, subject to such third parties meeting certain obligations.

Write to Chris Wack at chris.wack@wsj.com

(END) Dow Jones Newswires

March 12, 2021 10:21 ET (15:21 GMT)

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