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Apellis Pharmaceuticals (APLS) FDA Events

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FDA Events for Apellis Pharmaceuticals (APLS)

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.

Apellis Pharmaceuticals' Drugs in FDA Review

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 under review by the U.S. Food and Drug Administration (FDA). Below is a timeline of key regulatory milestones for this therapy.

Pegcetacoplan (VALIANT) - FDA Regulatory Timeline and 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

However, the company does has had drugs under review or in active clinical development.

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 June 6, 2025, involving pegcetacoplan. The update was categorized as "Data Presentation," with the company reporting: "Apellis Pharmaceuticals, Inc today presented new data from the open-label period of the Phase 3 VALIANT study, investigating EMPAVELI® (pegcetacoplan) for C3 glomerulopathy (C3G) and primary immune complex membranoproliferative glomerulonephritis (IC-MPGN)."

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 7/9/2025 by MarketBeat.com Staff
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