Results from Phase 3 Study of Rademikibart in Moderate-to-Severe Atopic Dermatitis to be Presented in the Late-Breaking Research Session at the 2026 American Academy of Dermatology (AAD) Annual Meeting
Rhea-AI Summary
Connect Biopharma (Nasdaq: CNTB) announced that results from a Phase 3 study of rademikibart in moderate-to-severe atopic dermatitis, conducted by partner Simcere, will be presented in the Late-Breaking Research session at the AAD Annual Meeting on March 28, 2026.
The presentation (RADIANT-AD) is scheduled for March 28, 2026, 9:48–10:00 a.m. MDT at Bellco Theatre 3. According to Connect Biopharma, the Phase 3 data provide a strong basis for Simcere’s pending NDA in China and highlight rademikibart’s potentially differentiated safety and efficacy, supporting future AD development outside China.
Positive
- Phase 3 data accepted to Late-Breaking Research session at AAD
- Data cited as a "strong basis" for Simcere's pending NDA in China
- Findings support potentially differentiated safety and efficacy
- Supports opportunity to pursue atopic dermatitis indication outside China
Negative
- Regulatory outcome remains pending for Simcere's NDA in China
- Connect relies on partner-conducted study and partner regulatory filings
- Connect's near-term focus remains on asthma and COPD, not immediate AD commercialization
News Market Reaction – CNTB
In the Mar 10 session, CNTB gained 5.28%, reflecting a notable positive market reaction. Argus tracked a peak move of +10.1% during that session. Our momentum scanner triggered 11 alerts that day, indicating notable trading interest and price volatility. Trading volume was above average at 1.9x the daily average, suggesting increased trading activity.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Previous Clinical trial Reports
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Aug 14 | Asthma education initiative | Positive | -8.9% | Partnership to expand nationwide asthma education tied to Seabreeze STAT studies. |
| May 14 | Phase 2 COPD launch | Positive | +1.2% | Initiation of Phase 2 COPD Seabreeze STAT trial evaluating rademikibart. |
| May 13 | Phase 2 asthma launch | Positive | -5.2% | Start of Phase 2 Seabreeze STAT asthma study for acute exacerbations. |
| Mar 31 | Positive Phase 2 asthma | Positive | +4.0% | Publication of positive global Phase 2 data in uncontrolled asthma patients. |
| May 22 | Late-breaking asthma data | Positive | +7.1% | Late-breaking ATS 2024 presentation with positive Phase 2b asthma results. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Clinical and trial-related news has produced mixed reactions, with both strong gains and sharp declines around rademikibart updates.
Over the past two years, CNTB has repeatedly highlighted rademikibart across asthma and COPD studies, including global Phase 2 data in uncontrolled asthma and new Phase 2 Seabreeze STAT trials. Prior clinical updates, such as late-breaking Phase 2b asthma data and Phase 3-enabling results, often led to notable but inconsistent price moves, with some days up over 7% and others down nearly 9%. Today’s Phase 3 atopic dermatitis presentation by Simcere adds dermatology data to this evolving clinical story.
Key Terms
phase III medical
randomized medical
double-blinded medical
placebo-controlled medical
atopic dermatitis medical
copd medical
new drug application (nda) regulatory
monotherapy medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
SAN DIEGO, March 10, 2026 (GLOBE NEWSWIRE) -- Connect Biopharma Holdings Limited (Nasdaq: CNTB) (Connect Biopharma, Connect, or the Company), a clinical-stage biopharmaceutical company focused on transforming care for the treatment of inflammatory diseases, today announced that the results of a Phase 3 study of rademikibart in moderate-to-severe atopic dermatitis (AD) conducted by the Company’s partner in China, Simcere Pharmaceutical Co., Ltd. (Simcere), will be presented in the Late-Breaking Research session at the 2026 AAD Annual Meeting, which takes place March 27-31, 2026, in Denver, Colorado.
“We are very encouraged by the acceptance of our partner’s Phase 3 atopic dermatitis study for an oral presentation in the coveted Late-Breaking Research session at AAD this month,” said Barry Quart, Pharm.D., CEO and Director of Connect Biopharma. “We believe the results obtained in this Phase 3 study provide a strong basis for the ultimate approval of Simcere’s pending New Drug Application (NDA) for rademikibart in China. While Connect’s near‑term priorities remain focused on asthma and chronic obstructive pulmonary disease (COPD), the results Simcere has generated in AD underscore rademikibart’s potentially differentiated safety and efficacy and support the opportunity for Connect to target AD as a future indication outside of China. We look forward to the presentation of these findings at AAD later this month.”
Presentation details are as follows:
Title: 79594 - Rademikibart monotherapy in adult and adolescent patients with moderate-to-severe atopic dermatitis (AD): A 1-year, phase III, randomized, double-blinded, placebo-controlled trial (RADIANT-AD)
Date / Time: Saturday, March 28, 2026, from 9:48 – 10:00 a.m. MDT
Location: Bellco Theatre 3
About Rademikibart
Rademikibart is a fully human monoclonal antibody targeting interleukin-4 receptor alpha (IL-4Rα), a common subunit of interleukin-4 receptor (IL-4) and interleukin-13 receptor (IL-13). We believe that by binding with IL-4Rα, rademikibart can block the functions of IL-4 and IL-13 effectively, thereby blocking the T helper 2 (Th2) inflammatory pathway to achieving the goal of treating Th2-related inflammatory diseases such as atopic dermatitis, asthma and COPD.
About Simcere
Simcere, founded in 1995, is an innovation and R&D-driven pharmaceutical company. The Company focuses on the therapeutic areas of neuroscience, oncology, autoimmune and anti-infection, with forward-looking layout of disease areas that may have significant clinical needs in the future, fulfilling the mission of “for patients, for life”. Driven by a dual-strategy of in-house R&D and synergistic innovation, Simcere has established strategic cooperation partnerships with multiple innovative biotechs and research institutes.
About Connect Biopharma
Connect Biopharma is a clinical-stage biopharmaceutical company dedicated to transforming care for asthma and COPD. Headquartered in San Diego, California, the Company is advancing rademikibart, a next-generation, potentially best-in-class antibody designed to target IL-4Rα. The Company is currently conducting global clinical studies of rademikibart for the treatment of acute exacerbations of asthma and COPD, areas with significant unmet need. Connect has granted an exclusive license to Simcere Pharmaceutical Co., Ltd., for rademikibart in Greater China. Under the exclusive license and collaboration agreement, Connect is eligible to receive remaining milestone payments up to an aggregate amount of approximately
For more information visit www.connectbiopharma.com.
Forward-Looking Statements
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, as amended (the Act). Forward-looking statements are statements that are not of historical fact and include, without limitation, statements regarding future events, our future financial condition, results of operations, business strategy and plans, prospective products (as well as their potential to achieve a differentiated, competitive, or favorable benefit or profile or trend, including on safety, tolerability, improvement, maintenance, clinical response, dosing, efficacy and/or convenience), planned or expected product approval applications or approvals, anticipated milestones and royalties, expected data readouts and enrollments, research and development plans and costs, potential future partnerships, expectations about existing partnerships, timing and likelihood of success, objectives of management for future operations, future results of anticipated product development efforts, adequacy of existing cash and potential partnership funding to fund operations and capital expenditure requirements, anticipated patient populations or market opportunities for our prospective products, if approved, as well as statements regarding industry trends. These statements are based on management’s current expectations of future events only as of the date of this press release and are inherently subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond our control, including, among other things: the ability of our clinical trials to demonstrate safety and efficacy of our product candidates and other positive results; whether we or our current or future partners will need expanded or additional trials in order to obtain regulatory approval for our product candidates; whether Simcere’s pending NDA for rademikibart in China will receive approval by the National Medical Products Administration (NMPA), and the timing of any such approval; our ability to obtain and maintain regulatory approval of our product candidates; existing regulations and regulatory developments in the U.S., the People’s Republic of China, Europe and other jurisdictions; the ability of our current cash and investments position to support planned operations; our plans and ability to obtain, maintain, protect and enforce our intellectual property rights and our proprietary technologies, including extensions of existing patent terms where available; our continued reliance on third parties to conduct additional clinical trials of our product candidates, and for the manufacture of our product candidates for preclinical studies and clinical trials; and the degree of market acceptance of our product candidates, if approved, by physicians, patients, healthcare payors and others in the medical community.
Words such as “aim,” “anticipate,” “believe,” “could,” “expect,” “feel,” “goal,” “intend,” “may,” “optimistic,” “plan,” “potential,” “promising,” “will,” and similar expressions are intended to identify forward-looking statements, though not all forward-looking statements necessarily contain these identifying words. The inclusion of forward-looking statements should not be regarded as a representation by Connect Biopharma that any of its expectations, projections or plans will be achieved. Actual results may differ materially due to the risks and uncertainties inherent in our business and other risks described in our filings with the SEC. Further information regarding these and other risks is included under the heading “Risk Factors” in our annual and periodic reports filed with the SEC. These forward-looking statements should not be taken as forecasts or promises nor should they be taken as implying any indication, assurance or guarantee that the assumptions on which such forward-looking statements have been made are correct or exhaustive or, in the case of the assumptions, fully stated in this presentation. Drug development and commercialization involve a high degree of risk, and only a small number of research and development programs result in commercialization of a product. Results in early-stage clinical trials may not be indicative of full results or results from later stage or larger scale clinical trials and do not ensure regulatory approval. You are cautioned not to place undue reliance on the scientific data presented or these forward-looking statements, which speak only as of the date of this presentation. Except as required by law, Connect Biopharma undertakes no obligation to publicly update any forward-looking statements, whether because of new information, future events or otherwise. Connect Biopharma claims the protection of the safe harbor for forward-looking statements contained in the Act for all forward-looking statements.
This press release discusses our product candidate, rademikibart, which is under clinical investigation and has not yet been approved for marketing by the U.S. Food and Drug Administration, the NMPA, or by any other regulatory agency. No representation is made as to the safety or effectiveness of rademikibart for the uses for which it is being studied. The trademarks included herein are the property of the owners thereof and are used for reference purposes only.
Investor Relations Contact:
Alex Lobo
Precision AQ
Alex.Lobo@precisionaq.com
(212) 698-8802
Media Contact:
Ignacio Guerrero-Ros, Ph.D., or David Schull
Russo Partners, LLC
Ignacio.guerrero-ros@russopartnersllc.com
David.schull@russopartnersllc.com
(858) 717-2310 or (646) 942-5604
