FDA Issues Complete Response Letter on Intermezzo On October 28, 2009, the U.S. FDA issued a complete response letter (CRL) on Transcept's (TSPT) new drug application (NDA) for Intermezzo. The news has sent the shares down roughly 45%. TSPT is down now over 60% from the high following the stock’s 14% decline yesterday before the news was public (an obvious leak at the FDA). The Good The FDA stated that it believes Transcept has submitted substantial evidence of effectiveness for the use of Intermezzo in the as-needed treatment of insomnia characterized by difficulty returning to sleep after awakening in the middle of the night (MOTN).  The FDA also recognized that the Intermezzo data did not indicate significant next-day residual effects. The Bad The FDA requested additional data demonstrating that Intermezzo, when taken as directed in the middle of the night, would not present ...

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 Pharmaceuticals, Inc.

(Public, NASDAQ:SOMX)

StocksHaven Investments profiles one of the most promising biomedical pharmaceutical company involved with a PDUFA with regards to a drug which could quite possibly revolutionize the treatment for insomnia, a condition affecting over 70 million Americans. The company has been making waves the past few months as investors and institutions gain confidence from the highly positive clinical trials, and the recent exclusive meeting with the FDA with regards to their NDA. Somaxon Pharmaceuticals is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary products and late-stage product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area. The lead product candidate is Silenor® (doxepin) for the treatment of insomnia. The FDA decision date on Silenor has been set to 12/4/09 for their NDA resubmission, the

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Below is a summary of updates to the BioMedReports.com FDA Calendar, which includes a database of about 200 entries. The calendar was originally created by Mike Havrilla to track companies with pending new drug, biological agent, or medical device new product decisions at the FDA. With the launch of BioMedReports.com, the FDA Calendar has expanded to include the following additional categories: pending new submissions to the FDA (e.g. NDA, BLA, 510k, PMA, sNDA, sBLA filings), pending complete response letter (CRL) re-submissions to the FDA, and pending late-stage pivotal Phase 3 clinical trial results which are designed to support a filing for FDA approval.

On 6/4/09, Abbott Labs [ABT: 45.42, +0.86 (+1.93%)] and AstraZeneca [AZN: 43.34, +1.70 (+4.08%)] announced that the companies have submitted a New Drug Application (NDA) to the FDA for an investigational compound to treat mixed dyslipidemia, a combination of two

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For Immediate Release

Chicago, IL - June 9, 2009 - Zacks Equity Research highlights Vodafone (VOD) as the Bull of the Day and Somaxon (SOMX) the Bear of the Day. In addition, Zacks Equity Research provides analysis on McDonald's Corporation (MCD), Starbucks (SBUX) and Yum! Brands Inc (YUM).

Full analysis of all these stocks is available at http://at.zacks.com/?id=2676.

Here is a synopsis of all five stocks:

Bull of the Day:

We maintain our Buy recommendation for Vodafone (VOD), the largest revenue-generating international wireless carrier. Operating results for fiscal 2009 were highlighted by respectable increases in subscriber count bolstered by record net additions for its Indian operation.

Vodafone continues to accelerate 3G wireless service deployments and expanding network availability across Asia, Eastern Europe and Africa, primarily through acquisitions. Additionally, the company is focused

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On 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. Despite this good news, we struggle to see how this drug can capture enough of the insomnia market to drive Somaxon to strong profitability.

The insomnia market is dominated by generic molecules, and without an onset claim, Silenor will already lose out on approximately half the market. Plus, Somaxon is running dangerously low on cash. We estimate the current cash balance is only enough to fund operations until July 2009.

Therefore, we expect a highly dilutive (30-40%) capital raise in the next week or two. We have a Sell rating on the shares and a target price of $0.50.Zacks Investment Research

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....

FDA Rejects Somaxon's Silenor for Insomnia -- Stock HammeredOn February 26, 2009, after the market closed, the FDA notified Somaxon Pharmaceuticals, Inc. (SOMX) that it could not approve Silenor (doxepin) for the treatment of insomnia. In the Complete Response letter, the FDA raised a number of issues relating to the interpretation of the efficacy data contained in the Silenor new drug application (NDA).The FDA did indicate, however, that it was open to a discussion of these concerns. The FDA did not specifically request the company to conduct additional clinical trials of Silenor, but Somaxon management believes that a discussion with the FDA will be necessary to gain a complete understanding of the implications for the rejection letter.In afterhours trading, Somaxon's stock is down 53% to $1.01.In a research report published at the beginning of February entitled, "Cautious Going Into Silenor ...

Somaxon Pharmaceuticals, Inc. (NASD: SOMX), a specialty pharmaceutical company focused on the in-licensing and development of proprietary product candidates for the treatment of diseases and disorders in the fields of psychiatry and neurology, recently announced that the company’s president and chief executive officer, Richard Pascoe, presented earlier this week at the Natixis Bleichroeder second annual Hidden Gems Conference in New York, NY.

At the conference, Mr. Pascoe stated that Somaxon has completed four successful Phase 3 clinical trials for its lead product candidate, Silenor® (doxepin HCl) for the treatment of insomnia. In each of these clinical trials, Silenor® demonstrated statistically significant and clinically meaningful results in the designated primary endpoint and in several other important secondary endpoints. Somaxon expects that the FDA will complete its review and provide an action letter to the company with respect to the NDA by December 1, 2008.

Regarding the results of the Silenor® clinical trial,

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