Free Trial

Apellis Pharmaceuticals (APLS) FDA Approvals

Apellis Pharmaceuticals logo
$19.62 +0.67 (+3.54%)
As of 02:28 PM Eastern
This is a fair market value price provided by Polygon.io. Learn more.

Apellis Pharmaceuticals' Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Apellis Pharmaceuticals (APLS). Over the past two years, Apellis Pharmaceuticals has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as pegcetacoplan and Pegcetacoplan. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

Pegcetacoplan FDA Regulatory Timeline and Events

Pegcetacoplan is a drug developed by Apellis Pharmaceuticals for the following indication: Paroxysmal nocturnal hemoglobinuria (PNH). This drug is approved by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Pegcetacoplan (VALIANT) FDA Regulatory Events

Pegcetacoplan (VALIANT) is a drug developed by Apellis Pharmaceuticals for the following indication: Primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G), two rare and debilitating kidney diseases. 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.

Apellis Pharmaceuticals FDA Events - Frequently Asked Questions

Yes, Apellis Pharmaceuticals (APLS) has received FDA approval for pegcetacoplan. This page tracks recent and historical FDA regulatory events related to Apellis Pharmaceuticals' drug portfolio.

In the past two years, Apellis Pharmaceuticals (APLS) has reported FDA regulatory activity for the following drugs: pegcetacoplan and Pegcetacoplan (VALIANT).

The most recent FDA-related event for Apellis Pharmaceuticals occurred on July 28, 2025, involving pegcetacoplan. The update was categorized as "FDA approved," with the company reporting: "Apellis Pharmaceuticals, announced that the U.S. Food and Drug Administration (FDA) has approved EMPAVELI® (pegcetacoplan) as the first treatment for C3 glomerulopathy (C3G) or primary immune complex membranoproliferative glomerulonephritis (IC-MPGN) in patients 12 years of age and older, to reduce proteinuria. C3G and primary IC-MPGN are rare kidney diseases, affecting 5,000 people in the United States.1"

Current therapies from Apellis Pharmaceuticals in review with the FDA target conditions such as:

  • Paroxysmal nocturnal hemoglobinuria (PNH) - pegcetacoplan
  • Primary immune-complex membranoproliferative glomerulonephritis (IC-MPGN) and C3 glomerulopathy (C3G), two rare and debilitating kidney diseases - Pegcetacoplan (VALIANT)

More FDA Event Resources from MarketBeat

  • 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:APLS) was last updated on 7/30/2025 by MarketBeat.com Staff
From Our Partners