Novavax Inc (NASDAQ:NVAX) Downgraded After Unimpressive Phase 3 Trial Results

Shares of Novavax, Inc (NASDAQ:NVAX) inched up 0.36 percent to $8.34, on Thursday with share price trading at a range of $8.10 to $8.49. 25.17 million shares have been traded with an average daily volume of 5.3 million shares. Unfortunately, when after hours trading resumed, shares fell dramatically—nearly 86 percent—to $1.31 per share.

This week, Novavax Inc (NASDAQ:NVAX) declared topline data from the results of two clinical trials for its RSV F-protein recombinant nanoparticle vaccine candidate, for older adults. Unfortunately, the RSV F vaccine Phase 3 Resolve(TM) trial—conducted with 11,856 adults over the age of 60-did not meet the pre-specified primary or secondary efficacy objectives. In addition, the trial did not demonstrate efficacy in the vaccine. Still, the vaccine was well tolerated, as has been the clinical experience.

The Phase 3 Resolve Trial was randomized, double-blind, and placebo controlled and conducted throughout 60 different sites across the United States. For this trial, the primary objective was to demonstrate the vaccine’s efficacy for preventing moderate-to-severe RSV-associated lower respiratory tract symptoms. In addition, the secondary objective for this trial was to demonstrate the RSV F vaccine’s efficacy for reducing all incidences of symptomatic respiratory disease due to to RSV. Finally, the trial had an additional endpoint of evaluating the safety of the unadjuvanted 135 mcg dose (when compared with placebo).

In the United States, roughly 2.5 million cases of RSV infection are reported every year. This respiratory tract infection can lead to hospitalization and even death among older adults. According to Novavax, approximately 900,000 medical interventions are the result of RSV infection every year.

Novavax, Inc (NASDAQ:NVAX) is a clinical-stage vaccine company which focuses on the discovery, development, and commercialization of recombinant nanoparticle vaccines adjuvants. Novavax, Inc operates largely within the development of recombinant vaccines segment; with its recombinant nanoparticle vaccine technology the company produces vaccine candidates that can respond to both known diseases as well as emerging diseases we are still learning about.

During the most recent fiscal quarter, Novavax Inc earned $2.50 million, significantly lower than analyst expectations of $8.03 million. The company has a negative net margin of 1,405.84 percent with a negative return on equity of 112.45 percent. In addition, the firm’s quarterly revenue was down 82.1 percent year-over-year. Still, analysts predict the company will post $1.07 earnings per share for the current fiscal year. Indeed, investors appear to have mixed feelings about the results.

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