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ALX Oncology (ALXO) FDA Events

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FDA Events for ALX Oncology (ALXO)

This section highlights FDA-related milestones and regulatory updates for drugs developed by ALX Oncology (ALXO). Over the past two years, ALX Oncology has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as ALX2004, ASPEN-04, ASPEN-06, and Evorpacept. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

ALX Oncology's Drugs in FDA Review

ALX2004 - FDA Regulatory Timeline and Events

ALX2004 is a drug developed by ALX Oncology for the following indication: For the treatment of epidermal growth factor receptor (EGFR)-expressing 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.

ASPEN-04 - FDA Regulatory Timeline and Events

ASPEN-04 is a drug developed by ALX Oncology for the following indication: For the Treatment of Head and Neck Cancers. 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.

ASPEN-06 - FDA Regulatory Timeline and Events

ASPEN-06 is a drug developed by ALX Oncology for the following indication: In Patients With HER2-Positive Gastric Cancer. 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.

Evorpacept - FDA Regulatory Timeline and Events

Evorpacept is a drug developed by ALX Oncology for the following indication: For the Treatment of Patients with Gastric Cancer. 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.

ALX Oncology FDA Events - Frequently Asked Questions

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

In the past two years, ALX Oncology (ALXO) has reported FDA regulatory activity for the following drugs: ASPEN-06, ALX2004, Evorpacept and ASPEN-04.

The most recent FDA-related event for ALX Oncology occurred on May 20, 2025, involving ALX2004. The update was categorized as "Provided Update," with the company reporting: "ALX Oncology Holdings Inc provides an overview of the clinical development program for its highly-differentiated antibody-drug conjugate (ADC), ALX2004, at the Company's R&D webcast event today."

Current therapies from ALX Oncology in review with the FDA target conditions such as:

  • In Patients With HER2-Positive Gastric Cancer - ASPEN-06
  • For the treatment of epidermal growth factor receptor (EGFR)-expressing solid tumors - ALX2004
  • For the Treatment of Patients with Gastric Cancer - Evorpacept
  • For the Treatment of Head and Neck Cancers - ASPEN-04

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