Oxygen Bio shares rise after FDA says development of drug Oxycyte can proceed

Posted by David Bracken on March 4, 2014 

Oxygen Biotherapeutics stock rose 14 percent Tuesday after the company announced that federal regulators have lifted their clinical hold on its treatment for traumatic brain injuries.

The decision by the Food and Drug Administration allows Morrisville-based Oxygen Bio to move ahead with clinical development of Oxycyte. The company has partnered with Wilmington-based PPD to complete the second phase of clinical trials of Oxycyte.

In September, Oxygen Bio submitted data from two animal studies that were designed to address FDA concerns about the drug. The FDA informed Oxygen Bio of the results of its review on Friday.

“We are pleased that the FDA has responded favorably to the data provided and removed the clinical hold to allow further clinical development of Oxycyte,” CEO John Kelley said in a statement.

In early January, Oxygen Bio’s stock surged 16 percent after it announced details of late-stage clinical trials for its cardiovascular drug Levosimendan.

Levosimendan has been granted fast-track status by the Food and Drug Administration, a designation that accelerates the review process for drugs that have the potential to offer significant improvement in treatment compared to products already on the market.

Oxygen Bio shares closed Tuesday at $7.10, up 90 cents. The stock is up 57 percent this year.

Staff writer David Bracken

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