BioPharmX Corporation Completes Pre-IND Meeting With U.S. FDA To Review Its Topical Acne Solution
MENLO PARK, Calif., March 18, 2015 /PRNewswire/ -- BioPharmX Corporation (OTCQB: BPMX), a specialty pharmaceutical company focused on the development of novel drug delivery products to address unmet needs in large, well-defined and underserved markets, today announced that its planned pre-IND (Investigational New Drug) meeting with the U.S. Food and Drug Administration (FDA) was held on March 11, 2015, as scheduled. The pre-IND meeting focused on the company's topical antibiotic acne compound currently under development and the company's proposed strategy for advancing its acne program and plans for conducting safety and toxicology studies, along with human clinical trials.
The company received FDA comments and exchanged a list of questions prior to the meeting. Following the conclusion of the meeting, the company believes that it has sufficient guidance from the FDA for advancing toward an IND application for phase II clinical trials.
"Based on our discussions with the FDA, we are encouraged to continue to advance the development of our topical antibiotic acne compound," said Jim Pekarsky, chief executive officer and co-founder of BioPharmX.
About BioPharmX Corporation
BioPharmX Corporation (OTCQB: BPMX) is a Silicon Valley-based specialty pharmaceutical company, which seeks to provide innovative products through unique, proprietary platform technologies for prescription, over-the-counter ("OTC"), and supplement applications in the fast-growing health and wellness markets, including women's health, dermatology, and otolaryngology (ears, nose & throat). To learn more about BioPharmX, visit www.BioPharmX.com.
Forward-Looking Statements
Statements in this news release relating to the business of BioPharmX, which are not historical facts, are "forward-looking statements." These forward-looking statements may be identified by words such as "expect," "anticipate," "believe," or similar expressions that are intended to identify such forward-looking statements. All forward-looking statements are expressly qualified in their entirety by this cautionary statement and the risks and other factors detailed in the company's filings with the Securities and Exchange Commission (SEC). These statements are based upon the current expectations and beliefs of management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements, including the risk that BioPharmX is unable to obtain FDA approval for its topical antibiotic acne compound or other products. Given these risks and uncertainties, you are cautioned not to place undue reliance on such forward-looking statements. The forward-looking statements included in this news release are made only as of the date hereof and the company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities law.
BioPharmX is a pending trademark of BioPharmX Inc.
SOURCE BioPharmX Corporation
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