FDA Events for ASP Isotopes (ASPI)
This section highlights FDA-related milestones and regulatory updates for drugs developed by ASP Isotopes (ASPI).
Over the past two years, ASP Isotopes has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Ytterbium-176. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Ytterbium-176 - FDA Regulatory Timeline and Events
Ytterbium-176 is a drug developed by ASP Isotopes for the following indication: to utilize Quantum Enrichment, a novel laser method of enrichment.
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:
- Ytterbium-176
- Announced Date:
- September 3, 2024
- Indication:
- to utilize Quantum Enrichment, a novel laser method of enrichment
Announcement
ASP Isotopes Inc announced advances in its construction program and the hiring of key staff.
AI Summary
ASP Isotopes Inc. has made significant progress with its construction program by completing its new Ytterbium-176 Quantum Enrichment facility nearly nine months ahead of schedule. This advanced facility, located in South Africa, uses a novel laser-based enrichment method that promises lower costs and improved efficiency compared to traditional techniques. The accelerated construction supports the company’s goal to offer highly enriched Ytterbium-176 for commercial sale during 2025 after a commissioning phase.
In addition to this construction milestone, ASP Isotopes has strengthened its leadership team by hiring Lt. Col. William (Bill) Eden, MBE, to head its nuclear fuel operations in the United Kingdom. Lt. Col. Eden brings extensive military and strategic experience, which will be key in advancing the company’s nuclear strategy and supporting their expanding role in the nuclear energy sector.
Read Announcement
ASP Isotopes FDA Events - Frequently Asked Questions
As of now, ASP Isotopes (ASPI) has not received any FDA approvals for its therapy in the last two years.
In the past two years, ASP Isotopes (ASPI) has reported FDA regulatory activity for Ytterbium-176.
The most recent FDA-related event for ASP Isotopes occurred on September 3, 2024, involving Ytterbium-176. The update was categorized as "Provided Update," with the company reporting: "ASP Isotopes Inc announced advances in its construction program and the hiring of key staff."
Currently, ASP Isotopes has one therapy (Ytterbium-176) targeting the following condition: to utilize Quantum Enrichment, a novel laser method of enrichment.
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:ASPI) was last updated on 7/13/2025 by MarketBeat.com Staff
