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EPIX Stockholders Claim Company Failed to Disclose Adverse Facts Regarding its New Drug Application for MS-325

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Case ID: 4210 | Stocks | 02/02/2006

A class action lawsuit has been filed in the United States District Court for the District of Massachusetts on behalf of persons who acquired the common stock of EPIX Pharmaceuticals, Inc. ("EPIX" or "Company"), between July 10, 2003 and January 14, 2005, inclusive (the "Class Period").

The Complaint alleges that EPIX and certain of its officers and directors violated the federal securities laws by issuing materially false and misleading statements concerning the Company's financial results and business condition while failing to disclose material adverse facts concerning its New Drug Application ("NDA") for MS-325, its principal product under development, including (1) that non-contrast MRA comparator scans used in the Phase III trials varied significantly which caused the efficacy of MS-325 to be compromised; (2) that the Company's Phase III trials generated a large number of uninterpretable images, which caused the efficacy of MS-325 to be compromised; (3) that problems described above resulted in varying and questionable statical treatments of the images seen during the Phase III trial; and (4) consequently, approval of the NDA for MS-325 by the U.S. Food and Drug Administration (the "FDA") was highly unlikely.

On January 14, 2005, EPIX announced that the FDA had completed its review of the NDA for MS-325, and found it to be approvable. However, in the approvable letter, the FDA requested additional clinical studies to demonstrate efficacy prior to approval. As a result of this announcement, shares of EPIX fell $3.98 per share or 27.17%, to close at $10.67 per share on unusually high trading volume.

If you are a member of the class as described in this story, you may call toll free 1-866-467-1400 to speak to a lawyer now, or you may make a claim on this page.


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