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Aptevo Therapeutics (APVO) FDA Events

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FDA Events for Aptevo Therapeutics (APVO)

This section highlights FDA-related milestones and regulatory updates for drugs developed by Aptevo Therapeutics (APVO). Over the past two years, Aptevo Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ADAPTIR, ALG.APV-527, APVO436, APVO442, and APVO603. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

Aptevo Therapeutics' Drugs in FDA Review

ADAPTIR - FDA Regulatory Timeline and Events

ADAPTIR is a drug developed by Aptevo Therapeutics for the following indication: for patients unfit for intensive chemotherapy. 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.

ALG.APV-527 - FDA Regulatory Timeline and Events

ALG.APV-527 is a drug developed by Aptevo Therapeutics for the following indication: 5T4-expressing tumor antigens in multiple solid tumor types. 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.

APVO436 - FDA Regulatory Timeline and Events

APVO436 is a drug developed by Aptevo Therapeutics for the following indication: Relapsed Acute Myeloid Leukemia. 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.

APVO442 - FDA Regulatory Timeline and Events

APVO442 is a drug developed by Aptevo Therapeutics for the following indication: Solid Tumors. 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.

APVO603 - FDA Regulatory Timeline and Events

APVO603 is a drug developed by Aptevo Therapeutics for the following indication: Solid Tumors. 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.

Aptevo Therapeutics FDA Events - Frequently Asked Questions

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

In the past two years, Aptevo Therapeutics (APVO) has reported FDA regulatory activity for the following drugs: ADAPTIR, ALG.APV-527, APVO436, APVO603 and APVO442.

The most recent FDA-related event for Aptevo Therapeutics occurred on June 18, 2025, involving ADAPTIR. The update was categorized as "New Data," with the company reporting: "Aptevo Therapeutics announced new clinical data from its ongoing Phase 1b/2 RAINIER trial evaluating mipletamig, its first-in-class CD123 x CD3 bispecific antibody, in combination with standard-of-care venetoclax and azacitidine (ven/aza) for newly diagnosed patients with acute myeloid leukemia (AML) who are unfit for intensive chemotherapy."

Current therapies from Aptevo Therapeutics in review with the FDA target conditions such as:

  • for patients unfit for intensive chemotherapy. - ADAPTIR
  • 5T4-expressing tumor antigens in multiple solid tumor types - ALG.APV-527
  • Relapsed Acute Myeloid Leukemia - APVO436
  • Solid Tumors - APVO603
  • Solid Tumors - APVO442

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:APVO) was last updated on 7/10/2025 by MarketBeat.com Staff
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