Expert Financial Analysis and Reporting

Transcept believes that the results of the highway driving study of Intermezzo reasonably answer the concerns of the FDA that caused the agency to issue a Complete Response Letter to the NDA in October of 2009.   There is reasonable hope that the FDA will agree with Transcept that the study does answer their concerns […]

Orexigen has just reported success in four phase III trials for Contrave in obesity. Contrave Overview The key efficacy measure in these trials was that ≥ 35% of patients on the drug lose at least 5% of body weight and that the proportion is double placebo or that mean weight loss is ≥ 5% difference […]

I have met numerous times with CFO, Graham Cooper. This was an opportunity to meet with the new CEO, Michael Narachi, who comes from Amgen. I am extremely impressed by his operational expertise and strategy. He should be an excellent CEO to lead the company into its commercial phase. Overview I am of the opinion […]

On December 3, 2010, an FDA advisory panel will review the NDA submitted by Orexigen Therapeutics for its new anti-obesity agent Contrave. This note previews and discusses possible issues that the panel will address. Introduction Their recommendation to the FDA as to whether Contrave should be approved obviously will have dramatic consequences for Orexigen’s stock. […]

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 […]

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 […]

I believe that Johnson & Johnson will experience an acceleration in earnings based on an outstanding pipeline of new drugs. I am recommending purchase.   Perspective on Stock Performance Johnson & Johnson (JNJ) is coming off three poor years in which its unit volume and sales have been flat. It has suffered from a host […]

Dendreon will be hosting its first quarter conference call on May 2, 2011 at 4:30 EST. I anticipate that Provenge sales in the 1Q, 2011 will be about $28 million, which is in line with Street expectations.   The key factors to listen for on the call will be: (1) whether the company reaffirms its […]

CMS may issue on March 31, its draft guidance for the national coverage analysis of Provenge for use in asymptomatic or minimally symptomatic hormone resistant prostate cancer; Along with most investors, I expect that the guidance will recommend coverage of Provenge for patients as described in the label. It is my belief that the primary […]

Investors are evaluating the impact on the earnings of Santarus following the recent launch of a generic to its key product Zegerid. Of perhaps more importance they are also trying to gauge how much and when a pipeline of new in-licensed products can bolster sales and earnings.   Santarus: Building a New Company on a […]