Shares of Pain Therapeutics, Inc. (NASDAQ:PTIE) ended Monday session in red amid volatile trading. The shares closed down -1.40 points or 51.28% at $1.33 with 16.49 million shares getting traded. Post opening the session at $0.98, the shares hit an intraday low of $0.96 and an intraday high of $1.37 and the price vacillated in this range throughout the day. The company has a market cap of $58.58 million and the numbers of outstanding shares have been calculated to be 46.14 million shares.
On Sept. 26, 2016 DURECT Corporation (DRRX) announced that its licensee, Pain Therapeutics (PTIE) has received a Complete Response Letter from the U.S. Food and Drug Administration (FDA) for Pain Therapeutics’ New Drug Application (NDA) for REMOXY® ER (oxycodone) extended-release capsules CII. Based on its review, the FDA has determined that the NDA cannot be approved in its present form and specifies additional actions and data that are needed for drug approval.
In a press release issued this morning by Pain Therapeutics, Pain Therapeutics states that “The CRL focuses on the abuse-deterrent properties of REMOXY ER and proposed drug labeling. The CRL makes no mention of clinical safety, drug efficacy, manufacturing, stability, bioequivalence or any other issues from a prior Complete Response Letter.”
The announcement continues that “Pain Therapeutics is evaluating the CRL and plan further discussions with the FDA. The CRL specifies additional actions that are needed in order to obtain approval of REMOXY ER with label claims against three routes of abuse (i.e., injection, inhalation and snorting). These actions may take approximately a year to conduct and may cost approximately $5MM, pending discussions with the FDA and outside clinical/regulatory consultants.”
Shares of EnteroMedics Inc (NASDAQ:ETRM) ended Monday session in green amid volatile trading. The shares closed up +0.017 points or 12.67% at $0.149 with 11.52 million shares getting traded. Post opening the session at $0.13, the shares hit an intraday low of $0.13 and an intraday high of $0.15 and the price vacillated in this range throughout the day. The company has a market cap of $10.18 million and the numbers of outstanding shares have been calculated to be 69.70 million shares.
EnteroMedics Inc (ETRM) on Sept. 19, 2016 announced that the European Patent Office has issued a Notice of Intention to Grant a European Patent covering safety features of the Company’s vBloc® Neurometabolic Therapy System. The intention to grant the European patent follows the granting of U.S. patent No. 9,393,420 on July 19, 2016, which covers safety features for an implantable neuroregulator with a rechargeable battery. EnteroMedics has been granted three U.S. patents to date in 2016. The Company holds more than 70 patents on its technology worldwide.
“Receipt of the Notice of Intention to Grant a European Patent underscores the strength and robust nature of our intellectual property portfolio, and reaffirms EnteroMedics’ dominant presence within the neuromodulation device industry in the areas of obesity and gastrointestinal disorders,” said Dan Gladney, President and CEO, EnteroMedics Inc. “As we continue to commercialize and seek broad reimbursement coverage for vBloc Therapy in the United States of America, we look forward to the opportunity to offer our technology in international markets.”