Somaxon - SOMX denied - try again

* Says letter did not raise any clinical safety issues
* Co says FDA has requested for amended REMS
* Co intends to schedule meeting with FDA for guidance
* Shares tank 71.7 pct

Dec 7 (Reuters) - Somaxon Pharmaceuticals Inc said U.S. health regulators declined to approve its insomnia drug Silenor for the second time this year, sending its shares down 72 percent before the bell.
The company had previously received a complete response letter in February from the U.S. Food and Drug Administration, which raised issues regarding efficacy data. [ID:nBNG439722].
Somaxon resubmitted the new drug application (NDA) for Silenor in June.
In the most recent complete response letter, the FDA stated that the Silenor NDA did not meet the approval standard for efficacy.
The letter did not raise any clinical safety issues but the FDA has requested the company submit an amended risk evaluation and mitigation strategy (REMS), including a medication guide to be distributed with the product, in any resubmission, the company said.
Somaxon said it intends to schedule a meeting with the FDA to seek specific guidance because the most recent complete response letter did not contain any specific requirement to conduct any additional clinical work or other specific guidance.
Shares of Somaxon were trading at $1.00 before the bell. They had closed at $3.53 Friday on Nasdaq.

Bank of America - BTFO AH - cono!

Bank of America Corporation (NYSE: BAC) is going to soon be out of the TARP. The report was first out by CNBC’s Charlie Gasparino right after 5 PM that Bank of America is about to do a large capital raise to exit out of the TARP. The the Wall Street Journal reported that Bank of America will be exiting the TARP. Their figure for a capital raise is $20 billion in new capital. It is also noted that Greg Curl may become interim-CEO.

Bank of America has now confirmed the reports in a press release noting that Bank of America will repay the entire $45 billion in TARP to U.S. taxpayers. The bank will ask holders to approve an increase in shares and will use $26.2 billion in excess liquidity in the repayment here. Asset sales are to be approved by the Federal Reserve ($4 billion approximately). It noted approximately $18.8 billion in proceeds from common equity equivalent securities sales and about $1.7 billion through restricted stock issuance.

This will dwarf the GE-Comcast deal for NBC Universal all day Thursday. Ken Lewis has not yet left, but this will be a crowning moment for him that will clear the way for him to leave the firm under a clear sky. Still, it is hard to not make a point here that will fume many readers… Maybe Ken Lewis should just be kept on for another year.

And if you are a compensation critic from Main Street America on how much these executives make, the day after these funds are repaid this salary and compensation energy should be directed elsewhere.

Bank of America shares closed down 1.5% at $15.65 today, and shares are down 1.6% at $15.40 after the news. Yes, this is good news that the bank can get out of the TARP and can stop having to answer to public and government criticism. But this is going to be dilutive at a minimum, and likely will be dilutive AND leveraging to its balance sheet unless you are a straight debit and credit person.

Rosen Law Firm Announces Class Action Lawsuit Against Hemispherx Biopharma, Inc.

• • Hemispherx Biopharma, Inc.

NEW YORK, NY--(Marketwire - 12/02/09) - The Rosen Law Firm, P.A. announces that a class action lawsuit has been filed on behalf of all purchasers of Hemispherx Biopharma Inc. ("Hemispherx") (AMEX:HEB - News) securities between February 18, 2009 and October 30, 2009, inclusive (the "Class Period").

Related Quotes

Symbol	Price	Change
HEB	0.70	-0.50

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To join the Hemispherx class action, go to the website at http://www.rosenlegal.com or call Laurence Rosen, Esq. or Phillip Kim, Esq. toll-free at 866-767-3653 or email lrosen@rosenlegal.com or pkim@rosenlegal.com for information on the class action. The case is pending in the United States District Court for the Eastern District of Pennsylvania.

NO CLASS HAS YET BEEN CERTIFIED IN THE ABOVE ACTION. UNTIL A CLASS IS CERTIFIED, YOU ARE NOT REPRESENTED BY COUNSEL UNLESS YOU RETAIN ONE. YOU MAY ALSO REMAIN AN ABSENT CLASS MEMBER. YOU MAY ALSO RETAIN COUNSEL OF YOUR CHOICE.

The Complaint alleges that during the Class Period, defendants misled investors regarding the status and time frame for approval of Hemispherx's New Drug Application ("NDA") for Ampligen with the U.S. Food and Drug Administration ("FDA"). Specifically, defendants failed to disclose that the FDA had requested several reports from the Company before the NDA could even be considered, thus delaying the possible approval of Ampligen by several months at a minimum. Then, on November 2, 2009, when the Company belatedly disclosed this information, the price of Hemispherx's securities dropped from $1.45 on the previous trading day to close at $1.13 on November 3, 2009, a drop of more than 20%. The lawsuit seeks to recover damages for investors resulting from the drop in the share price related to the alleged fraud.

A class action lawsuit has already been filed on behalf of Hemispherx shareholders. If you wish to serve as lead plaintiff, you must move the Court no later than January 11, 2010. If you wish to join the litigation or to discuss your rights or interests regarding this class action, please contact plaintiff's counsel, Laurence Rosen, Esq. or Phillip Kim, Esq. of The Rosen Law Firm toll free at 866-767-3653 or via e-mail at lrosen@rosenlegal.com or pkim@rosenlegal.com.

HEB DENIED BY FDA -Hemispherx Biopharma

* FDA asks company to conduct additional study
* FDA asks for safety and efficacy data * Shares fall 45 pct to 66 cents in extended trade

Dec 1 (Reuters) - Hemispherx Biopharma Inc said U.S. health regulators did not approve its experimental drug Ampligen for the treatment of chronic fatigue syndrome, sending its shares down 45 percent in after-hours trade.
In a complete response letter to the company, the U.S. Food and Drug Administration stated that the two primary clinical studies submitted with the new drug application did not provide credible evidence of efficacy.
The FDA recommended at least one additional clinical study which shows a convincing effect and confirms safety in the target population, Hemispherx said in a statement.
The FDA also asked the company to resolve outstanding inspection issues at some of its facilities producing Ampligen, that included the facility located in New Brunswick, New Jersey and one of its third party manufacturing facilities, Hollister-Stier Laboratories.
Hemispherx said it has not determined the impact of the recommendations on timelines and overall cost of the program.
The company said it is reviewing the complete response letter and will seek an expedited meeting with the FDA to discuss its recommendations.
Shares of the company fell 45 percent to 66 cents in after market trade. They closed at $1.20 Tuesday on the American Stock Exchange.