|Healthcare Review: Ventrus Biosciences, Dehaier Medical Systems, Novavax, MannKind, Momenta Pharmaceuticals|
|By Staff and Wire Reports|
|Thursday, 05 June 2014 13:45|
The S&P 500 rose to hit an intraday record high for the seventh time in eight sessions on Thursday after the European Central Bank cut rates to record lows and outlined further accommodative monetary policy actions. Also helping stocks: hedge fund manager David Tepper was reported by CNBC as saying the ECB move partly "alleviated" his concerns about the market, after having said last month he was worried stock prices were stretched. The ECB cut the deposit rate to -0.10 percent and will move further to persuade banks to lend. ECB head Mario Draghi said the bank's governing council will intensify preparations related to outright purchases of asset-backed securities.
Shares of pico cap Ventrus Biosciences ($VTUS) jump on 3x higher volume. Today's action follows a breakout on May 29 when prices popped 23% on 14-fold surge in volume. Traders appear to be taking positions before the company's pre-IND meeting with the FDA on June 19 where the parties will discuss guidance regarding an approval path for Dolizem (diltiazem hydrochloride cream) as a treatment for anal fissures. Based on a positive outcome of the meeting, Ventrus plans to file an NDA in 2H 2014 with an expected PDUFA date about a year later.
The China Food and Drug Administration approves Dehaier Medical Systems' ($DHRM) Morpheus Ox software. The approval completes the regulatory registration for the four key components of the company's Sleep Respiratory Solutions: the second generation DHR998 Sleep Diagnostic Device, photoplethysmography (PPG) sensor, sleep diagnostic software and continuous positive airway pressure ventilator.
Novavax ($NVAX) says it'll use the offering's proceeds for "general corporate purposes, the advancement of its clinical-stage vaccine candidates and its preclinical research programs, manufacturing and process development activities, capital expenditures and other strategic purposes."
MannKind ($MNKD) surged to a 52-week high of $11.11 on Thursday on high volume as the impending July 15 date for FDA approval of the company’s inhaled insulin drug Afrezza approaches. Wednesday marked what was likely the first day of significant momentum trading on MannKind with a little more than a month to go before the anticipated approval date.
The FDA designates Momenta Pharmaceuticals' ($MNTA +2.1%) oncology drug candidate necuparanib an Orphan Drug for the treatment of pancreatic cancer. Necuparanib is a heparan sulfate mimetic, derived from unfractionated heparin. It retains its antitumor properties while minimizing its anticoagulant activity.