Expert Financial Analysis and Reporting

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. […]

Meeting With CEO Steve Worland Anadys’ CEO Steve Worland was in town for the Piper Jaffrey conference along with Investor Relations head Amy Conrad. I wanted to get their thoughts on why Anadys had been performing so poorly since the stock offering of October 15, 2010 in which the company raised $23.3 million. Key Points: […]

I had a telephone conversation with CEO Steve Worland to discuss the negatives and positives for Anadys over the next year or so. Conclusion There are no significant catalysts over the next year and the product development landscape for HCV drugs grows more complex and difficult to understand by the day. The potential role of […]

I met with CEO Steve Worland and IR contact Amy Conrad at their offices in San Diego. This was my first meeting with Mr. Worland. Company Overview The company ended the second quarter with $25.4 million of cash. The quarterly burn rate for the first two quarters was about $9.0 million so that the company […]

I had a phone conversation with CEO Steve Worland in which he gave me an update on the company’s lead drug, ANA-598 for the treatment of hepatitis C. Overview Anadys’ lead drug ANA-598 is for treating hepatitis C. This disease is now treated with a combination of interferon alpha and ribavirin. About 40% to 45% […]

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 […]