Key Developments: NeurogesX Inc (NGSX.PK)
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24 May 2013
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Latest Key Developments (Source: Significant Developments)
Trading In NeurogesX, Inc. Common Stock To Move From NASDAQ To OTCBB
NeurogesX, Inc. 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. Full Article
Robbins Umeda LLP Announces Investigation Of NeurogesX, Inc
Robbins Umeda LLP announced that it is investigating possible breaches of fiduciary duty and other violations of the law by certain officers and directors at NeurogesX, Inc. In particular, the Company failed to disclose adverse facts concerning the employment of Dr. Jeffrey K. Tobias, the Company's former Chief Medical Officer and Executive Vice President of Research and Development. Tobias oversaw all the research and development for the drugs in NeurogesX's portfolio, and therefore was a crucial officer for NeurogesX. Despite Tobias's importance to NeurogesX, representatives of the Company failed to disclose and actively concealed the fact that Tobias was seeking other employment. As a result of these actions, NeurogesX's stock traded at artificially high prices. On September 27, 2011, the Company announced Tobias' resignation. Upon this announcement, NeurogesX stock value declined almost 40%. By October 3, 2011, the Company had lost over half of its market value. Robbins Umeda LLP highlights that NeurogesX shareholders have the option to file a shareholder derivative action to hold those officers and directors accountable for damaging the Company. Remedies commonly sought in derivative actions include corporate governance reforms designed to prevent future misconduct, removal of officers or directors whose misconduct injured the corporation, and monetary payments in the form of damages and disgorgement of ill-gotten gains. Full Article
Levi & Korsinsky Notifies Investors With Losses On Their Investment In NeurogesX, Inc. Of Class Action Lawsuit
Levi & Korsinsky announced that a class action lawsuit has been commenced in the United States District Court for the Southern District of New York on behalf of investors who purchased NeurogesX, Inc. ("NeurogesX" or the "Company") common stock between May 9, 2011 and September 27, 2011. The complaint alleges that the Company's Board of Directors issued materially false and misleading statements and/or failed to disclose material adverse facts concerning the employment of Dr. Jeffrey K. Tobias, the Company's former Chief Medical Officer and Executive Vice President of Research and Development. Specifically, the complaint alleges that representatives of NeurogesX, including Tobias himself, failed to disclose and/or actively concealed the fact that Tobias was seeking other employment. As a result of the aforementioned allegations, NeurogesX's stock traded at artificially high prices. On September 27, 2011, the Company announced Tobias' resignation. Upon this announcement, shares of NeurogesX declined almost 40%. By October 3, 2011, the Company had lost over half its market value. Full Article
NeurogesX Inc Provides Update On Qutenza (Capsaicin) 8% Patch For New Indication To Treat HIV-PN Following FDA Advisory Committee Review
NeurogesX Inc 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 (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 in the management of pain associated with HIV-PN. Full Article
NeurogesX Inc Announces $3.0 Million Private Placement
NeurogesX Inc announced that on January 31, 2012 it entered into a securities purchase agreement in connection with a private placement to a group of institutional accredited investors and is expected to receive approximately $3.0 million in gross proceeds from the sale of 2,969,685 common shares at $1.01 per share based on the consolidated closing bid price of NGSX common stock on the NASDAQ Global Market on January 31, 2012. The funding was led by a large, global institutional investor and included certain other existing investors. The funding was initiated by an inbound inquiry. Full Article
NeurogesX Inc Appoints Ronald Martell As President And Chief Executive Officer
NeurogesX Inc announced that the Board of Directors has appointed Ronald A. Martell as President and Chief Executive Officer (CEO), and a member of the Board. Commensurate with Ron's appointment, long time President and CEO, Tony DiTonno retired as of December 31, 2011. Full Article
NeurogesX Inc Confirms FDA Advisory Committee To Review sNDA For Qutenza (capsaicin) 8% Patch For HIV-Associated Peripheral Neuropathy (HIV-PN)
NeurogesX Inc confirmed that the Division of Anesthesia, Analgesia and Addiction Products (DAAAP) of the U.S. Food and Drug Administration (FDA) has scheduled an Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) meeting on February 9, 2012, to review NeurogesX' supplemental New Drug Application (sNDA) for Qutenza® (capsaicin) 8% patch for the management of neuropathic pain associated with HIV-associated peripheral neuropathy (HIV-PN). Qutenza is currently approved in the United States for the management of neuropathic pain associated with postherpetic neuralgia (PHN). Full Article
NeurogesX Inc Reports Positive Phase 2 Results for NGX-1998 for Treatment of Postherpetic Neuralgia
NeurogesX Inc announced positive top-line results from its Phase 2 clinical study of NGX-1998, a topical liquid formulation of high-concentration capsaicin, in patients with postherpetic neuralgia (PHN). The Company believes that the data support moving forward to a Phase 3 clinical development program following an End-of- Phase 2 meeting with the Food and Drug Administration for NGX-1998, which NeurogesX believes could occur in the first half of 2012. The 12-week, multicenter, randomized, double-blinded, placebo-controlled clinical trial met its protocol-specified objectives, which include the primary endpoint of a percentage change from baseline vs. placebo in a patient-reported numeric pain rating scale (NPRS) score during Weeks 2 through 8. A total of 183 patients were enrolled in the Phase 2 study. Patients were randomized into one of three groups: NGX-1998 capsaicin 10% solution, NGX-1998 capsaicin 20% solution or placebo, according to an unequal allocation scheme of 2:2:1. NGX-1998 exhibited a dose response. Although no topical anesthetic was used during the second stage of the study the patients were able to tolerate the treatment procedure. No patients discontinued the study due to adverse events, and the incidence of adverse events and serious adverse events in patients treated with NGX-1998 were similar to the placebo-treated group. Full Article
NeurogesX Inc Submits Supplemental New Drug Application For Qutenza (capsaicin) 8% Patch For HIV-Associated Peripheral Neuropathy (HIV-PN)
NeurogesX Inc announced it submitted a supplemental new drug application (sNDA) to the U.S. Food and Drug Administration (FDA) seeking to expand the label for Qutenza (capsaicin) 8% patch to include an indication for the management of pain due to HIV-associated peripheral neuropathy (HIV-PN), also known as HIV-associated neuropathy (HIV-AN) and HIV-distal sensory polyneuropathy (HIV-DSP). The sNDA seeks approval for a 30-minute application of Qutenza for the treatment of neuropathic pain associated with HIV-PN. As part of the application, NeurogesX is also requesting a Priority Review designation. FDA Priority Review status is given to drug candidates that offer major advances in treatment, or provide a treatment where no adequate therapy exists, and accelerates the standard review time from ten months to six months. Full Article
NeurogesX Inc Secures $20 Million Debt Facility
NeurogesX Inc announced that it has entered into a $20 million loan agreement with Hercules Technology Growth Capital, Inc. (Nasdaq: HTGC). The loan agreement includes both a $5 million accounts receivable line of credit and a $15 million term loan. Proceeds are expected to be used to further support commercialization activities for Qutenza (capsaicin) 8% patch, the clinical development of the Company's lead product candidate, NGX-1998, a non-patch topically applied liquid formulation of high-concentration capsaicin, as well as general corporate purposes. Full Article
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