FDA Approves IND for Vaxart’s Oral Tablet; Shares Rise

Vaxart Inc.’s (VXRT) shares closed 11.1% higher on August 2, and then rose another 2.1% in pre-market trading on August 3. The stock price moved after the clinical-stage biotechnology company got the U.S. Food and Drug Administration’s (FDA) nod for its Investigational New Drug (IND) application for the S-only oral tablet SARS-CoV-2 vaccine candidate.

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Encouraged by the FDA approval, Vaxart CEO Andrei Floroiu said, “This is great news because it allows us to move forward with our first S-only vaccine construct. As we said at the end of the first quarter, we will explore multiple S-only constructs in clinical trials alongside the S+N construct that has already completed its Phase I trial.”

Floroiu added, “Together, the S-only and S+N constructs are part of our unique oral tablet COVID-19 vaccine candidate portfolio, which we believe could make a significant contribution to the fight against COVID-19 globally.”

The U.S. regulator’s approval followed the preliminary data released from Vaxart’s current Non-Human Primate study. It indicated that the S-only vaccine produced much higher serum antibodies than the one expressing both S and N proteins, the company said.

This February, Vaxart revealed that the Phase 1 clinical trial of the oral S+N COVID-19 vaccine had been completed. The data released from the study demonstrated that the investigational oral vaccine triggered multiple immune responses against SARS-CoV-2 antigens, while reaching primary and secondary endpoints of safety and immunogenicity, respectively, the company said.

Vaxart is likely to commence the Phase II clinical trial with the S-only construct in the second half of 2021. (See Vaxart stock charts on TipRanks)

Pleased with the recent FDA approval, Piper Sandler analyst Yasmeen Rahimi maintained a Buy rating with a price target of $18 (125.3% upside potential) on Vaxart.

Rahimi believes that IND clearance for the S-only COVID-19 vaccine candidate has provided an opportunity for the company to identify safe candidates for further clinical development.

The consensus rating among analysts is a Strong Buy based on 3 Buys versus 1 Hold. The average Vaxart price target stands at $12.50 and implies upside potential of 56.5% to current levels.

On top of this, TipRanks data shows that financial blogger opinions are 81% Bullish on Vaxart, compared to a sector average of 71%.