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ADC Therapeutics (ADCT) FDA Events

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FDA Events for ADC Therapeutics (ADCT)

This section highlights FDA-related milestones and regulatory updates for drugs developed by ADC Therapeutics (ADCT). Over the past two years, ADC Therapeutics has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as Claudin-6, ZYNLONTA, and ZYNLONTA. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

ADC Therapeutics' Drugs in FDA Review

Claudin-6 - FDA Regulatory Timeline and Events

Claudin-6 is a drug developed by ADC Therapeutics for the following indication: In ovarian and NSCLC cancer models. 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.

ZYNLONTA - FDA Regulatory Timeline and Events

ZYNLONTA is a drug developed by ADC Therapeutics for the following indication: In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). 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.

ZYNLONTA (loncastuximab tesirine-lpyl) - FDA Regulatory Timeline and Events

ZYNLONTA (loncastuximab tesirine-lpyl) is a drug developed by ADC Therapeutics for the following indication: Refractory Diffuse Large B-Cell Lymphoma. 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.

ADC 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, ADC Therapeutics (ADCT) has reported FDA regulatory activity for the following drugs: ZYNLONTA, ZYNLONTA (loncastuximab tesirine-lpyl) and Claudin-6.

The most recent FDA-related event for ADC Therapeutics occurred on June 16, 2025, involving ZYNLONTA. The update was categorized as "Updated data," with the company reporting: "ADC Therapeutics SA announced updated data from a Phase 2 multicenter investigator-initiated trial (IIT) of ZYNLONTA® to treat relapsed/refractory marginal zone lymphoma (r/r MZL) will be presented during a poster session at the 18th International Conference on Malignant Lymphoma (ICML) in Lugano, Switzerland on Friday, June 20."

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

  • In patients with relapsed or refractory diffuse large B-cell lymphoma (r/r DLBCL). - ZYNLONTA
  • Refractory Diffuse Large B-Cell Lymphoma - ZYNLONTA (loncastuximab tesirine-lpyl)
  • In ovarian and NSCLC cancer models - Claudin-6

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 (NYSE:ADCT) was last updated on 7/10/2025 by MarketBeat.com Staff
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