Why Akers Biosciences (AKER) Is Crashing 30% Today

The surprising withdrawal of an application for approval at the FDA is sending shares reeling.


After reporting that it’s withdrawing a FDA application for approval of its health and wellness line, Tri-cholesterol test, PIFA Chlamydia, shares in Akers Biosciences (NASDAQ:AKER) are falling nearly 30% at 11:38AM EDT.

Akers announced that it’s pulling its application for approval after a meeting with the FDA revealed regulator concerns about the filing. The company will re-evaluate its options with regards to this product development opportunity.

In response, Akers CEO John J. Gormally said, “setback to the desired commercialization timeline for this product is disappointing, however, PIFA Chlamydia continues to be a priority for the Company, and the board believes this course of action will allow the board and management to better evaluate all options. At the same time, we remain focused on driving sales growth of our currently commercialized products and, in particular, PIFA Heparin/PF4 Rapid Assay, through expanded distribution and a strategic focus on clinical end-users and integrated delivery network customers.”

Subsequently, Raymond F. Akers Jr., Ph.D has resigned as a director of the Company with immediate effect.

 

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