Post archive for ‘Company Reports’
Dapagliflozin’s Date with the FDA’s Endocrinologic and Metabolic Drugs Advisory Committee (BMY, $29.17)
Overview and Investment Thesis The strong Bristol-Myers pipeline story is key to the investment thesis and is driven by three potential blockbusters: Yervoy, which was just approved; apixiban which has reported very encouraging phase III data and is likely to be approved in 2012; and dapagliflozin. Of the three, the outlook for dapagliflozin is the […]
Intermezzo is Likely to be Approved on its July 14, 2011 PDUFA Date; Then What (TSPT, $7.98)
Investment Thesis Transcept’s new drug for insomnia, Intermezzo, received a Complete Response Letter on October 26, 2009 in which the FDA acknowledged that it was effective. However, the agency failed to approve the drug because of concerns about dosing and potential next day residual effects. Transcept addressed and in my opinion has successfully answered these […]
ANDA Filing Aganist Ofirmev Is Not Unduly Concerning (CADX, $9.25)
Investment Opinion I believe that the Ofirmev approval is a game changer that can propel Cadence into a successful, medium tier, earnings driven bio-pharmaceutical company. While I am recommending purchase of Cadence, I think that it important for investors to understand the risks and uncertainties of the investment outlook. This note discusses the patent challenge […]
Provenge Receives Final CMS Reimbursement Approval (DNDN, $41.40)
CMS Approval Removes Investor Concern CMS issued its final national coverage decision on Provenge yesterday and confirmed the preliminary decision that specifically states that treatment with Provenge is reasonable and necessary. This assures provider reimbursement for Medicare beneficiaries when Provenge is used on-label to treat asymptomatic and minimally symptomatic castrate resistant prostate cancer patients. This […]
Yervoy Was A Star at American Society of Oncology: Commercial Potential Is Enormous (BMY, $29.15)
Investment Overview I have previously written about Bristol-Myers Squibb (BMY) as having possibly the best pipeline among the major pharmaceutical firms. Despite the new product outlook, I estimate that the loss of sales from products coming off patent will cause overall sales to decrease from $20.4 billion in 2011 to $16.6 billion in 2013. The […]
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. […]