ARNA – Quick take on FDA Adcom

Our coverage of the anti-obesity sector continues. Yesterday, the FDA released the briefing documents regarding Arena’s application for Lorcaserin. Lorcaserin, or Lorqess, is a novel therapeutic candidate for treatment of obesity. Brief History: In 2010, Arena submitted the NDA for Lorcaserin, a subsequent AdCom voted against the application, five on the roster voted for the […]

VVUS, OREX, ARNA – Understanding the Advisory Committee

Playing VVUS, OREX, ARNA through FDA Adcomm and Qnexa PDUFA Over the past several months, these three companies, with their respective late-stage anti-obesity drug candidates, have experienced a considerable increase in volatility and share price, due in part to new regulatory revelations regarding clinical pathways to regulatory approval. We believe there will continued volatility leading […]

VVUS – Quick Update – Vivus alters NDA for Qnexa, changes REMS

Vivus Pharmaceuticals (NASDAQ:VVUS)  reached an agreement today with the FDA, to alter both it’s REMS and Label for obesity drug candidate, Qnexa. Previous Proposed Label Management took a very conservative approach when filing the initial NDA.  Given questions about teratogencity of topiramate, one of the active ingredients in Qnexa, Vivus’s management proposed a label that […]

FDA Setbacks Make Vivus a Buying Opportunity

Vivus (NASDAQ:VVUS), a specialty pharmaceutical company, has faced some setbacks with its drug candidate, Qnexa, an investigational treatment for obesity, obstructive sleep apnea and diabetes. In October 2010, Vivus received a Complete Response Letter from the FDA, outlining a path to approval, which left investors who expected approval dissappointed. In January 2011, the company met […]

Vivus Investors Flee to Arena Pharmaceuticals

Jason Chew Vivus shares tanked after an expert panel voted 10 to 6 against approving its obesity drug, Qnexa. The panel was particularly worried that Vivus only had one year data for its drug- not long enough in its opinion to gather long term safey data in light of Qnexa’s CNS and Cardiovascular side effects. Qnexa […]

Vivus Has a Hit in Qnexa

Obesity has a high prevalence in the US and is now frequently cited as being a national health issue. It is on the rise in almost every industrialized and some industrializing nations. There are currently no blockbuster weight loss drugs due to lack of efficacy, though many have failed due to unwanted side effects. Some […]

Weight loss, as easy as taking a Qnexa pill

Vivus Pharmaceuticals shocked the health-care industry earlier this year when it announced positive phase III results for it’s new obesity miracle drug. The drug, dubbed Qnexa, is a combination of two, already approved therapies, phentermine and topiramate. Qnexa, combines phentermine, the stimulant that boost the metabolism, with topiramate, an anti-convulsant that also interferes with binge-eating […]