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MacroGenics (MGNX) FDA Events

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FDA Events for MacroGenics (MGNX)

This section highlights FDA-related milestones and regulatory updates for drugs developed by MacroGenics (MGNX). Over the past two years, MacroGenics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as lorigerlimab and vobramitamab. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

MacroGenics' Drugs in FDA Review

lorigerlimab - FDA Regulatory Timeline and Events

lorigerlimab is a drug developed by MacroGenics for the following indication: In patients with mCRPC. 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.

vobramitamab duocarmazine - FDA Regulatory Timeline and Events

vobramitamab duocarmazine is a drug developed by MacroGenics for the following indication: In metastatic castration-resistant prostate cancer (mCRPC. 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.

MacroGenics FDA Events - Frequently Asked Questions

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

In the past two years, MacroGenics (MGNX) has reported FDA regulatory activity for the following drugs: lorigerlimab and vobramitamab duocarmazine.

The most recent FDA-related event for MacroGenics occurred on March 20, 2025, involving lorigerlimab. The update was categorized as "Provided Update," with the company reporting: "MacroGenics, Inc. provided an update on its recent corporate progress"

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

  • In patients with mCRPC - lorigerlimab
  • In metastatic castration-resistant prostate cancer (mCRPC - vobramitamab duocarmazine

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