During Tuesday’s Morning trade, Shares of Pluristem Therapeutics Inc.(NASDAQ:PSTI), lost -0.96% to $1.03.
Pluristem Therapeutics, declared that it has reached a contract with Japan’s Pharmaceuticals and Medical Devices Agency (PMDA) on the design of the final trial needed to apply for conditional approval of PLX-PAD cells in the treatment of critical limb ischemia (CLI). The approval of the protocol for the 75-patient trial was part of a larger agreement on the development of PLX-PAD via Japan’s new accelerated regulatory pathway for regenerative medicine.
“With this achievement we have advanced our strategy to expedite commercialization of our cell products. Pluristem is now positioned favorably to accelerate negotiations with those Japanese pharma companies interested in becoming dominant players in the expanding regenerative medicine market in Japan,” stated Pluristem Chairman and CEO Zami Aberman.
The trial will collect data on 75 patients suffering from CLI. These patients will be randomized into three groups of 25. Group one will receive an initial 150 million PLX-PAD cell dose followed eight weeks later by a second 150 million cell dose; group two will be treated with an initial 300 million PLX-PAD cells followed eight weeks later by a second dose of 300 million cells; group three will receive two doses of placebo. The cells will be injected into a leg muscle using a standard syringe. Efficacy and safety will be determined from outcomes measured nine months after administration of the first dose. The primary efficacy endpoint will be diagnosis of a patient as CLI-free for 60 days. Pluristem anticipates to submit the formal Clinical Trial Notification (CTN) to the PDMA, based on the agreement reached with the regulatory body, in early 2016. The PMDA is predictable to respond officially within 30 days. Earlier in 2015, the PMDA cleared PLX-PAD cells for use in clinical studies in Japan, a prerequisite to conducting this clinical trial.
Pluristem Therapeutics Inc., through its partner, Pluristem Ltd., operates as a bio-therapeutics company in Israel. The company focuses on the research, development, clinical trial, and manufacture of cell therapeutics products and related technologies for the treatment of various ischemic and inflammatory conditions.
Shares of International Game Technology PLC (NYSE:IGT), declined -0.42% to $16.51, during its current trading session.
International Game Technology PLC, declared that it now offers content from the legacy GTECH game portfolio on its social gaming app, Double Down Casino®, with recently’s launch of Treasures of the Pyramids™ for mobile and desktop.
“Launching our first legacy GTECH title on DoubleDown Casino establishes a noteworthymilestone for the new IGT, showcasing our combined strengths from the two legacy organizations,” said Joe Sigrist, Double Down Interactive Senior Vice President and General Manager. “Treasures of the Pyramids is a well-known, top-performing title in land-based casinos. Leveraging its popularity provides our social players with more engaging content as we continue IGT’s momentum as the leader in cross-platform content creation and distribution.”
Treasures of the Pyramids features an Egyptian-themed symbol set with a familiar base game and bonus mechanics which players will recognize from the land-based game. Its five-reel, 40-payline configuration displays the legacy title’s iconic wild panther symbol spread across two reels, and can give players the chance to trigger 100 free games in the bonus round with a variety of multipliers.
International Game Technology PLC operates and provides a range of services and technology products across lotteries, machine gaming, sports betting, and interactive gaming markets in North America, Asia, and Europe.
Finally, JA Solar Holdings Co., Ltd. (ADR) (NASDAQ:JASO), lost -0.82%, and is now trading at $9.72.
Park Lane Advisor has initiated coverage on the following equities: Oclaro Inc. (OCLR), JA Solar Holdings Company Ltd (JASO), SunEdison Semiconductor Ltd (SEMI), and Xcerra Corporation (XCRA). Free research report on Oclaro can be accessed at http://www.parklaneadvisor.com/ On Monday, December 21, 2015, the NASDAQ Composite ended at 4,968.92, up 0.93%, the Dow Jones Industrial Average advanced 0.72%, to finish the day at 17,251.62, and the S&P 500 closed at 2,021.15, up 0.78%. The gains were broad based as all the sectors ended the session in positive. Register for your complimentary reports at the links given below.
On Monday, shares in JA Solar Holdings Co. Ltd ended the session 2.05% higher at $9.96. The stock stated a trading volume of 1.29 million shares, above its three months average volume of 0.76 million shares. Shares of the company traded at a PE ratio of 5.44. JA Solar Holdings Co. Ltd’s shares have gained 20.87% in the last one month, 26.72% in the previous three months and 21.61% on YTD basis. The company is trading 14.95% above its 50-day moving average and 14.96% above its 200-day moving average. Moreover, shares of JA Solar Holdings Co. Ltd have an RSI of 72.62.
JA Solar Holdings Co., Ltd., together with its auxiliaries, designs, develops, manufactures, and sells photovoltaic solar cells and solar power products based on crystalline silicon technologies. The company’s principal products comprise monocrystalline and multicrystalline solar cells and modules.
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