Pomerantz LLP announces that a class action lawsuit has been filed against Lexicon Pharmaceuticals, Inc. (“Lexicon” or the “Company”) (NASDAQ: LXRX) and certain of its officers and directors. The class action, filed in United States District Court, Southern District of Texas, and indexed under 19-cv-00301, is on behalf of a class consisting of all behalf of persons and/or entities who purchased or otherwise acquired Lexicon securities between March 11, 2016 and January 17, 2019, both dates inclusive (the “Class Period”), seeking to recover damages caused by Defendants’ violations of the federal securities laws and to pursue remedies under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (the “Exchange Act”) and Rule 10b-5 promulgated thereunder, against the Company and certain of its top officials.
If you are a shareholder who purchased Lexicon securities between March 11, 2016, and January 17, 2019, you have until April 1, 2019, to ask the Court to appoint you as Lead Plaintiff for the class. A copy of the Complaint can be obtained at www.pomerantzlaw.com. To discuss this action, contact Robert S. Willoughby at firstname.lastname@example.org or 888.476.6529 (or 888.4-POMLAW), toll-free, Ext. 9980. Those who inquire by e-mail are encouraged to include their mailing address, telephone number, and the number of shares purchased.
Lexicon was founded in 1995 and is headquartered in The Woodlands, Texas. Lexicon is a biopharmaceutical company that focuses on the development and commercialization of pharmaceutical products for the treatment of human diseases.
“Sotagliflozin” is the scientific name of one of Lexicon’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 entered into a collaboration and license agreement with Sanofi S.A. (“Sanofi”), a French multinational pharmaceutical company. Under the collaboration and license agreement, Lexicon granted Sanofi an exclusive, worldwide, royalty-bearing right and license to develop, manufacture and commercialize Sotagliflozin. Lexicon 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.”
The complaint alleges that throughout the Class Period, Defendants made materially false and misleading statements regarding the Company’s business, operational and compliance policies. Specifically, Defendants made false and/or misleading statements and/or failed to disclose that: (i) 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; (ii) the health risks posed by Sotagliflozin were severe enough to threaten its FDA approval prospects; and (iii) as a result, Lexicon’s public statements were materially false and misleading at all relevant times.
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.”
On news of the Advisory Committee’s stalemate, Lexicon’s stock price fell $1.74 per share, or 22.6%, to close at $5.96 per share on January 18, 2019.