FDA Events for Semper Paratus Acquisition (TVGN)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Semper Paratus Acquisition (TVGN).
Over the past two years, Semper Paratus Acquisition has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
TVGN. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
TVGN 489 - FDA Regulatory Timeline and Events
TVGN 489 is a drug developed by Semper Paratus Acquisition for the following indication: To treat acute, high-risk Covid-19 patients.
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:
- TVGN 489
- Announced Date:
- October 8, 2024
- Indication:
- To treat acute, high-risk Covid-19 patients.
Announcement
Tevogen Bio announced topline results from its Proof-of-Concept (POC) clinical trial designed to evaluate the safety and feasibility of TVGN 489, the company's first clinical product utilizing the internally developed ExacTcell™ technology, for the treatment of acute high-risk SARS-CoV-2 patients.
AI Summary
Tevogen Bio announced promising topline results from its Proof-of-Concept clinical trial of TVGN 489, its first clinical product using the proprietary ExacTcell™ technology. The trial evaluated the safety and feasibility of this off-the-shelf, genetically unmodified T cell therapeutic for acute high-risk SARS-CoV-2 patients. Researchers observed no dose-limiting toxicities or significant adverse events, including any cases of cytokine release syndrome. In addition, the study met key endpoints by demonstrating a reduction in viral load and a boost in cellular and humoral immune responses against COVID-19. Treated patients, including many immunocompromised individuals, returned to their baseline health within 14 days, with no recorded reinfections or cases of Long COVID during the six-month follow-up. These encouraging results highlight TVGN 489’s potential as a new treatment option for vulnerable patients battling SARS-CoV-2 infections.
Read Announcement- Drug:
- TVGN 489
- Announced Date:
- June 25, 2024
- Indication:
- To treat acute, high-risk Covid-19 patients.
Announcement
Tevogen Bio Holdings Inc. reports publication of its phase I clinical trial data of TVGN 489, its investigational allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes (CTLs) immunotherapy by the journal Blood Advances.
AI Summary
Tevogen Bio Holdings Inc. announced that data from its phase I clinical trial of TVGN 489 has been published in the journal Blood Advances. TVGN 489 is an investigational immunotherapy designed as allogeneic SARS-CoV-2 specific Cytotoxic CD8+ T lymphocytes. In the trial, twelve high-risk patients, including many who were immunocompromised, received a single infusion of TVGN 489 at one of four escalating doses. The treatment was well-tolerated and achieved strong results; 92% of treated patients showed 88% or greater viral elimination by day 4, and all patients had over 99% clearance by day 14. Notably, the donor T cells unexpectedly persisted throughout a six-month follow-up, suggesting a potential link to sustained disease control. These promising findings support further studies to confirm the safety and efficacy of TVGN 489 in patients at a higher risk of severe COVID-19 outcomes.
Read Announcement
Semper Paratus Acquisition FDA Events - Frequently Asked Questions
As of now, Semper Paratus Acquisition (TVGN) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Semper Paratus Acquisition (TVGN) has reported FDA regulatory activity for TVGN 489.
The most recent FDA-related event for Semper Paratus Acquisition occurred on October 8, 2024, involving TVGN 489. The update was categorized as "Top-line results," with the company reporting: "Tevogen Bio announced topline results from its Proof-of-Concept (POC) clinical trial designed to evaluate the safety and feasibility of TVGN 489, the company's first clinical product utilizing the internally developed ExacTcell™ technology, for the treatment of acute high-risk SARS-CoV-2 patients."
Currently, Semper Paratus Acquisition has one therapy (TVGN 489) targeting the following condition: To treat acute, high-risk Covid-19 patients..
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:TVGN) was last updated on 7/13/2025 by MarketBeat.com Staff
