Key Developments: Pain Therapeutics Inc (PTIE.O)
2.88USD
22 May 2013
$-0.20 (-6.49%)
$3.08
$3.09
$3.10
$2.85
409,942
328,260
$5.86
$2.34
Latest Key Developments (Source: Significant Developments)
Pain Therapeutics Inc Declares Special One-Time Cash Distribution to Shareholders
Pain Therapeutics Inc announced that a committee of its Board of Directors has declared a special one-time cash distribution of $0.75 per share to shareholders, or an aggregate of about $34 million. The Record Date for this distribution is December 17, 2012. The Company expects to complete the distribution on or around December 24, 2012. Full Article
Faruqi & Faruqi, LLP Announces Investigation Of Pain Therapeutics, Inc. On Behalf Of Shareholders
Faruqi & Faruqi, LLP, a national law firm concentrating on investor rights, consumer rights and the enforcement of federal antitrust laws, is investigating potential wrongdoing at Pain Therapeutics Inc. The investigation focuses on whether certain executive officers and directors of PTIE breached their fiduciary duties by releasing false and misleading statements regarding its lead drug, REMOXY, and the likelihood that REMOXY would be approved by the Food and Drug Administration (FDA). REMOXY is marketed as a painkiller with a formulation designed to reduce potential risks of unintended use. Specifically, the investigation concerns possible breaches of fiduciary duties by the Company's executive officers and directors for failing to disclose that REMOXY was not approvable by the FDA due to chemistry, manufacturing and control deficiencies that caused inconsistent results during laboratory tests of REMOXY. Full Article
Harwood Feffer LLP Announces Investigation Of Pain Therapeutics, Inc.
Harwood Feffer LLP announced that it is investigating potential claims against the board of directors of Pain Therapeutics, Inc. (Pain Therapeutics or the Company), concerning the Company’s failure to comply with U.S. Food and Drug Administration (FDA) regulations in the manufacture and testing of a new drug. On June 24, 2011, Pain Therapeutics announced that the Company had received a Complete Response Letter from the FDA denying the Company’s New Drug Application (NDA) for REMOXY. In response, Company stock declined $3.94 per share or nearly 43%, to close at $5.30 per share on June 24, 2011. On June 27, 2011, the Company disclosed that the FDA’s Complete Response Letter raised concerns related to, among other things, the chemistry, manufacturing and controls sections of the NDA for REMOXY. In response, the Company stock declined an additional $1.37 per share or nearly 26%, to close at $3.93 per share on June 27, 2011. The Company may have improperly failed to disclose that REMOXY was not approvable by the FDA due to chemistry, manufacturing, and control deficiencies that caused unreliable results during laboratory tests. The investigation concerns whether the board of directors has breached its fiduciary duties, mismanaged the Company and/or wasted corporate assets at the expense of Pain Therapeutics shareholders. Full Article
Robbins Umeda LLP Announces Investigation Of Pain Therapeutics, 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 Pain Therapeutics, Inc.. Robbins Umeda LLP's investigation focuses on whether officials at Pain Therapeutics breached their fiduciary duties to shareholders, maintained woefully inadequate controls, and wasted corporate assets to the detriment of the Company and investors. In particular, the firm is investigating allegations that certain Officers and Directors misled the public to believe that, based on data gathered from clinical trials, the Company would receive Food and Drug Administration (FDA) approval for the Company's drug, REMOXY. On June 24, 2011, Pain Therapeutics announced that it had received a letter from the FDA stating that the agency had not approved the New Drug Application for REMOXY. As a result, the Company's stock market capitalization declined by more than $173.4 million, or nearly 43%. Furthermore, on June 27, 2011, the Company disclosed that the FDA's decision not to grant approval for REMOXY was based in part on chemistry, manufacturing and control deficiencies associated with the drug that yielded inconsistent results during laboratory trials. As a result of this revelation, Pain Therapeutics' stock market capitalization declined an additional $60 million, or nearly 26%. Full Article
Faruqi & Faruqi, LLP Announces Investigation Of Pain Therapeutics, Inc.
Faruqi & Faruqi, LLP, a national securities law firm, announced that it is investigating potential securities fraud at Pain Therapeutics, Inc. The investigation focuses on whether the Company and its executives violated federal securities laws by failing to disclose that Pain Therapeutics` new drug REMOXY was not approvable by the U.S. Food and Drug Administration (FDA) due to chemistry, manufacturing, and control deficiencies that caused unreliable results during laboratory tests. On June 24, 2011, Pain Therapeutics announced that the Company had received a Complete Response Letter from the FDA denying the Company`s New Drug Application (NDA) for REMOXY. As a result of this shocking revelation, Company shares declined $3.94 per share or nearly 43%, to close at $5.30 per share on June 24, 2011. On June 27, 2011, the Company disclosed that the FDA`s Complete Response Letter raised concerns related to, among other things, the chemistry, manufacturing and controls sections of the NDA for REMOXY. In the aftermath of this disclosure, the Company`s shares declined an additional $1.37 per share or nearly 26%, to close at $3.93 per share on June 27, 2011. Full Article
Pomerantz Law Firm Files Class Action Against Pain Therapeutics, Inc.
Pomerantz Haudek Grossman & Gross LLP announced that it has filed a class action lawsuit against Pain Therapeutics, Inc. and certain of its officers. The class action (1-11-CV-1034), filed in the United States District Court, Western District of Texas, is on behalf of a class consisting of all persons or entities who purchased PTIE securities during the period from February 3, 2011 through June 23, 2011 (the "Class Period"). This class action is brought under Sections 10(b) and 20(a) of the Securities Exchange Act of 1934, 15 U.S.C. Sections 78j(b) and 78t(a); and SEC Rule 10b-5 promulgated thereunder by the SEC, 17 C.F.R. Section 240.10b-5. The Complaint alleges that, during the Class Period, PTIE made false and/or misleading statements and/or failed to disclose material facts about a new drug, REMOXY. Specifically, PTIE failed to disclose that REMOXY was not approvable by the U.S. Food and Drug Administration due to chemistry, manufacturing, and control deficiencies that caused inconsistent results during laboratory tests. Full Article
Bronstein, Gewirtz & Grossman, LLC Investigates Pain Therapeutics, Inc.
Bronstein, Gewirtz & Grossman, LLC announced that it is investigating potential claims on behalf of purchasers of the securities of Pain Therapeutics, Inc, concerning whether the Company and certain of its officers and directors have violated federal securities laws. Full Article
Pain Therapeutics, Inc. Receives Complete Response Letter From U.S. Food and Drug Administration
Pain Therapeutics, Inc. announced that a Complete Response Letter was received on June 23, 2011 from the U.S. Food and Drug Administration (FDA) on the resubmission to the new drug application (NDA) for REMOXY (oxycodone) Extended-Release Capsules CII. Based on its review, the FDA has determined that the NDA for REMOXY is not approved. The FDA's Complete Response Letter raised concerns related to, among other matters, the Chemistry, Manufacturing, and Controls section of the NDA for REMOXY. Certain drug lots showed inconsistent release performance during in vitro testing. It is not known at this time whether this is an artifact of the testing method or a manufacturing deficiency. Full Article
Pfizer and Pain Therapeutics, Inc. Receives FDA Complete Response Letter for REMOXY
Pfizer and Pain Therapeutics, Inc. announced that a Complete Response Letter was received from the U.S. Food and Drug Administration (FDA) on the resubmission to the new drug application (NDA) for REMOXY (oxycodone) Extended-Release Capsules CII. Pfizer is working to evaluate the issues described in the Complete Response Letter and plans to have further discussions with FDA around them. REMOXY is an investigational extended-release oral formulation of oxycodone for the relief of moderate to severe pain requiring continuous, around-the-clock opioid treatment. REMOXY was developed by Pain Therapeutics, Inc. using DURECT Corporation’s ORADUR technology, which is designed to discourage common methods of tampering. In 2005, King Pharmaceuticals, Inc. entered into an agreement with Pain Therapeutics, Inc. to develop and commercialize REMOXY. Pain Therapeutics, Inc. filed the initial NDA for REMOXY in June 2008 and received a Complete Response Letter in December 2008. King Pharmaceuticals, Inc. assumed full control of the development of REMOXY in March 2009 and filed a resubmission to the REMOXY NDA on December 23, 2010. Pfizer obtained rights to REMOXY upon the close of its acquisition of King Pharmaceuticals, Inc. on February 28, 2011. Full Article
Pfizer yet to decide on Pain Therapeutics' painkiller
- Pfizer Inc said it could not decide whether to pursue regulatory approval for Pain Therapeutics Inc's painkiller Remoxy, for which the United States Food and Drug Administration sought additional studies.
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