Last $0.10 USD
Change Today -0.0046 / -4.30%
Volume 338.7K
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As of 8:10 PM 07/11/14 All times are local (Market data is delayed by at least 15 minutes).

affymax inc (AFFY) Key Developments

Affymax Terminates Omontys' Product Collaboration and License Agreement with Takeda Pharmaceutical Company, Effective September 10, 2014

Affymax revealed the termination of its Omontys (peginesatide) product collaboration and license agreement with Takeda Pharmaceutical Company, effective September 10, 2014. Under a previous agreement, Affymax and Takeda voluntarily recalled all lots of Omontys and suspended promotional activities in the US upon postmarketing reports of serious hypersensitivity reactions including anaphylaxis, which may be life-threatening or fatal. Based on the postmarketing reports and related discussions with Takeda, Affymax has elected not to exercise its rights with respect to the Omontys New Drug Application.

Affymax and Takeda Announce Termination of Omontys(R) (peginesatide) Product Collaboration and License Agreement

Affymax, Inc. and Takeda Pharmaceutical Company Limited announced that their Omontys(R) (peginesatide) product collaboration and license agreement will terminate effective September 10, 2014. In February 2013, Affymax and Takeda voluntarily recalled all lots of Omontys and suspended promotional activities in the U.S. following postmarketing reports of serious hypersensitivity reactions including anaphylaxis, which may be life-threatening or fatal. Takeda has conducted a detailed investigation of these reactions. The investigation has confirmed no quality or manufacturing issues were present but has not identified a specific root cause for the reactions that were observed. Based on these findings and related discussions with Takeda, Affymax has elected not to exercise its rights with respect to the Omontys New Drug Application (NDA). Takeda will work with the U.S. Food and Drug Administration to withdraw the Omontys NDA. The Board of Directors of Affymax is reviewing its strategic options as a result of the termination of the collaboration with Takeda.

Affymax To Review Strategic Options

The Board of Directors of Affymax, Inc. (OTCPK:AFFY) is reviewing its strategic options as a result of the termination of the collaboration with Takeda Pharmaceutical Company Limited (TSE:4502). Affymax and Takeda would terminate their Omontys product partnership in September. The firms would also withdraw their new drug application with the U.S. Food and Drug Administration.

Affymax, Inc., Annual General Meeting, Jun 26, 2014

Affymax, Inc., Annual General Meeting, Jun 26, 2014., at 10:00 Pacific Standard Time. Location: Seaport Conference Center, 459 Seaport Court. Agenda: To elect two Class II director nominees to hold office until the 2017 annual meeting of stockholders; and to conduct any other business properly brought before the meeting.

Affymax, Inc. Auditor Raises 'Going Concern' Doubt

Affymax, Inc. filed its 10-K on Mar 31, 2014 for the period ending Dec 31, 2013. In this report its auditor, Ernst & Young LLP, gave an unqualified opinion expressing doubt that the company can continue as a going concern.

 

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