This section highlights FDA-related milestones and regulatory updates for drugs developed by Vaxart (VXRT).
Over the past two years, Vaxart has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Bivalent and oral. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Bivalent (Norovirus) - FDA Regulatory Timeline and Events
Bivalent (Norovirus) is a drug developed by Vaxart for the following indication: Norovirus Vaccine.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Bivalent (Norovirus)
- Announced Date:
- March 11, 2025
- Indication:
- Norovirus Vaccine
Announcement
Vaxart, Inc announced the initiation of a Phase 1, open label, dose ranging clinical trial evaluating its second-generation oral norovirus vaccine constructs head-to-head against its first-generation constructs.
AI Summary
Vaxart, Inc. has started a Phase 1 trial to evaluate its new oral norovirus vaccine. This open label, dose-ranging study will compare the company’s second-generation vaccine constructs directly against its first-generation constructs. The trial aims to assess safety and measure immune responses that have previously been linked to protection in similar studies.
Vaxart is working to improve its oral bivalent norovirus vaccine, which is administered in pill form. The company hopes that the improved formulations will lead to better immune responses, addressing a significant public health need as norovirus continues to spread. Topline data from the trial is expected as early as mid-2025, and successful outcomes might lead to further studies involving Phase 2 and Phase 3 trials in the future.
Read Announcement- Drug:
- Bivalent (Norovirus)
- Announced Date:
- April 30, 2024
- Indication:
- Norovirus Vaccine
Announcement
Vaxart, Inc announced that it has completed the topline analysis for the Phase 1 clinical trial evaluating Vaxart's oral pill bivalent norovirus vaccine candidate.
AI Summary
Vaxart, Inc. announced that it has completed the topline analysis for its Phase 1 clinical trial of an oral pill bivalent norovirus vaccine candidate. The trial, which focused on lactating mothers, showed that the vaccine induced a significant increase in antibodies. In the high dose group, there was a 4.0-fold increase for the G1.1 strain and a 6.0-fold increase for the GII.4 strain in breast milk. These results suggest that the vaccine could help passively protect infants by transferring antibodies from mothers via breast milk.
The trial also reported no serious vaccine-related adverse events or dose-limiting toxicity, highlighting the candidate’s safety. These encouraging outcomes mark an important advancement in the ongoing effort to develop a vaccine that may help protect young children from norovirus, a virus responsible for millions of cases and substantial healthcare and economic burdens each year.
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oral pill COVID-19 - FDA Regulatory Timeline and Events
oral pill COVID-19 is a drug developed by Vaxart for the following indication: In adults previously immunized against COVID-19 infection.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- oral pill COVID-19
- Announced Date:
- December 2, 2024
- Indication:
- In adults previously immunized against COVID-19 infection.
Announcement
Vaxart, Inc. announced completion of enrollment of the sentinel cohort of a Phase 2b clinical trial evaluating Vaxart's oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator.
AI Summary
Vaxart, Inc. announced that it has successfully completed enrollment of the sentinel cohort for a Phase 2b clinical trial. This trial is designed to compare Vaxart’s oral pill COVID-19 vaccine candidate with an approved mRNA vaccine. The sentinel cohort includes 400 participants, with 200 receiving the new oral vaccine and 200 receiving the approved mRNA vaccine.
Dr. James F. Cummings, the company’s Chief Medical Officer, described this milestone as an important step that highlights the strong collaboration and trust among the team, participants, and investigators. The study will undergo review by an independent Data and Safety Monitoring Board and the FDA based on 30-day safety data. With positive feedback, the trial is set to expand to enroll approximately 10,000 participants, further moving Vaxart closer to demonstrating the potential benefits of its mucosal vaccine technology.
Read Announcement- Drug:
- oral pill COVID-19
- Announced Date:
- September 30, 2024
- Indication:
- In adults previously immunized against COVID-19 infection.
Announcement
Vaxart, Inc. announced the initiation of the sentinel cohort of its Phase 2b clinical trial evaluating Vaxart's oral pill COVID-19 vaccine candidate against an approved mRNA vaccine comparator.
AI Summary
Vaxart, Inc. announced the start of the sentinel cohort for its Phase 2b clinical trial, which will compare its next generation oral pill COVID-19 vaccine candidate with an approved mRNA vaccine. The trial’s first phase will involve 400 healthy adult participants in the United States, with 200 receiving Vaxart’s oral vaccine and 200 receiving the mRNA comparator. This initial portion of the study will evaluate the safety, immune response, and effectiveness of the oral pill vaccine, marking a key step in Vaxart’s pursuit of a more sustainable solution to COVID-19. Once the 30-day safety data is reviewed by an independent Data and Safety Monitoring Board and the FDA, the trial will expand to include 10,000 participants. Funding for this phase is provided under the U.S. government’s Project NextGen initiative.
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