FDA Events for Talphera (TLPH)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Talphera (TLPH).
Over the past two years, Talphera has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Nafamostat. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Nafamostat - FDA Regulatory Timeline and Events
Nafamostat is a drug developed by Talphera for the following indication: For Anticoagulation of the Extracorporeal Circuit.
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:
- Nafamostat
- Announced Date:
- August 19, 2024
- Indication:
- For Anticoagulation of the Extracorporeal Circuit
Announcement
Talphera, Inc. announced the first patient has been enrolled in the NEPHRO CRRT study.
AI Summary
Talphera, Inc. announced that the first patient has been enrolled in the NEPHRO CRRT study, marking an important milestone. This trial will evaluate the safety and effectiveness of nafamostat as an anticoagulant for patients undergoing continuous renal replacement therapy (CRRT). The study will involve 166 patients across up to 14 clinical sites in the United States. Its primary goal is to measure the mean post-filter activated clotting time over the first 24 hours, comparing nafamostat to a placebo, with the study lasting 72 hours.
Dr. Stuart Goldstein, a respected nephrologist from Cincinnati Children’s Hospital Medical Center, led the enrollment and emphasized the potential benefits of nafamostat for patients requiring CRRT. Talphera is hopeful that, if approved, nafamostat will offer a new and improved option over current anticoagulants used in the United States.
Read Announcement
Talphera FDA Events - Frequently Asked Questions
As of now, Talphera (TLPH) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Talphera (TLPH) has reported FDA regulatory activity for Nafamostat.
The most recent FDA-related event for Talphera occurred on August 19, 2024, involving Nafamostat. The update was categorized as "Enrollment Update," with the company reporting: "Talphera, Inc. announced the first patient has been enrolled in the NEPHRO CRRT study."
Currently, Talphera has one therapy (Nafamostat) targeting the following condition: For Anticoagulation of the Extracorporeal Circuit.
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:TLPH) was last updated on 7/10/2025 by MarketBeat.com Staff
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