Healthcare Review: Tekmira Pharmaceuticals, Orexigen Therapeutics, Amedisys, Sarepta Therapeutics, Cynosure Print E-mail
By Staff and Wire Reports   
Wednesday, 30 July 2014 13:55
U.S. stocks rose as the Federal Reserve continued to trim monthly asset purchases and data showed better-than-forecast economic growth. The S&P 500 climbed 0.3 percent to 1,974.95 as of 2:14 p.m. in New York, erasing earlier losses. The Dow Jones Industrial Average added 8.74 points to 16,920.85. The Nasdaq 100 Index increased 0.7 percent. Policy makers tapered monthly bond buying to $25 billion in their sixth consecutive $10-billion cut, staying on pace to end the purchase program in October. Fed officials led by Chair Janet Yellen are stepping up a debate over when to raise interest rates for the first time since 2006 as unemployment falls faster than expected and inflation picks up toward their 2 percent goal.

Shares of thinly-traded Tekmira Pharmaceuticals ($TKMR) jump on a 3x surge in volume as investors anticipate FDA action to the persistent Ebola outbreak in Africa. The company has an RNAi therapeutic in development to treat Ebola infection. The FDA designated it Fast Track in March 2014.

The European Medicines Agency sends a 180 List of Outstanding Issues to Orexigen Therapeutics ($OREX) regarding its Marketing Authorization Application (MAA) for NB32 (naltrexone/bupropion), its investigational drug candidate for weight loss. Orexigen believes it addressed the key questions the EMA raised in its 120-day assessment, but the 180 LOI raises new issues. Specifically, CHMP wants further justification of the balance of benefits and risks of NB32 treatment, additional information regarding post-approval risk minimization measures and pharmacovigilance activities as well as details about the company's bupropion suppliers.

Amedisys ($AMED) Q2 results: Net Service Revenue: $305.0M (-3.5%); Operating Expenses: $292.4M (-6.2%); Operating Income: $12.6M (+193.0%); Net Income: $7.6M (+313.9%); EPS: $0.23 (+283.3%); Quick Assets: $11.2M (-35.3%); CF Ops: ($89.1M) (-365.2%).

Shares of Sarepta Therapeutics ($SRPT) jump on increased volume after FDA Center for Drug Evaluation and Research chief Janet Woodcock stated that the agency is exploring all "potential pathways" to approve new drugs to treat Duchenne muscular dystrophy. She also specifically mentioned the possibility that agency would place Sarepta's eteplirsen in its accelerated approval program.

Cynosure's ($CYNO) BOD promotes EVP, COO and CFO Timothy W. Baker to President effective August 1, 2014. He assumes the title from Michael Davin, who will remain Chairman and CEO. Mr. Baker has been with the company since 2004.




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