FDA waives BioPharmX study, in what many would consider a huge break for the company.
FDA Waives BioPharmX Study
The Palo Alto-based specialty pharmaceutical company that develops products for dermatologists announced via press release early this morning that the FDA has waived its requirement for a dermal carcinogenicity study. Normally, several years of non-clinical research is required by the FDA for pharmaceutical treatments.
The drug that isn’t required to go through the clinical study is BPX-01, a topical gel used to treat inflammatory acne. The drug received the waiver based on the results of a 39-week minipig toxicity study on minocycline products. The minipig study found no pre-neoplastic or hyperplastic changes that might indicate a carcinogenic potential.
BioPharmX BP of Clinical and Regulatory Affairs, AnnaMarie Daniels, commented in the press release:
“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.”
BioPharmX is currently in various discussions with a number of partners regarding BPX-01 for the treatment of acne. The company has received several written letters of interest and BioPharmX is currently considering all the financial and strategic benefits of the various options.
BioPharmX Stock Jumps 16%
Immediately following the press release that was pushed out this morning, the BioPharmX (NYSE:BPMX) stock jumped up in price as soon as the markets opened.
As per Yahoo Finance, BioPharmX closed the market yesterday at $0.200 a share and opened today at $0.230. The stock closed the market today at $0.232 a share, up $0.0321, which was a 16.06% increase from the previous trading day.
BioPharmX’s stock is down -57.47% in its 52-week change. Currently, the company’s market cap is sitting at $44.43 million.
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