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Connect Biopharma Holdings Limited reports clinical and corporate developments for a clinical-stage biopharmaceutical company focused on inflammatory diseases. Its principal program is rademikibart, an antibody designed to target interleukin-4-receptor alpha, with company updates centered on asthma, chronic obstructive pulmonary disease and moderate-to-severe atopic dermatitis.
Recurring news includes rademikibart clinical data, Seabreeze STAT asthma and COPD study updates, Data Monitoring Committee and regulatory-related disclosures, partner activity involving Simcere in China, financial results, financing activity, investor conference participation and governance matters.
Connect Biopharma Holdings Limited (Nasdaq: CNTB), a biopharmaceutical firm focused on T cell-driven therapies for inflammatory diseases, announced its participation in several upcoming investor and scientific conferences. Key events include the 6th Annual Dermatology Drug Development Summit in Boston (Nov 1-3), where CEO Zheng Wei will present on Nov 2, and others through December, including the Piper Sandler Healthcare Conference in New York. The company continues to develop promising therapies, including its lead candidate targeting IL-4Rα for atopic dermatitis.
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Connect Biopharma (Nasdaq: CNTB) announced positive topline results from a pivotal trial of its lead candidate, CBP-201, for moderate-to-severe atopic dermatitis in 255 patients in China. The primary endpoint, achieving an IGA of 0 or 1 at Week 16, was met significantly (30.3% for CBP-201 vs. 7.5% placebo, p 0.001). Key secondary endpoints also showed significant efficacy. CBP-201 was well tolerated, with safety profiles similar to placebo. The company plans to advance discussions for a New Drug Application (NDA) in China.
Connect Biopharma Holdings Limited (Nasdaq: CNTB) will report topline results from its pivotal trial of lead candidate CBP-201 for moderate-to-severe atopic dermatitis (AD) in China. This highly anticipated announcement is set for tomorrow, October 4, 2022, and will be followed by a conference call and webcast at 5:30 a.m. PDT/8:30 a.m. EDT. The trial results will be significant for investors closely monitoring the company’s progress in treating inflammatory diseases.
Connect Biopharma (CNTB) announced key developments and financial results for the six months ending June 30, 2022. The company expects to report top-line data for its lead drug CBP-201 in atopic dermatitis in October 2022, ahead of schedule. They completed a global Phase 2b trial for CBP-201 showing positive efficacy, and R&D expenses rose to RMB 340.8 million due to ongoing clinical trials. The net loss was RMB 401.3 million, a decrease from the previous year's loss. The company has sufficient funds to support operations into at least 2024.
Connect Biopharma Holdings Limited (Nasdaq: CNTB) announced it will report financial results for the six months ending June 30, 2022, on September 13, 2022, after market close. The company will host a webcast and conference call at 1:30 p.m. PDT to discuss these results along with a corporate update. Connect Biopharma focuses on developing therapeutics for T cell-driven inflammatory diseases, with key candidates including CBP-201 for atopic dermatitis and asthma, and CBP-307 for ulcerative colitis.
Connect Biopharma Holdings Limited (Nasdaq: CNTB) announced the successful completion of its first-in-human Phase 1 study for CBP-174, an oral H3 receptor antagonist aimed at treating pruritus linked to allergic and inflammatory skin diseases, including atopic dermatitis. The trial demonstrated that CBP-174 was safe and well-tolerated with no serious adverse events reported. Vital signs and laboratory results showed no clinically notable safety findings. The Company aims to further evaluate CBP-174, intending to improve the quality of life for patients suffering from skin conditions worldwide.
CANbridge Pharmaceuticals, Inc. (1228.HK) reported its financial results for H1 2022, showcasing a revenue increase to RMB34.7 million, up RMB22.5 million from the prior year, largely driven by sales from Hunterase® and Nerlynx®. R&D expenses decreased to RMB158.3 million, leading to a reduced loss of RMB249.0 million. The company initiated three Phase II trials and announced positive Phase I results for CAN106, alongside advancements in its gene therapy platform. Upcoming milestones include potential NDA approval for CAN108 in H1 2023.
Connect Biopharma announced that it can conduct primary analysis of its pivotal trial for CBP-201, targeting moderate-to-severe atopic dermatitis, based on 255 enrolled patients. Top-line results are expected by year-end 2022, earlier than planned. The company aims to initiate pre-NDA discussions in 2024, targeting potential approval in China by 2025. The trial's secondary endpoints include EASI response rates, adding to the anticipation for CBP-201's efficacy against current treatments. The Phase 3 program timeline remains unchanged, with patient enrollment expected by late 2022.
Connect Biopharma Holdings Limited (Nasdaq: CNTB) received notification from Nasdaq regarding a deficiency in its share price, which closed below $1.00 for thirty consecutive business days. The company has until December 13, 2022, to regain compliance with Nasdaq Listing Rule 5550(a)(2). If the share price closes above $1.00 for ten consecutive business days within this period, compliance will be achieved. The company may also be eligible for an additional compliance period if necessary, provided certain conditions are met.