Tag archive for ‘Arena Pharmaceuticals’
Implications for Lorquess From FDA Request for Extremely Large Cardiovascular Outcomes Study for Orexigen’s Contrave (ARNA, $1.31)
Stock Opinion The FDA has shown great reluctance to approve three anti-obesity agents under development: Orexigen’s ($2.11, OREX) Contrave, Vivus’ ($8.17, VVUS) Qnexa and Arena’s ($1.38, ARNA) Lorques. All three drugs received complete response letters following their NDA submissions and the companies are in the process of addressing the FDA’s concerns before refilling their NDAs. […]
FDA Advisory Committee Vote on Lorcaserin is Negative (ARNA, $3.74)
Yesterday, the FDA advisory committee voted 9 to 5 against approval of Lorcaserin. I listened to the day long proceedings and also tuned in to the conference call with investors that the company held this morning. I have a number of takeaways. The panel and FDA are charged with weighing the benefits of the drug […]
Trying to Define Path Forward for Lorcaserin with FDA (ARNA,$1.49)
Arena held a conference call on March 11, 2011 to update investors on the possible regulatory path forward for lorcaserin. It is trying to answer concerns raised by the FDA and addressed in the advisory committee last September on the finding that lorcaserin is associated with mammary tumors in rats and the relevance for women […]