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Rezolute (RZLT) FDA Events

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FDA Events for Rezolute (RZLT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Rezolute (RZLT). Over the past two years, Rezolute has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Ersodetug and RZ358. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Rezolute's Drugs in FDA Review

Ersodetug - FDA Regulatory Timeline and Events

Ersodetug is a drug developed by Rezolute for the following indication: For Hypoglycemia Due to Congenital Hyperinsulinism. 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.

RZ358 - FDA Regulatory Timeline and Events

RZ358 is a drug developed by Rezolute for the following indication: Post-gastric bypass hypoglycemia (PGBH). 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.

Rezolute FDA Events - Frequently Asked Questions

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

In the past two years, Rezolute (RZLT) has reported FDA regulatory activity for the following drugs: Ersodetug and RZ358.

The most recent FDA-related event for Rezolute occurred on July 9, 2025, involving Ersodetug. The update was categorized as "Abstract," with the company reporting: "Rezolute, Inc announced that the abstract titled "Preliminary Patient Demographics And Baseline Characteristics From A Phase 3 Study (sunRIZE) Of Ersodetug For Hypoglycemia Due To Congenital Hyperinsulinism: Trial In Progress" has been selected for a late-breaking presentation at ENDO 2025 taking place July 12-15, 2025 in San Francisco, CA, USA."

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

  • For Hypoglycemia Due to Congenital Hyperinsulinism - Ersodetug
  • Post-gastric bypass hypoglycemia (PGBH) - RZ358

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:RZLT) was last updated on 7/10/2025 by MarketBeat.com Staff
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