Neurogesx....EU & US Zulassung innerhalb 5 Monate - 500 Beiträge pro Seite

[BrauchGeld]

Hier eine Aktie die für 300-500 % gut ist, also die Chancen überwiegen eindeutig .
Qutenza (Post-Herpetic Neuralgia) << 3 Mrd US$ Markt da bleibt bestimmt was für NGSX übrig .

Ich bin leider etwas müde in den nächsten Tagen folgt mehr .

Neurogesx (NGSX)

MarktKap : 21 Mio US$
Cash: 30,8 Mio US$ <<<<< CASH HÖHER ALS MARKTKAP
Kurs : 1,21 US$

2009 – 2010 Milestones

1H09 EU Commercial Partnership
1H09 MAA Decision
2H09 PDUFA for Qutenza (PHN)
2H09 Qutenza EU Launch
1H10 Qutenza U.S. Launch

Investor Präsentation Jan 2009 << LESEN
http://files.shareholder.com/downloads/NGSX/586554520x0x2693…

Qutenza Summary $3B Growing Neuropathic Pain Market

* Large, underserved market with current product limitations
* Strong growth for branded products (> generics growth)
* Positive patient and physician feedback
* Approaching commercialization
* Marketing applications filed in EU and U.S.
* Pre-commercialization activities ongoing (pricing, reimbursement)
* Potential regulatory decisions in 1H09 (EMEA) and 3Q09 (FDA)
* Potential Commercialization in late 2009 and early 2010
* Europe: Launch 2H 09 with commercial partner (discussions ongoing)
* US: Launch 1H 10 with own sales force and/or potential partner

[BrauchGeld]

Und schon 33% im plus
http://finance.yahoo.com/q?s=ngsx&x=0&y=0

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.805.361 von BrauchGeld am 19.03.09 18:00:18

Insider
http://finance.yahoo.com/q/it?s=NGSX

Institutional Holdings << Fidelity hat mehr als 9 US$ pro Aktie bezahlt !!!
http://www.nasdaq.com/asp/holdings.asp?symbol=NGSX&symbol=SP…

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.805.389 von BrauchGeld am 19.03.09 18:04:28

Jetzt schon bei 1,67 US$ (38%) klinngggggggelinggggg


NeurogesX Announces Publication of Phase 3 Data for QUTENZA(TM) (NGX-4010) in
Postherpetic Neuralgia (PHN) by The Lancet Neurology
SAN MATEO, Calif., Jan 12, 2009 /PRNewswire-FirstCall via COMTEX News Network/ --
http://files.shareholder.com/downloads/NGSX/586554520x0x2635…

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.805.430 von BrauchGeld am 19.03.09 18:08:53

Was für ein Timing ...yappppaaaaadabbaaaaaduuuuu

http://www.forbes.com/feeds/afx/2009/03/19/afx6189092.html

BRIEF-Decisions from European Medicines Agency's CHMP
03.19.09, 12:47 PM EDT
pic

LONDON, March 19 (Reuters) - Meeting highlights from the EMEA's Committee for Medicinal Products for Human Use, 16-19 March 2009:

Initial evaluation - positive opinions
Article Controls

The European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) adopted positive opinions, recommending the granting of a marketing authorisation, for the following medicines: * Ellaone (ulipristal acetate), from Laboratoire HRA Pharma, indicated for emergency contraception within 120 hours (5 days) of unprotected sexual intercourse or contraceptive failure. EMEA review began on 25 June 2008, with an active review time of 203 days. * Modigraf (tacrolimus), from Astellas Pharma Europe B.V., indicated for the prophylaxis and treatment of transplant rejection in adult and paediatric kidney, liver or heart allograft recipients. EMEA review began on 26 December 2007, with an active review time of 205 days. * Qutenza (capsaicin), from NeurogesX (nasdaq: NGSX - news - people ) UK Ltd, indicated for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain. EMEA review began on 27 September 2007, with an active review time of 202 days. * Renvela (sevelamer carbonate), from Genzyme (nasdaq: GENZ - news - people ) Europe B.V., indicated for the control of hyperphosphataemia in adult patients receiving haemodialysis or peritoneal dialysis, and for the control of hyperphosphataemia in adult patients with chronic kidney disease not on dialysis with serum phosphorus > 1.78 mmol/l. EMEA review began on 26 March 2008, with an active review time of 204 days.

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.805.311 von BrauchGeld am 19.03.09 17:54:37

Sie explodiert gerade und die Nachricht ist noch nicht überall angekommen yaaahhoooooooooo

http://finance.yahoo.com/q?s=ngsx&x=0&y=0

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.805.868 von BrauchGeld am 19.03.09 19:00:37

Die super dupa Nachricht wurde von Neurogesx immer noch nicht veröffentlich das sieht man auch am Volumen ....

Also EU zulassung ist so gut wie in der Tasche jetzt fehlt nur noch der Partner der soll noch im 1H kommen

FDA entscheidet im August über Qutenza ...

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.806.016 von BrauchGeld am 19.03.09 19:18:59

Das hier ist Qutenza damit ihr wisst worum es geht ....

Phase-3-Studie von NeurogesX über postzosterische Neuralgie erfüllt primären Endpunkt

NeurogesX Inc., (News) ein privates spezialisiertes Pharmaunternehmen, meldete heute positive Ergebnisse aus einer doppelt verblindeten kontrollierten Multicenter-Studie der Phase 3 mit Transacin(TM) (NGX-4010), dem neuartigen hoch konzentrierten Transcapsaicin-Hautpatch des Unternehmens für Patienten mit postzosterischer Neuralgie (PHN). Die Testpersonen der Studie meldeten bereits nach einer einzigen einstündigen Auftragung von Transacin eine statistisch signifikante Schmerzlinderung (p = 0,001), womit die Studie ihren festgelegten primären Endpunkt erfüllt hat. Während der ersten Woche ergab sich nach der Behandlung einer signifikante Schmerzminderung (p = 0,04), die während des gesamten 12-wöchigen Untersuchungszeitraums erhalten blieb. Nach 12 Wochen war bei mehr als der Hälfte der mit Transacin behandelten Patienten eine Besserung ihres Zustandes eingetreten, was anhand eines Fragebogens zur „Patient Global Impression of Change” festgestellt wurde.

Die Studie wurde an 53 klinischen Zentren in den USA durchgeführt. Dabei erhielten 402 Patienten mit PHN nach Zufallsaufteilung entweder eine einzige einstündige Behandlung mit Transacin oder einen entsprechend abgestimmten KOntrollpatch mit niedrig dosiertem Capsaicin. Die Testpersonen wurden anschließend 12 Wochen lang beobachtet. In dieser Zeit beurteilten sie ihre Schmerzen täglich anhand einer numerischen Schmerzbeurteilungsskala zwischen 0 (keine Schmerzen) und 10 (schlimmstmögliche Schmerzen).

„Transacin könnte eine wichtige therapeutische Alternative für Patienten mit postzosterischer Neuralgie darstellen, einer häufigen, aber schwierig in den Griff zu bekommenden Form von neuropathischen Schmerzen, von der einer von fünf Patienten mit Herpes Zoster betroffen ist”, erklärt Misha-Miroslav Backonja, M.D., einer der Prüfärzte der Studie und Director of Research and Education des University of Wisconsin Pain Treatment Center in Madison, Wisconsin, USA. „Wir brauchen dringend neue Medikamente, die den Patienten mit dieser schmerzhaften Erkrankung Linderung verschaffen.”

„Bei der Behandlung neuropathischer Schmerzen besteht ein großer unerfüllter medizinischer Bedarf, und dies in ein wichtiger Schritt in Richtung der Bereitstellung einer wirksamen, peripheren Behandlungsoption”, stellt Jeffrey Tobias, M.D., Chief Medical Officer bei NeurogesX. fest. „Wir werten derzeit die Studienergebnisse aus und werden die Ergebnisse voraussichtlich Anfang nächsten Jahres bei einer wissenschaftlichen Konferenz präsentieren können.”

„Diese Studie ist eine wichtige Validierung sowohl für Transacin als auch für NeurogesX und bietet Hoffnung für viele Patienten, die schon lange an neuropathischen Schmerzen leiden. Wir glauben, dass eine peripher wirksame Therapie ohne die klassischen Nebenwirkungen, die bei den derzeitigen Therapien auftreten, sowohl von den Ärzten als auch von den Patienten gut aufgenommen werden wird”, so Anthony A. DiTonno, Präsident und CEO von NeurogesX. „Diese Daten, kombiniert mit unseren bereits vorliegenden positiven Phase-3-Ergebnissen mit Transacin bei schmerzhafter HIV-assoziierter Neuropathie (HIV-AN), bilden die Grundlage für einen Zulassungsantrag bei den Behörden der Europäischen Union, den wir in der ersten Jahreshälfte 2007 einreichen wollen.”

Der aktuelle Entwicklungsplan des Unternehmens für Transacin sieht die Einreichung eines Zulassungsantrags als neuartiges Arzneimittel (New Drug Application, NDA) bei der US-amerikanischen Zulassungsbehörde FDA mit Daten aus den PHN- und HIV-AN-Programmen bis Mitte 2008 vor. NeurogesX rekrutiert derzeit Patienten für zwei Phase-3-Bestätigungsstudien, um die erforderlichen Daten für den NDA-Zulassungsantrag zusammenzustellen; eine Studie zu PHN, die an Standorten in den USA und Kanada stattfindet, sowie eine Studie zu HIV-AN an Standorten in den USA, Kanada, Großbritannien und Australien.

Weitere Informationen über die Phase-3-Studien von NeurogesX gibt es im Internet unter http://www.clinicaltrials.gov/ct/show/NCT00321672?order=6 und http://clinicaltrials.gov/ct/show/NCT00300222?order=1.

Über Transacin (NGX-4010)

Bei Transacin handelt es sich um einen topischen, vom Arzt aufgetragenen Patch, der hoch dosiertes Transcapsaicin enthält, eine synthetische Form des natürlicherweise vorkommenden TRPV1-Agonisten Capsaicin. Im Gegensatz zu derzeitigen Behandlungsformen bei neuropathischen Schmerzzuständen, bei denen Opioide und andere Wirkstoffe eingesetzt werden, welche im Zentralnervensystem wirken und Benommenheit bzw. andere systemische Nebenwirkungen verursachen können, wirkt der Patch peripher auf der Haut, d. h. dort, wo der Schmerz häufig herkommt. Aufgrund des neuartigen Patch-Verabreichungssystems und weil Transacin auf der Haut wirkt, dürfte die Wahrscheinlichkeit des Auftretens von Sicherheitsbedenken oder Nebenwirkungen mit negativem Einfluss auf die Lebensqualität gering sein.

Über NeurogesX

NeurogesX ist ein privates spezialisiertes pharmazeutisches Unternehmen, das sich schwerpunktmäßig mit der Entwicklung neuartiger Behandlungen für das Management neuropathischer Schmerzzustände beschäftigt. Die ersten Produkte des Unternehmens zielen auf die Bekämpfung chronischer Schmerzen bei postzosterischer Neuralgie (PHN), schmerzhafte HIV-assoziierter Neuropathie (HIV-AN) und schmerzhafter diabetischer Neuropathie (PDN) ab. NeurogesX plant die Einreichung einer Marktzulassung in Europa im ersten Halbjahr 2007 bzw. die Beantragung eines NDA-Zulassungsantrags in den USA bis 2008. Mehr Informationen über NeurogesX gibt es im Internet unter www.neurogesx.com.

[invest2002]

[BrauchGeld]

Anscheinend hebt NGSX die Nachricht für morgen auf, vorher sammeln die Insider einwenig Aktien ..

Wie auch immer die aussichten für Neuroges sind grandios

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.806.866 von BrauchGeld am 19.03.09 20:52:30

Jetzt ist es da nachbörslich ....

http://finance.yahoo.com/news/NeurogesX-QutenzaTM-NGX4010-pr…


Press Release Source: NeurogesX, Inc.
NeurogesX' Qutenza(TM) (NGX-4010) Receives Positive Committee Recommendation in European Union

Thursday March 19, 2009, 4:24 pm EDT


Broad Label Indicated for Peripheral Neuropathic Pain in Non-Diabetic Adults

Conference Call Scheduled Friday, March 20 at 9am ET

SAN MATEO, Calif., March 19 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX - News), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, announced today that the European Medicines Agency's (EMEA) Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010), for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain.

Qutenza is a high-concentration capsaicin dermal patch designed to provide rapid, localized and sustained relief from peripheral neuropathic pain. The CHMP's positive recommendation will be evaluated by the European Commission, and a decision on marketing authorization is expected in the next 60 to 90 days.

Anthony DiTonno, President and CEO, commented, "The CHMP's positive recommendation for approval of Qutenza in the European Union provides significant validation for both Qutenza and NeurogesX. Since its founding in 2000, NeurogesX has been dedicated to bringing Qutenza to market for patients with neuropathic pain, a patient population that is largely unsatisfied with existing approved therapies. We are excited to be on the doorstep of potential commercialization. In preparation for a potentially positive final decision by the European Commission, we will be focused on finalizing a relationship with a commercial partner in Europe over the next few months."

Dr. Jeffrey Tobias, Chief Medical Officer, commented, "We believe that, if approved, Qutenza may become an important addition to the treatment options currently available for peripheral neuropathic pain in non-diabetic adult patients. By providing a localized treatment option applied directly to the site of pain, Qutenza can produce up to three months of pain relief following a single 30- or 60-minute application. Clinical studies have demonstrated that Qutenza can be used alone or in combination with other pain medications. This is particularly important in the treatment of peripheral neuropathic pain where patients often require management with more than one medication."

The CHMP's positive opinion recommending approval of Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults was made in reliance on NeurogesX' commitment to conduct certain post-marketing studies. These post-marketing commitments, which are often required by the CHMP as a condition of an approval recommendation, may include an open-label safety study of Qutenza in on-label indications, as well as a clinical safety and efficacy study in painful diabetic neuropathy.

Conference Call Details

The Company will hold its quarterly conference call on Friday, March 20, 2009 at 9:00 a.m. ET (6:00 a.m. PT) to discuss fourth quarter and year-end 2008 results and the CHMP's positive opinion recommending E.U. approval of Qutenza in non-diabetics with peripheral neuropathic pain. To participate in the conference call, please dial 1-877-407-0789 (USA) or 1-201-689-8562 (International). In addition, a dial-up replay of the conference call will be available beginning March 20, 2009 at 8:00 p.m. ET (5:00 p.m. PT) and ending on March 30, 2009. The replay telephone number is 1-877-660-6853 (USA) or 1-201-612-7415 (International), Account Number: 3055, Conference ID Number: 317851.

[BrauchGeld]

Heute mittag gibts eine Konferenz und da die Nachricht nachörslich erst kam rechne ich wieder mit Kursgewinn .

Neurogesx (NGSX)

MarktKap : 33 Mio US$ << gerade mal 2 milliönchen über cash
Cash: 30,8 Mio US$
Kurs : 1,92 US$

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.808.864 von BrauchGeld am 20.03.09 09:15:33

Hier die Zahlen von NGSX gerade erschienen ....Alles sieht klasse aus

Cash, cash equivalents and short-term investments were approximately $24.5 million at December 31, 2008, compared to $30.8 million at September 30, 2008.

Stephen Ghiglieri, CFO, commented, "Our regulatory and commercialization timelines for Qutenza in the United States and Europe have remained on track. We have focused our cash resources on regulatory and pre-commercialization activities for Qutenza, deferring further clinical development of Qutenza, NGX-1998 and our preclinical prodrug development programs. Based on this conservative strategy, we believe we have sufficient cash runway through the anticipated timing of European Commission and FDA decisions, and through at least December 31, 2009. Potential proceeds received from our anticipated European commercial partnership, including upfront or near-term milestone payments, would be additive and have not been factored into our current cash forecast. With the potential for European and U.S. commercial partnerships, and other non-equity based sources of funding, we do not currently intend to raise equity capital in the public markets."

NeurogesX Reports Fourth Quarter and Year-End 2008 Results
Friday March 20, 8:00 am ET


Qutenza(TM) Receives Positive Committee Recommendation in European Union
Corporate Highlights:

- CHMP issued positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain

ADVERTISEMENT


- Qutenza NDA accepted for review by U.S. FDA for PHN

Upcoming 2009 Milestones:

- European commercial partnership for Qutenza anticipated first half of 2009

- European Commission decision on MAA for Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults alone or in combination with other medicinal products for pain anticipated first half of 2009

- FDA PDUFA date of August 16, 2009 for Qutenza NDA to manage pain associated with PHN

SAN MATEO, Calif., March 20 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX - News), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for the fourth quarter and full year ended December 31, 2008 and provided an update on recent developments.

During 2008, NeurogesX continued to make significant progress on the regulatory front in the United States and Europe. In October 2008, the Company submitted a new drug application (NDA) on schedule to the U.S. Food and Drug Administration (FDA) requesting marketing approval of Qutenza for the management of pain associated with postherpetic neuralgia (PHN). In December 2008, the NDA was accepted by the FDA for review, resulting in a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009.

Regarding the European regulatory process for Qutenza, on March 19, 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of the marketing authorization application (MAA) for Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults either alone or in combination with other medicinal products for pain. The MAA, filed under the centralized procedure, is subject to a final decision by the European Commission on the CHMP's recommendation. This decision is usually rendered approximately 60 to 90 days from the date of the CHMP's recommendation.

Anthony DiTonno, President and CEO, commented, "With the final European Commission decision expected within the next 60 to 90 days, and a U.S. marketing application under review, we believe that we are closer than ever before to becoming a commercial enterprise. We are pleased with the proposed label for Qutenza in the European Union, which includes all peripheral neuropathic pain conditions in non-diabetic adults either alone or in combination with other medicinal products for pain and supports our goal of finalizing a commercial partnership for the European Union during the first half of 2009. In the United States our NDA for Qutenza was accepted and is currently under review by the FDA for the PHN indication, with a scheduled PDUFA date of August 16, 2009. We continue to plan for the potential U.S. commercialization of Qutenza. Both our U.S. and European commercial strategies continue to focus on maximizing the value of Qutenza, and we are excited about the upcoming events for the coming year."

[BrauchGeld]

Party woooohhooooooohoooo

[BrauchGeld]

einfach wunderschön und immer noch soooooooooo billig

[BrauchGeld]

Antwort auf Beitrag Nr.: 36.813.452 von BrauchGeld am 20.03.09 16:31:04

Hab ein teil verkauft die hälfte lasse ich weiter laufen ....

Bin in eine neue sehr attraktive Aktie eingestiegen stelle die später vor ....

[BrauchGeld]

NGSX hält sich gut über 3$, ich hoffe trotzdem das die Aktie nochmal runterkommt um weiter aufzustocken....

http://seekingalpha.com/article/127556-neurogesx-fundamental…

NeurogesX, Inc.’s (NGSX) Qutenza, a cutaneous (skin) patch designed to treat peripheral neuropathic pain conditions, has significant market opportunity, in our view. The neuropathic pain market is multi-billion dollar, and the clinical data, at least in post-hepatic neuralgia (PHN), looks very good.

We are very pleased to see the positive opinion issued by the EMEA-CHMP in March 2009. We note that treatment of neuropathic pain often involves multiple products, and that the Qutenza profile of infrequent dosing with no systemic side-effects or drug-drug interactions will fit very well into the poly-pharmacy model.

In this regard, we are very pleased that the proposed EU label allows for the use of poly-pharmacy. Odds now clearly favor approval in the EU in the next 60 to 90 days. According to management, they are in "very late stage" discussions with potential pan-European partners, and a deal should be in place by the end of the 2nd quarter 2009. This could represent significant upside for shareholders once the deal is announced.

The U.S. PDUFA action date is set for August 2009. Our best guess is that management looks to launch the product in early 2010 with a small specialty field force of around 20-25 representatives. Funding for the launch in the U.S. should come from the upfront licensing payment for the European partnership.

Right now, we expect that management is working through the delicate balance of securing enough upfront cash to fund a potential U.S. launch alone vs. agreeing to future royalties and potential backend milestones so they can participate in the European upside from Qutenza sales. This specialized group will target the top quartile or so of the 5,000 pain centers and 10,000 neurologists that are high-prescribers for PHN. When progress is made here, management will probably look to expand through a co-promotion agreement with a larger organization.

NeurogesX stock is thinly-traded and, as a result, highly volatile. We like the name, but we urge caution when establishing a position. The stock is up nicely on the positive CHMP review news. There very well may be profit-taking and a pullback to follow. This could represent an attractive re-entry point for investors. Our target is $5.

[buy-out]

NeurogesX Reports First Quarter 2009 Results
On Thursday May 7, 2009, 4:01 pm EDT

European Commission Decision on Qutenza(TM) Expected in 1H 2009

Company to Provide Update on FDA review of Qutenza During Conference Call Today

Corporate Highlights:

- CHMP issued positive opinion recommending approval of Qutenza(TM) (formerly NGX-4010) for treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain

Upcoming 2009 Milestones:

- European Commission decision on MAA for Qutenza anticipated first half of 2009

- European commercial partnership for Qutenza targeted first half of 2009

- FDA PDUFA date of August 16, 2009 for Qutenza NDA to manage pain associated with PHN

SAN MATEO, Calif., May 7 /PRNewswire-FirstCall/ -- NeurogesX, Inc. (Nasdaq: NGSX - News), a biopharmaceutical company focused on developing and commercializing novel pain management therapies, today reported results for the first quarter ended March 31, 2009 and provided an update on recent developments.

During the first quarter of 2009, NeurogesX continued to focus on seeking regulatory approvals and on pre-commercialization activities for its lead product candidate Qutenza (formerly NGX-4010). On March 19, 2009, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMEA) issued a positive opinion recommending approval of the marketing authorization application (MAA) for Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain.

The CHMP's recommendation for the MAA, filed under the centralized procedure, is subject to a final decision by the European Commission, usually rendered approximately 60 to 90 days after the CHMP's recommendation. In preparation for potential marketing authorization and commercialization, NeurogesX has continued active discussions with potential European marketing partners and anticipates completing a transaction in the first half of 2009.

Qutenza is also undergoing U.S. regulatory review, and the United States Food and Drug Administration (FDA) has scheduled a Prescription Drug User Fee Act (PDUFA) date of August 16, 2009 to review the new drug application (NDA) for the management of pain associated with postherpetic neuralgia (PHN).

Anthony DiTonno, President and CEO, commented, "We are confident that Qutenza is closer than ever to commercialization as we await the European Commission's decision on our MAA, expected within the coming weeks. We are in late stage discussions with potential European commercial partners for Qutenza, supported by the proposed broad E.U. label for peripheral neuropathic pain conditions in non-diabetic adults, either alone or in combination with other medicinal products for pain. We also continue to plan for the potential U.S. commercialization of Qutenza. Our top priority remains to secure U.S. and European regulatory approvals and become a commercial-stage company. We look forward to several upcoming milestones in 2009."

First Quarter 2009 Financial Results

Total operating expenses for the first quarter of 2009 were approximately $4.5 million, down 46% from approximately $8.3 million in the same period of 2008. The decrease primarily resulted from a $3.5 million decrease in research and development costs. Year-over-year operating expenses were lower as the Company deferred development programs in order to focus resources on regulatory processes and to continue preparations for potential commercialization of Qutenza in both Europe and the United States.

Net loss for the first quarter of 2009 was approximately $4.6 million, compared to a net loss of approximately $8.0 million for the first quarter of 2008. Net loss per share attributable to common stockholders was $0.26 per share and $0.46 per share for the three months ended March 31, 2009 and 2008, respectively, based on weighted average shares outstanding of 17,568,600 and 17,468,395 respectively.

Cash, cash equivalents and short-term investments were approximately $18.8 million at March 31, 2009, compared to $24.5 million at December 31, 2008.

Stephen Ghiglieri, CFO, commented, "We have focused our cash resources to prosecute our MAA and NDA for Qutenza and to support strategies for obtaining adequate reimbursement for Qutenza in the United States, while deferring further clinical development of Qutenza, NGX-1998 and our preclinical prodrug development programs. As a result of our conservative cost management strategy, we believe that our cash runway is sufficient to last at least until December 31, 2009. Potential near-term proceeds from a European commercial partnership, which we expect to finalize in the first half of 2009, would provide additional runway and have not been accounted for in our current cash forecast. As we pursue European and U.S. commercial partnerships, and other non-equity based sources of funding, we do not currently intend to raise equity capital in the public markets at our present valuation."

Development Update

Currently, NeurogesX is primarily focused on completing the development through regulatory approval, of Qutenza for patients with PHN in the United States and for peripheral neuropathic pain in non-diabetic adults in the E.U.

The CHMP's positive opinion recommending E.U. approval of Qutenza for the treatment of peripheral neuropathic pain in non-diabetic adults, either alone or in combination with other medicinal products for pain, was made in reliance on NeurogesX' commitment to conduct certain post marketing studies of Qutenza following approval. Post-marketing commitments are often required by the CHMP as a condition for recommending approval. An open-label safety study of Qutenza in on-label indications is planned to be conducted following launch of Qutenza in the E.U. In addition, a protocol evaluating the clinical safety and efficacy of Qutenza in painful diabetic neuropathy will be discussed with the CHMP following approval of the MAA. It is anticipated that these studies could potentially be conducted and/or funded by a European commercial partner.

NGX-1998 is the Company's second-generation, liquid formulation of the same active ingredient found in Qutenza. The liquid formulation is being developed to address neuropathic pain conditions, providing similar efficacy in a shorter treatment time versus Qutenza. NGX-1998 has been evaluated in three Phase 1 studies and is currently being considered for entry into Phase 2 evaluation, subject to receipt of additional funding.

NeurogesX is also seeking business development partners to advance its acetaminophen and opioid prodrug product candidates.

NGX-9674 and NGX-5752, novel prodrugs of acetaminophen, have been evaluated in in vivo and in vitro preclinical studies and demonstrate approximately 10 times greater solubility in water versus acetaminophen.
NGX-1576, a novel prodrug coupling acetaminophen to a liver protectant, has been evaluated in vitro and in vivo. Equivalent dose levels of NGX-1576 in mice produced significantly less liver toxicity than acetaminophen, while additional data demonstrated the production of equivalent plasma levels of acetaminophen.
NGX-6052, the most advanced molecule synthesized in NeurogesX' opioid prodrug platform, has been evaluated in proof of concept in vivo and in vitro preclinical studies for its potential to deliver therapeutic efficacy with a potential for an improved side effect profile and possible abuse-deterrent attributes.


Conference Call Details

The Company will hold its quarterly conference call today at 4:30 p.m. ET (1:30 p.m. PT) to discuss first quarter 2009 results and recent corporate updates.

To participate, please dial 1-877-407-0789 (USA) or 1-201-689-8562 (International). To access the live web cast please visit the Investor Relations section on the corporate web site at http://www.neurogesx.com.

A replay of the conference call will be available beginning May 7, 2009 at 7:30 p.m. ET (4:30 p.m. PT) and ending on May 17, 2009 by dialing 1-877-660-6853 (USA) or 1-201-612-7415 (International), Account Number: 3055, Conference ID Number: 320580. A replay of the webcast will also be available on the corporate website for one month, through June 7, 2009.

[BrauchGeld]

Bin heute komplett raus aus NGSX die Aktie ist gut gelaufen, ist zwar immer noch sehr günstig aber brauch leider das geld für eine andere Aktie .

[BrauchGeld]

Zulassung kommt mitte August .. Ich Dorftrottel hab verkauft