Key Developments For Somaxon Pharmaceuticals, Inc.
Somaxon Pharmaceuticals, Inc. (SOMX.O) (Consolidated Issue listed on NASDAQ Capital Market)
Somaxon Pharmaceuticals, Inc. Completes $6 Million Private Equity Financing
Somaxon Pharmaceuticals, Inc. announced private placement of approximately 5.1 million shares of its common stock at a price of $1.05 per share and seven-year warrants to purchase up to approximately 5.1 million additional shares of its common stock, exercisable in cash or by net exercise at a price of $1.155 per share, for aggregate gross proceeds of approximately $6 million. The price paid for the common stock is equal to the consolidated closing bid price on the Nasdaq Capital Market on the day of pricing, July 2, 2009.
Somaxon Pharmaceuticals, Inc. Announces $6 Million Private Equity Financing And Acceptance Of NDA Resubmission Of Silenor For Treatment Of Insomnia
Somaxon Pharmaceuticals, Inc. announced it has entered into a purchase agreement to issue and sell in a private placement approximately 5.1 million shares of its common stock and warrants to purchase up to approximately 5.1 million additional shares of its common stock, for aggregate gross proceeds of approximately $6 million. The price to be paid for the common stock, $1.05 per share, is equal to the consolidated closing bid price on the Nasdaq Capital Market on the day of pricing, which was July 2, 2009. The seven-year warrants are exercisable at a price of $1.155 per share. The private placement is expected to close on July 8, 2009. In addition, the Company announced that the FDA has accepted for review the resubmission of its New Drug Application for Silenor (doxepin) for the treatment of insomnia and confirmed that the review cycle will be six months, resulting in a new FDA action date of December 4, 2009.
Somaxon Pharmaceuticals, Inc. Announces Resignation Of David F. Hale As Chairman-Form 8-K
Somaxon Pharmaceuticals, Inc. reported in its Form 8-K that pursuant to the employment agreement, as amended, between David F. Hale and Somaxon Pharmaceuticals, Inc., Mr. Hale's service as Somaxon's Executive Chairman of the Board came to an end as of Somaxon's 2009 Annual Meeting of Stockholders, which was held on June 9, 2009. From and after the 2009 Annual Meeting, Mr. Hale will return to his previous role as Somaxon's non-executive Chairman of the Board.
Somaxon Pharmaceuticals, Inc. Resubmits New Drug Application For Silenor (Doxepin) For The Treatment of Insomnia
Somaxon Pharmaceuticals, Inc. announced that it has resubmitted its New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Silenor (doxepin) for the treatment of insomnia. 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, or 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. The FDA has indicated that the review cycle for the resubmission will be six months.
Somaxon Pharmaceuticals, Inc. Announces Update On New Drug Application For Silenor (Doxepin) For Treatment Of Insomnia
Somaxon Pharmaceuticals, Inc. announced an an update on the status of its New Drug Application (NDA) for 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 NDA and indicated that the FDA was open to a discussion of these concerns. In the meeting, the FDA stated that to obtain approval of a chronic insomnia treatment, objective and subjective efficacy must be established in adult and elderly patient populations, and efficacy must be shown both at the beginning of treatment and on a persistent basis, defined as at least one month. The Company plans to conduct additional analyses of its clinical data focused on the durability of subjective sleep maintenance efficacy in adults with primary insomnia. The Company will complete these analyses as soon as possible.
