| Three Extreme FDA Medical Device / Diagnostic Trades Mike Havrilla submits:Below is a selection of companies with stock prices below $5 per share and upcoming binary events in the form of FDA decisions for medical device /diagnostic submissions to the Agency. A common strategy used by many investors is to buy a basket of several small or micro-cap companies (generally less than $1 billion market cap stocks) with pending binary events approximately 3-6 months ahead of the expected catalyst date and sell into the expected upward momentum in both stock price and trading volume. Medical device and diagnostic submissions for FDA marketing clearance represent a unique niche within the space of trading binary events since there are no firm decision deadlines for decisions by the Agency and there is often a great deal of variability in the review periods. For example, Cambridge Medical (CAMH.OB) received marketing clearance for its Microvolt T-Wave Alternans OEM module used in cardiac stress testing systems in less than three months while other companies such as Nephros [NEPH.OB] ($0.54, $22 million market cap) have been waiting for over one year.Complete Story » seekingalpha.com |
Anthera's Lead Drug: A High-Risk, High-Reward Proposition Jason Chew submits: After the 2000 bubble and crash, the biotech IPO has finally begun to crack open a bit. First, Ironwood (IRWD) tested the waters in February with the largest IPO in two years. Anthera (ANTH) soon followed March 4, raising just $37.1 million after cutting its IPO price from the $13-$15 range to just $7. An additional $17.1 million was raised in a private placement to existing shareholders for a combined $54.2 million. It ended Q1 with $56.7 million. The stock closed at $6.60 Friday. Anthera has three drugs in clinical development: A-002 for Acute Coronary Syndrome, A-623 for Lupus, and A-001 for Acute Chest Syndrome. Since its IPO, Anthera has begun recruiting patients into a pivotal Phase III trial for its lead drug, A-002 (varespladib methyl). A-002 is a novel inhibitor of sPLA2, an isoform of PLA2 implicated in acute inflammation. sPLA2 is a very interesting target; inhibition of this enzyme is thought to block the synthesis of a family of pro-inflammatory mediators known as Eicosanoids, which include Prostaglandins and Leukotrienes. COX inhibitors such as Celebrex also have this activity, but have potential side effects. A-002 is a high-risk, high-reward proposition. The current trial will enroll 6500 patients and last 18 months. Anthera will need to bring a partner on board soon. And although its current Phase III trial is for Acute Coronary Syndrome, it has significant blockbuster potential as a cardiovascular treatment competing with the likes of Lipitor if it proves to be safe and shows improvements in efficacy. GSK has a similar compound in development now in a second Phase III trial. If approved, their drug, darapladib, is expected to reach sales of over $1 billion.Anthera’s market cap of $150 million reflects the risk embedded in its drug. If GSK’s darapladib does well, I would expect investors to warm up to Anthera’s A-002.Disclosure: No PositionComplete Story » seekingalpha.com |
Cord Blood America Inc. is Today's Focus Stock on MicroStockProfit.com (GlobeNewswire) DALLAS -- MicroStockProfit.com announces an investment report featuring Cord Blood America Inc. . The report includes financial, comparative and investment analyses, and industry information you need to know to make an educated investment decision. us.rd.yahoo.com |
Options For Colon Cancer Screening Colonoscopy is the prevailing method of testing for colorectal cancer screening in the U.S., but two other options—and novel efforts by health care organizations—may improve low rates of screening. online.wsj.com |
PAREXEL International to Present at Piper Jaffray Healthcare Conference [PR Newswire] - PAREXEL International Corporation announced today it will be presenting at the Piper Jaffray Healthcare Conference in New York. Â James Winschel, Sr. Vice President and Chief Financial Officer will be making a presentation on PAREXEL at 2:30 pm E.T. on Tuesday, November 30, 2010. us.rd.yahoo.com |