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Levi & Korsinsky announces it has commenced an investigation of Gemphire Therapeutics Inc. (“Gemphire” or “the Company”) (NASDAQ: GEMP) concerning possible violations of federal securities laws.
On August 4, 2016, Gemphire issued materials related to its August 2016 Initial Public Offering. In the Prospectus related to the IPO, Gemphire stated that the FDA had “determined that [product candidate] gemcabene was a potential peroxisome proliferator-activated receptor (PPAR) agonist. As a result, the FDA imposed a partial clinical hold, which restricts us from conducting clinical trials for gemcabene beyond six months in duration, and requires us to conduct two-year rat and mouse carcinogenicity studies before conducting trials of longer than six months.”
Then on August 6, 2018, Gemphire announced that the FDA would require additional data from the Company in order to lift the clinical hold on gemcabene, and that the “End of Phase 2 meeting, and consequently the initiation of Phase 3 trials investigating gemcabene in dyslipidemia indications and long-term safety exposure trials needed for registration, will not take place until the partial hold has been lifted.”
Then on August 10, 2018, Gemphire issued a press release announcing the termination of the phase 2a clinical trial of gemcabene in pediatric non-alcoholic fatty liver disease, citing unexpected problems: “The increase in liver fat was deemed an unexpected problem by the trial investigator because it was an unexpected consistent pattern of worsening of the disease… which the investigator believed was likely due to the drug.”
Then on August 13, 2018, Gemphire announced that the development of Gemphire would be paused.