BioPharmX Corp (NYSEAMERICAN: BPMX) is flying early on in the market this morning, and for good reason. The company announced that the United States Food and Drug Administration (FDA) has waived a requirement for BPX-01, elminating years of required research prior to FDA review. With the news in mind, investors are sending the stock screaming for the top. Today, we’ll talk about:
- The regulatory update;
- what we’re seeing from BPMX stock as a result; and
- what we’ll be watching for ahead.
BPMX Announces FDA News
As mentioned above, BioPharmX is flying early on in the trading session this morning after the company announced regulatory news. In a press release issued about 20 minutes ago, the company announced that the United States FDA has waived its requirement for dermal a carcinogenicity study surrounding BPX-001. This news means that several years of non-clinical research that’s normally required for FDA review has been eliminated in the development of the treatment.
In the release, BPMX reminded investors that BPX-01 is a novel topical gel formation of minocycline. The treatment is currently under development for the indication of inflammagory acne. The company said that the waiver was received based on the results of a 29-week dermal minipig toxicity study as well as the extensive safety history of minocycline products.
During the 39-week minipig study, the company found no pre-neoplastic or hyperplastic changes that might be indicative of carcinogenic potential. Also, BPX-01 Phase 2 acne clinical studies proved to be negative in terms of cutaneous toxicity. Based on this data, the FDA has agreed that no new useful information was likely to be gained by additional non-clinical animal studies.
In a statement, AnnaMarie Daniels, executive Vice President of Clinical and Regulatory Affairs, had the following to offer:
The FDA waiver is important because it shaves years off of our non-clinical research, accelerating our regulatory schedule and eliminating concerns about the added time and costs of our non-clinical development… Our minipig study confirmed years of prior research showing that our BPX-01 topical minocycline poses no new carcinogenic threat to humans.
The company also provided more good news. In the release, BioPharmX announced the release of a post hoc analysis of the Phase 2b data assessing the impact of BPX-01 on the treatment of acne vulgaris in women. In the analysis, the BPMX found that female subjects outperformed the overall study population in the Investigator Global Assessment (IGA) outcomes. In a statement, Hilary Baldwin, Medical Director of the Acne Treatment & Research Center in Morristown, NJ, and co-chair of the BPMX Medical Advisory Board, had the following to offer:
The results from the female subgroup analysis of BPX-01 in the Phase 2b acne trial is very relevant, and offers promise to a large patient population suffering from acne… There is a significant need for a product that offers not only efficacy, but just as importantly, cosmetic elegance for women whose treatment options must fit their lifestyles and skin care regimens.
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 causes mvoes. In the case of BioPharmX, the news proved to be overwhelmingly positive. After all, the elimination of years of pre-clinical studies advances the company in a big way when it comes to the development time table surrounding BPX-01. So, it comes as no surprise to see investors sending the stock on a run for the top. As is almost always the case, our partners at Trade Ideas were the first to alert us to the gains. Currently (9:34), BPMX is trading at $0.24 per share after a gain of $0.35 per share or 17.65% 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 BPMX. In particular, we’re interested in following the continued development of BPX-01 as the treatment seems to be showing promise. Nonetheless, we’ll continue to follow the story closely and bring the news to you as it breaks!
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