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Oklahoma City, OK (January 29, 2019) – On January 28, 2019, a securities class action lawsuit was filed in the United States District Court for the Southern District of Texas against Lexicon Pharmaceuticals, Inc. (NASDAQ: LXRX). The complaint alleges violations of federal securities laws, Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 and Rule 10b-5, including allegations of issuing a series of material or false misrepresentations to the market which had the effect of artificially inflating the market price during the Class Period, which is March 11, 2016 through January 17, 2019. More specifically, 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.
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.”
On January 17, 2019, Lexicon announced that the Endocrinologic and Metabolic Drugs Advisory Committee of the U.S. Food and Drug Administration 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.
Plaintiff seeks to recover damages on behalf of all Lexicon Pharmaceuticals, Inc. shareholders who purchased common stock during the Class Period and are therefore a member of the Class as described above. You may move the Court no later than Monday, April 1, 2019 to serve as a lead plaintiff for the entire Class. However, in order to do so, you must meet certain legal requirements pursuant to the Private Securities Litigation Reform Act of 1995.
If you wish to discuss this action, obtain further information and participate in this or any other securities litigation, or should you have any questions or concerns regarding this notice or preservation of your rights, please contact: Robin Hester at email@example.com