Free Trial

Connect Biopharma (CNTB) FDA Approvals

Connect Biopharma logo
$1.51 +0.19 (+14.65%)
Closing price 03:59 PM Eastern
Extended Trading
$1.46 -0.05 (-3.31%)
As of 05:44 PM Eastern
Extended trading is trading that happens on electronic markets outside of regular trading hours. This is a fair market value extended hours price provided by Polygon.io. Learn more.

Connect Biopharma's Drugs in the FDA Approval Process

This section highlights FDA-related milestones and regulatory updates for drugs developed by Connect Biopharma (CNTB). Over the past two years, Connect Biopharma has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as IL-4Rα and Rademikibart. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend. Select a button below to view the list of FDA events for that drug.

IL-4Rα FDA Regulatory Events

IL-4Rα is a drug developed by Connect Biopharma for the following indication: For asthma. 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.

Rademikibart FDA Regulatory Timeline and Events

Rademikibart is a drug developed by Connect Biopharma for the following indication: For Moderate-To-Severe Atopic Dermatitis. 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.

Connect Biopharma FDA Events - Frequently Asked Questions

In the past two years, Connect Biopharma (CNTB) has not received FDA approval for any therapies. However, the company does have drugs under review or in active clinical development.

In the past two years, Connect Biopharma (CNTB) has reported FDA regulatory activity for the following drugs: Rademikibart and IL-4Rα.

The most recent FDA-related event for Connect Biopharma occurred on September 29, 2025, involving IL-4Rα. The update was categorized as "Data Presentation," with the company reporting: "Connect Biopharma Holdings today presented data supporting rademikibart, the Company's investigational, next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody, at the European Respiratory Society (ERS) Congress 2025, taking place September 27 – October 1, 2025, in Amsterdam, Netherlands and virtually."

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

  • For Moderate-To-Severe Atopic Dermatitis - Rademikibart
  • For asthma - IL-4Rα

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:CNTB) was last updated on 9/30/2025 by MarketBeat.com Staff
From Our Partners