Follow Us GraphicFacebook IconTwitter IconLinkedIn Icon
Search Graphic

Expert Financial Analysis and Reporting

Post archive for ‘Smith On Stocks Blog’

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 […]

FDA Cardiovascular and Renal Advisory Committee Goes Against FDA View and Recommends Approval of Xarelto

The FDA had apparently slammed the door shut on approval of Johnson & Johnson’s Xarelto (rivaroxaban) for stroke prevention in patients with non-valvular atrial fibrillation (SPAF). The FDA reviewer in his briefing papers to the committee had recommended that the product be given a Complete Response Letter (not approvable at this time). The reviewer did […]

Hopes for Rivaroxaban Are Dashed (JNJ, $65.00)

  Investment Opinion The FDA problems encountered with rivaroxaban are a significant, but not crushing negative for the investment thesis of Johnson & Johnson (JNJ). I would still be buyer of the stock. This is a very large company not overly dependent on any one current or future product and still has an excellent new […]

Dapagliflozin is Voted Down 6 to 9 by Advisory Committee: What’s Next (BMY, $28.77)

Overview of Advisory Committee Meeting   The FDA Endocrinologic and Metabolic Drugs Advisory Committee voted 6-9 against approval of dapagliflozin for the treatment of type II diabetes. This will almost certainly result in a Complete Response Letter from the FDA on the PDUFA date of October 28. As I pointed out in a recent report […]

Santarus 2009 Analyst Day Highlights (SNTS, $1.98)

Management was quite optimistic about prospects for 2009 as both Zegerid and Glumetza are doing well. The company is looking for a 24% gain in product revenues. Summary of Key Points 1. The Santarus analyst meeting was very encouraging in regards to the new product outlook. 2. The company could end the year with $65 […]