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Stock Market & Financial Investment News

News Breaks
August 8, 2014
14:54 EDTPDLI, DEPOPDL BioPharma says concluding talks with SEC on Depomed deal accounting
PDL BioPharma (PDLI) disclosed in a regulatory filing that the company is currently concluding discussions with the SEC staff after receiving a comment letter to the company's Annual Report on Form 10-K for the fiscal year ended December 31, 2013, that requested additional information about the company’s accounting for the royalty purchase and sale agreement with Depomed (DEPO). "The Company’s responses to those comments may affect the narrative disclosures and financial statements included in the Company’s Quarterly Report on Form 10-Q for the period ended June 30, 2014. All of the comments cannot be resolved by the prescribed due date for the Current Quarterly Report without unreasonable effort or expense," PDL stated. The company intends to file its current quarterly report by not later than Monday, August 18, PDL added.
News For PDLI;DEPO From The Last 14 Days
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September 23, 2014
09:05 EDTPDLIPDL BioPharma informed of a class action lawsuit
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September 19, 2014
10:07 EDTPDLIHigh option volume stocks
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September 17, 2014
18:02 EDTPDLIPDL BioPharma issues statement on resignation of corporate auditors
PDL BioPharma was orally notified by its independent registered accounting firm, Ernst & Young, or EY, that it was resigning effective September 11. The resignation was confirmed in a letter delivered to the company on September 15, and reported in PDL's Form 8-K filed on September 16. PDL has issued the following statement in response to the announcement: "We have received a number of inquiries on the reason for the resignation of EY. We were surprised by the resignation as we did not have any disagreements with EY on accounting practices, scope or procedures nor did we have any reportable events that would have caused EY to resign their position as our auditors," stated Peter Garcia, VP and CFO of PDL. "We thank EY for their years of service to the company and have already begun the process of appointing new auditors, which we expect to announce in the coming weeks. We currently expect to continue our financial reporting in a timely manner." PDL BioPharma dropped 12% today following the revelation of Ernst & Young's resignation as corporate auditors.
16:18 EDTDEPODepomed says FDA recognizing 7 years orphan-drug exclusivity for Gralise in PHN
Depomed (DEPO) disclosed in a filing that on September 16 the company received a letter from the FDA informing the company that pursuant to the order issued on September 5 by a judge of the U.S. District Court for the District of Columbia, the FDA is recognizing seven years of orphan-drug exclusive approval for the company’s Gralise for the management of postherpetic neuralgia. The letter also confirms the FDA will not approve any abbreviated New Drug Application referencing Gralise during the period of orphan-drug exclusive approval, which began on January 28, 2011. The FDA has 60 days after issuance of the order in Depomed, Inc. v. HHS to file a notice appealing the order to the United States Court of Appeals for the Federal Circuit. The period of orphan drug exclusivity applicable to Gralise for PHN is separate from marketing exclusivity arising from the previously disclosed decision issued on August 19 in the company’s patent litigation lawsuit against Actavis (ACT) related to an ANDA filed by Actavis seeking to market generic versions of Gralise. The decision found that Actavis infringed all seven of the company’s patents asserted in the litigation, upheld the validity of the patents and enjoined FDA approval of the Actavis ANDA until February 26, 2024, the latest expiration date of the infringed patents. On September 15, Actavis filed a notice appealing the decision to the United States Court of Appeals for the Federal Circuit, Depomed stated. Previously disclosed settlement agreements between the Company and two other Gralise ANDA filers permit the sale of generic Gralise beginning on January 1, 2024.
10:48 EDTPDLIHigh option volume stocks
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September 9, 2014
18:31 EDTPDLIOn The Fly: After Hours Movers
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16:04 EDTPDLIPDL BioPharma sees Q3 revenue $165M, consensus $149.25M
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