Foamix Pharmaceuticals Ltd (NASDAQ: FOMX) is flying early on in the trading session this morning, and for good reason. The company released clinical results that proved to be overwhelmingly positive. Of course, the announcement of positive results led the stock on a run for the top. Today, we’ll talk about:
- The results;
- what we’re seeing from FOMX stock as a result; and
- what we’ll be watching for ahead.
FOMX Climbs On Strong Clinical Results
As mentioned above, Foamix Pharmaceuticals is having an incredibly strong start to the trading session this morning after announcing positive clinical results. In a press release issued early this morning, the company provided top-line results of its third Phase 3 clinical trial of FMX101 for the treatment of moderate to severe acne.
In the release, FOMX said that the study met both co-primary endpoints. These included absolute change from baseline in inflammatory lesion count at week 12 and IGA treatment success at week 12, defined as an IGA score of 0 or 1. The company also said that the safety profile of FMX101 proved to be consistent with that determined from the two prior Phase 3 clinical trials. In a statement, David Domzalski, CEO at FOMX, had the following to offer:
We are extremely pleased with the topline results of this confirmatory Phase 3 trial. These study results should support a finding that FMX101 appears to be safe and effective in the treatment of moderate-to-severe acne… This is the most significant milestone to date for Foamix and brings us closer to helping patients who struggle with the physical and psycho-social effects of acne. If approved, we believe FMX101 would be the first topical minocycline product available for patients in the United States.
On behalf of Foamix, I wish to thank all patients, caregivers/guardians, investigators and support staff who participated in the advancement of this clinical program. With the conclusion of this third study, we are now in position to finalize our efforts to submit the company’s first NDA.
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 the news leads to moves. In the case of Foamix Pharmaceuticals, the news proved to be overwhelmingly positive. After all, strong clinical data means that the company is likely to submit an NDA with the FDA relatively soon. So, it comes as no surprise to see that excited investors are sending the stock on a run for the top. As is normally the case, our partners at Trade Ideas were the first to alert us to the gains. At the moment (9:05), FOMX is trading at $7.75 per share after a gain of $1.83 per share or 30.91% 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 FOMX. In particular, we’re interested in following the story surrounding the company’s continued work to bring FMX101 to market as the treatment seems to be producing strong results. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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