FDA Events for Akari Therapeutics (AKTX)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Akari Therapeutics (AKTX).
Over the past two years, Akari Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
PAS-nomacopan. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
PAS-nomacopan - FDA Regulatory Timeline and Events
PAS-nomacopan is a drug developed by Akari Therapeutics for the following indication: Treatment for geographic atrophy (GA).
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:
- PAS-nomacopan
- Announced Date:
- August 19, 2024
- Indication:
- Treatment for geographic atrophy (GA).
Announcement
Akari Therapeutics that the company has received positive and constructive Pre-IND (PIND) feedback from the FDA on July 29, 2024, which provides additional clarity on Akari's final Investigational New Drug Application (IND)- enabling preclinical plans, drug manufacturing and Phase 1 clinical strategy for long-acting PAS-nomacopan for intravitreal treatment of geographic atrophy (GA).
AI Summary
Akari Therapeutics announced that it received positive and constructive Pre-IND feedback from the FDA on July 29, 2024. This feedback provides additional clarity on the company’s final Investigational New Drug (IND) application by outlining key aspects of its preclinical studies, drug manufacturing, and Phase 1 clinical strategy for its long-acting PAS-nomacopan. The drug is designed for intravitreal treatment of geographic atrophy (GA) and may offer benefits such as longer intervals between injections and a potential decrease in the risk of choroidal neovascularization.
With this regulatory guidance, Akari’s path forward to filing an IND application in 2025 is clearer. The company is preparing to utilize a full-scale batch of GMP-manufactured drug substance for the final IND-enabling studies, setting the stage for its first clinical studies aimed at offering improved therapy options for patients with GA.
Read Announcement
Akari Therapeutics FDA Events - Frequently Asked Questions
As of now, Akari Therapeutics (AKTX) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Akari Therapeutics (AKTX) has reported FDA regulatory activity for PAS-nomacopan.
The most recent FDA-related event for Akari Therapeutics occurred on August 19, 2024, involving PAS-nomacopan. The update was categorized as "Positive Feedback," with the company reporting: "Akari Therapeutics that the company has received positive and constructive Pre-IND (PIND) feedback from the FDA on July 29, 2024, which provides additional clarity on Akari's final Investigational New Drug Application (IND)- enabling preclinical plans, drug manufacturing and Phase 1 clinical strategy for long-acting PAS-nomacopan for intravitreal treatment of geographic atrophy (GA)."
Currently, Akari Therapeutics has one therapy (PAS-nomacopan) targeting the following condition: Treatment for geographic atrophy (GA)..
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:AKTX) was last updated on 7/12/2025 by MarketBeat.com Staff
