Gemphire Therapeutics Inc (NASDAQ: GEMP) is having a rough start in the pre-market this morning, and for good reason. The comapny announced a clinical update, stating that the FDA has requested more data surrounding one of its treatments, and setting the timeline further back. Today, we’ll talk about:
- The news;
- what we’re seeing from GEMP as a result; and
- what we’ll be watching for ahead.
GEMP Announces Clinical Development Update
As mentioned above, Gemphire Therapeutics is having a rough start to the trading session this morning after providing an update with regard to clinical activities. In a press release issued earlyt his morning, the company announced that the United States Food and Drug Administration (FDA) has requested that the company produce data from a sub-chronic toxicology study in order to provide information to support lifting the partial clinical hold on gemcabene. The partial clinical hold affects clinical trials with a longer than six month duration. In the release, GEMP said that the initiation of Phase 3 trails investigating the treatment in dylipidemia indications and long-term safety exposure trials are needed for registration, but will not take place until the partial hold has been lifted. In a statement, Dr. Steven Gullans, CEO at GEMP, had the following to offer:
We are working closely with the FDA to release the partial clinical hold on gemcabene, with the goal of proceeding to an End of Phase 2 meeting and reaching agreement on the design of a Phase 3 clinical program… Our confidence in gemcabene’s safety profile is supported by the fact that it has been observed to be safe in nearly 1,200 human subjects in 24 Phase 1 and 2 clinical trials. In fact, gemcabene’s safety performance in previous human clinical provided the basis for the FDA to allow the agent to be evaluated in a multi-center, investigator-led ongoing NAFLD trial in pediatric patients.
In the meantime, we are continuing to execute on our ongoing Phase 2a POC clinical trials of gemcabene in NAFLD/NASH. Gemphire is well capitalized, with $28 million cash on hand as of June 30 2018. Based on current projections, taking into account the delay of significant cash expenditures for clinical trials and manufacturing and the amended terms of the loan agreement with SVB, we believe we have sufficient resources to fund operations into the fourth quarter of 2019.
What We’re Seeing From The Stock
One of the first lessons that we learn when we start to dig into the market is that it’s important to keep a close eye on the news. After all, the news moves the market. When it comes to Gemphire Therapeutics, the news proved to be pretty negative. After all, with the announcement in mind, the timeline to potential approval has been extended and investors don’t like to wait. So, it’s no surprise that concerns are hitting investors, sending the stock tumbling down. Of course, our partners at Trade Ideas were the first to alert us to the declines. At the moment (8:31), GEMP is trading at $5.20 per share after a loss of $2.14 per share or 29.16% thus far today.
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What We’ll Be Watching For Ahead
Moving forward, the CNA Finance team will continue to keep a close eye on GEMP. In particular, we’re interested in following the story surrounding the company’s ongoing work to bring gemcabene as well as the rest of the company’s clinical-stage pipeline. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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