Novavax Rallies After FDA Accords Fast Track Designation For Investigational Coronavirus Vaccine

Novavax, Inc. NVAX, which is on the cusp of initiating a late-stage clinical trial of its coronavirus vaccine candidate in the U.S., said Monday that the vaccine candidate has received fast track designation from the FDA.

What Happened: Novavax said the FDA has granted fast track designation for NVX-CoV2373, which is a stable, prefusion protein made using Novavax's nanoparticle technology that includes its proprietary MatrixM adjuvant.

"The FDA's decision to grant Fast Track Designation for NVX-CoV2373 reflects the urgent need for a safe and effective vaccine to prevent COVID-19, and we look forward to working closely with the agency to accelerate access to this vaccine," said Gregory Glenn, Novavax's president of R&D, said in a statement. 

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Why It's Important: Fast track designation is a provision that facilitates development by expediting the review of drugs and biologics that treat serious conditions and fill an unmet medical need.

The designation allows the sponsor company to have frequent meetings with the FDA to discuss the development plan; frequent written communication with the regulatory agency about dynamics such as study design and the use of biomarkers; seek accelerated approval and priority review, if relevant criteria are met; and apply for a rolling review.

Related Link: The Week Ahead In Biotech: Supernus, Sanofi Await FDA Decisions

What's Next: Novavax's vaccine candidate is being evaluated in a Phase 3 trial in the U.K. The company plans to initiate late-stage trials in the U.S. and Mexico by the end of November.

"Depending on the overall COVID-19 attack rate, interim data in the U.K. trial, which is also event-driven, are expected as soon as early first quarter 2021," Novavax said.

The company is also working on a combined influenza and COVID-19 vaccine that could be used in a post-pandemic setting.

Novavax is scheduled to release its third-quarter results after the close Monday, with analysts, on average, modeling EPS of $1.73 on revenue of $230.56 million.

NVAX Price Action: Novavax shares were up 5.29% at $94.61 at last check Monday. 

Related Link: Attention Biotech Investors: Mark Your Calendar For These November PDUFA Dates