Archive for June, 2011
Orexigen Therapeutics (OREX)
The FDA has shown great reluctance to approve three anti-obesity agents under development: Orexigen’s Contrave, Vivus Qnexa and Arena’s 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.The potential for Contrave approval in the US is […]
The Bull and Bear Case for Anadys (ANDS, $1.00)
The investment thesis for Anadys is almost totally based on the prospects for its lead drug, ANA 598, which is being developed for treating hepatitis C. This drug has shown itself to be safe and phase I data supports the belief that it is an effective agent. It is now in a phase II trial […]
Upgrading to Buy Based On Regaining Glaxo’s Rights in Entereg (ADLR, $1.65)
Investment Thesis Adolor has gained back Glaxo’s rights to Entereg (alvimopan) in a transaction that I regard as a highly positive, company changing event. Entereg has the critical sales mass to enable Adolor to be a self-sufficient, cash flow positive company. I believe that the Entereg sales run rate entering 2012 could be on the […]
Implications Stemming From FDA Requirement for Extremely Large Cardiovascular Outcomes Study for Orexigen’s Contrave (VVUS, $8.00)
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. […]
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. […]
Orexigen Receives Crushing News That FDA Will Require Extremely Large Cardiovascular Outcomes Study In Order for Contrave To Gain Approval (OREX, $1.83)
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. […]
Thoughts on Recent Poor Stock Performance (ANDS, $1.09)
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: […]
Investment Negatives and Positives (ANDS, $2.06)
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 […]
Initial Meeting with Anadys’ CEO Steve Worland (ANDS, $2.33)
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 […]
Update on Anadys’ Lead Drug, ANA-598 for Hepatitis C (ANDS, $2.06)
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% […]