Newsmakers: Exelixis, Keryx Biopharmaceuticals, Intuitive Surgical, Avanir Pharmaceuticals, Mast Therapeutics Print
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Wednesday, 26 March 2014 13:34
U.S. stocks mostly edged higher on Wednesday as geopolitical tensions over Ukraine appeared to ease and the latest U.S. economic data pointed to improving conditions, though investors found few reasons to push shares up substantially. Russia and the West drew a tentative line under the Ukraine crisis after U.S. President Barack Obama and his allies agreed to hold off on more damaging economic sanctions unless Moscow goes beyond the seizure of Crimea, as Russian President Vladimir Putin said last week that he didn't want to do. The development seemed to limit the odds that the biggest East-West conflict since the Cold War could escalate further, removing a potential headwind from markets. While few U.S. companies have direct exposure to the region, investors had been worried about any fallout from prolonged tensions.

Shares of Exelixis ($EXEL) are down big on a 10x surge in volume in response the DMC recommendation to continue the Comet-1 trial. Apparently, many shareholders expected the committee to recommend stopping the trial because of significant efficacy of cabozantinib. Some observers now believe the drug may not be successful.

Shareholders of Keryx Biopharmaceuticals ($KERX) want to give Congress a hug after its proposal to delay putting ESRD drugs into to the ACA-mandated payment bundle until 2024 instead of 2016.This bodes well for the company's lead compound, KRX-0502, a treatment for hyperphosphatemia in patients with chronic kidney disease on dialysis. The product's PDUFA date is June 7.

The da Vinci maker Intuitive Surgical, Inc. (NASDAQ:ISRG) is up to its corporate ears in lawsuits. Shareholders are miffed over its perceived underreporting of adverse events and tepid disclosures of FDA-mandated product recalls. The city of Birmingham pension fund recently joined the fray with its suit claiming that management knew of severe patient injuries and deaths related to the device as early as October 2011 but hid the information from regulators. Insider stock sales by certain executives during this time add fuel to the fund's complaint. Intuitive faces 76 product liability lawsuits, suits from insurers accusing the firm of withholding claims and a securities class action complaint. Shares are down 27% from the February 1, 2013 high of $585.67.

The FDA has accepted Avanir Pharmaceuticals' ($AVNR) New Drug Application (NDA) for the company's AVP-825 "breath powered" drug-device combination for treating migraines.

Mast Therapeutics ($MSTX) initiates a Phase II study of MST-188 in patients with acute lower-limb ischemia, which is a complication of peripheral arterial disease that can lead to a limb being amputated and

even death.




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