Welcome to our dedicated page for Connect Biopharma Holdings news (Ticker: CNTB), a resource for investors and traders seeking the latest updates and insights on Connect Biopharma Holdings stock.
Connect Biopharma Holdings Ltd (NASDAQ: CNTB) delivers innovative immune modulation therapies targeting autoimmune diseases and chronic inflammation. This news hub provides investors and healthcare professionals with timely updates on clinical developments, regulatory milestones, and strategic partnerships.
Key resources include: Phase trial results analysis, FDA submission alerts, licensing agreements, and scientific conference presentations. Track progress across the company’s pipeline including CBP-201 (atopic dermatitis) and CBP-307 (ulcerative colitis) candidates.
All content undergoes strict verification to ensure accuracy and relevance. Bookmark this page for consolidated access to earnings reports, management commentary, and peer-reviewed research updates. Check regularly for developments in T-cell modulation therapies and autoimmune treatment advancements.
Connect Biopharma (NASDAQ:CNTB) announced that its Chinese partner Simcere Pharmaceutical has submitted a New Drug Application (NDA) to China's NMPA for rademikibart, targeting atopic dermatitis treatment in adults and adolescents.
The submission follows a 2023 exclusive licensing agreement where Simcere acquired rights to develop, manufacture, and commercialize rademikibart in Greater China. Connect remains eligible for up to $110 million in milestone payments plus tiered royalties up to low double-digit percentages on net sales. The opportunity is significant, with an estimated 70 million atopic dermatitis patients in China.
Connect Biopharma (NASDAQ: CNTB), a clinical-stage biopharmaceutical company specializing in asthma and COPD treatments, has announced its participation in two upcoming investor conferences in June 2025. The company will deliver corporate presentations at the Noble Capital Markets Virtual Conference on June 4th at 9:00 a.m. ET and the Jefferies Healthcare Conference on June 5th at 7:35 a.m. ET. The Jefferies presentation will be available via webcast and accessible through Connect's investor relations website, with replays of both events available for approximately 90 days.
Connect Biopharma (NASDAQ: CNTB) has initiated its Phase 2 Seabreeze STAT COPD study to evaluate rademikibart as a treatment for acute exacerbations in COPD patients. The study, approved by the FDA, will assess the drug's safety and efficacy as an adjunct to standard care in patients with COPD and type 2 inflammation.
The trial will enroll approximately 160 participants globally with acute COPD exacerbation and eosinophil count ≥300 cells/μL. Participants will receive either a single dose of rademikibart or placebo. The primary endpoint will measure treatment failure rate over 28 days following acute exacerbation. The company expects to report topline data in 1H 2026.
This initiative follows promising post-hoc analysis from their Phase 2b Asthma study, showing potential benefits particularly in patients with elevated baseline eosinophil counts. Currently, about 1.3 million patients visit emergency departments annually for COPD flare-ups, with 50% experiencing treatment failure within four weeks.
Connect Biopharma (NASDAQ: CNTB) has announced it will present four posters at the American Thoracic Society (ATS) 2025 International Conference in San Francisco from May 18-21, 2025. The presentations focus on their drug candidate rademikibart for treating moderate-to-severe asthma and COPD.
The presentations include studies on: rademikibart's efficacy in COPD-like patients, its effect on blood eosinophil counts, structural properties of the drug's IL-4Rα complex, and rapid improvement in lung function for asthma patients. The company plans to initiate parallel Phase 2 trials in Q2 2025.
Key presenters include Dr. Michael Wechsler and Dr. Raúl Collazo, with sessions covering topics such as asthma and COPD clinical studies, biomarkers in lung disease, and treatment modalities in inflammatory lung diseases.
Connect Biopharma (NASDAQ: CNTB) has received positive feedback from the FDA regarding its Type C meeting for rademikibart, advancing plans for two parallel Phase 2 trials in Q2 2025. The trials will evaluate the drug's effectiveness in patients with moderate-to-severe asthma or COPD experiencing acute exacerbations.
Each trial will enroll approximately 160 patients with eosinophils ≥300 cells/µL, testing a single 600 mg subcutaneous dose of rademikibart over 28 days following an acute exacerbation. Previous Phase 2 studies showed the drug was well-tolerated and improved pulmonary function within 24 hours.
The company expects to report trial data in H1 2026 and maintains a cash runway into 2027. Currently, about 45% of patients receiving standard care experience treatment failure within 28 days post-exacerbation, highlighting a significant unmet medical need.