The HavRx Regulatory Catalyst Index Update report is currently tracking 313 total entries that include select pending binary event data (FDA decisions, clinical trials) with 206 companies tracked, 155 companies under $10 per share, and 117 companies under $5 per share.
<font> <font> 1.) GenVec (NASDAQ:GNVC) ($2.90) (market cap = $362 million) </font> </font>
<font> TNFerade (DNA carrier, adenovector with gene for TNF-alpha) </font>
<font> Phase 3 Pancreatic Cancer Clinical Trial (PACT) </font>
<font> GNVC announced on 1/15/10 the 184th death in PACT study and guided for 10-12 weeks at the time for interim data to be reported while the final data analysis will occur after 276 deaths are reached. More recently, GNVC reported earnings and provided guidance for expected interim results in March or April 2010. </font>
<font> <font> 2.) Acura Pharma (NASDAQ:ACUR) ($5.16) (market cap = $226 million) </font> </font>
<font> Acurox (oxycodone and niacin) Tablets </font>
<font> FDA Advisory Panel Meeting, 505(b)(2) NDA Resubmission </font>
<font> Acurox is partnered with King Pharma (NYSE:KG) and both companies reported results to support the abuse-deterrant potential of this pain drug candidate on 3/8/10. A Complete Response Letter (CRL) was received from FDA in June 2009 and a joint meeting of the Anesthetic / Life Support Drugs and Drug Safety / Risk Management Advisory Committees of the FDA is scheduled for 4/22/10. </font>
<font> <font> 3.) Cadence Pharma (NASDAQ:CADX) ($9.26) (market cap = $468 million) </font> </font>
<font> Ofirmev (intravenous or IV formulation of acetaminophen) </font>
<font> The FDA issued a CRL on 2/11/10 that noted third-party manufacturer deficiencies (with a submitted response to FDA on 2/18/10) and indicated that no additional clinical studies are required required. CADX is seeking approval of Ofirmev for the treatment of pain and the reduction of fever in adults and children and expects to resubmit the NDA once all inspection-related issues are resolved. </font>
<font> <font> 4.) Cytori Therapeutics (NASDAQ:CYTX) ($4.59) (market cap = $196 million) - Celution System </font> </font>
<font> CYTX is scheduled to report full six-month results from the APOLLO trial (heart attack) and preliminary six-month results from the PRECISE trial (chronic ischemia on 5/7/10 at the Stem Cell Therapy and Cardiovascular Innovation conference in Madrid, Spain. These safety and feasibility studies will evaluate the potential of autologous (patient-derived) adipose (fat tissue) derived stem and regenerative cells in the acute and chronic cardiac disease settings based on output from the Company's Celution System. </font>
<font> www.mikehavRx.com </font> <font> is your prescription for stock index investing updates focused on the healthcare sector, medical innovation, and pending binary events such as FDA decisions and clinical trials, which are tracked in the actively managed HavRx Regulatory Catalyst Index. </font>
<font> Disclosure: Long CYTX </font>
$4.59 (03/27/10)
