Follow Us GraphicFacebook IconTwitter IconLinkedIn Icon
Search Graphic

Expert Financial Analysis and Reporting

Post archive for ‘Smith On Stocks Blog’

Issuance of Complete Response Letter for Eliquis Doesn’t Alter My Buy on Bristol-Myers Squibb

Investment Opinion I believe that the issuance of a Complete Response Letter to Bristol-Myers Squibb (BMY) and Pfizer (PFE) for the use of Eliquis to prevent stokes caused by atrial fibrillation is a minor setback and believe that the issue can be resolved and the product approved by October at the earliest and April of […]

InSite Vision: Initiating Coverage on a Promising Company with a Robust Late Stage Product Portfolio

I have just published a new report and initiated coverage of InSite Vision (INSV, $0.30) with a Buy. The core technology of InSite Vision is its DuraSite drug delivery system that delivers drugs more effectively to the eye. The continual blinking of the eye can quickly wash out topical formulations and in order to retain […]

Initiating Coverage of A.P. Pharma with a Buy (APPA, $0.42)

I have just published a report initiating coverage on A.P. Pharma (APPA, $0.42) in which I recommend purchase; my 2015 price target is $5.00+. The recommendation is keyed to the projected approval of APF530 for the treatment of chemotherapy induced nausea and vomiting in early 2013 and launch in the US in mid-2013. Most newly […]

Dendreon Turns Reins Over to New CEO

Key Points Dendreon has made a sweeping change in management by bringing in John Johnson, who was serving as a board member, to be the new President, CEO and Chairman-elect of the Board of Directors. He immediately replaces Mitchell Gold as CEO and Richard Brewer has stepped down as Chairman of the Board. Mr. Gold […]

New Scientific Abstact Suggests That Median Overall Survival for Provenge is 7.8 Months, Not 4.1 (DNDN, $14.09)

Conclusions I think that most physicians and investors were aware that the analysis of Dendreon’s (DNDN) Provenge in the Phase III IMPACT Trials understated its effect on survival because of the use of frozen Provenge (Frovenge) in the control group. In a new scientific paper, the authors concluded that after adjusting for this factor, the median […]

Johnson & Johnson’s Turnaround Led by New Drug Products is Underway (JNJ, $65.15)

Investment Conclusion JNJ has gone through three very difficult years as EPS increased only slightly from $4.63 in 2009 to $5.00 in 2011. The most important challenge faced was the loss of patents on the major drugs, Risperdal, Topamax, Levaquin, Duragesic and Concerta which saw aggregate sales drop from $5.8 billion in 2009 to an […]

Investors’ Concerns About the Intermezzo Launch Weighs on the Stock and Creates a Buying Opportunity

Investment View I believe that Transcept’s (TSPT) Intermezzo is an important new drug for insomnia and will be a commercial success. I am anticipating that Transcept’s marketing partner Purdue Pharmaceuticals will launch the product in mid-2012. There was a time when new product approvals and launches produced investor exuberance. Now they seem to be met […]

Cubist Makes Attractive Bid for Adolor

Investment View of the Proposed Acquisition Cubist announced today that it had signed a definitive agreement to acquire Adolor.   Adolor has been one of my four recommendations. My price target was $4.50 in 2013 based on sales and earnings of Entereg alone and before taking into account the potential for ADL5945. Please refer to […]

Contrave Is Given New Life as FDA Reverses its Position on Design of Cardiovacular Outcomes Trial (OREX, $2.45)

Investment Opinion Orexigen’s (OREX) anti-obesity drug Contrave has been given new life as the FDA reversed a previous position that would have required a cardiovascular outcomes trial involving 60,000 to 100,000 patients and which might have taken four to six years to complete in order to gain US approval for Contrave. In a press release […]

Transcept to Resubmit Intermezzo NDA; Hopes for a Class I Review

Resubmission of Intermezzo NDA Transcept Pharmaceuticals in a press release today (September 15) said that it plans to resubmit its NDA on Intermezzo following a meeting with the FDA. The key parts of the resubmission are: Transcept proposes to reduce the recommended Intermezzo dose for women from 3.5 mg to 1.75 mg, and to keep […]