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Scilex Holding Company (Nasdaq: SCLX) announced final court approval of a settlement agreement with Takeda Pharmaceuticals, resolving a patent infringement lawsuit related to Scilex's intention to expand the label for its liquid colchicine product, Gloperba®. The U.S. District Court for the District of Delaware approved the settlement, allowing Scilex a non-exclusive license to certain Takeda patents. Following this, Scilex requested the FDA convert its tentative approval of the expanded Gloperba® label to final approval.
The expanded label aims to address unmet medical needs, offering specific dosing guidance for patients with renal impairment. Market research shows high interest among rheumatologists for Gloperba®'s precision dosing capabilities. The expanded label would provide dosing flexibility and personalized adjustment options for patients, aligning with American College of Rheumatology guidelines.
Scilex Holding Company is taking steps to combat manipulative and naked short selling practices in its common stock. The company provided information to its stockholders regarding short selling activities. Scilex believes there are approximately 10 million shares being sold short and more than 10 million Dividend Shares sold as 'naked short' positions. It is determined to protect shareholder value and rights by addressing these practices.
