Vaxart, Inc. (VXRT) Obtains Clearance from the FDA to Begin COVID-19 vaccine candidate Trials

The Biotech firm moves one step forward to begin Phase 1 trials for COVID-19 vaccine candidate. Vaxart is ready to conduct trials upon healthy adults ages 18 to 55 years old.

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On Monday, the news of the FDA approval to being Phase 1 clinical trial of theCovid-19 vaccine candidate helped the Vaxart, Inc. (VXRT) shares to surge almost 50%. However, in today’s market, the stock price is trading in a bearish zone, down by almost 15.75% as of 11:54 A.M. EDT.

The reason forthe sudden price dip today (Sept. 15) can be drivenby Vaxart being held accountable for whether the company and certain of its executives or directors have engaged in securities fraud or other unlawful business practices. Pomerantz LLP is investigating claims on behalf of Vaxart’s investors and the investigation firm is conducting an inquiry against the biotechnology firm.

The FDA Approval

Vaxart recently announced that the U.S, Food and Drug Administration (FDA) completed reviewing the Investigational New Drug (IND) application that was submitted by the company for a Phase 1 clinical trial of its Covid-19 vaccine candidate last month.

The FDA approved the IND and Vaxart is now allowed to conduct the first human-based clinical trials for the COVID-19 vaccine. Vaxart is working on the development of an oral vaccine to fight against COVID-19 virus. The company expects to obtain mucosal and systemic immune responses from the potential vaccine candidate based on VXRT’soral tablet vaccine platform.

The company plans to conduct anopen-label, dose-ranging trial among adults between 18 years and 55 years. The primary objective is to examine the safety and reactogenicity of two-doses of the vaccine candidate, whereas, the secondary objectives include the occurrence of symptomatic COVID-19, immunogenicity, and immune response duration. Vaxart intends to commence enrollment for the study later this month.

The Chief Operating Officer of Vaxart, Andrei Floroiu stated:

“The IND clearance and the initiation of our Phase 1 clinical trial moves us a step closer to proving the superiority of our convenient oral COVID-19 solution in the clinic. We are thus excited to start enrollment for our Phase 1 this month.”

The oral table vaccine being developed by Vaxart would offer a much more attractive mode of administration than injectables. The company believes that it might confer superior protection against COVID-19 due to the activation of mucosal immunity.

The company is conducting a SARS-CoV-2 challenge study in hamsters to obtain initial data showing efficacy and other insights into the optimal dose regimen. The results of the hamster-based study are anticipated in mid-October. Moreover, Vaxart is also looking forward to attaining results from a non-human primate (NHP) challenge study that is testing its vaccine in a harmonized protocol as part of Operation Warp Speed.

Market Overview

Vaxart, Inc. (VXRT) is trading in a bearish zone today after making a major push on Monday. The stock currently trades at $6.55 plunging by almost 16%. VXRT began today’s trading session at $7.54. While the shares price of Vaxart on Monday soared as high as up to $8.11.