Core Points - Viridian Therapeutics has successfully submitted a Biologics License Application (BLA) for its investigational therapy, veligrotug, to the U.S. FDA for the treatment of thyroid eye disease (TED) [1][2] - The BLA submission is supported by data from two pivotal phase 3 clinical trials, THRIVE and THRIVE-2, which met all primary and secondary endpoints [2][5] - Veligrotug has received Breakthrough Therapy Designation, which may support eligibility for Priority Review by the FDA [1][3] Company Overview - Viridian Therapeutics is a biotechnology company focused on developing potentially best-in-class medicines for serious and rare diseases [1][6] - The company is advancing multiple candidates for TED, including veligrotug and VRDN-003, with ongoing global phase 3 clinical trials [7] - Viridian's expertise in antibody discovery and protein engineering enables the development of differentiated therapeutic candidates [6][8] Clinical Development - Veligrotug is an intravenously delivered anti-insulin-like growth factor-1 receptor (IGF-1R) antibody in phase 3 development for TED [4] - The pivotal trials THRIVE and THRIVE-2 demonstrated a rapid onset of clinical benefit and statistically significant effects on multiple diplopia endpoints [5][7] - The BLA submission aims for a potential commercial launch of veligrotug in mid-2026, contingent on FDA approval [3]

Core Viewpoint - The report from CMB International maintains a "Buy" rating for Kangfang Biotech (09926), highlighting positive overall survival (OS) trends from the HARMONi trial, which enhances confidence in its first-line indication potential [1] Group 1: Clinical Trial Results - The HARMONi trial assessed the efficacy of AK112 combined with chemotherapy versus chemotherapy alone in second-line treatment for third-generation EGFR-TKI resistant NSCLC patients, showing that Western patients had inferior progression-free survival (PFS) risk ratios compared to Chinese patients [1] - In the primary PFS analysis (n=345, median follow-up of 22.3 months), the median PFS for AK112 combined with chemotherapy was 6.8 months compared to 4.4 months for chemotherapy alone (HR=0.52, p<0.001) [2] - In longer follow-up (median 29.7 months), the PFS HR slightly worsened to 0.57, attributed to increased data maturity in Western populations, with North American and European patients showing PFS HR of 0.67 and Chinese patients at 0.55 [2] Group 2: Overall Survival Analysis - In the final OS analysis (n=438, overall median follow-up of 29.7 months), the median OS for the AK112 combined group was 16.8 months versus 14.0 months for the chemotherapy group, with an HR of 0.79 (95% CI: 0.62–1.01, p=0.0570), indicating an overall positive OS trend [3] - In non-predefined longer follow-up (32.7 months), the OS HR improved to 0.78 (95% CI: 0.62–0.98) for the Western patient cohort, with a nominal p-value of 0.0332, emphasizing the importance of mature long-term OS data for evaluating efficacy in Western patients [3] - North American patients showed strong OS results with an HR of 0.70, despite a wide confidence interval (0.38–1.30), while European patients had limited sample size and follow-up time [4]