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Vaxart Gets FDA Nod for Phase I Study on Coronavirus Vaccine

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Vaxart, Inc. (VXRT - Free Report) announced that the FDA has cleared its investigational new drug (IND) application to begin the phase I study on its oral coronavirus vaccine candidate. The company plans to initiate a phase I study on the same later this month.

The open-label, dose-ranging study will evaluate the oral COVID-19 vaccine candidate in healthy adults aged between 18 years and 55 years. The primary goal of the study is to investigate the safety and reactogenicity of two-doses of the said vaccine. Secondary objectives include immunogenicity, duration of immune response and the occurrence of symptomatic COVID-19.

Vaxart filed the IND application for the oral COVID-19 vaccine candidate to the FDA in August 2020.

Shares of Vaxart were up 46.8% following the above news. In fact, the stock has skyrocketed 2119.7% so far this year against the industry’s decline of 9.1%.



Notably, Vaxart is currently conducting a SARS-CoV-2 challenge study on hamsters, a species of rodents, to provide efficacy data and insights into the optimal dose regimen of its vaccine candidate. Results from the study are expected mid next month.

Meanwhile, in June 2020, Vaxart’s oral COVID-19 vaccine candidate was selected for investigation in a non-human primate (NHP) challenge study. This new study is being organized and funded by Operation Warp Speed (OWS), which is a new national program to provide substantial quantities of safe, effective vaccine for Americans by January 2021. The company is currently awaiting results from this study.

Notably, the oral vaccine candidate is being developed leveraging the company’s proprietary oral vaccine platform VAAST.

We note that Vaxart has a contract with Emergent BioSolutions (EBS - Free Report) and Kindred Biosciences, to produce bulk vaccines under cGMP for its clinical studies.  The vaccine tablets will be manufactured at Vaxart.

Several drugmakers are working relentlessly to develop a vaccine for the deadly coronavirus disease, which has so far infected 29.3 million people globally and killed more than 0.9 million.

Large pharma companies, such as AstraZeneca, Johnson & Johnson, Pfizer as well as small biotechs like Moderna (MRNA - Free Report) and Novavax (NVAX - Free Report) among others are actively engaged in developing a vaccine to fight the COVID-19 pandemic.

Zacks Rank

Vaxart currently carries a Zacks Rank #4 (Sell).

You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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