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Revelation Biosciences (REVB) FDA Events

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FDA Events for Revelation Biosciences (REVB)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Revelation Biosciences (REVB). Over the past two years, Revelation Biosciences has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Gemini, interleukin-10, PRIME, and RVL-HV02. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Revelation Biosciences' Drugs in FDA Review

Gemini - FDA Regulatory Timeline and Events

Gemini is a drug developed by Revelation Biosciences for the following indication: In patients with CKD. 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.

interleukin-10 - FDA Regulatory Timeline and Events

interleukin-10 is a drug developed by Revelation Biosciences for the following indication: Anti-inflammatory cytokine. 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.

PRIME - FDA Regulatory Timeline and Events

PRIME is a drug developed by Revelation Biosciences for the following indication: In CKD Patients. 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.

RVL-HV02 - FDA Regulatory Timeline and Events

RVL-HV02 is a drug developed by Revelation Biosciences for the following indication: to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program). 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.

Revelation Biosciences FDA Events - Frequently Asked Questions

However, the company does has had drugs under review or in active clinical development.

In the past two years, Revelation Biosciences (REVB) has reported FDA regulatory activity for the following drugs: PRIME, Gemini, interleukin-10 and RVL-HV02.

The most recent FDA-related event for Revelation Biosciences occurred on February 26, 2025, involving PRIME. The update was categorized as "Dose Update," with the company reporting: "Revelation Biosciences, Inc. announced dosing of the first patient in the PRIME (PReconditioning IMmunostimulatory Evaluation) Phase 1b clinical study of intravenous single ascending doses of Gemini in patients with Stage 3 and 4 Chronic Kidney Disease (CKD)."

Current therapies from Revelation Biosciences in review with the FDA target conditions such as:

  • In CKD Patients - PRIME
  • In patients with CKD. - Gemini
  • Anti-inflammatory cytokine - interleukin-10
  • to prevent or reduce the severity and duration of post-surgical infection (GEMINI-SSI program) - RVL-HV02

More FDA Event Resources from MarketBeat

  • 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

This page (NASDAQ:REVB) was last updated on 7/10/2025 by MarketBeat.com Staff
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