FDA Events for Genenta Science (GNTA)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Genenta Science (GNTA).
Over the past two years, Genenta Science has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Temferon. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Temferon - FDA Regulatory Timeline and Events
Temferon is a drug developed by Genenta Science for the following indication: Glioblastoma Multiforme.
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.
- Drug:
- Temferon
- Announced Date:
- October 2, 2024
- Indication:
- Glioblastoma Multiforme
Announcement
Genenta Science announce that the Agenzia Italiana del Farmaco (AIFA) has approved a new Phase 1 clinical trial for metastatic Renal Cell Cancer (mRCC), marking a significant expansion of the potential applications for Genenta's flagship product, Temferon™.
AI Summary
Genenta Science announced that Italy’s drug agency, AIFA, has approved a new Phase 1 clinical trial for metastatic Renal Cell Cancer (mRCC). This trial marks an important expansion for Genenta’s flagship product, Temferon™, which was initially developed for treating other solid tumors. The approval by AIFA, in line with European regulatory standards, will allow researchers to explore Temferon’s potential in mRCC—a disease with few treatment options and a median overall survival of less than two years for high-risk patients. Temferon works by reprogramming the tumor environment and activating the immune system through the delivery of IFNα. The trial is expected to begin in the fourth quarter of 2024, offering a new experimental treatment path for patients with advanced renal cell cancer.
Read Announcement
Genenta Science FDA Events - Frequently Asked Questions
As of now, Genenta Science (GNTA) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Genenta Science (GNTA) has reported FDA regulatory activity for Temferon.
The most recent FDA-related event for Genenta Science occurred on October 2, 2024, involving Temferon. The update was categorized as "Foreign Approval," with the company reporting: "Genenta Science announce that the Agenzia Italiana del Farmaco (AIFA) has approved a new Phase 1 clinical trial for metastatic Renal Cell Cancer (mRCC), marking a significant expansion of the potential applications for Genenta's flagship product, Temferon™."
Currently, Genenta Science has one therapy (Temferon) targeting the following condition: Glioblastoma Multiforme.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- 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:GNTA) was last updated on 7/13/2025 by MarketBeat.com Staff
Free GNTA Stock Alerts