Investigation Overview
An investigation on behalf of investors of Gemphire Therapeutics Inc. (NASDAQ: GEMP) shares over potential securities laws violations by Gemphire Therapeutics and certain of its directors and officers in connection with certain financial statements was announced.
The investigation by a law firm focuses on possible claims on behalf of purchasers of the securities of Gemphire Therapeutics Inc. (NASDAQ: GEMP) concerning whether a series of statements by Gemphire Therapeutics regarding its business, its prospects and its operations were materially false and misleading at the time they were made.
Livonia, MI based Gemphire Therapeutics Inc., a clinical-stage biopharmaceutical company, focuses on developing and commercializing therapies for the treatment of dyslipidemia and non-alcoholic steatohepatitis (NASH).
On August 4, 2016, Gemphire Therapeutics Inc., issued materials related to its August 2016 Initial Public Offering. In the Prospectus related to the IPO, Gemphire Therapeutics Inc., 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.
Shares of Gemphire Therapeutics Inc. (NASDAQ: GEMP) reached as high as $1.27 per share in July 2017.
Then on August 6, 2018, Gemphire Therapeutics Inc., 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 Therapeutics Inc., 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 Therapeutics Inc., announced that the development of Gemphire would be paused.