Novavax Rallies On Phase 3 Coronavirus Study Updates, Imminent Phase 2 Readout

Novavax, Inc. NVAX issued an update Tuesday on a late-stage study of its coronavirus vaccine program, sending its shares higher. 

US Late-Stage Study Kicks Off In Late November: Gaithersburg, Maryland-based Novavax said it expects the Phase 3 trial of its coronavirus vaccine candidate NVX-CoV2373 in the U.S. and Mexico to begin by the end of November.

NVX-CoV2373 is a stable perfusion protein made with nanoparticle technology and including Novavax's proprietary Matrix M adjuvant.

Novavax said it has made significant progress in large-scale manufacturing, but is experiencing delays versus its original timing estimates.

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The company plans to use production from its contract manufacturing site at Fujifilm Diosynth Biotechnologies' Morrisville, North Carolina site in the Phase 3 clinical trial.

The Phase 3 trial in the U.S. is funded by the federal government through the Operation Warp Speed. To harmonize with the clinical trial design of rivals, Novavax said it plans to enroll up to 30,000 participants in the U.S. and Mexico, with proportional representation among diverse populations that are most vulnerable to COVID-19 distributed across race/ethnicity, age and those living with co-morbidities.

Related Link: Novavax To Evaluate Flu-COVID-19 Vaccine Combo

Interim Readout From UK Study Due In Q1: In an update on the U.K. leg of the Phase 3 trial, which was initiated in late September, Novavax said it has enrolled over 5,500 participants out of the enhanced target of 15,000 volunteers.

The company expects enrollment to be completed by the end of November, and said it plans to release interim data in the event-driven trial as early as the first quarter of 2021, contingent on the overall COVID-19 attack rate.

Data from the trial is expected to serve as the basis for global licensure, Novavax said.

Upcoming Novavax Catalyst: Novavax also said it will present data from its ongoing Phase 1/2 clinical trial, including new Phase 2 reactogenicity data, on Friday during the CDC's Advisory Committee on Immunization Practices meeting.

NVAX Price Action: At last check, Novavax shares were surging 5.61% to $92.28.

Related Link: COVID-19 Vaccine Developer Novavax In Spotlight As Insiders Offload Shares