Oxygen Biotherapeutics' (OXBT) shares soar 30% after the FDA verbally lifts a hold on clinical trials of the company's Oxycyte treatment for traumatic brain injury (TBI).
The FDA's decision comes after Oxygen submitted animal study data in September that addressed the agency's concerns about the use of Oxycyte. The studies assessed the product's interaction with the immune system and the risks of intracerebral hemorrhage.
Oxygen is enrolling patients in Israel for a Phase II-b study to evaluate the safety and tolerability of Oxycyte in patients with severe non-penetrating traumatic brain injury (STOP-TBI). (PR)