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Indaptus Therapeutics (INDP) FDA Events

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FDA Events for Indaptus Therapeutics (INDP)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Indaptus Therapeutics (INDP). Over the past two years, Indaptus Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Decoy20. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Decoy20 - FDA Regulatory Timeline and Events

Decoy20 is a drug developed by Indaptus Therapeutics for the following indication: Advanced Solid Tumors. 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.

Indaptus Therapeutics FDA Events - Frequently Asked Questions

As of now, Indaptus Therapeutics (INDP) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Indaptus Therapeutics (INDP) has reported FDA regulatory activity for Decoy20.

The most recent FDA-related event for Indaptus Therapeutics occurred on June 2, 2025, involving Decoy20. The update was categorized as "Dosing Update," with the company reporting: "Indaptus Therapeutics, announces that the first patient has been dosed in the expansion arm of its Phase 1b/2 clinical trial evaluating Decoy20 in combination with BeOne's (formerly known as Beigene) PD-1 checkpoint inhibitor, tislelizumab.Inc."

Currently, Indaptus Therapeutics has one therapy (Decoy20) targeting the following condition: Advanced Solid Tumors.

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:INDP) was last updated on 7/11/2025 by MarketBeat.com Staff
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