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SOMX - WAIT Today a Black Closing Marubozu was formed. This shows that the day opened and then prices initially went up but then they reversed direction moving below the opening level and finally closing at the low of the day.
Source: http://www.americanbulls.com/StockPage.asp?CompanyTicker=SOMX&MarketTicker=NASD&TYP=S
More info: http://investorshub.advfn.com/boards/board.aspx?board_id=20991
Paladin Labs Inc. (TSX:PLB) and Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) today announced that Paladin has filed a New Drug Submission (NDS) that has been accepted for review by Health Canada for Silenor® (doxepin) for the treatment and symptomatic relief of insomnia.
loading up in low 50's.............200k........double bagger short term..
SOMX breaking out, near term .80's target price for now...
It wasn't meant to be anything but factual information. If anything it would have been bearish for the stock, note the selling for the past several quarters. I am not in SOMX, but it is on my watch list for a possible Jan bounce. I will likely be buying into the stock soon...
Don't understand if you mean this is bullish or not. I don't see insiders buying shares...
GLAD TO BE ON BOARD FOR THE RUN TO $$$9$$$
4:37PM Somaxon Pharmaceuticals announces FDA feedback on Silenor OTC regulatory pathway and changes to commercial team (SOMX) 0.80 -0.07 : Co announced that it recently had a meeting with the U.S. Food & Drug Administration (FDA) relating to the over-the-counter (OTC) development program for Silenor(R). In the meeting, which Somaxon attended jointly with its Silenor partner Procter & Gamble, the FDA provided clinical and regulatory guidance that the company believes provides a clear path forward toward an OTC version of Silenor. Somaxon believes that the FDA's guidance provides an opportunity to develop an OTC label that is tailored to Silenor's clinical profile and differentiated from other OTC sleep products. Somaxon believes that Silenor's characteristics, including its lack of addiction potential and its clinical efficacy and safety profile, make it an ideal candidate to be the first prescription insomnia product to be converted to an OTC product. Somaxon also announced changes to its commercial team that promotes Silenor for the treatment of insomnia characterized by difficulty with sleep maintenance.
Somaxon Pharmaceuticals Announces FDA Feedback on Silenor OTC Regulatory Pathway and Changes to Commercial Team
PRESS RELEASE
Oct. 3, 2011, 4:35 p.m. EDT
SAN DIEGO, Oct 03, 2011 (BUSINESS WIRE) --
Somaxon Pharmaceuticals, Inc. SOMX +25.00% , a specialty pharmaceutical company, today announced that it recently had a meeting with the U.S. Food & Drug Administration (FDA) relating to the over-the-counter (OTC) development program for Silenor(R). In the meeting, which Somaxon attended jointly with its Silenor partner Procter & Gamble, the FDA provided clinical and regulatory guidance that the company believes provides a clear path forward toward an OTC version of Silenor.
Somaxon believes that the FDA's guidance provides an opportunity to develop an OTC label that is tailored to Silenor's clinical profile and differentiated from other OTC sleep products. Somaxon believes that Silenor's characteristics, including its lack of addiction potential and its clinical efficacy and safety profile, make it an ideal candidate to be the first prescription insomnia product to be converted to an OTC product.
Somaxon also announced changes to its commercial team that promotes Silenor for the treatment of insomnia characterized by difficulty with sleep maintenance. In particular, Somaxon announced that:
-- it has amended the Co-Promotion Agreement with Procter & Gamble so that Procter & Gamble's exclusive negotiation period relating to OTC rights to Silenor is extended from 60 to 120 days, and to discontinue the co-promotion services under the agreement as of December 31, 2011.
-- it has appointed Michael Allen as Senior Vice President, Sales and Marketing. Mr. Allen replaces Jeff Raser, who has resigned from the company to pursue other interests.
-- it has provided notice to Publicis Touchpoint Solutions, Inc. that it intends to hire the Publicis sales force promoting Silenor as Somaxon employees during the fourth quarter of 2011. In connection with the conversion of the sales force, Somaxon will terminate the Professional Detailing Services Agreement with Publicis effective as of December 31, 2011.
"Our first year of marketing Silenor has provided us with a host of learnings relating to the market and the most efficient use of our resources to promote Silenor for the treatment of insomnia," said Richard W. Pascoe, Somaxon's President and Chief Executive Officer. "We believe that the changes we are announcing today will enable us to focus our sales and marketing resources in the most efficient and effective way as we move forward through the fourth quarter and into 2012."
"The changes to the Procter & Gamble agreement represent the natural evolution of our relationship at this stage in Silenor's commercial growth, allowing us to reallocate resources from sales support toward Silenor consumer awareness initiatives, while continuing to explore the potential for a Silenor OTC life cycle management opportunity with a highly differentiated label," continued Pascoe.
"We are excited to add Mike Allen to our team given his extensive track record of success in leading sales, marketing and managed care teams to drive product growth. Hiring the dedicated sales team as Somaxon employees will allow us to more closely align the incentives of the sales force with our commercial and corporate objectives, reduce the per-representative cost of our sales force, and enhance sales force effectiveness."
"Lastly, we wish to thank Jeff Raser for his contributions to the company over the years, and we wish him well in his future endeavors."
Mr. Allen brings to Somaxon over 25 years of commercial experience in the pharmaceutical industry, including 15 years in general management and senior sales and marketing positions. Mr. Allen was most recently Senior Vice President, Commercial Operations at ProteoGenix, Inc., and he previously held senior commercial management positions at Tercica, Inc., Prometheus Laboratories Inc. and Ther-Rx Corp. In each of these positions Mr. Allen played a leading role in creating commercial infrastructures and launching products. Mr. Allen also served in a number of senior commercial roles at Serono Inc., including positions as General Manager, Serono Canada, and Executive Vice President, North American Reproductive Endocrinology Business Unit. During his tenure at Serono, Mr. Allen led a number of successful flagship product launches and had direct responsibility for all aspects of a commercial operation generating more than $250M in annual revenue.
There is no termination fee or other material obligation that will result from the termination of the Publicis agreement. As a result of the discontinuation of co-promotion services under the Procter & Gamble agreement, Procter & Gamble will be entitled to a low single-digit royalty on net sales of Silenor for the 2012 fiscal year.
Conference Call Information and Forward-Looking Statements
On Tuesday, October 4, 2011, Somaxon will conduct a conference call with interested parties beginning at 8:30 a.m. ET (5:30 a.m. PT) to discuss the FDA's OTC feedback, the changes to the Silenor commercial team and related matters. The conference call will be available to interested parties through a live audio Internet broadcast at http://investors.somaxon.com/eventdetail.cfm . The call will also be archived and accessible at this site for approximately two weeks. Alternatively, callers may participate in the conference call by dialing (480) 629-9835, conference call ID 4477168. A telephonic replay will be available for approximately two weeks following the conclusion of the call by dialing (303) 590-3030, and entering passcode 4477168.
Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company's commercial plans and activities relating to Silenor, prescription trends, the company's financial status and performance, the potential to develop an OTC version of Silenor, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded products and late-stage product candidates to treat important medical conditions where there is an unmet medical need and/or high-level of patient dissatisfaction, currently in the central nervous system therapeutic area. Somaxon's product Silenor, now available by prescription in the United States, is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
For more information, please visit the company's web site at www.somaxon.com .
Safe Harbor Statement
Somaxon cautions readers that statements included in this press release and the conference call that are not a description of historical facts are forward-looking statements. For example, statements regarding the hiring by Somaxon of Mr. Allen and the sales force, the anticipated reduction in per-representative cost and enhancement of effectiveness of such sales force, the potential to enter into a separate agreement with Procter & Gamble relating to OTC rights for Silenor, the potential to successfully develop an OTC Silenor product and Somaxon's other commercial activities and plans are forward-looking statements. The inclusion of forward-looking statements should not be regarded as a representation by Somaxon that any of its plans will be achieved. Actual results may differ materially from those set forth in this release and the conference call due to the risks and uncertainties inherent in Somaxon's business, including, without limitation, Somaxon's ability to successfully commercialize Silenor; the market potential for insomnia treatments, and Somaxon's ability to compete within that market; the potential to enter into an agreement with Procter & Gamble relating to OTC rights for Silenor; Somaxon's ability, together with any partner, to receive FDA approval for an OTC version of Silenor; Somaxon's ability to successfully hire a sales force, including the transition of Publicis representatives to Somaxon employees; the scope, validity and duration of patent protection and other intellectual property rights for Silenor; whether the approved label for Silenor is sufficiently consistent with such patent protection to provide exclusivity for Silenor; Somaxon's ability to successfully enforce its intellectual property rights and defend its patents, including any developments relating to the recent submission of abbreviated new drug applications for generic versions of Silenor 3 mg and 6 mg and related patent litigation; the possible introduction of generic competition for Silenor; changes in healthcare reform measures and reimbursement policies; the ability of Somaxon to ensure adequate and continued supply of Silenor to successfully meet anticipated market demand; Somaxon's ability to raise sufficient capital to fund its operations, and the impact of any such financing activity on the level of its stock price; the impact of any inability to raise sufficient capital to fund ongoing operations, including any patent infringement litigation; the potential for an event of default under Somaxon's loan agreement with Silicon Valley Bank and Oxford Finance Corporation, and the corresponding risk of acceleration of repayment and potential foreclosure on the assets pledged to secure the loan; Somaxon's ability to operate its business without infringing the intellectual property rights of others; Somaxon's reliance on its licensee, Paladin, for critical aspects of the commercial sales process for Silenor outside of the United States; the performance of Paladin and its adherence to the terms of its contracts with Somaxon; inadequate therapeutic efficacy or unexpected adverse side effects relating to Silenor that could adversely impact commercial success, or that could result in recalls or product liability claims; other difficulties or delays in development, testing, manufacturing and marketing of Silenor; the timing and results of post-approval regulatory requirements for Silenor, and the FDA's agreement with Somaxon's interpretation of such results; and other risks detailed in Somaxon's prior press releases as well as in its periodic filings with the Securities and Exchange Commission.
Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement, and Somaxon undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. This caution is made under the safe harbor provisions of Section 21E of the Securities Exchange Act of 1934.
SOURCE: Somaxon Pharmaceuticals, Inc.
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http://www.marketwatch.com/story/somaxon-pharmaceuticals-announces-fda-feedback-on-silenor-otc-regulatory-pathway-and-changes-to-commercial-team-2011-10-03
SOMX
SOMX : why $1.00 a share? Is there any hope?
http://www.fool.com/investing/high-growth/2011/08/04/somaxons-bore-of-a-quarter.aspx
Thursday's Top Prospects: xxx, SOMX, and xxx Voted Best of the Best
By Bryan Murphy
Published: September 15, 2011 6:10:25 AM PDT
xxx, Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX), and xxx have been deemed today's most bullish stocks, according to the investment community. Is the collective wisdom of the market's players on target though, or is this just a ruse for xxx, xxx, and SOMX? Take a look.
Somaxon Pharmaceuticals, Inc. is the very top pick this Thursday, and understandably so. This biopharma name has been beaten down all year, falling from around $3.00 in January to lows around $0.89 since early August. That was the beginning of the recovery phase for SOMX though - horizontal support kept this small cap in position for yesterday's breakout move.... a pop from $1.00 to $1.20, which just happened to push this chart above the recent sideways range as well as well above the 20-day moving average line.
The clincher is the volume. On Wednesday, 1.36 million shares of SOMX traded hands (about $1.5 million worth of this $56 million company), which was the strongest volume we've seen since early August when Somaxon Pharmaceuticals was in the process of going from bad to worse. This IS a major bullish reversal effort.
____________________________________________________________
http://www.smallcapnetwork.com/Thursdays-Top-Prospects-MBI-SOMX-and-STP-Voted-Best-of-the-Best/s/via/1789/article/view/p/mid/1/id/66/
SOMX
There had been rumors all day on the Yahoo board about a buyout and Roth had been mentioned along with the rumor. Took off early in the day and had very high volume (3.5 times average volume).
Quote:
__________________________________________________________
11:00 EDT SOMX
theflyonthewall.com: Roth Capital's senior pharmaceuticals analyst holds a conference call
Subscribe for More Information :theflyonthewall.com
__________________________________________________________
http://boardcentral.com/boards/SOMX/70195971_Re_From_the_Flyonthewall
SOMX
Somaxon Pharma SOMX Oppenheimer Outperform » Perform
http://www.briefing.com/investor/calendars/upgrades-downgrades/
I have been buying SOMX the last couple of days. Insiders and fund companies still seem to be interested in SOMX.
http://www.insidercow.com/history/company.jsp?company=somx&B1=Search!
http://quotes.barrons.com/somx/ownership
SOMX keeps trying to break out. Currently up 10.86% on a flat market day. Is it because listed as a stock to day trade?
http://daytradingstockblog.blogspot.com/2011/08/stocks-to-buy-81911-august-19-2011_18.html
Also, listed among NASDAQ stocks with the highest up potential:
47 Somaxon Pharmaceuticals, Inc. (SOMX) 274.2%
http://www.nasd100.com/2011/08/top-nasdaq-stocks-with-highest-upside-potential.html
SOMX
SMOX down to $1.29 after quarter report and access to 45 m (private) financing:
Somaxon Pharmaceuticals Reports Second Quarter 2011 Financial Results; Company Announces Access to up to $45 Million in Financing
* Total Net Product Sales Grow to $6.2 Million
* Company Secures $15 Million Term Loan and Enters into $30 Million “At-the-Market” Offering Program
* Company Reduces Total Annual Operating Expense Guidance to $75-$78 Million
Conference call scheduled today at 4:30 p.m. ET (1:30 p.m. PT); Simultaneous webcast at http://investors.somaxon.com/eventdetail.cfm
Related Quotes
Symbol Price Change
SOMX 1.30 -0.21
Press Release Source: Somaxon Pharmaceuticals, Inc. On Tuesday August 2, 2011, 4:05 pm EDT
SAN DIEGO--(BUSINESS WIRE)-- Somaxon Pharmaceuticals, Inc. (Nasdaq:SOMX - News), a specialty pharmaceutical company, today announced financial results for the quarter ended June 30, 2011. For the second quarter of 2011, Somaxon reported net product sales of $6.2 million, compared to net product sales of $2.3 million in the first quarter of 2011. The company had no product sales in the second quarter of 2010. The net loss for the second quarter of 2011 was $14.9 million, or a loss of $0.33 per share, compared to a net loss of $5.7 million, or a loss of $0.16 per share, in the second quarter of 2010.
Somaxon also announced that it has obtained a $15 million term loan from Oxford Finance Corporation and Silicon Valley Bank. Additionally, the company has entered into an “At-the-Market” (ATM) equity offering sales agreement with Citadel Securities LLC, under which Somaxon may from time to time offer and sell shares of its common stock having an aggregate offering price of up to $30 million through Citadel. Somaxon expects to use the aggregate funds of up to $45 million to, among other things, satisfy working capital needs in the commercial activities relating to Silenor®, the company’s first FDA-approved product indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
“During the second quarter of 2011, we continued to make positive strides towards Silenor’s long-term commercial success by increasing Silenor net product sales to $6.2 million and growing Silenor prescriptions by over 36% over the previous quarter,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “In addition, we continued to make solid progress with our managed care contracting efforts, so that we now have approximately 159 million covered lives in a Tier 2, 3 or 4 unrestricted position and approximately 110 million covered lives on contracted formularies.”
“Moreover, having access to additional working capital further supports our financial position as we continue these commercial activities and as we seek to leverage our sales force to broaden our product portfolio, with the goal of building a sustainable business dedicated to delivering long-term stockholder value,” continued Pascoe.
Recent Highlights
* Somaxon secured a $15.0 million term loan from Oxford Finance and Silicon Valley Bank. General terms of the loan arrangement include interest-only payments through December 2011, and the principal, together with interest, must be repaid by December 2013.
* Under the “At-the-Market” equity offering sales agreement, Somaxon may from time to time offer and seek to sell up to $30 million of its common stock through Citadel at prevailing market prices, at prices related to prevailing market prices or at negotiated prices.
* In June 2011, Somaxon entered into a license agreement with Paladin Labs, Inc., pursuant to which Paladin will commercialize Silenor in Canada, South America, the Caribbean and Africa. Somaxon received $5.5 million through a combination of an up-front payment and an equity investment from Paladin. Once Silenor is commercialized in the licensed territories, Somaxon will also be eligible to receive sales-based milestone payments of up to $128.5 million, as well as a tiered double-digit percentage of net sales in the licensed territories.
* Somaxon has continued to make significant progress in expanding access to Silenor to patients at affordable co-pays. CVS/CaremarkPCS Health agreed to improve its current commercial formulary position for Silenor to Tier 2 unrestricted from Tier 3 unrestricted, beginning October 1, 2011. CVS/CaremarkPCS Health manages commercial healthcare plans covering approximately 50 million lives. This important agreement will position Silenor more favorably on the CVS/CaremarkPCS Health formulary than any other branded product for the treatment of insomnia.
* Somaxon has come to agreement with Medicare Part D health insurance plans covering a total of over 3 million lives, and the company continues to actively seek to add coverage on additional Part D plans. The company has also reached agreement with the U.S. Department of Veteran’s Affairs to make Silenor eligible for formulary inclusion by the regional Veterans Integrated Services Network plans, and the company has continued its efforts to establish Silenor as the insomnia treatment of choice within the Department of Defense institutions where Silenor is currently contracted.
* Beginning in early April 2011, Somaxon implemented the eVoucher co-pay assistance program under which co-pay amounts of $85 or below for patients with a commercial health insurance pharmacy benefit will be automatically reduced to $15 at the time of payment at approximately 33,000 participating pharmacies (a list of participating pharmacies is available at www.silenor.com). The company’s Sleep Saver program, which offers up to $25 off of patient co-pay amounts at the point of sale, also continues to be available to commercial plan patients who are unable to take advantage of the eVoucher program.
Second Quarter 2011 Financial Results
Net product sales of Silenor for the second quarter of 2011 was $6.2 million. As expected and in accordance with U.S. generally accepted accounting principles, the company has revised its revenue recognition methodology to record sales of Silenor when units are sold to its wholesale distributors, rather than when units are dispensed through patient prescriptions. Net product sales to wholesale distributors in the second quarter of 2011 was $3.5 million, and the remainder of net product sales for the quarter consists of net product sales previously deferred.
Cost of sales was $0.7 million for the second quarter of 2011. Gross profit was $5.6 million for the second quarter of 2011, and gross margin was 89%.
Total operating expenses for the second quarter of 2011 were $20.5 million, including $1.4 million of non-cash, share-based compensation expense, compared with $5.7 million, including $1.3 million of non-cash, share-based compensation expense, for the second quarter of 2010. These increases in total operating expenses are primarily due to an increase in selling, general and administrative (SG&A) expenses relating to commercial activities for Silenor.
SG&A expense was $20.1 million for the second quarter of 2011, compared to $4.9 million for the second quarter of 2010. This increase reflected the costs associated with commercial activities relating to Silenor and an increase in salary and personnel-related expenses due to an increase in overall headcount.
Research and development expense was $0.5 million for the second quarter of 2011, compared to $0.8 million for the second quarter of 2010.
Net loss for the second quarter of 2011 was $14.9 million, or a loss of $0.33 per share, compared with a net loss of $5.7 million, or a loss of $0.16 per share, for the second quarter of 2010.
At June 30, 2011, Somaxon had cash, cash equivalents and short-term investments totaling $30.9 million, compared to $54.8 million at December 31, 2010.
Revised Operating Expense Guidance for Full Year of 2011
For the full year of 2011, Somaxon is lowering the range of its expected total operating expense to be approximately $75-$78 million, including non-cash, share-based compensation expense. Non-cash, share-based compensation expense is expected to be approximately $4 million. The projected decrease in full year of 2011 total operating expense compared to previous guidance primarily relates to decreases in SG&A expense.
Actual financial results for the full year of 2011 could vary based upon many factors, including but not limited to the rate of growth of Silenor sales and the actual cost of commercial activities.
$15 Million Term Loan
Under the loan agreement, Somaxon will repay interest on a monthly basis at the fixed, per-annum rate of 7.50% through December 31, 2011, and thereafter Somaxon will repay the principal and interest on a monthly basis through the maturity date of December 31, 2013. The loan is secured by a first priority security interest in all of the company’s assets, other than its intellectual property and its rights under license agreements granting it rights to intellectual property. In connection with entering into the loan agreement, Somaxon issued to the lenders warrants to purchase shares of the company’s common stock, and Somaxon terminated its previous loan agreement with Comerica Bank.
$30 Million At-the-Market Offering Program
Under the ATM equity offering sales agreement, sales of common stock, if any, through Citadel, will be made by means of ordinary brokers’ transactions, in private negotiated transactions, or otherwise, at market prices prevailing at the time of sales, prices related to prevailing market prices or negotiated prices.
Somaxon has filed registration statements (including prospectuses) and prospectus supplements with the Securities and Exchange Commission (SEC) to enable the offering of common stock described in this communication. Current and potential investors should read the prospectuses in those registration statements, the prospectus supplements relating to the at-the-market offering and other documents the company has filed with the SEC for more complete information about Somaxon and the at-the-market offering program. These documents may be obtained for free by visiting EDGAR on the SEC Web site at www.sec.gov. Alternatively, Somaxon or Citadel will send the prospectus supplements (including the prospectuses) upon request. Such requests may be made by contacting Citadel Securities LLC, 601 Lexington Avenue, 28th Floor, New York, NY 10003, or by calling 212-847-8880, or 877-219-5193 (toll free).
This press release does not constitute an offer to sell or a solicitation of an offer to buy, nor may there be any sale of Somaxon’s common stock in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful prior to registration or qualification under the securities law of any state or jurisdiction.
Conference Call Information and Forward-Looking Statements
On Tuesday, August 2, 2011, Somaxon will conduct a conference call with interested parties beginning at 4:30 p.m. ET (1:30 p.m. PT) to discuss results and highlights of the second quarter ended June 30, 2011.
The conference call will be available to interested parties through a live audio Internet broadcast at http://investors.somaxon.com/eventdetail.cfm. The call will also be archived and accessible at this site for approximately two weeks. Alternatively, callers may participate in the conference call by dialing (877) 941-6010 (domestic) or (480) 629-9643 (international), conference call ID 4459273. A telephonic replay will be available for approximately two weeks following the conclusion of the call by dialing (800) 406-7325 (domestic) or (303) 590-3030 (international), and entering passcode 4459273.
Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s commercial activities relating to Silenor, prescription trends, the company’s financial status and performance, including its financing activities and plans, and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.
Global Hunter Securities Analysts Initiate Coverage on Somaxon Pharmaceuticals, Inc. (SOMX)
Wednesday, July 20, 2011 8:12 AM
Equities research analysts at Global Hunter Securities initiated coverage on shares of Somaxon Pharmaceuticals, Inc. (NASDAQ: SOMX) in a research note to investors on Wednesday. The analysts set an "accumulate" rating and a $3.40 price target on the stock.
Separately, analysts at Piper Jaffray (NYSE: PJC) downgraded shares of Somaxon Pharmaceuticals, Inc. from an "overweight" rating to a "neutral" rating in a research note to investors on Monday, June 13rd. They now have a $2.50 price target on the stock. Also, analysts at Oppenheimer (NYSE: OPY) reiterated an "outperform" rating on shares of Somaxon Pharmaceuticals, Inc. in a research note to investors on Thursday, June 9th.
Somaxon Pharmaceuticals, Inc. (Somaxon) is a specialty pharmaceutical company focused on the in-licensing and development of product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area. On March 18, 2010, the food and drug administration (FDA) notified the Company that it approved its New Drug Application (NDA) for Silenor (doxepin) three mlilligram and six milligram tablets for the treatment of insomnia characterized by difficulty with sleep maintenance. Silenor is an oral tablet formulation of doxepin at strengths of three milligram and six milligram. Doxepin has been marketed from 75 milligram to 300 milligram per day and is indicated for the treatment of depression and anxiety. The Company’s clinical development program for Silenor included four Phase III clinical trials, and the primary efficacy endpoint achieved statistical significance in each trial.
Stay on top of analysts' coverage with American Banking & Market News' daily email newsletter that provides a concise list of analysts' upgrades, analysts' downgrades and analysts' price target changes for each day.Click here to register.
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http://www.newsystocks.com/News/4100586/global-hunter-securities-analysts-initiate-coverage-on-somaxon-pharmaceuticals-inc-somx
SOMX
Up 8.18% to $1.85 pre-market. Reversal in effect??
SOMX
3 Biotech Plays on the Move; BioSante, Aeterna, Somaxon
Posted by luckywinner on Jul 12, 2011 | View Comments
(Info from other companies deleted)
Shares of Somaxon Pharmaceuticals Inc. (NASDAQ: SOMX), a San Diego-based specialty pharmaceutical company engaged in the in-licensing and development of product candidates for the treatment of diseases and disorders in the central nervous system therapeutic area, are climbing in today’s trading. At last check, Somaxon shares were trading 2.37% higher at $1.73, with volume at 477,250.
Last month Somaxon announced the completion of a previously signed private placement transaction with Paladin Labs. The private placement was part of Somaxon’s exclusive collaboration with Paladin under which Paladin will commercialize Silenor® for the treatment of insomnia characterized by difficulty with sleep maintenance. Paladin will commercialize Silenor in Canada, South America and Africa.
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http://www.beaconequity.com/3-biotech-plays-on-the-move-biosante-aeterna-somaxon-2011-07-12/
SOMX
I already sold this pos a time ago....a little bit late to react at my post IMO
that's it? he gets paid $1.5M a year. throwing 1% to hook you up doesn't sound encouraging, but looks like a trap?
Somaxon Discloses Patent-Infringement Suit Against Mylan
DOW JONES NEWSWIRES
Somaxon Pharmaceuticals Inc. (SOMX) said it is suing Mylan Pharmaceuticals Inc. (MYL) for trying to market a generic version of its Silenor sleep medication.
The suit filed in the U.S. District Court for the District of Delaware claims Mylan's abbreviated new drug application infringes on Somaxon's patent, according to the company's filing with the Securities and Exchange Commission. In May, Somaxon filed a similar lawsuit against Par Pharmaceutical Inc. (PRX) over that firm's efforts to market its own generic version of Silenor.
Somaxon earlier last month said its first-quarter loss widened sharply on higher costs, though it reported product sales, of which it had none a year earlier.
Somaxon shares fell 6% to $2.05 after-hours Tuesday, after gaining about as much during the session. Mylan shares were unchanged at $23.75 after-hours.
-By Drew FitzGerald, Dow Jones Newswires; 212-416-2909; Andrew.FitzGerald@ dowjones.com
(END) Dow Jones Newswires
06-28-111811ET
Copyright (c) 2011 Dow Jones & Company, Inc.
Read more: http://www.nasdaq.com/aspx/company-news-story.aspx?storyid=201106281811dowjonesdjonline000371&title=somaxon-discloses-patent-infringement-suit-against-mylan#ixzz1QfXtAFqm
yeah yeah it is movin movin.....lolllllllll
President and CEO of Somaxon Pharmaceuticals Inc. (SOMX) Richard W Pascoe buys 11100 shares of SOMX on 06/10/2011 at an average price of $2.25 a share.
SOMX to be deleted from the Russell index in the coming weeks:
http://www.russell.com/indexes/tools-resources/reconstitution/reconstitution-changes.asp
Yikes!! I got out with a small loss at 2.38. Keeping this one on watch
Somaxon and Paladin Announce Silenor® Ex-US Collaboration
Somaxon and Paladin Announce Silenor® Ex-US Collaboration
Date : 06/08/2011 @ 8:00AM
Source : Business Wire
Stock : Somaxon Pharmaceuticals, Inc. (SOMX)
Quote : 2.3 0.0 (0.00%) @ 7:22AM
Somaxon and Paladin Announce Silenor® Ex-US Collaboration
Somaxon (NASDAQ:SOMX)
Intraday Stock Chart
Today : Wednesday 8 June 2011
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX) and Paladin Labs Inc. (TSX: PLB) today announced that they have entered into an exclusive collaboration under which Paladin will commercialize Silenor® (doxepin) for the treatment of insomnia characterized by difficulty with sleep maintenance in Canada, South America and Africa. According to IMS Canada, the value of the Canadian insomnia market, mainly comprised of zopiclone, exceeded $79 million in 2010 alone and has been growing at a 5 year CAGR of 10%.
Under the terms of the agreements, Somaxon will receive an up-front payment of US$500,000, and Paladin will purchase 2,184,769 shares of Somaxon’s common stock for a purchase price of US$5 million. Once Silenor is commercialized in the licensed territories, Somaxon will also be eligible to receive sales-based milestone payments of up to US$128.5 million as well as a tiered double-digit percentage of net sales in the licensed territories. Paladin will be responsible for regulatory submissions for Silenor in the licensed territories and will have the exclusive right to commercialize Silenor in the licensed territories. Governance of the collaboration will occur through a joint committee structure.
“Paladin is the ideal partner for the commercialization of Silenor in Canada and the emerging markets given its impressive track record of achieving regulatory approval and effectively commercializing branded pharmaceutical products,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “This transaction helps us further our goal of maximizing the value of Silenor for our stockholders, as we estimate that the licensed territories present a very significant addition of people suffering from insomnia. We have also maintained rights to the product in the United States, Europe and Japan.”
“We are pleased to partner with Somaxon to commercialize Silenor in Canada, South America and Africa. Silenor is an excellent fit with Paladin's commercial capabilities and portfolio, and we believe that there is a significant unmet need for Silenor. Importantly, this agreement also provides further momentum to our geographic footprint expansion across emerging markets,” said Jonathan Ross Goodman, President and Chief Executive Officer of Paladin Labs Inc. “Based on our due diligence on Silenor's U.S. launch progress to date, its longer term commercial potential in that market, and of course its intellectual property protection and position, we are comfortable making a sizeable investment in Somaxon.”
About Silenor®
Silenor is a low-dose (3 mg and 6 mg) oral tablet formulation of doxepin, and is the first and only non-scheduled prescription sleep medication approved to treat insomnia characterized by difficulties with sleep maintenance. Sleep maintenance is defined as waking frequently during the night and/or waking too early and being unable to return to sleep. For more information, please visit www.silenor.com.
Important Safety Information
A doctor should be consulted if insomnia worsens or is not better within 7 to 10 days. This may mean that there is another condition causing the sleep problem.
Patients should be sure that they are able to devote 7 to 8 hours to sleep before being active again. Silenor should be taken within 30 minutes of bedtime. Patients should not take Silenor with alcohol or with other medicines that can cause drowsiness. Silenor should not be taken with or within two weeks after taking a monoamine oxidase inhibitor (MAOI). Patients should not take Silenor if they have untreated narrow angle glaucoma, if they have severe urinary retention, if they have severe sleep apnea or if they are allergic to any of the ingredients in Silenor. Until patients know how they will react to Silenor, they should not drive or operate machinery at night after taking Silenor, and they should be careful in performing such activities during the day following taking Silenor. Before taking Silenor, patients should tell their doctors if they have a history of depression, mental illness or suicidal thoughts. Patients should call their doctors right away if after taking Silenor they walk, drive, eat or engage in other activities while asleep. Drowsiness was the most common adverse event observed in clinical trials.
For more information, please see the complete Prescribing Information, including the Medication Guide, at www.silenor.com or www.somaxon.com.
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded pharmaceutical products and late-stage product candidates to treat important medical conditions where there is an unmet medical need and/or high-level of patient dissatisfaction, currently in the central nervous system therapeutic area. Somaxon's product Silenor® (doxepin), now available by prescription in the United States, is indicated for the treatment of insomnia characterized by difficulties with sleep maintenance.
To be added to Somaxon Pharmaceuticals' email list, please visit http://bit.ly/Somaxon-email-list.
For more information, please visit the company's web site at www.somaxon.com.
About Paladin Labs Inc.
Paladin Labs Inc., headquartered in Montreal, Canada, is a specialty pharmaceutical company focused on acquiring or in-licensing innovative pharmaceutical products for the Canadian and world markets. With this strategy, a focused national sales team and proven marketing expertise, Paladin has evolved into one of Canada's leading specialty pharmaceutical companies. Paladin's shares trade on the Toronto Stock Exchange under the symbol PLB. For more information about Paladin, please visit the company's web site at www.paladinlabs.com.
Forward-Looking Statements Related to Paladin
This press release may contain forward-lookin
SOMX $2.60. Almost 52 weeks low level. I wonder if generic version of its drug application announced today exerting downward pressure on stox price.
GLLs
mlkr
DD should give more explanations for his such sentences and disclose his short sale position.
1:24AM Somaxon Pharma receives notice from Zydus Pharmaceuticals that it has filed an Abbreviated New Drug Application for a generic version of Silenor. (SOMX) 2.57 : Co announces Somaxon received a notice from Zydus Pharmaceuticals USA that it has filed with the FDA an Abbreviated New Drug Application for a generic version of Silenor. Co is currently reviewing the details of the notice and intends to vigorously enforce its intellectual property rights relating to Silenor, but cannot predict the outcome of this matter or guarantee the outcome of any litigation. Silenor is protected by nine patents covering approved methods of use of the product and its formulation.
Anyone on here get in last year @8.65 And still holding for a comeback?
Somaxon Pharmaceuticals Reports First Quarter 2011 Financial Results
Somaxon (NASDAQ:SOMX)
Intraday Stock Chart
Today : Tuesday 3 May 2011
Somaxon Pharmaceuticals, Inc. (Nasdaq: SOMX), a specialty pharmaceutical company, today announced financial results for the first quarter ended March 31, 2011.
“During the first quarter of 2011, we continued to lay the foundation for Silenor’s® long-term commercial success by growing Silenor net product sales 73% and the number of new Silenor patients by approximately 50% over the previous quarter,” said Richard W. Pascoe, Somaxon’s President and Chief Executive Officer. “In addition, we decreased patient co-pays through managed care contracting so that over 110 million lives are now covered in contracted formularies, expanded our consumer marketing programs so that to date over 1.5 million advertising impressions have been made and over 230,000 insomniacs have been reached, increased our specialty sales force by over 30% and received an additional method of use patent relating to Silenor having an expiration date no earlier than August 2027.”
“For the remainder of 2011, we expect to continue to increase the growth of Silenor through the combined efforts of the Somaxon and Procter & Gamble sales forces, advancing our efforts to make Silenor available and affordable to any patient who may benefit from its unique product profile for sleep maintenance insomnia, and driving greater brand awareness through targeted consumer advertising,” continued Pascoe. “In addition, we intend to leverage our commercial infrastructure to broaden our business, to extend the Silenor franchise and to effectively manage our financial and other corporate resources, with the goal of building a sustainable specialty pharmaceutical business dedicated to delivering long-term stockholder value.”
Recent Highlights
Somaxon has continued to make significant progress in expanding access to Silenor at affordable co-pays. Recently, RxSolutions, Inc., Express Scripts, Inc. and Medco Health, national pharmacy benefit managers that manage commercial healthcare plans covering a total of approximately 50 million lives, agreed to add Silenor to their commercial formularies. Silenor will be covered in a Tier 2 unrestricted position at Medco Health, which is a preferred position relative to the other branded insomnia products on this formulary. Silenor will be covered in a Tier 3 unrestricted position at RxSolutions and Express Scripts. Including these agreements, Silenor is currently contracted for reimbursement on commercial plans covering over 110 million lives, most frequently in an unrestricted position, and Silenor is currently reimbursed on other commercial plans representing approximately an additional 90 million lives, with final formulary positioning subject to final negotiation with such plans.
Somaxon has come to agreement with Medicare Part D health insurance plans covering a total of over 3 million lives. The company has also reached agreement with the U.S. Department of Veteran’s Affairs to make Silenor eligible for formulary inclusion by the regional Veterans Integrated Services Network plans.
Beginning in early April 2011, Somaxon implemented the eVoucher co-pay assistance program under which co-pay amounts of $85 or below for patients having access to commercial health insurance will be automatically reduced to $15 at the time of payment at approximately 33,000 participating pharmacies. This program is intended to support Somaxon’s goal of making Silenor available and affordable to anyone whose physician determines they may benefit from Silenor’s unique safety and efficacy profile. The company’s existing Sleep Saver program will continue to be available to patients that are unable to take advantage of the eVoucher program.
On March 29, 2011, Somaxon announced that it had received from the U.S. Patent and Trademark Office U.S. patent no. 7,915,307, entitled “Methods of Improving the Pharmacokinetics of Doxepin.” This patent generally relates to dosing Silenor at least three hours after a meal to promote faster onset of action and reduce the potential for next-day residual sedation. This patent will expire no earlier than August 2027 and has been listed in the Orange Book.
As of early April 2011, Somaxon, through its contract sales force partner Publicis Touchpoint Solutions, Inc., had fully deployed an additional 35 sales representatives that are exclusively promoting Silenor. As a result of this expansion, Silenor is now promoted by 250 sales representatives between Somaxon’s sales force and that of its co-promotion partner Procter & Gamble.
As of early April 2011, Somaxon deployed a team of eight contracted Federal Account Managers who will focus specifically on generating Silenor demand at Military Treatment Facilities and other Department of Defense institutions where Silenor is currently contracted.
First Quarter 2011 Financial Results
For the first quarter of 2011, Somaxon recorded shipments of Silenor to its wholesale distributors totaling $2.2 million, and recognized net product sales of $2.3 million. In accordance with U.S. generally accepted accounting principles, Somaxon defers revenue recognition of the amounts of Silenor shipments to wholesale distributors that are not yet estimated to be dispensed through patient prescriptions. As of March 31, 2011, deferred revenue totaled $3.0 million and is reported net of $0.6 million of associated discounts and allowances on Somaxon’s balance sheet.
Cost of sales was $0.4 million for the first quarter of 2011, which represented the costs of product dispensed through prescriptions. Gross profit was $2.0 million for the first quarter of 2011. Expressed as a percentage of net product sales, gross margin was 84.4% for first quarter of 2011.
Total operating expenses for the first quarter of 2011 were $19.0 million, including $1.2 million of non-cash, share-based compensation expense, compared with $4.2 million, including $2.2 million of non-cash, share-based compensation expense, for the first quarter of 2010. These increases in total operating expenses are primarily due to an increase in selling, general and administrative (SG&A) expenses relating to commercial activities for Silenor.
SG&A expense was $18.6 million for the first quarter of 2011, compared to $3.1 million for the first quarter of 2010. This increase reflected the costs associated with commercial activities relating to Silenor and an increase in salary and personnel-related expenses due to an increase in overall headcount.
Research and development expense was $0.4 million for the first quarter of 2011, compared to $1.1 million for the first quarter of 2010.
Net loss for the first quarter of 2011 was $17.0 million, or $0.38 per share, compared with $4.2 million, or $0.16 per share, for the first quarter of 2010.
At March 31, 2011, Somaxon had cash, cash equivalents and short-term investments totaling $43.3 million, compared to $54.8 million at December 31, 2010. The company believes, based on its current operating plan, that its cash, cash equivalents and short-term investments as of March 31, 2011 will be sufficient to fund its operations through at least the first quarter of 2012.
Conference Call Information and Forward-Looking Statements
On Tuesday, May 3, 2011, Somaxon will conduct a conference call with interested parties beginning at 4:30 p.m. ET (1:30 p.m. PT) to discuss results and highlights of the first quarter ended March 31, 2011.
The conference call will be available to interested parties through a live audio Internet broadcast at http://investors.somaxon.com/eventdetail.cfm. The call will also be archived and accessible at this site for approximately two weeks. Alternatively, callers may participate in the conference call by dialing (888) 549-7880 (domestic) or (480) 629-9867 (international), conference call ID 4435541. A telephonic replay will be available for approximately two weeks following the conclusion of the call by dialing (800) 406-7325 (domestic) or (303) 590-3030 (international), and entering passcode 4435541.
Discussion during the conference call may include forward-looking statements regarding such topics as, but not limited to, the company’s commercial activities relating to Silenor, prescription trends, the company’s financial status and performance and any comments the company may make about its future plans or prospects in response to questions from participants on the conference call.
To be added to Somaxon’s e-mail list, please visit http://bit.ly/Somaxon-email-list.
About Somaxon Pharmaceuticals, Inc.
Headquartered in San Diego, CA, Somaxon Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the in-licensing, development and commercialization of proprietary branded products and late-stage product candidates to treat important medical conditions where there is an unmet medical need and/or high-level of patient dissatisfaction, currently in the central nervous system therapeutic area. Somaxon’s product Silenor, now available by prescription in the United States, is indicated for the treatment of insomnia characterized by difficulty with sleep maintenance.
For more information, please visit the company’s web site at www.somaxon.com.
Now I have! Thanks!
Yes I am still watching. It looks like a good entry point!
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