|Healthcare Review: EDAP TMS, Pozen, Syneron, Advaxis, AcelRx Pharmaceuticals|
|By Staff and Wire Reports|
|Monday, 28 July 2014 14:54|
Stocks turned higher, recovering from an early loss, as investors looked ahead to a busy week of data and corporate earnings.The Dow Jones Industrial Average gained 35 points, or 0.2%, to 16996 in early afternoon trading, reversing a loss of as much as 83 points earlier in the session. The S&P 500 tacked on three points, or 0.1%, to 1981, while the Nasdaq Composite Index advanced four points, or 0.1%, to 4454. Traders said no particular piece of news was behind the move higher, though trading volumes were light and investors have shown a consistent willingness to buy market pullbacks.
Shares of EDAP TMS S.A. ($EDAP) drop on a 3x surge in volume. Earlier today, the FDA released its briefing documents for Wednesday's meeting of the Gastroenterology and Urology Devices Panel. The Committee will discuss the company's PMA for the use of Ablatherm HIFU as a treatment for prostate cancer. Investors appear to lack confidence in a positive vote. The agency's comments in the documents imply that reviewers have numerous questions/issues that need to be resolved regarding its clinical trial data.
Shares of Pozen ($POZN) get smacked down on a 2x surge in volume in sympathy with Horizon Pharma's (HZNP -33.2%) bad news. Pozen earns a 10% royalty on Vimovo sales.
Syneron's ($ELOS) PicoWay laser gets CE Mark clearance for tattoo removal and for the treatment of pigmented lesions. The device uses two wavelengths (532 nm and 1064 nm) delivered in picosecond pulses. The company will launch the product in Q3. It anticipates FDA clearance by late 2014.
The Japan Patent Office issues a Notice of Allowance to Advaxis ($ADXS) for its patent application relating to its Lm-LLO cancer immunotherapy platform technology. The patent covers composition of matter and methods of use for combining the company's immunogenic recombinant tLLO fused to full and partial antigens of particular interest to target cancers.
Shares of AcelRx Pharmaceuticals (NASDAQ:ACRX) are off 34% on heavy volume in response to the company receiving a CRL from the FDA regarding its NDA for Zalviso (sufentanil sublingual tablet system). The agency requested more information regarding how the company will ensure the proper use of the device. Its request included the providing of bench data demonstrating a reduction in the incidence of optical systems errors which require premature drug cartridge change, changes to the Instructions for Use and additional data to support the product's shelf life claims.