Novavax: FDA Allows To Utilize Accelerated Approval Pathway For NanoFlu

(RTTNews) - Novavax, Inc. (NVAX) said the U.S. FDA has informed that accelerated approval pathway is available to Novavax for its NanoFlu vaccine. Novavax plans to begin pivotal Phase 3 clinical trial by the fall of 2019. The company will meet with the FDA in the third-quarter to discuss the Phase 3 trial design. Earlier in the year, Novavax reported positive top-line results from Phase 2 clinical trial of NanoFlu in older adults.

Separately, Novavax said the company and Catalent Biologics' Paragon Gene Therapy unit reached an arrangement under which Paragon Gene Therapy will assume the leases to two Novavax manufacturing facilities. The deal provides a cash payment at closing of approximately $18 million, and reduces Novavax' operating costs allowing it to focus on advancing NanoFlu and ResVax.