NEW YORK, NY / ACCESSWIRE / September 12, 2018 / It was a day of unexplainable gains for two biotech stocks on Tuesday. Both Agile Therapeutics and BioPharmX catapulted higher despite any significant news.
RDI Initiates Coverage on:
Agile Therapeutics, Inc.
Agile Therapeutics, Inc. shares closed up 116.83% on Tuesday with around 52.1 million shares traded. Average trading volume for the stock is just a little over 500,000 shares. There was no explanation for the boost in share price and trading volume yesterday. It was at the beginning of August that the company announced second quarter results and an update on Twirla, it's investigational low-dose, non-daily, combination hormonal contraceptive patch. The company announced that FDA’s Office of Drug Evaluation III (ODEIII) has denied the company’s appeal of the complete response letter issued for the new drug application of Twirla®. As per the press release, "the company is planning to appeal the decision of the ODEIII to the Office of New Drugs. FDA regulations for dispute resolution are governed by 21 CFR 10.75, which provides a mechanism whereby an applicant can obtain formal review of any FDA decision by the employee’s supervisor." For the second quarter, the women's health company reported a loss of $5.3 million. The company had a loss of 16 cents per share which was one penny better than the 17 cent loss analysts had been expecting.
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BioPharmX Corporation shares closed up 35.20% on nearly 32 million shares traded on Tuesday. The specialty pharmaceutical company did not have any apparent news to explain the share price climb. It was at the end of last month that BioPharmX reported second quarter results, reporting a net loss of $4.4 million, or $0.02 per share, compared with a net loss of $3.7 million, or $0.05 per share, during the prior fiscal year's second quarter. "This quarter has been filled with significant progress for the company," said Anja Krammer, BioPharmX president and co-founder. "In acne, the FDA granted a CARC waiver, potentially shaving years off of additional dermal carcinogenicity studies for BPX-011, and in rosacea, we received IRB approval to begin the BPX-041 phase 2 program. To help guide these development programs, we also formed a Special Advisory Council consisting of experts across a variety of fields. Additionally, this quarter saw our third patent awarded this year, underscoring the value of the HyantX™ delivery system."
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