NeurogesX Inc (fka NGSX)

[Fonzy35]

Why the drop? Just late filling?

[ShysterChaser]

Has everybody been able to recognize that New roGue SeX has received the dreaded "E" suffix?

The elevator now approaches the bowels of the earth transporting NGSX.

The Mayans might have had capsasin, but they didn't go public with it; it took the wizards at NotGoodSeX to figure out how to really fail with that old Mayan red hot chili pepper juice concoction. All IMHO.

[ShysterChaser]

Was that an end-of-the-week PAINTING OF THE TAPE exercise we witnessed today?

Desperate times call for desperate actions, eh.

New roGue SeX (NGSX) is slipping into deep doo-doo. All IMHO.

[ShysterChaser]

Elevator is going DOWN.

No hints of an interested acquiring buyer or taker-over appearing.

Drifting towards sub-penny status. Put some capsacisin on it and sell it as a resurrection of Mayan medicine! All IMHO.

Happy Easter, everybody.

[ShysterChaser]

Is New Rogue Sex on its way out?

Can capsacin save this shaky outfit from collapse before an acquiring something finds it and takes it for sub-pennies on the dollar?

"Step right up, ladies & gents, we gots a Californication biotech company for sale right cheer, right now!"

Too bad the Mayans didn't patent their medicinal formulary! All IMHO.

[ShysterChaser]

Today's 8k reads like a pre-bankruptcy notification.

"Insufficient funds...."

Laying off employees.

Closing down operations.

Seeking acquisition.

You would have thought that some rich Mayan would pick up on this great opportunity to market red hot chili pepper juice to treat pain just for nostalgic purposes and to keep a medicinal cultural practice alive. All IMHO.

[randomtask16]

8-k out...
http://www.sec.gov/Archives/edgar/data/1385830/000119312513128041/d513407d8k.htm

[kingsransome]

news on the wires,,hmmmmmmmmm

[ShysterChaser]

Somebody must have slapped some capsacin on a Maya holy man!

My calendar reads 12/21/12 and I think that I am still alive!

Go NGSX....the world was saved by capsacin. All IMHO.

[bob smith]

Gl mate!

Opportunity may arise in the future!

Later

[BlockTrade]

Out today!! with even money, minus commission..........Lol

[ShysterChaser]

Wouldn't bet the outhouse, either.

Nothing positive going on here, boys. Too much debt, pipeline products not going to market anytime soon, no interest in patents and intellectual property for redhot chili pepper juice.

Mayan calendar still predicting end-of-the-world this month; may be coming to NGSX sooner. All IMHO.

[bob smith]

wouldn't bet the house........

worth a small gamble!


gl

[BlockTrade]

Hope I didn't bet on the wrong horse here.....Lol

[mlkrborn]

Surf; Thnx. I was waiting for R/S on this one too. I am hopeful for bounce on NGSX . ANTH and TZYM still not getting filled in some additional buy orders. MM doesnt like my buy orders @ 0.66-67 it seems. Is PACB a buy back again @$1.57. Or, did it already run off its steam with a 100 percent bounce back? Your call was a great as always....
GL
tia
mlkr

[surf1944]

NGSX going on to my buy list, even with the potential R/S, the stock has a chance for a good bounce with stock loss selling ending in the next couple of weeks....

[mlkrborn]

Surf;
Good point.
Still on side lines too.
GL
mlkr

[bob smith]

NeurogesX Reports Third Quarter 2012 Results
Tweet Print
Neurogesx, Inc. (OTCBB:NGSX)
Intraday Stock Chart
Today : Thursday 15 November 2012
Recent Highlights:
•End-of-Phase 2 FDA interaction sets guidance to enable initiation of NGX-1998 Phase 3 studies
•Presented NGX-1998 Phase 2 trial data at World Congress; showed clear dose response from well-tolerated treatment
SAN MATEO, Calif., Nov. 14, 2012 (GLOBE NEWSWIRE) -- NeurogesX, Inc. (OTCQB:NGSX) (OTCBB:NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, today provided an update on recent developments and reported results for its third quarter ended September 30, 2012.
Ronald Martell, President and CEO, stated, "We continue on track with our goal to enable the initiation of our Phase 3 clinical program with NGX-1998, our next generation liquid formulation of prescription-strength capsaicin, by the end of the year. Based on our End-of-Phase 2 interaction with the FDA regarding our proposed development program, we could expect to begin enrolling patients in the first quarter of 2013."
Recent Developments
In August 2012, NeurogesX received End-of-Phase 2 guidance from the U.S. Food and Drug Administration ("FDA") regarding its previously announced plans for the Phase 3 clinical development of NGX-1998 as a treatment for neuropathic pain conditions, including key elements of its overall development plan related to manufacturing, applicator development and clinical trial design.
Also in August 2012, data from the Company's Phase 2 study for NGX-1998 was presented at the 14th World Congress on Pain in Milan, Italy. The presentation highlighted the Company's Phase 2 clinical trial, a multicenter, placebo-controlled, double-blind trial in PHN. The results from the trial indicated that NGX-1998 may be a safe, efficacious and convenient treatment for patients with PHN and other types of neuropathic pain.
Third Quarter 2012 Results
Total revenue for the third quarter ended September 30, 2012 was $2.8 million, which consisted of $2.2 million in collaboration revenue, primarily from the amortization of upfront license fees received under the Astellas Agreement, and $0.6 million in U.S. Qutenza revenue recognition. U.S. Qutenza recognized revenue in the third quarter of 2012 was $0.3 million lower than the second quarter of 2012. As a result of NeurogesX' decision in March 2012 to suspend direct promotional activities, the Company has observed a decrease in end user demand for Qutenza in the United States and as a result, the Company expects that future revenue from U.S. Qutenza sales will be lower. Included in collaboration revenues in the third quarter was $0.4 million of royalties recognized from Astellas sales of Qutenza in the Astellas Territory. This represents royalties from Astellas' second quarter of 2012 activity and was up from $0.3 million recognized in the third quarter of 2011.
Operating expenses for the third quarter of 2012 were $4.2 million, compared to $11.5 million in the third quarter of 2011. The lower operating expenses in the current quarter reflected the lower expense levels following the March 2012 reorganization.
Cost of goods sold for the third quarter of 2012 was $72,000, compared to $279,000 in the third quarter of 2011. Cost of goods sold includes product costs, fixed monthly charges related to the Company's third party logistics provider for warehousing and shipping activities, excess inventory charges and royalty obligations due to intellectual property licensors.
Research and development expenses for the third quarter of 2012 were $1.3 million, compared to $3.0 million in the third quarter of 2011. The year-over-year change reflected lower employee related costs resulting from restructuring plans implemented in both October 2011 and March 2012. Additionally, development costs were lower in the third quarter of 2012 due to lower spending on non-clinical development programs related to both Qutenza and NGX-1998, lower external consulting costs and lower spending associated with the Phase 2 clinical trial for NGX-1998 in the third quarter of 2012.
Selling, general and administrative expenses for the third quarter of 2012 were $2.8 million, compared to $8.2 million in the third quarter of 2011. This decrease was primarily related to the Company's decision to stop direct promotional activities of Qutenza in March 2012 as well as the broader effect of the restructuring activities implemented in October 2011 and March 2012.
Net loss for the third quarter of 2012 was $3.8 million, or $0.11 per share, compared to a net loss of $11.4 million, or $0.43 per share, for the third quarter of 2011.
Cash, cash equivalents and short-term investments were $17.5 million at September 30, 2012, compared to $34.3 million at December 31, 2011.
About NeurogesX, Inc.
NeurogesX, Inc. (OTCQB:NGSX) (OTCBB:NGSX) is a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies to address unmet medical needs and improve patients' quality of life.
The Company's lead product, Qutenza®, is currently approved in the United States and the European Union. Qutenza is available in the United States for the management of neuropathic pain associated with PHN. In Europe, Qutenza is being marketed by Astellas Pharma Europe Ltd. ("Astellas"), the European affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.
The Company's most advanced product candidate, NGX-1998, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions. NGX-1998 has completed three Phase 1 clinical trials and one Phase 2 clinical trial in PHN patients, and the Company believes that NGX-1998 is ready to enter Phase 3 development.
The Company's early-stage pipeline includes pre-clinical compounds which include a number of prodrugs of acetaminophen. The Company has evaluated certain of these compounds in vitro and in vivo.
Safe Harbor Statement
This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include but are not limited to: the planned entry of NGX-1998 into Phase 3 development and the expected timing of entry into, and beginning enrollment for, a Phase 3 trial and expectations of lower revenues from future sales of Qutenza. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: difficulties or delays in the clinical development of NGX-1998, including difficulties or delays in initiating Phase 3 development of NGX-1998 and in beginning enrollment; difficulties or delays in obtaining additional resources for continuing operations in general and for development of NGX-1998 in particular; difficulties in obtaining new, or maintaining current, strategic partnerships for the development or commercialization of NGX-1998 and Qutenza; and development by others of competitive therapies for indications that NeurogesX' product and product candidates target. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
NEUROGESX, INC.
Consolidated Statements of Operations
(in thousands, except per share information)

Three Months Ended

September 30, Nine Months Ended

September 30,
2012 2011 2012 2011
Net product revenue $ 583 $ 763 $ 2,258 $ 1,825
Collaborative revenue 2,251 2,128 6,606 6,720
Total revenues 2,834 2,891 8,864 8,545

Operating expenses:
Cost of goods sold 72 279 847 534
Research and development 1,326 2,953 5,798 11,154
Selling, general and administrative 2,776 8,239 13,463 28,871
Total operating expenses 4,174 11,471 20,108 40,559
Loss from operations (1,340) (8,580) (11,244) (32,014)
Interest income 8 15 31 61
Interest expense (2,475) (2,799) (9,163) (7,298)
Other (expense) income, net (8) (11) (84) (53)
Net loss $ (3,815) $ (11,375) $ (20,460) $ (39,304)

Basic and diluted net loss per share $ (0.11) $ (0.43) $ (0.63) $ (1.89)

Shares used to compute basic and diluted net loss per share 33,244 26,372 32,703 20,746

NEUROGESX, INC.
Consolidated Balance Sheets
(in thousands, except share and per share data)

September 30,

2012 December 31,

2011
(unaudited) (note 1)
Assets
Current assets:
Cash and cash equivalents $ 7,955 $ 9,148
Short-term investments 9,544 25,161
Trade receivable 446 1,166
Receivable from collaborative partner 67 502
Inventories 53 654
Prepaid expenses and other current assets 1,120 1,364
Restricted cash 160 160
Total current assets 19,345 38,155

Property and equipment, net 264 547
Restricted cash 50 251
Other assets 343 274
Total Assets $ 20,002 $ 39,227
Liabilities and Stockholders' Deficit
Liabilities
Current Liabilities
Accounts payable $ 380 $ 1,321
Accrued compensation 933 2,084
Accrued research and development 284 282
Other accrued expenses 903 2,245
Deferred product revenue, net 364 1,075
Deferred collaborative revenue 7,242 7,261
Long-term obligations - current portion 8,402 4,829
Total current liabilities 18,508 19,097
Non-current liabilities
Deferred collaborative revenue 19,681 25,098
Other long-term liabilities 162 146
Long-term obligations, net of current portion 64,722 62,746
Total non-current liabilities 84,565 87,990
Commitments and contingencies
Stockholders' deficit:
Preferred stock -- --
Common stock 33 30
Additional paid-in capital 243,427 238,181
Accumulated other comprehensive income 1 1
Accumulated deficit (326,532) (306,072)
Total stockholders' deficit (83,071) (67,860)
Total liabilities and stockholders' deficit $ 20,002 $ 39,227

Note 1 -- The balance sheet at December 31, 2011 has been derived from the audited consolidated financial statements at that date.

CONTACT: NeurogesX, Inc.
Stephen Ghiglieri
Executive Vice President, COO and CFO
[phone]

Additional Contacts:
The Ruth Group
Stephanie Carrington /
Nicole Greenbaum (investors)
[phone] / 7009
[e-mail] /
[e-mail]

Tracy Lessor (media)
[phone]
[e-mail]

[ShysterChaser]

Reread your post. Source seems to be a company pronouncement, not a scientific paper open to analysis and criticism from the assembled conferees at the Milano Congress on Pain. Are you going to source your message? Where is the link?

And my frictionless perpetual motion machine might be efficacious, efficient, and economical in the worldwide transportation industry!

"May be" reads like one of those Safe-Harbored future projections. All IMHO.

[ShysterChaser]

And the source for this declaration is?????

Company rhetoric protected under Safe-Harbor laws or newspaper report from a reliable writer? Something else????

Such reports from a Phase 2 study neither guarantees a Phase 3 clinical trial or much of anything else without some bux be attracted to co-venture, partner, or just finance further studies.

All IMHO.

[ShysterChaser]

Link please.

Was this a poster presentation or an actual paper presented in a scientific session at the 14th Congress on Pain in Milano?

Makes a difference; if it was a poster presentation it can be viewed as publicity. A paper presented at a scientific session has much more prestige.

Your link and clear answer to the type of presentation will be appreciated. Thanks.

[surf1944]

11:01AM Neurogesx NGX-1998 was well-tolerated treatment demonstrated clear dose-response in patients (NGSX) 0.24 +0.02 : Co presented data from its Phase 2 study on NGX-1998 at the 14th World Congress on Pain in Milan, Italy. NGX-1998 is the Company's next generation liquid formulation of prescription-strength capsaicin. The presentation highlighted the Company's Phase 2 clinical trial, a multicenter, placebo-controlled, double-blind trial in postherpetic neuralgia (PHN). The results from the trial indicate that NGX-1998 may be a safe, efficacious and convenient treatment for patients with PHN and other types of neuropathic pain. NeurogesX plans to enable a Phase 3 clinical trial in neuropathic pain by the end of 2012.

[bob smith]

NeurogesX' NGX-1998 Well-Tolerated Treatment Demonstrated Clear Dose-Response in Patients

gl

[ShysterChaser]

Now if they could only get some bux put together so that they could open Phase 3 trials for the latest iter of red hot chili pepper juice derivatives! All IMHO.

[surf1944]

NeurogesX receives additional notice of allowance covering NGX-1998 in U.S.
Theflyonthewall.com – Thu, Aug 2, 2012 9:04 AM EDT.. .

NeurogesX announced it has received an additional notice of allowance from the U.S. Patent and Trademark Office, or USPTO, related to the company's family of patents for NGX-1998, the company's next generation liquid formulation of prescription-strength capsaicin. The allowed patent application expands on the company's patent entitled, "Methods and compositions for administration of TRPV1 agonists." The claims in the allowed application relate to methods of treating capsaicin-responsive conditions with a liquid formulation containing between 10% and 30% by weight of a TRPV1 agonist and certain penetration enhancer combinations. The capsaicin-responsive conditions referenced in the patent application include various types of pain, such as neuropathic pain and pain associated with skin cancer. The patent issuing from this application is expected to expire in 2024.

[ShysterChaser]

Feeling bad about your current investment in Not Good SeX?

Need a little morale lift?

Load up "Sugar Sugar" by Stevie Wonder and think about how you want NGSX to be your play toy. All IMHO.

[ShysterChaser]

Would you care to explain WHY NGSX would be a better buy AFTER a REVERSE-split?

Psychology?

A split doesn't change the fundamentals or speed up the Phase 3 trials for NGS-1999.

To some of us, a REVERSE split would be comparable to rearranging the deck chairs on the Titanic as the vessel sinks. All IMHO.

[surf1944]

Likely to see a R/S, not worth a buy until split....

[ShysterChaser]

My investment involvement with NGSX.

DISCLOSURE: I own NO shares of NGSX; we are not direct beneficial owners of NGSX shares.

I participate in an investment program. Awhile back, we were looking for opportunities in the medical treatment area which looked like future stocks with great appreciation potential.

The primary fields were cancer treatment and weight reduction. We rejected the cancer field as miracles are few and far between; we rejected weight reduction formulas as the FDA hadn't approved a weight reduction pill for more than a dozen years.

The secondary arenas included pain management and inflammation reduction. We discussed, cussed, and cogitated over the investment direction for a few weeks. We narrowly selected pain management, whereupon the disgruntled investors who wanted inflammation reduction took their money and went in that direction.

Needless to say, we ended up owning circa ?millions of NGSX shares plus we negotiated rights to purchase lots of shares at a "reasonable" price at a later date. And, no, we did not buy in at $00.18! We are stuck awaiting success from NGS-1999 or something else in the pipeline or Cue10Zah making a comeback or ???? Meanwhile, the inflammation treatment investors have seen their investment in one of their choices soar above $5 per share.

Come on, NGSX. Show us that our choice was not misplaced and that pain management using capsaisin and its derivatives will soon pay off. Am I dreaming....or what. NGSX does not look like such a great decision today. All IMHO.

[ShysterChaser]

The NASDAQ panel that declined to give NGSX additional time to return to capitalization compliance and decided to delist the company did not cast a positive nod in NGSX' direction. As I read it, the panel basically said that it had major doubts that the value of NGSX would rise above $50,000,000 any time soon.

Anybody read the latest Income Statement for the January - March 2012 reporting period for NGSX? Nothing very positive for that period nor for the entire last year.

Woe is us. All IMHO.

[mlkrborn]

Delisting: $0.22 now
Trading in NeurogesX Common Stock to Move From NASDAQ to OTCBB
Press Release: NeurogesX – 4 hours ago

E
NeurogesX, Inc.
RELATED QUOTES
Symbol Price Change
NGSX 0.22 -0.06

SAN MATEO, Calif., June 29, 2012 (GLOBE NEWSWIRE) -- NeurogesX, Inc. (NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, today announced that it has been notified by The NASDAQ Stock Market (NASDAQ) that trading in the Company's securities will be suspended on NASDAQ effective with the open of trading on Friday, June 29, 2012. On that same date, the Company's common stock will be eligible to trade on the Over the Counter Bulletin Board (OTCBB), a market tier for OTC-traded companies that are registered and current in their reporting obligations with the Securities and Exchange Commission. The Company's trading symbol will remain NGSX.
As previously announced, on April 17, 2012, NASDAQ notified the Company that its securities were subject to suspension and delisting based upon the Company's non-compliance with the $50 million market value of listed securities requirement for continued listing for The NASDAQ Global Market. The Company appealed the determination to a NASDAQ Listing Qualifications Panel and a hearing was subsequently held. However, by letter dated June 27, 2012, the Panel indicated that it had determined not to grant the Company additional time to regain compliance with the continued listing criteria and, accordingly, that NASDAQ would move to suspend and delist the Company's securities from the exchange.

[ShysterChaser]

Thanks for posting the news from NGSX.

Unfortunately, the market reaction today was not that positive for the stock. An eight (8) cent drop to $00.28 seems significant, percentage-wise. That NGSX has now lost over 90% of its share value in the last year is not very hopeful.

What is going on?
How many employees left in San Mateo?
What are they doing?
How is NGX-1998 doing?
What else is in the pipeline?

Being an indirect, passive investor in NGSX through an investment package has not paid off for me. All IMHO.

[bob smith]

NeurogesX, Inc. (Nasdaq:NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, today announced it has received two notices of allowance from the United States Patent and Trademark Office (USPTO) for patents covering NGX-1998, the Company's next generation liquid formulation of prescription strength capsaicin.

The first notice of allowance expands on NeurogesX' current patent entitled, "Methods and Compositions for Administration of TRPV1 Agonists," and includes claims that more specifically define the components of the liquid formulation of NGX-1998. The patent issuing from this application will have a term that expires in 2024.

The second notice of allowance is for the Company's patent entitled, "Compositions and Kits for the Removal of Irritating Compounds from Bodily Surfaces." This allowance includes claims relating to methods for removing capsaicin from the body using a surfactant-free, polyethylene glycol gel, and is complementary to the NGX-1998 patent family. The patent issuing from this application will have a term that expires in 2022.

"The two notices of allowance strengthen our U.S. patent estate for NGX-1998," Ronald Martell, President and CEO, commented. "Our Phase 2 data suggest that NGX-1998's product profile, including a five-minute application for up to three months of pain relief, make it an exciting advance in pain therapy. We are continuing our efforts to move into Phase 3 clinical trials as expeditiously as possible."

As previously announced, the Company expects to meet with the U.S. Food and Drug Administration (FDA) for an End of Phase 2 meeting in the third quarter of 2012. At the meeting, NeurogesX intends to discuss a 505(b)(2) clinical development program for NGX-1998 and gain greater clarity on the level of clinical data necessary for approval of NGX-1998. After the FDA meeting, the Company anticipates it will initiate a Phase 3 clinical trial by the end of 2012.

About NeurogesX, Inc.

NeurogesX, Inc. (Nasdaq:NGSX) is a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies to address unmet medical needs and improve patients' quality of life.

The Company's lead product, Qutenza®, is currently approved in the United States and the European Union. Qutenza® is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza® is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.

The Company's most advanced product candidate, NGX-1998, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 has completed three Phase 1 clinical trials and one Phase 2 clinical trial in PHN patients, and the Company believes that NGX-1998 is ready to enter Phase 3 development.

The Company's early-stage pipeline includes pre-clinical compounds which include a number of prodrugs of acetaminophen. The Company has evaluated certain of these compounds in vitro and in vivo.

Safe Harbor Statement

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include but are not limited to statements regarding: expectations, timing and subject matter for NeurogesX' planned End of Phase 2 meeting with the U.S. Food and Drug Administration; NGX-1998 being ready for entry into Phase 3 development and the planned timing of entry of NGX-1998 into a Phase 3 clinical trial. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: NGX-1998 may fail to demonstrate sufficient safety or efficacy in clinical trials to support further development or potential marketing approval; difficulties or delays in further clinical development of NGX-1998, including difficulties or delays in initiating Phase 3 clinical trials; adverse outcomes with respect to, or delay of, the End-of-Phase 2 meeting with the FDA; market acceptance of Qutenza in already approved indications may not be sufficient to support further pursuit of commercialization of Qutenza or could have an effect on NeurogesX' development or other plans with respect to NGX-1998; Qutenza, NGX-1998 and NeurogesX' other product candidates may have unexpected adverse side effects; delay or prevention of commercialization or development activities due to unexpected expenses or a lack of sufficient resources; and difficulties or delays in identifying potential strategic partners for Qutenza and NGX-1998 and negotiating and entering into agreements with such entities. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
CONTACT: NeurogesX, Inc.
Stephen Ghiglieri
Executive Vice President, COO and CFO
[phone]
[e-mail]

The Ruth Group
Stephanie Carrington (investors)
[phone]
[e-mail]

Victoria Aguiar (media)
[phone]
[e-mail]

[ShysterChaser]

And the market yawningly acknowledged this great capsaisin news for NGSX with a whopping endorsement of $00.0007!

Go emperor dearest: Make NGSX a huge success for treating pain. Capsasin from Mayan times to the Empire of the Rising Sun....How absolutely wonderful. All IMHO.

[bob smith]

NeurogesX, Inc. (Nasdaq:NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, today announced the Japanese Patent Office (JPO) has issued patent No. 4931128 to NeurogesX for its next generation product candidate NGX-1998, a topically applied liquid formulation of prescription strength capsaicin designed to treat pain associated with neuropathic pain conditions. The patent, entitled "Methods and Compositions for Administration of TRPV1 Agonists," will remain in effect in Japan until 2024. The issued claims include formulation, system, and kit claims.

Separately, the JPO has allowed NeurogesX patent application No. 2008-504395, entitled "Oils of Capsaicinoids and Methods of Making and Using the Same." The allowed claims relate to the composition and creation of capsaicinoid oils and oils for treating capsaicin-responsive conditions. The patent scheduled to issue from this application is expected to expire in 2026.

"We believe this issued patent enhances the value of NGX-1998 in the Japanese market in the near-term, and the allowed application enables the potential for additional future value through possible product line extension. These patents enhance our position as a leader in the development and commercialization of capsaicin based therapies," said Ronald Martell, President and CEO. "We expect these milestones will better position NeurogesX as we continue to seek potential development and commercial partners for major global markets."

The issuance of Japanese patent No. 4931128 for NGX-1998 follows the notice of patent allowance the Company received in February 2012. In April 2011, NeurogesX was granted patent protection for NGX-1998 in the United States under an identically titled patent having a term that extends to 2027. A similar patent application is under review in Europe.

About NeurogesX, Inc.

NeurogesX, Inc. (Nasdaq:NGSX) is a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies to address unmet medical needs and improve patients' quality of life.

The Company's lead product, Qutenza®, is currently approved in the United States and the European Union. Qutenza® is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza® is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.

The Company's most advanced product candidate, NGX-1998, is a topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 has completed three Phase 1 clinical trials and one Phase 2 clinical trial in PHN patients, and the Company believes that NGX-1998 is ready to enter Phase 3 development.

The Company's early-stage pipeline includes pre-clinical compounds which include a number of prodrugs of acetaminophen. The Company has evaluated certain of these compounds in vitro and in vivo.

Safe Harbor Statement

This press release contains forward-looking statements for purposes of the Private Securities Litigation Reform Act of 1995 (the Act). NeurogesX disclaims any intent or obligation to update these forward-looking statements, and claims the protection of the Safe Harbor for forward-looking statements contained in the Act. Examples of such statements include but are not limited to statements regarding: the benefits of issuance of the NGX-1998 patent and the patent application allowance in Japan for potentially enhancing the value of NGX-1998 in the Japanese market and the Company's position as a leader in research and development of capsaicin based therapies, including through potential product line extensions, and for positioning NeurogesX in its efforts to seek development and commercial partners; and NGX-1998 being ready for entry into Phase 3 development. Such statements are based on management's current expectations, but actual results may differ materially due to various risks and uncertainties, including, but not limited to: NGX-1998 may fail to demonstrate sufficient safety or efficacy in clinical trials to support further development or potential marketing approval; difficulties or delays in further clinical development of NGX-1998, including difficulties or delays in initiating Phase 3 clinical trials; adverse outcomes with respect to, or delay of, the End-of-Phase 2 meeting with the FDA; market acceptance of Qutenza in already approved indications may not be sufficient to support further pursuit of commercialization of Qutenza or could have an effect on NeurogesX' development or other plans with respect to NGX-1998; Qutenza, NGX-1998 and NeurogesX' other product candidates may have unexpected adverse side effects; delay or prevention of commercialization or development activities due to unexpected expenses or a lack of sufficient resources; and difficulties or delays in identifying potential strategic partners for Qutenza and NGX-1998 and negotiating and entering into agreements with such entities. For further information regarding these and other risks related to NeurogesX' business, investors should consult NeurogesX' filings with the Securities and Exchange Commission.
CONTACT: NeurogesX, Inc.
Stephen Ghiglieri
Executive Vice President, COO and CFO
[phone]
[e-mail]

Additional Contacts:
The Ruth Group
Stephanie Carrington (investors)
[phone]
[e-mail]

Victoria Aguiar (media)
[phone]
[e-mail]

[ShysterChaser]

Anybody reading/posting/lurking here short this glorious biotech stock?

Anybody start shorting this beaut circa TEN (10) bux and still not covering?

How low can this red hot chili juice-derivative go?

Still looking to buy the common stock cheap and treat it as a warrant while waiting for NSX-198 to emerge from the pipeline and obtain FDA approval; just because Q10Zah didn't hit it BIG, that is not to preclude NGSX from succeeding with something somewhere down the line. All IMHO.

[ShysterChaser]

Can anyone affirm that the NASDAQ has given NGSX a pass on the potential delisting due to past failure of the corporation to maintain the Minimum Market Value of Publicly-Held Corporations?

Somewhere I was led to believe that for NGSX, the minimum was $50MILLIONS for ten (10) days. Now I have been informed that the correct number is only $15millions, which NGSX currently attains. The extension goes through the end of October 2012.

So it seems, on quick analysis, that NGSX has squeaked through and avoided the delisting prospect for the next six months. And the next possible blockbuster product (NSX-1998) in the capsaisin pipeline is bucking for Phase 3 trials and might come to market, if approved, in 2014? Hang on, comrades; NGSX could be a long-term investment, after all. All IMHO.

[ShysterChaser]

Awfully quiet message board here....

Have many of the investors fallen into the ranks of forlorn stuck bagholders and moved on elsewhere?

Be of good courage, comrades. The share price did not collapse to the quarter-per-share range and seems to be steady to rising.

It is Maytime; the flowers are blooming. And maybe NGSX will show some life or maybe even progress. All IMHO.

[ShysterChaser]

Whew, it could have been much worse except for the After Hours boost that NGSX got. Was that merely an exercise in PAINTING-the-TAPE or was it real?

Roller-coaster for the company and the shareholders. All IMHO.

[ShysterChaser]

GO 4 it! Hombre del sol....

A market happens when there are BOTH buyers and sellers! All IMHO.

[sonnyman]

NGSX Im in at these prices will add on more on dips

[ShysterChaser]

WARNING...Warning..warning.

Techies who disregard fundamentals may find themselves in great peril.

Things like
1. Management.
2. Financials (including debt).
3. Sales.
4. Product development.
5. Market share.
6. Determination Letters regarding potential NASDAQ delisting.

Monday could be an interesting day on the markets for NGSX. All IMHO.

[kingsransome]

the turn we have waited for,,http://www.barchart.com/chart.php?sym=NGSX&style=technical&template=&p=DO&d=M&sd=&ed=&size=M&log=0&t=CANDLE&v=1&g=1&evnt=1&late=1&o1=&o2=&o3=&sh=100&indicators=KELT%2820%2C16737792%2C16777113%29%3BEXPMA%289%2C%29%3BACCUM%2816750848%29%3BATR%2814%2C10066329%2C13395558%29%3BCHKMF%2820%2C2135825%29%3BSMACD%2812%2C26%2C9%2C16737792%2C10053375%2C13421721%29%3BMOMENT%2820%2C13395558%29%3BMFI%2814%2C255%2C100%2C39168%2C16711680%29%3BSRSI%2814%2C6710886%2C20%2C255%2C16711680%29%3BRSI%2814%2C0%2C100%2C10079487%2C10040064%29%3BTRIX%2815%2C1734356%29%3BOSC%287%2C14%2C28%2C13408614%2C100%2C16763904%2C6724095%29%3BMACD%2812%2C26%2C9%2C16737792%2C10053375%2C13421721%29&chartindicator_14_code=KELT&chartindicator_14_param_0=20&chartindicator_14_param_1=16737792&chartindicator_14_param_2=16777113&chartindicator_15_code=EXPMA&chartindicator_15_param_0=9&chartindicator_15_param_1=&chartindicator_16_code=ACCUM&chartindicator_16_param_0=16750848&chartindicator_17_code=ATR&chartindicator_17_param_0=14&chartindicator_17_param_1=10066329&chartindicator_17_param_2=13395558&chartindicator_18_code=CHKMF&chartindicator_18_param_0=20&chartindicator_18_param_1=2135825&chartindicator_19_code=SMACD&chartindicator_19_param_0=12&chartindicator_19_param_1=26&chartindicator_19_param_2=9&chartindicator_19_param_3=16737792&chartindicator_19_param_4=10053375&chartindicator_19_param_5=13421721&chartindicator_20_code=MOMENT&chartindicator_20_param_0=20&chartindicator_20_param_1=13395558&chartindicator_21_code=MFI&chartindicator_21_param_0=14&chartindicator_21_param_1=255&chartindicator_21_param_2=100&chartindicator_21_param_3=39168&chartindicator_21_param_4=16711680&chartindicator_22_code=SRSI&chartindicator_22_param_0=14&chartindicator_22_param_1=6710886&chartindicator_22_param_2=20&chartindicator_22_param_3=255&chartindicator_22_param_4=16711680&chartindicator_23_code=RSI&chartindicator_23_param_0=14&chartindicator_23_param_1=0&chartindicator_23_param_2=100&chartindicator_23_param_3=10079487&chartindicator_23_param_4=10040064&chartindicator_24_code=TRIX&chartindicator_24_param_0=15&chartindicator_24_param_1=1734356&chartindicator_25_code=OSC&chartindicator_25_param_0=7&chartindicator_25_param_1=14&chartindicator_25_param_2=28&chartindicator_25_param_3=13408614&chartindicator_25_param_4=100&chartindicator_25_param_5=16763904&chartindicator_25_param_6=6724095&chartindicator_26_code=MACD&chartindicator_26_param_0=12&chartindicator_26_param_1=26&chartindicator_26_param_2=9&chartindicator_26_param_3=16737792&chartindicator_26_param_4=10053375&chartindicator_26_param_5=13421721&addindicator=&submitted=1&fpage=&txtDate=#jump

[ShysterChaser]

My due diligence financial research on NGSX reveals that as of the close of the markets yesterday, the market capitalization for the company was circa $18millions. A corporation to keep in good standing and maintain a continuing NASDAQ listing position should have a market capitalization of $50,000,000.00 or more. I calculate that the current NGSX market cap amounts to 36% of the minimum standard market cap for a NASDAQ listing.

Since the market cap of NGSX approaches only 40% of the required market capitalization, delisting appears to be a strong possibility. All IMHO.

Comments?

[ShysterChaser]

The potential of delisting for NGSX seems to be out there after a letter was issued about the stock trading for too long below the NASDAQ minimum standard price. Delisting is not a trivial matter. All IMHO.

Thoughts?

[surf1944]

7:53AM On The Wires (WIRES) :nNeurogesX (NGSX) has engaged JSB-Partners to assist the co in executing its business development objectives that include selecting potential development and commercial partners and entering into partnerships for the U.S. and other major global markets for its lead product candidate NGX-1998 and its commercialized product Qutenza patch.

7:38AM Neurogesx engages JSB-Partners to execute business development strategy (NGSX) 0.52 : Co announced that it has engaged JSB-Partners, a global life sciences advisor, to assist the co in executing its business development objectives that include selecting potential development and commercial partners and entering into partnerships for the United States and other major global markets, which remain unpartnered, for its lead product candidate NGX-1998 and its commercialized product Qutenza (capsaicin 8%) patch.

[surf1944]

7:30AM Neurogesx provides update on NGX-1998 clinical program: end of Phase 2 meeting with FDA expected in Q3 (NGSX) 0.39 : Co announced that the FDA has accepted the co's request for an End-of-Phase 2 meeting to discuss the continued clinical investigation of NGX-1998 as a treatment for certain neuropathic pain conditions including, specifically, the Company's plans for entering NGX-1998 into Phase 3 development. The Company anticipates that the End-of-Phase 2 meeting will occur in the third quarter of 2012.

[MrMetal]

wel although not aproved for HIV-PN it still has great potential

[mlkrborn]

Whatever happened to march 7 FDA decision?
THURSDAY, FEBRUARY 9, 2012
NeurogesX Provides Update on Qutenza(R) (Capsaicin) 8% Patch for New Indication to Treat HIV-PN Following FDA Advisory Committee Review



NeurogesX Provides Update on Qutenza(R) (Capsaicin) 8% Patch for New Indication to Treat HIV-PN Following FDA Advisory Committee Review

FDA Expected to Make Decision by March 7, 2012

SAN MATEO, Calif., Feb. 9, 2012 (GLOBE NEWSWIRE) -- NeurogesX (Nasdaq:NGSX), a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies, today announced that the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) to the U.S. Food and Drug Administration (FDA) did not recommend FDA approval of a new indication for Qutenza(R) (Capsaicin) 8% patch for the management of neuropathic pain (nerve pain) related to HIV associated peripheral neuropathy (HIV-PN).

While the FDA will consider recommendations of the Committee, the decision regarding the approval of a new indication is determined by the FDA. Currently, the Company's supplemental new drug application (sNDA) remains under evaluation, with Priority Review status granted by the FDA. A decision from the Agency is expected by March 7, 2012, under the Prescription Drug User Fee Act (PDUFA).

The Committee's recommendation followed today's presentations by the Company and the FDA. The Committee reviewed the efficacy and safety data from clinical studies of Qutenza(R) in the management of pain associated with HIV-PN.

"We will continue to work closely with the FDA to address the Advisory Committee's comments as the Agency finalizes its review of our sNDA," said Ronald Martell, CEO and President of NeurogesX. "We remain confident that Qutenza(R) has the potential to address significant, unmet medical needs and to improve the quality of life for patients with HIV-PN. We would like to thank the FDA and the Advisory Committee members for their careful and thoughtful deliberation on this matter."

About HIV-PN

HIV-PN is the most common neurological complication of HIV infection; researchers believe peripheral neuropathy is the driving force behind up to half of pain clinic visits among HIV patients1. Many patients with HIV are afflicted with symptoms ranging from mild tingling to severe and excruciating pain. HIV-PN is thought to be caused by multiple factors related to HIV infection including, injury of sensory neurons by HIV virus proteins, the immune system's fight against HIV and some antiretroviral drugs.

There is currently no FDA-approved or standard-of-care treatment for pain associated with HIV-PN.

In the United States, there are an estimated 1.2 million people infected with HIV2. The prevalence of HIV-PN remains high with use of combination anti-retroviral therapy, with an estimated 140,000 individuals in need of pain management intervention3.

About Qutenza(R)

Qutenza(R) (capsaicin) 8% patch, containing a prescription strength capsaicin, is approved by the U.S. Food and Drug Administration (FDA) for the management of neuropathic pain associated with postherpetic neuralgia (PHN). Qutenza(R) is also approved in the European Union and is marketed by Astellas Pharma Europe Ltd. (Astellas), the European affiliate of Tokyo-based Astellas Pharma Inc.

Clinical studies have shown that a single one-hour Qutenza(R) application can provide three months relief from pain associated with postherpetic neuralgia (PHN), the nerve pain that can occur after shingles.

In clinical trials, serious adverse reactions included application-associated pain and increase in blood pressure. The most common treatment-emergent adverse reactions (greater than or equal to five percent of Qutenza(R) patients and greater than control) were application-site erythema, application-site pain, application-site pruritus, and application-site papules.

For full Patient Information, visit http://www.qutenza.com/

For full Prescribing Information, visit http://www.qutenza.com/_docs/qutenza_full_PI_.pdf

About NeurogesX, Inc.

NeurogesX, Inc. (Nasdaq:NGSX) is a specialty pharmaceutical company focused on developing and commercializing a portfolio of novel non-opioid, pain management therapies to address unmet medical needs and improving patients' quality of life.

The Company's lead product, Qutenza(R) is currently approved in the United States and the European Union. Qutenza(R) is now available in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). In Europe, Qutenza(R) is being marketed by Astellas Pharma Europe Ltd. (Astellas), the European affiliate of Tokyo-based Astellas Pharma Inc., for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.

The Company's most advanced product candidate, NGX-1998, is a Phase 3 ready, topically applied liquid formulation containing a high concentration of capsaicin designed to treat pain associated with neuropathic pain conditions such as PHN. NGX-1998 has completed three Phase 1 clinical trials and one Phase 2 clinical trial in PHN patients.

The Company's early-stage pipeline includes pre-clinical compounds which include a number of prodrugs of acetaminophen. The Company has evaluated certain of these compounds in vitro and in vivo.

http://www.investorvillage.com/smbd.asp?mb=11130&mn=27&pt=msg&mid=11610732

[mlkrborn]

Recent developments: Note FDA datelines. Marc 7 was a crucial date for FDA's decision.

March 8, 2012
7:40a
NeurogesX: Believes 20% Capsaicin Formulation Of NGX-1998 May Provide Similar Efficacy, Safety As Qutenza (Dow Jones)
7:39a
NeurogesX: Received Complete Response Letter On Qutenza From FDA (Dow Jones)
7:39a
NeurogesX: Needs To Submit Addl Clinical Data To Get FDA Approval For Qutenza (Dow Jones)
7:39a
NeurogesX: Doesn't Anticipate Investing In Further Clinical Studies For Qutenza At This Time (Dow Jones)


March 14, 2012
12:35p
NeurogesX Raised To Outperform From Neutral By Wedbush >NGSX (Dow Jones)
March 8, 2012
7:40a
NeurogesX: Believes 20% Capsaicin Formulation Of NGX-1998 May Provide Similar Efficacy, Safety As Qutenza (Dow Jones)
7:39a
NeurogesX: Received Complete Response Letter On Qutenza From FDA (Dow Jones)
7:39a
NeurogesX: Needs To Submit Addl Clinical Data To Get FDA Approval For Qutenza (Dow Jones)
7:39a
NeurogesX: Doesn't Anticipate Investing In Further Clinical Studies For Qutenza At This Time (Dow Jones)
7:37a
NeurogesX Intends To Cut Estimated 2012 Cash Burn Rate To Between $5.5M-$6.5M/Qtr (Dow Jones)
7:37a
NeurogesX 2011-End Cash, Equivalents, S/T Investments $34.3M >NGSX (Dow Jones)
7:36a
NeurogesX Sees 2012 Oper Expenses Ex-Noncash Stk Expenses Cut By 32% From Prior Levels (Dow Jones)
7:35a
NeurogesX To Cut 57% Of Work Force >NGSX (Dow Jones)
7:33a
NeurogesX: Goal Is To Complete Required Initiatives To Prepare For Initiation Of A Ngx-1998 Phase 3 Clinical Trial Yr-End (Dow Jones)
7:33a
NeurogesX To Focus On Securing Addl Resources To Provide Cap To Complete NGX-1998 Trial (Dow Jones)
7:32a
NeurogesX To Restructure Ops To Minimize Cash Burn, Align Comml Ops Spending (Dow Jones)
7:30a
NeurogesX Reports Fourth Quarter and Year-End 2011 Results (GlobeNewswire)
7:30a
NeurogesX 4Q Loss/Shr 34c >NGSX (Dow Jones)
7:30a
NeurogesX 4Q Rev $2.96M >NGSX (Dow Jones)
February 29, 2012
8:30a
NeurogesX to Hold Conference Call to Discuss Fourth Quarter and Full Year 2011 Results (GlobeNewswire)