A lawsuit was filed on behalf of investors in Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) shares over alleged securities laws violations.
San Diego, CA -- (SBWIRE) -- 02/20/2019 -- The Shareholders Foundation announces that an investor, who purchased shares of Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX), filed a lawsuit s over alleged violations of Federal Securities Laws by Lexicon Pharmaceuticals, Inc.
Investors who purchased shares of Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) have certain options and should contact the Shareholders Foundation at firstname.lastname@example.org or call +1(858) 779 - 1554.
The Woodlands, TX based Lexicon Pharmaceuticals, Inc., a biopharmaceutical company, focuses on the development and commercialization of pharmaceutical products for the treatment of human diseases. Sotagliflozin" is the scientific name of one of Lexicon Pharmaceuticals, Inc's orally-delivered small molecule drug candidates under development. Sotagliflozin is in Phase 3 clinical trials for the treatment of type 1 and type 2 diabetes.
In November 2015, Lexicon Pharmaceuticals, Inc entered into a collaboration and license agreement with Sanofi S.A. ("Sanofi"), a French multinational pharmaceutical company. Under the collaboration and license agreement, Lexicon Pharmaceuticals, Inc granted Sanofi an exclusive, worldwide, royalty-bearing right and license to develop, manufacture and commercialize Sotagliflozin. Lexicon Pharmaceuticals, Inc is responsible for all clinical development activities relating to type 1 diabetes and retains an exclusive option to co-promote and have a significant role, in collaboration with Sanofi, in the commercialization of Sotagliflozin for the treatment of type 1 diabetes in the United States. Sanofi is responsible for all clinical development and commercialization of Sotagliflozin for the treatment of type 2 diabetes worldwide and is solely responsible for the commercialization of Sotagliflozin for the treatment of type 1 diabetes outside the United States.
On May 22, 2018, Sanofi filed a New Drug Application ("NDA") for "Zynquista" (the trademarked, commercialized name of Sotagliflozin) with the U.S. Food and Drug Administration ("FDA"). The NDA for Zynquista was based on data from the inTandem clinical trial program that included three Phase 3 clinical trials (called, respectively, "inTandem1," "inTandem2," and "inTandem3") assessing the safety and efficacy of Zynquista in approximately 3,000 adults with inadequately controlled type 1 diabetes.
According to Jorge Insuasty, Senior-Vice President, Global Head of Development, Sanofi, "[i]f approved, Zynquista would be the first oral antidiabetic drug approved in the U.S. for use by adults with type 1 diabetes, in combination with insulin."
On January 17, 2019, Lexicon announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the FDA (the "Advisory Committee") had "voted eight to eight on the question of whether the overall benefits of [Lexicon's product] Zynquista (sotagliflozin) outweighed the risks to support approval."
The plaintiff claims that between March 11, 2016 and January 17, 2019, the Defendants made false and/or misleading statements and/or failed to disclose that the data from Lexicon's Phase 3 clinical trials assessing the safety and efficacy of Sotagliflozin in treating type 1 diabetes were not as positive as Lexicon represented, that the health risks posed by Sotagliflozin were severe enough to threaten its FDA approval prospects, and that as a result, Lexicon's public statements were materially false and misleading at all relevant times.
Those who purchased shares of Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX) have certain options and should contact the Shareholders Foundation.
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The Shareholders Foundation, Inc. is a professional portfolio monitoring and settlement claim filing service, , which does research related to shareholder issues and informs investors of securities class actions, settlements, judgments, and other legal related news to the stock/financial market. Shareholders Foundation, Inc. is in contact with a large number of shareholders and offers help, support, and assistance for every shareholder. The Shareholders Foundation, Inc. is not a law firm. Referenced cases, investigation, and/or settlements are not filed/reached and/or related to Shareholders Foundation. The information is provided as a public service. It is not intended as legal advice and should not be relied upon.
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