May 6, 2014, 7:08 AM
- The FDA approves AstraZeneca's (AZN) Epanova (omega-3-carboxylic acids) as an adjunct to diet to reduce triglyceride levels in adults with severe hypertriglyceridemia (>=500 mg/dl). It is the first approved omega-3 in free fatty acid form. Patients can take as few as two capsules/day.
- In some patients Epanova increases LDL-Cholesterol so this parameter should be monitored periodically during therapy. This will undoubtedly be a selling point for Amarin's (AMRN) Vascepa (icosapent ethyl) since it lowers LDL-C.
Jul. 9, 2013, 11:46 AM
Omthera Pharmaceuticals (OMTH -0.7%) says it's submitted a New Drug Application to the FDA seeking approval for the marketing and sale of Epanova for the treatment for patients with severe hypertriglyceridemia. The submission is driven by positive results from two Phase III trials that examined the effectiveness of Epanova in lowering very high triglycerides, and in reducing non-HDL cholesterol in combination with a statin.| Jul. 9, 2013, 11:46 AM
Jun. 4, 2013, 3:05 AM
Epizyme (EPZM), which ended its first day of trading Friday up 40% from its initial $15 price, briefly broke the $30 mark on Monday before ending the day +21.75%. It's the third biotech IPO to quickly grow 50% since April, the others being Chimerix (CMRX) and Omthera (OMTH) - in the latter case due to the quick buyout offer from AstraZeneca.| Jun. 4, 2013, 3:05 AM
May 28, 2013, 8:42 AMOmthera (OMTH): Q1 EPS of -$3.08 misses by $0.77. (PR) | May 28, 2013, 8:42 AM
May 28, 2013, 8:11 AM
May 28, 2013, 2:48 AM
AstraZeneca (AZN) has agreed to acquire Omthera Pharmaceuticals (OMTH) for up to $443M as the U.K. company carries out its strategy of building up its cardiovascular drug business. The price includes an upfront payment of $323M, or $12.70 a share, which represents an 88% premium to Omthera's close on Friday. AstraZeneca will pay another $120M based on the success of Omthera's experimental drug Epanova for treating very high levels of triglycerides, a fat found in the blood. (PR)| May 28, 2013, 2:48 AM
May 7, 2013, 11:29 AM
BofA initiates recently public Omthera Pharmaceuticals (OMTH +7.5%) at Buy with a $10 price target, saying the company "has a compelling valuation compared to the only other omega-3 pure play [and] Epanova has significant growth potential [but] does not have to become a blockbuster" for the stock to rise. Similarly, Leerink Swann starts the stock at Outperform ($12 price target) citing a positive outlook for Epanova, and Piper Jaffray assumes coverage at Overweight with a target of $15.| May 7, 2013, 11:29 AM