Valion Bio, Inc. Common Stock's Drug in the FDA Approval Process
This section highlights FDA-related milestones and regulatory updates for drugs developed by Valion Bio, Inc. Common Stock (VBIO).
Over the past two years, Valion Bio, Inc. Common Stock has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Entolimod. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Entolimod FDA Regulatory Events
Entolimod is a drug developed by Valion Bio, Inc. Common Stock for the following indication: For Gastrointestinal Acute Radiation Syndrome.
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:
- Entolimod
- Announced Date:
- March 26, 2026
- Indication:
- For Gastrointestinal Acute Radiation Syndrome
Announcement
Tivic Health Systems Inc announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to sponsor and conduct a series of preclinical studies evaluating Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS).
AI Summary
Tivic Health Systems announced an agreement with the National Institute of Allergy and Infectious Diseases (NIAID) to sponsor and conduct preclinical studies of Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS). The program aims to test whether Entolimod can protect GI tissue and reduce radiation-induced mucosal necrosis, a major cause of death after high-dose radiation exposure.
The first study will be run at the Armed Forces Radiobiology Research Institute (AFRRI). Research will start in mice and could move to non-human primates if early results show benefit. These studies are intended to generate the preclinical evidence needed to advance development.
NIAID will fund and carry out the studies through its non-clinical and preclinical services, covering all study-related costs and giving Tivic access to advanced infrastructure without extra capital outlay.
Entolimod is a TLR5 agonist that activates NF-κB signaling and has shown tissue-protective effects in preclinical work, potentially addressing GI damage not targeted by current ARS treatments.Read Announcement
Valion Bio, Inc. Common Stock FDA Events - Frequently Asked Questions
As of now, Valion Bio, Inc. Common Stock (VBIO) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Valion Bio, Inc. Common Stock (VBIO) has reported FDA regulatory activity for Entolimod.
The most recent FDA-related event for Valion Bio, Inc. Common Stock occurred on March 26, 2026, involving Entolimod. The update was categorized as "Provided Update," with the company reporting: "Tivic Health Systems Inc announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, to sponsor and conduct a series of preclinical studies evaluating Entolimod™ for gastrointestinal acute radiation syndrome (GI-ARS)."
Currently, Valion Bio, Inc. Common Stock has one therapy (Entolimod) targeting the following condition: For Gastrointestinal Acute Radiation Syndrome.
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FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
FDA progress for NASDAQ:VBIO last updated on 3/26/2026 by MarketBeat.com Staff. We continuously monitor for new FDA events and market data.
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