Connect Biopharma Holdings Ltd Stock Price, News & Analysis

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 presented clinical data for rademikibart, their investigational anti-IL-4Rα antibody, at EAACI 2025. The Phase 2b trial results showed significant improvements in lung function and asthma control for patients with eosinophilic-driven type 2 asthma. Rademikibart demonstrated rapid improvement in prebronchodilator FEV1 from Week 1, sustained through 24 weeks. The drug achieved notable reductions in annualized asthma exacerbation rates: 63% in patients with elevated baseline eosinophils, 69% in elevated FeNO patients, and 74% in those with both markers elevated. The company expects to report topline data from ongoing Phase 2 acute exacerbation studies in asthma and COPD in the first half of 2026.

Connect Biopharma (Nasdaq: CNTB) announced two oral presentations scheduled for the European Academy of Allergy and Clinical Immunology (EAACI) 2025 Annual Congress in Glasgow, UK. Dr. Rekha Chaudhuri will present findings on their drug Rademikibart, focusing on its effects in treating eosinophilic-driven, Type 2 asthma. The first presentation will discuss reduction in annualized exacerbations, while the second will cover improvements in lung function. Both presentations are scheduled for June 13th, 2025, from 3:00-4:30 PM BST. The presentations will later be available on Connect's website under the presentations and publications section.

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) presented promising data for rademikibart, their next-generation IL-4Rα antibody, at the ATS 2025 International Conference. The Phase 2b trial results showed significant improvements in lung function (FEV1) within 24 hours and reduced acute exacerbations in asthma patients. The drug demonstrated particular efficacy in patients with elevated eosinophil counts. Notably, rademikibart showed a superior safety profile compared to dupilumab, with approximately 30% decrease in eosinophil counts at Week 24, versus dupilumab's 50-120% increase. Structural analysis revealed rademikibart's optimized binding to IL-4Rα, with ~60° rotation compared to dupilumab, resulting in stronger and more stable interaction. Phase 2 studies in asthma and COPD are ongoing with topline data expected in 1H26.

Connect Biopharma (NASDAQ: CNTB) reported Q1 2025 financial results and significant progress in its clinical development programs. The company initiated two Phase 2 Seabreeze STAT studies evaluating rademikibart for acute exacerbations in both asthma and COPD, with topline data expected in 1H 2026. Published data showed promising results, with rademikibart demonstrating rapid improvements in lung function, particularly in eosinophilic-driven asthma patients showing a +420 mL difference from placebo. The company maintains a strong financial position with $84.0 million in cash and investments, providing runway into 2027. Q1 2025 resulted in a net loss of $10.3 million ($0.19 per share), compared to $8.7 million ($0.16 per share) in Q1 2024.

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 initiated the Phase 2 Seabreeze STAT Asthma study to evaluate rademikibart as an adjunct treatment for acute asthma exacerbations. The study, approved by the FDA, will assess the drug's safety and efficacy in approximately 160 participants with asthma and type 2 inflammation. Previous Phase 2 trial results published in AJRCCM showed rademikibart's ability to improve lung function within 24 hours of administration, with sustained improvements through 24 weeks. The primary endpoint will measure treatment failure rate over 28 days following an acute exacerbation. The company expects to report topline data in 1H 2026 and plans to initiate a similar Phase 2 study in COPD patients. If successful, rademikibart could become the first biologic indicated for acute asthma exacerbations.

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.