Arena Pharmaceuticals Inc. (ARNA) has completed enrollment in its phase II trial of Ralinepag for the treatment of pulmonary arterial hypertension, with about 60 patients. The company expects to report results from this study mid-2017.
ARNA closed Wednesday's trading at $1.40, down 5.07%.
Northwest Biotherapeutics (NWBO) has decided to voluntarily withdraw its common stock from listing on Nasdaq on or about December 19, 2016 and begin trading on the over-the-counter market the same day.
The decision comes in the backdrop of the company's failure to comply with NASDAQ's Listing Rule 5635(d) related to a series of financing transactions that were completed between May 15, 2016 and October 13, 2016.
NWBO closed Wednesday's trading at $0.54, up 4.33%.
Kitov Pharmaceuticals Holdings Ltd. (KTOV) is all set to submit the New Drug Application for its lead drug candidate KIT-302 for osteoarthritis pain during Q1 2017.
KTOV closed Wednesday's trading at $3.51, up 2.03%.
Ocera Therapeutics Inc. (OCRX) has completed enrollment in its Phase 2b study of OCR-002 in hospitalized patients with hepatic encephalopathy.
The trial, dubbed STOP-HE, has enrolled approximately 230 patients, and top-line data from this study are expected in the first quarter of 2017.
OCRX closed Wednesday's trading at $2.10, down 10.64%.
Dupixent, an investigational drug for the treatment of moderate to severe atopic dermatitis in adult patients, has been accepted for review by the European Medicines Agency. A decision can be expected to be announced by the regulatory agency within 210 days.
Dupixent is being co-developed by Sanofi (SNY) and Regeneron Pharmaceuticals Inc.'s (REGN). The drug candidate is already under priority review by the FDA, with a decision date set for March 29, 2017.
REGN closed Wednesday's trading at $362.01, down 1.88%.
Revance Therapeutics Inc. (RVNC) has initiated subject dosing in its phase III program of its investigational drug candidate DaxibotulinumtoxinA for Injection for the treatment of moderate to severe glabellar lines in adults.
The phase III program, dubbed SAKURA, consists of two pivotal trials. Topline clinical results from the pivotal trials are expected in the fourth quarter of 2017.
RVNC closed Wednesday's trading at $16.80, down 6.93%.
A little over a month after settling the Fanapt patent litigation with Taro Pharmaceutical Industries Ltd, which had sought to produce a generic version of the schizophrenia drug, Vanda Pharmaceuticals Inc. (VNDA) has made peace with another litigant - this time with Apotex.
As per the settlement terms, Apotex has been granted a non-exclusive license by Vanda to manufacture and commercialize Apotex's version of Fanapt in the U.S. effective November 2, 2027, unless prior to that date Vanda obtains pediatric exclusivity for Fanapt, in which case, the license will be effective May 2, 2028. Apotex may enter the market earlier under certain limited circumstances.
Fanapt net product sales grew to $19.8 million in the third quarter of 2016 compared to $16.7 million in the year-ago quarter.
VNDA closed Wednesday's trading at $15.40, down 3.75%.
Shares of Voyager Therapeutics Inc. (VYGR) surged over 35% in after-hours on Wednesday, following positive interim results from phase Ib trial of VY-AADC01 for advanced Parkinson's disease.
The trial met the primary objective of safety and increased surgical coverage of ascending doses of VY-AADC01 in the putamen, a region of the brain associated with motor function in Parkinson's disease at six and twelve months. There was an increased AADC enzyme activity, enhanced response to Levodopa, and dose-related, clinically meaningful improvements in various measures of patients' motor function, according to the trial results.
VYGR closed Wednesday's trading at $13.73, down 1.93%. In after-hours, the stock was up 35.47% to $18.60.
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