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Portage Biotech (PRTG) FDA Events

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FDA Events for Portage Biotech (PRTG)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Portage Biotech (PRTG). Over the past two years, Portage Biotech has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ADPORT-601 and INT230-6. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Portage Biotech's Drugs in FDA Review

ADPORT-601 - FDA Regulatory Timeline and Events

ADPORT-601 is a drug developed by Portage Biotech for the following indication: Adenosine 2A inhibitor. 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.

INT230-6 (PORT-1) - FDA Regulatory Timeline and Events

INT230-6 (PORT-1) is a drug developed by Portage Biotech for the following indication: 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.

Portage Biotech FDA Events - Frequently Asked Questions

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

In the past two years, Portage Biotech (PRTG) has reported FDA regulatory activity for the following drugs: INT230-6 (PORT-1) and ADPORT-601.

The most recent FDA-related event for Portage Biotech occurred on November 18, 2024, involving INT230-6 (PORT-1). The update was categorized as "Provided Update," with the company reporting: "Intensity Therapeutics, Inc. announced that Christian F. Meyer M.D., Ph.D., Assistant Professor of Oncology and lead medical oncologist for adult sarcoma patients at Johns Hopkins University's Sidney Kimmel Cancer Center, presented final safety and efficacy data from the Company's Phase 1/2 clinical trial of INT230-6 that was used as a monotherapy in patients with relapsed, refractory, and metastatic sarcomas, along with an overview of the Company's ongoing INVINCIBLE-3 Study design (NCT06263231)."

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

  • Solid Tumors - INT230-6 (PORT-1)
  • Adenosine 2A inhibitor - ADPORT-601

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