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Genprex (GNPX) FDA Events

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FDA Events for Genprex (GNPX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Genprex (GNPX). Over the past two years, Genprex has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Acclaim-1, Acclaim-3, EORTC-NCI-AACR, GPX-002, Oncoprex, quaratusugene, and Reqorsa®. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Genprex's Drugs in FDA Review

Acclaim-1 - FDA Regulatory Timeline and Events

Acclaim-1 is a drug developed by Genprex for the following indication: In lung cancer. 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.

Acclaim-3 - FDA Regulatory Timeline and Events

Acclaim-3 is a drug developed by Genprex for the following indication: In lung cancer. 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.

EORTC-NCI-AACR - FDA Regulatory Timeline and Events

EORTC-NCI-AACR is a drug developed by Genprex for the following indication: Molecular Targets and Cancer Therapeutics. 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.

GPX-002 - FDA Regulatory Timeline and Events

GPX-002 is a drug developed by Genprex for the following indication: Diabetes Gene Therapy. 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.

Oncoprex - FDA Regulatory Timeline and Events

Oncoprex is a drug developed by Genprex for the following indication: For the NPRL2 tumor suppressor gene. 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.

quaratusugene ozeplasmid - FDA Regulatory Timeline and Events

quaratusugene ozeplasmid is a drug developed by Genprex for the following indication: Treatment of small cell lung cancer. 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.

Reqorsa® Gene Therapy - FDA Regulatory Timeline and Events

Reqorsa® Gene Therapy is a drug developed by Genprex for the following indication: For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma. 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.

REQORSA®+ Tecentriq - FDA Regulatory Timeline and Events

REQORSA®+ Tecentriq is a drug developed by Genprex for the following indication: For the Treatment of Small Cell Lung Cancer. 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.

Genprex FDA Events - Frequently Asked Questions

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

In the past two years, Genprex (GNPX) has reported FDA regulatory activity for the following drugs: Reqorsa® Gene Therapy, GPX-002, REQORSA®+ Tecentriq, Oncoprex, EORTC-NCI-AACR, Acclaim-3, Acclaim-1 and quaratusugene ozeplasmid.

The most recent FDA-related event for Genprex occurred on June 24, 2025, involving GPX-002. The update was categorized as "Presentation," with the company reporting: "Genprex, Inc announced that its research collaborators presented positive preclinical research from studies of GPX-002, the Company's diabetes gene therapy drug candidate, at the 2025 American Diabetes Association (ADA) 85th Scientific Session in Chicago."

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

  • For the treatment of Ras inhibitor resistant lung cancer, mesothelioma and glioblastoma. - Reqorsa® Gene Therapy
  • Diabetes Gene Therapy - GPX-002
  • For the Treatment of Small Cell Lung Cancer - REQORSA®+ Tecentriq
  • For the NPRL2 tumor suppressor gene - Oncoprex
  • Molecular Targets and Cancer Therapeutics - EORTC-NCI-AACR
  • In lung cancer - Acclaim-3
  • In lung cancer - Acclaim-1
  • Treatment of small cell lung cancer - quaratusugene ozeplasmid

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