We are initiating coverage of Transcept Pharmaceuticals (TSPT) with an ‘Outperform’ rating and a $12 price target. Among the key points to our investment thesis are as follows: Intermezzo approval in late October 2009 is a high probability event. We base this optimism on the fact that the company is utilizing the 505(b)(2) pathway for approval of a new low-dose formulation of zolpidem, a molecule that has been already approved by the FDA and is available generic. Since the original approval of zolpidem as Ambien in 1994, the U.S. FDA has since reviewed the molecule multiple times, including three recent formulation approvals of a controlled release tablet with Ambien CR in September 2005, an oral spray with ZolpiMist in December 2008 and a sublingual tablet with Edluar in May 2009. Intermezzo, a sublingual low-dose (3.5mg) formulation of zolpidem will be specifically intended for the use as-needed ...

Somaxon re-files Silenor NDAOn June 4, 2009, Somaxon (SOMX) announced that is has resubmitted the new drug application (NDA) to the U.S. FDA for Silenor (doxepin) for the treatment of insomnia. The submission comes roughly three and a half months after the FDA issued a Complete Response Letter (CRL) in late February 2009, and two months after management met with the FDA in early April 2009 to discuss the issues raised in the CRL.The resubmission includes additional statistical analyses of the company's clinical data relating to the durability of subjective sleep maintenance efficacy. It also includes the results of the company's completed clinical trial of doxepin that evaluated the potential for electrocardiogram (ECG) effects. The results of that clinical trial demonstrated that Silenor had no effect on QT interval prolongation when administered at 6 mg or under exaggerated exposure conditions of 50 mg....

In response to BioMedReports.com subscriber emails, we will add periodic article coverage of emerging small/micro-cap companies outside of the healthcare sector which offer similar high risk/reward trades as the Extreme Trade article series of pending FDA decisions and clinical trial results.

Options Media Group [OPMG: 0.00, N/A (N/A)] is a leading company in the fast-growing Email Service Provider (ESP) space which offers its clients a full array of direct, mobile, digital, and Internet marketing solutions with the ability to create, execute, and track e-marketing campaigns to a highly targeted audience. Services include email marketing, mobile (SMS or text messaging) marketing, SMS keyword marketing, and custom lead generation as a full-service marketing solution focused on new media outreach which is more targeted and effective than traditional outlets such as print, television, and radio.

In mid-May, OPMG released its 1Q09 operating results, which included revenue

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Highlighted stocks include Sanofi-Aventis (SNY) and Biogen-Idec (BIIB).On February 11, 2009, Sanofi-Aventis (SNY) announced financial results for the 4th quarter 2008. Revenue of EUR7,456 million increased by 3% from the 4th quarter of 2007, and was ahead of our estimate of EUR7,101 million. Revenue benefitted from strong sales of Lantus, Lovenox, Plavix and Ambien CR.Revenue was also positively impacted by foreign exchange translation. EPS, adjusted for non-recurring charges, was EUR1.25 in the 4th quarter, compared to our estimate of EUR1.24. Relative to our expectations, EPS was negatively impacted by higher R&D and SG&A spend and a slightly tighter-than-expected gross margin, partially offset by a lower tax rate.For the full-year 2008, revenue of EUR28.8 billion was down 1% from 2007, while EPS increased by 2% to EUR5.36. Foreign exchange negatively impacted sales and EPS by 5% and 8%, respectively, for the ...