2026 could be a pivotal year for Zura Bio Ltd. (ZURA), with key data readouts for its lead investigational drug expected to significantly influence the company's strategic direction and market position.Zura is a clinical-stage, multi-asset immunology company advancing treatments for immune-mediated diseases where there is an unmet medical need. Its lead product candidate is Tibulizumab, a potential first-in-class dual-pathway biologic designed to target cytokines IL-17A and BAFF. Tibulizumab is currently b ...

Core Insights - Sanofi's brivekimig demonstrated positive results in the HS-OBTAIN phase 2a study for treating moderate-to-severe hidradenitis suppurativa (HS), showing clinically meaningful improvements in the primary endpoint of Hidradenitis Suppurativa Clinical Response (HiSCR50) [1][3][6] - The study indicated that brivekimig was well tolerated, with no serious adverse events reported [1][4] - The results will be presented at the European Academy of Dermatology and Venereology (EADV) 2025 Congress in Paris [1] Study Details - The HS-OBTAIN study was a randomized, double-blind, placebo-controlled trial assessing the efficacy and safety of brivekimig in biologic-naïve adults with moderate-to-severe HS [3][8] - Patients were randomized 2:1 to receive brivekimig 150 mg or placebo subcutaneously every two weeks for 16 weeks, followed by a 12-week open-label period and an 8-week safety follow-up [9] - The primary efficacy endpoint was the percentage of participants achieving HiSCR50 at week 16, with additional endpoints including HiSCR75, HiSCR90, and draining tunnel count [9] Efficacy Results - At week 16, 67% of patients in the brivekimig group achieved HiSCR50 compared to 37% in the placebo group, with a probability of superiority of 99.28% [7] - For HiSCR75, 54% of patients treated with brivekimig achieved this endpoint versus 22% with placebo [7] - HiSCR90 was achieved by 31% of patients in the brivekimig group compared to 9% in the placebo group [7] - The mean percent change from baseline in draining tunnel count was -56.0% for brivekimig versus +10.9% for placebo [7] Company Commitment - Sanofi emphasizes its commitment to addressing underlying inflammation in chronic inflammatory skin diseases through innovative treatments like brivekimig [5][6] - The company is exploring brivekimig's potential across a range of immune-mediated diseases [6][10]

Core Insights - Alumis Inc. has completed patient enrollment in pivotal clinical trials for its investigational therapy envudeucitinib, with topline data expected in early Q1 2026 for plaque psoriasis and Q3 2026 for systemic lupus erythematosus [1][2][5] - The company has successfully merged with ACELYRIN, Inc., enhancing its financial position and supporting the advancement of its late-stage immunology pipeline [1][2][7] - As of June 30, 2025, Alumis reported cash, cash equivalents, and marketable securities totaling $486.3 million, which is expected to fund operations into 2027 [1][10] Clinical Development - The Phase 3 ONWARD program for envudeucitinib includes two parallel global trials designed to evaluate its efficacy and safety in adult patients with moderate-to-severe plaque psoriasis, with topline data expected in early Q1 2026 [5][8] - The Phase 2b LUMUS trial for systemic lupus erythematosus has enrolled 408 patients, with topline data anticipated in Q3 2026 [5][8] Financial Performance - For the quarter ended June 30, 2025, Alumis reported total revenue of $2.7 million, primarily from collaboration revenue, compared to no revenue in the same quarter of 2024 [7][15] - Research and development expenses increased to $108.8 million for Q2 2025, up from $48.6 million in Q2 2024, driven by clinical trial costs and merger-related expenses [7][15] - The company recorded a net income of $59.3 million for Q2 2025, including a non-operating gain of $187.9 million from the merger with ACELYRIN, compared to a net loss of $56.5 million in Q2 2024 [7][15] Corporate Developments - The merger with ACELYRIN has strengthened Alumis' balance sheet, allowing for the advancement of its late-stage pipeline through multiple planned key data readouts [6][9] - The company has appointed Sanam Pangali as Chief Legal Officer and Corporate Secretary, bringing nearly two decades of legal expertise [6][8] Pipeline Updates - Alumis is advancing A-005, a fully CNS-penetrant TYK2 inhibitor, towards Phase 2 clinical trials for multiple sclerosis, expected to initiate in the first half of 2026 [8] - The company is also developing lonigutamab, a next-generation therapy for thyroid eye disease, which has received Fast Track Designation from the FDA [8][11]

Core Insights - Climb Bio, Inc. has received FDA clearance for clinical trials of its lead asset, budoprutug, targeting primary membranous nephropathy (pMN), immune thrombocytopenia (ITP), and systemic lupus erythematosus (SLE) [1][3] - The company has expanded its pipeline to include CLYM116, an anti-APRIL monoclonal antibody for IgA nephropathy (IgAN) [2][3] - Climb Bio ended 2024 with a strong financial position, reporting cash and equivalents of $212.5 million, expected to fund operations through 2027 [6][12] Company Developments - Climb Bio appointed Perrin Wilson, Ph.D. as Chief Business Officer, bringing over 17 years of experience in the pharmaceutical and biotech industry [4] - The company has initiated clinical trials for budoprutug in pMN and ITP, with plans to dose the first patients in the second half of 2025 and the first half of 2025, respectively [2][7] - CLYM116 is currently in IND-enabling studies, with initial preclinical data expected to be shared in the second half of 2025 [2][3] Financial Performance - For the year ended December 31, 2024, Climb Bio reported a net loss of $73.9 million, which included $51.7 million in acquired in-process research and development expenses [6][14] - Research and development expenses for the full year 2024 were $14.3 million, compared to $15.4 million in 2023 [6][14] - General and administrative expenses for the full year 2024 were $16.0 million, down from $24.9 million in 2023 [6][14]