Connect Biopharma's Drug 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
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.
- Drug:
- Rademikibart
- Announced Date:
- July 9, 2025
- Indication:
- For Moderate-To-Severe Atopic Dermatitis
Announcement
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.
AI Summary
Connect Biopharma Holdings Limited announced that its exclusive partner in China, Simcere Pharmaceutical Co., Ltd., has submitted a New Drug Application (NDA) for the drug candidate rademikibart to China’s National Medical Products Administration (NMPA). The submission is for the treatment of atopic dermatitis, a condition that affects millions of adults and adolescents in China. Rademikibart is designed to block interleukin-4 receptor alpha (IL-4Rα) to interfere with key steps in the inflammatory process, potentially offering a new solution for inflammatory diseases. This action comes as part of a collaboration between Connect Biopharma and Simcere, which gives Simcere exclusive rights to develop, manufacture, and commercialize the drug in Greater China. The move marks a significant step forward in addressing the growing market needs for atopic dermatitis treatment in the region.
Read Announcement- Drug:
- Rademikibart
- Announced Date:
- June 13, 2025
- Indication:
- For Moderate-To-Severe Atopic Dermatitis
Announcement
Connect Biopharma Holdings announced the presentation of clinical data supporting rademikibart, the Company's investigational, next-generation, potentially best-in-class anti-interleukin-4-receptor alpha (IL-4Rα) antibody, at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, taking place June 13-16, 2025, in Glasgow, United Kingdom and virtually.
AI Summary
Connect Biopharma Holdings has announced that it will present new clinical data for its investigational drug, rademikibart, at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress. The event will be held in Glasgow, United Kingdom, and virtually from June 13-16, 2025. Rademikibart is a next-generation, anti-interleukin-4-receptor alpha antibody designed to treat eosinophilic-driven type 2 asthma. The clinical findings indicate that the drug quickly improves lung function and asthma control, showing sustained benefits over time. Moreover, the data reveal significant reductions in annualized asthma exacerbation rates, especially in patients with high levels of markers such as eosinophils and FeNO. These promising results add to the evidence supporting the potential of rademikibart as an effective treatment for asthma and provide a strong basis for ongoing clinical development.
Read Announcement- Drug:
- Rademikibart
- Announced Date:
- June 3, 2025
- Indication:
- For Moderate-To-Severe Atopic Dermatitis
Announcement
Connect Biopharma Holdings Limited announced two oral presentations at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress, taking place June 13-16, 2025, in Glasgow, United Kingdom and virtually.
AI Summary
Connect Biopharma Holdings Limited has announced that it will present two oral sessions at the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress. The congress, which will be held both virtually and in Glasgow, United Kingdom, takes place from June 13-16, 2025.
Both presentations are scheduled for Friday, June 13th from 3:00 p.m. to 4:30 p.m. BST and will feature Dr. Rekha Chaudhuri discussing important clinical findings. One session focuses on reducing annualized exacerbations with Rademikibart in eosinophilic driven, Type 2 Asthma, while the other highlights improvements in lung function using the same treatment. After the presentations, the content will be available for review on Connect Biopharma’s website under the presentations and publications section, providing further insights into their ongoing efforts to advance asthma and COPD therapies.
Read Announcement- Drug:
- Rademikibart
- Announced Date:
- May 14, 2025
- Indication:
- For Moderate-To-Severe Atopic Dermatitis
Announcement
Connect Biopharma Holdings announced the initiation of its Phase 2 Seabreeze STAT COPD study (NCT06940154) following written agreement on the final study protocol from the U.S. Food and Drug Administration.
AI Summary
Connect Biopharma Holdings has announced the start of its Phase 2 Seabreeze STAT COPD study (NCT06940154) after receiving written agreement on the final study protocol from the U.S. Food and Drug Administration. This important milestone marks the initiation of a randomized, double-blind, placebo-controlled trial aimed at evaluating the safety and effectiveness of rademikibart as an addition to the standard care for acute COPD exacerbations in patients with type 2 inflammation.
The study plans to enroll approximately 160 participants globally, with a focus on reducing treatment failures during the critical 28-day period following an exacerbation. The company expects to report topline data in the first half of 2026, reinforcing its commitment to developing a fast-acting treatment option to improve outcomes for COPD patients.
Read Announcement- Drug:
- Rademikibart
- Announced Date:
- May 14, 2025
- Estimated Event Date Range:
- January 1, 2026 - June 30, 2026
- Target Action Date:
- H1 2026
- Indication:
- For Moderate-To-Severe Atopic Dermatitis
Announcement
Connect Biopharma Holdings Limited Expect to report topline data from the Seabreeze STAT COPD study in 1H 2026
AI Summary
Connect Biopharma Holdings Limited announced the start of its Phase 2 Seabreeze STAT COPD study, a trial designed to assess the safety and efficacy of rademikibart as an add-on to standard care for acute exacerbations in COPD patients with type 2 inflammation. The study, which follows agreement on the final protocol with the U.S. Food and Drug Administration, aims to enroll around 160 global participants. Researchers will compare a single subcutaneous dose of rademikibart against a placebo, focusing on outcomes like treatment failure over a 28-day period and changes in lung function.
The company plans to report topline data from this pivotal study in the first half of 2026. This milestone is part of Connect Biopharma’s broader efforts to address the urgent need for fast, effective treatments for acute exacerbations in patients with COPD.
Read Announcement- Drug:
- Rademikibart
- Announced Date:
- April 1, 2025
- Indication:
- For Moderate-To-Severe Atopic Dermatitis
Announcement
Connect Biopharma Holdings announced positive feedback from its Type C meeting with the U.S. Food and Drug Administration (FDA), Division of Pulmonology, Allergy, and Critical Care, in the Office of Immunology and Inflammation.
AI Summary
Connect Biopharma Holdings announced that the FDA’s Division of Pulmonology, Allergy, and Critical Care provided positive feedback during its recent Type C meeting. The FDA aligned with Connect’s plan to start two parallel Phase 2 trials evaluating rademikibart, a potential treatment for patients with moderate-to-severe asthma or COPD experiencing an acute exacerbation. In these trials, about 160 patients per study will receive a single 600 mg subcutaneous dose to address the need for rapid treatment during the vulnerable 28-day period following an exacerbation. The focus is on reducing the risk of recurring exacerbations, a need that has not been met by any currently approved biologic therapies. Connect plans to begin patient enrollment in the second quarter of 2025, with results expected to be reported in the first half of 2026.
Read Announcement- Drug:
- Rademikibart
- Announced Date:
- March 31, 2025
- Indication:
- For Moderate-To-Severe Atopic Dermatitis
Announcement
Connect Biopharma Holdings announced the online publication of positive results from the global Phase 2 trial of rademikibart in patients with moderate-to-severe uncontrolled asthma in the American Journal of Respiratory and Critical Care Medicine (AJRCCM).
AI Summary
Connect Biopharma Holdings has announced the online publication of positive Phase 2 trial results for rademikibart in the American Journal of Respiratory and Critical Care Medicine (AJRCCM). The global study involved 322 adults with moderate-to-severe uncontrolled asthma, where rademikibart demonstrated a rapid onset of action with significant lung function improvements observed as early as one week and maintained through a 24-week treatment period.
Notably, in patients with eosinophilic-driven asthma (baseline ≥300 eosinophils/µL) receiving the 300 mg dose, the mean difference in forced expiratory volume in one second (FEV1) compared to placebo was +420 mL at Week 24, marking one of the largest improvements seen with a biologic. These findings support rademikibart’s potential as a novel treatment option for patients with asthma and Type 2 inflammation.
Read Announcement- Drug:
- Rademikibart
- Announced Date:
- May 22, 2024
- Estimated Event Date Range:
- April 1, 2024 - June 30, 2024
- Target Action Date:
- Q2 2024
- Indication:
- For Moderate-To-Severe Atopic Dermatitis
Announcement
Connect Biopharma Holdings Limited announced that End of Phase 2 (EoP2) meeting is scheduled with the U.S. Food and Drug Administration (FDA) for Q2 2024
AI Summary
Connect Biopharma Holdings Limited announced that it has scheduled an End of Phase 2 (EoP2) meeting with the U.S. Food and Drug Administration (FDA) for Q2 2024. This meeting will be a crucial step as the company outlines the Phase 3 regulatory path for its lead candidate, rademikibart, which is being developed to treat moderate-to-severe asthma.
The company recently shared promising results from its global Phase 2b trial, where improvements in lung function and asthma control were observed early—by Week 1—and sustained through Week 24. As Connect Biopharma prepares for this key discussion with the FDA, it aims to clarify the path forward for advancing rademikibart and providing a new treatment option for patients with chronic inflammatory diseases.
Read Announcement- Drug:
- Rademikibart
- Announced Date:
- May 22, 2024
- Indication:
- For Moderate-To-Severe Atopic Dermatitis
Announcement
Connect Biopharma Holdings Limited announced today that Edward Kerwin, M.D. presented a late-breaking poster presentation on the positive results from the rademikibart global Phase 2b trial in patients with moderate-to-severe asthma at the American Thoracic Society (ATS) 2024 International Conference, taking place May 17-22, 2024 in San Diego, CA.
AI Summary
Connect Biopharma Holdings Limited announced that Dr. Edward Kerwin presented a late-breaking poster at the ATS 2024 International Conference in San Diego, CA. The poster shared positive results from the global Phase 2b trial testing rademikibart in patients with moderate-to-severe uncontrolled asthma.
The trial showed that treatment with rademikibart led to significant improvements in lung function, with patients experiencing benefits as early as Week 1 and at Week 12, which were sustained through Week 24. In addition, patient-reported asthma control improved significantly over the same period. An exploratory analysis indicated further lung function gains in patients with higher eosinophil levels. These findings underscore the potential of rademikibart as a promising therapy for improving lung function and asthma control in this patient population.
Read Announcement
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
FDA Event Stage Terminology & Abbreviation Guide
- 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 7/30/2025 by MarketBeat.com Staff
