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Connect Biopharma (CNTB) FDA Events

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FDA Events for Connect Biopharma (CNTB)

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 Rademikibart. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.

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

As of now, Connect Biopharma (CNTB) has not received any FDA approvals for its therapy in the last two years.

In the past two years, Connect Biopharma (CNTB) has reported FDA regulatory activity for Rademikibart.

The most recent FDA-related event for Connect Biopharma occurred on July 9, 2025, involving Rademikibart. The update was categorized as "NDA Filing," with the company reporting: "Connect Biopharma Holdings Limited announced that the Company's collaborator and exclusive licensee in China, Simcere Pharmaceutical Co., Ltd. ("Simcere"), has submitted its New Drug Application for rademikibart to the National Medical Products Administration of China ("NMPA") for the treatment of atopic dermatitis ("AD") in adults and adolescents."

Currently, Connect Biopharma has one therapy (Rademikibart) targeting the following condition: For Moderate-To-Severe Atopic Dermatitis.

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 7/9/2025 by MarketBeat.com Staff
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