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Belite Bio (BLTE) FDA Events

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FDA Events for Belite Bio (BLTE)

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

Tinlarebant - FDA Regulatory Timeline and Events

Tinlarebant is a drug developed by Belite Bio for the following indication: In Stargardt Disease. 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.

Belite Bio FDA Events - Frequently Asked Questions

As of now, Belite Bio (BLTE) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Belite Bio (BLTE) has reported FDA regulatory activity for Tinlarebant.

The most recent FDA-related event for Belite Bio occurred on July 2, 2025, involving Tinlarebant. The update was categorized as "Enrollment Update," with the company reporting: "Belite Bio, Inc announced the completion of enrollment in the PHOENIX trial, a global, 24-month Phase 3 pivotal trial evaluating the safety and tolerability of Tinlarebant and its potential to reduce atrophic lesion growth rate in patients diagnosed with geographic atrophy (GA) in dry age-related macular degeneration (AMD)."

Currently, Belite Bio has one therapy (Tinlarebant) targeting the following condition: In Stargardt Disease.

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:BLTE) was last updated on 7/9/2025 by MarketBeat.com Staff
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