Key Developments: Impax Laboratories Inc (IPXL.O)
18.80USD
24 May 2013
$0.20 (+1.08%)
$18.60
$18.60
$18.94
$18.45
372,692
1,210,257
$27.25
$14.41
Latest Key Developments (Source: Significant Developments)
Impax Laboratories Inc's Impax Pharmaceuticals And Glaxosmithkline Plc Terminate Collaboration On IPX066 (RYTARYTM)
Impax Laboratories Inc's Impax Pharmaceuticals and Glaxosmithkline Plc announced that they are terminating their collaboration for the development and commercialization of IPX066 outside the United States (U.S.) and Taiwan. IPX066 (known as RYTARY in the U.S.) is an investigational extended-release capsule formulation of carbidopa-levodopa being developed for the symptomatic treatment of adult patients with idiopathic Parkinson's disease and is not approved anywhere in the world. Under the terms of the agreement entered into in December 2010, GSK's right to develop and commercialize IPX066 outside the U.S. and Taiwan will transfer back to Impax effective at the end of July 2013. The decision has been reached because of delays in the anticipated regulatory approval and launch dates in countries in which GSK has rights to commercialize the product. Impax intends to initiate activities to find a partner or partners for markets outside the U.S. looking to grow their non-US neurology franchise. Full Article
Levi & Korsinsky Notifies Investors With Losses On Their Investment In Impax Laboratories Inc Of Class Action Lawsuit
Levi & Korsinsky announced that a class action lawsuit has been commenced in the United States District Court for the Northern District of California on behalf of investors who purchased Impax Laboratories Inc stock between June 6, 2011 and March 4, 2013. Full Article
Levi & Korsinsky Notifies Investors with Losses on Their Investment in Impax Laboratories Inc of Class Action Lawsuit and Deadline of May 6, 2013 to Seek Lead Plaintiff Position
Levi & Korsinsky announced that a class action lawsuit has been commenced in the United States District Court for the Northern District of California on behalf of investors who purchased Impax Laboratories Inc stock between June 6, 2011 and March 4, 2013. The complaint alleges that during the Class Period, the Company and certain of its officers and directors made materially false and misleading statements in connection with manufacturing deficiencies at the Company’s Hayward facility. On March 4, 2013, Impax announced that the FDA had completed an inspection of the Company’s Hayward, California facility, finding twelve problems at the facility that the Company needed to correct. Impax also announced that due to continuing manufacturing deficiencies, the Company did not expect to launch its RytaryTM drug until 2014. Upon this news, shares of Impax fell 26%, to close at $14.80 per share on March 5, 2013. Full Article
Law Offices of Todd M. Garber Announces Lead Plaintiff Deadline In Class Action Lawsuit Against Impax Laboratories Inc
The Law Offices of Todd M. Garber announced that shareholders of Impax Laboratories Inc have until May 6, 2013 to move for lead plaintiff status in the shareholder lawsuit filed in the United States District Court for the Northern District of California. The lawsuit was filed on behalf of a class (the “Class”) comprising all purchasers of Impax common stock between June 6, 2011 and March 4, 2013, inclusive (the Class Period). The Complaint alleges that during the Class Period the Company and certain of its officers and directors violated federal securities laws by making false and misleading statements in connection with manufacturing deficiencies at the Company’s Hayward, California, facility, including the impact these deficiencies would have on the Company’s ability to gain FDA approval for its drug RytaryTM. On March 4, 2013 the Company announced that the FDA had completed an inspection of the Hayward facility. According to the Company, the FDA found twelve problems at the facility that the Company needed to correct. The Company further announced that due to continuing manufacturing deficiencies, Impax did not expect to be able to launch its RytaryTM drug until 2014. On this news, shares of Impax declined $5.20 per share, or 26%, to close at $14.80 per share on March 5, 2013, on unusually heavy volume. Full Article
Law Offices of Todd M. Garber Announces Class Action Lawsuit Against Impax Laboratories Inc
The Law Offices of Todd M. Garber announced that a class action lawsuit has been filed in the United States District Court for the Northern District of California on behalf of a class (the Class) comprising all purchasers of the common stock of Impax Laboratories Inc between June 6, 2011 and March 4, 2013, inclusive (the Class Period). The Complaint alleges that during the Class Period the Company and certain of its officers and directors violated federal securities laws by making false and misleading statements in connection with manufacturing deficiencies at the Company’s Hayward, California, facility, including the impact these deficiencies would have on the Company’s ability to gain FDA approval for its drug RytaryTM. On March 4, 2013 the Company announced that the FDA had completed an inspection of the Hayward facility. According to the Company, the FDA found twelve problems at the Hayward facility that the Company needed to correct. The Company further announced that due to continuing manufacturing deficiencies, Impax did not expect to be able to launch its RytaryTM drug until 2014. On this news, shares of Impax declined $5.20 per share, or 26%, to close at $14.80 per share on March 5, 2013 on unusually heavy volume. Full Article
Glancy Binkow & Goldberg LLP Announces Lead Plaintiff Deadline in the Class Action Lawsuit Against Impax Laboratories Inc
Glancy Binkow & Goldberg LLP announced that purchasers of the common stock of Impax Laboratories Inc between June 6, 2011 and March 4, 2013, inclusive, have until May 6, 2013 to file a motion with the Court to be appointed as lead plaintiff. The shareholder lawsuit was filed in the United States District Court for the Northern District of California. Full Article
Law Offices of Howard G. Smith Announces Lead Plaintiff Deadline In Class Action Lawsuit Against Impax Laboratories Inc
Law Offices of Howard G. Smith announced that investors of Impax Laboratories, Inc. (Impax or the Company) have until May 6, 2013 to move the Court to serve as lead plaintiff in the securities fraud class action lawsuit filed in the United States District Court for the Northern District of California on behalf of a class (the Class) comprising all purchasers of Impax common stock between June 6, 2011 and March 4, 2013, inclusive (the Class Period). Impax is a specialty pharmaceutical company involved in the development, manufacture and marketing of bioequivalent pharmaceutical products and branded products. The Complaint alleges that during the Class Period the Company and certain of its officers and directors violated federal securities laws by making false and misleading statements in connection with manufacturing deficiencies at the Company`s Hayward, California, facility, including the impact these deficiencies would have on the Company`s ability to gain FDA approval for its drug RytaryTM. On March 4, 2013 the Company announced that the FDA had completed an inspection of the Hayward facility. According to the Company, the FDA found twelve problems at the Hayward facility that the Company needed to correct and, due to continuing manufacturing deficiencies, Impax did not expect to be able to launch its RytaryTM drug until 2014. On this news, shares of Impax declined $5.20 per share, or 26%, to close at $14.80 per share on March 5, 2013, on unusually heavy volume. Full Article
Lifshitz Law Firm Announces Class Action Lawsuits Against Impax Laboratories Inc
Lifshitz Law Firm announced that a class action suit was filed in the United States District Court for the Northern District of California on behalf of purchasers of Impax Laboratories Inc between June 6, 2011 through March 4, 2013, inclusive (the Class Period). The Complaint alleges defendants misrepresented and/or failed to disclose that at its Hayward facility: (1) the Company failed to maintain proper quality control and manufacturing practices in violation of current GMP; (2) the Company failed to take proper remedial actions to correct quality control issues previously identified by the FDA in prior inspections; and (3) the Company failed to disclose the extent of the adverse impact the manufacturing deficiencies could have on the Company's ability to successfully launch its new drug, Rytary. Full Article
Law Offices of Howard G. Smith Announces Class Action Lawsuit Against Impax Laboratories Inc
Law Offices of Howard G. Smith announced that a class action lawsuit has been filed in the United States District Court, Northern District of California on behalf of all purchasers of the common stock of Impax Laboratories Inc between June 6, 2011 and March 4, 2013, inclusive (the Class Period). The Complaint alleges that during the Class Period, the Company and certain of its officers and directors violated the federal securities laws by making false and misleading statements in connection with manufacturing deficiencies at the Hayward facility, including the impact these deficiencies would have on the Company’s ability to gain FDA approval for its drug RytaryTM. On March 4, 2013, the Company announced that the FDA had completed an inspection of the Company’s Hayward, California facility. According to the Company, the FDA found twelve problems at the Hayward facility that the Company needed to correct. The Company further announced that due to continuing manufacturing deficiencies, Impax did not expect to be able to launch its RytaryTM drug until 2014. On this news, shares of Impax declined $5.20 per share, or 26%, to close at $14.80 per share on March 5, 2013, on unusually heavy volume. Full Article
Robbins Arroyo LLP Investigates Impax Laboratories Inc
Shareholder rights firm Robbins Arroyo LLP is investigating whether officers and directors of Impax Laboratories, Inc. (NASDAQ: IPXL) breached their fiduciary duties to shareholders by failing to correct the Company's inadequate quality controls and deficiencies in its manufacturing processes. The FDA Notifies the Company of Its Significant Violations of Current Good Manufacturing Practice Regulations. On June 3, 2011, Impax received a warning letter from the Food and Drug Administration (FDA) following an on-site inspection of Impax's Hayward, CA pharmaceutical manufacturing facility conducted between December 13, 2010 and January 21, 2011. In the warning letter, the FDA notified Impax of the company's significant violations of Current Good Manufacturing Practice regulations for Finished Pharmaceuticals. Continued Manufacturing Deficiencies Persist at Impax's Hayward Facility Delay Bringing Rytary to Market. On March 3, 2013, Impax announced the results of a subsequent FDA inspection of the Hayward Facility that included a re-inspection in connection with the May 2011 warning letter and a pre-approval inspection for the Company's newly developed drug, Rytary. Following this inspection, the FDA issued a Form 483, "Notice of Inspectional Observances,documenting 12 problems, three of which were previously observed and noted in the 2011 warning letter. Full Article
Impax, GSK end Parkinson's disease partnership
- Impax Laboratories Inc said partner GlaxoSmithKline Plc ended their collaboration on Impax's experimental Parkinson's disease drug due to regulatory and launch delays in the countries in which GSK has rights to market the drug.
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