|Healthcare Review: Tekmira Pharmaceuticals, Orexigen Therapeutics, Amedisys, Sarepta Therapeutics, Cynosure|
|By Staff and Wire Reports|
|Wednesday, 30 July 2014 13:55|
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.