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Belite Bio Reports Topline P-III (DRAGON) Trial Data on Tinlarebant for Stargardt Disease Type 1 (STGD1)

Shots: Trial assessed tinlarebant (5mg, QD, PO; n=69) vs PBO (n=35) in 104 STGD1 pts (12-20yrs.), meeting its 1EP of 36% reduction in lesion growth per retinal imaging, quantified as 35.7% using the pre-specified MMRM model & confirmed at 35.4% with a post-hoc autoregressive-MMRM analysis Trial also showed reduced lesion growth rate by 33.6% in fellow…
December 2, 2025

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Celltrion
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Celltrion Reports Post-Hoc Analysis of P-III (LIBERTY-CD) Trial of Zymfentra (Infliximab-dyyb) in Crohn’s Disease Across Disease Locations

Shots: Celltrion has reported post-hoc analysis of the P-III (LIBERTY-CD) study of Zymfentra (infliximab-dyyb; SC) vs PBO in pts with mod. to sev. Crohn's disease, which has been published in the Clinical Gastroenterology and Hepatology Among 329 pts, 52.6% had colon-dominant (n=173) & 47.4% ileum-dominant CD (n=105); at Wk. 54, infliximab SC showed superior efficacy…
November 27, 2025

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Renalys Pharma Reports the Topline P-III Trial Data of Sparsentan for Japanese Patients with IgA Nephropathy

Shots: Renalys Pharma has reported topline P-III trial data assessing sparsentan (RE-021; PO) in Japanese pts with IgA nephropathy, with MHLW’s NDA submission based on trial results planned in 2026 Trial met its 1EP, with a least-squares geometric mean UPCR reduction of 58.54% after 36wks. in Japanese IgAN pts (N=35) & showed favorable safety Additionally,…
November 26, 2025

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Kelun Biotech
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Kelun-Biotech Reports P-III (OptiTROP-Lung05) Trial Data on Sacituzumab Tirumotecan + Keytruda for PD-L1-Positive NSCLC

Shots: Kelun-Biotech has reported P-III (OptiTROP-Lung05) trial data assessing sacituzumab tirumotecan (sac-TMT/SKB264/MK-2870) + Keytruda vs Keytruda monotx. as a 1L treatment for PD-L1-positive locally advanced or metastatic NSCLC with PD-L1 TPS ≥1% The trial met its 1EP of improved PFS, as concluded by IDMC & showed a favorable trend in the OS Additionally, the company…
November 25, 2025

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Bayer
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Bayer Reports Topline P-III (OCEANIC-STROKE) Trial Data on Asundexian for Secondary Stroke Prevention

Shots: Bayer has reported P-III (OCEANIC-STROKE) trial data assessing asundexian (50mg, QD, PO) vs PBO, both in combination with antiplatelet therapy, in pts (n=12,300) for prevention of ischemic stroke after a non-cardioembolic ischemic stroke or high-risk transient ischemic attack Trial met its primary efficacy & safety EPs, with a significant reduction in the risk of…
November 24, 2025

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Merck new
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Merck Reveals Topline P-III (MK-8591A-053) Trial Data on Doravirine/Islatravir to Treat HIV-1 Infection

Shots: The P-III (MK-8591A-053) trial data assessed 100mg doravirine/0.25mg islatravir (DOR/ISL; QD, PO) vs 50mg bictegravir/200mg emtricitabine/25mg tenofovir alafenamide (BIC/FTC/TAF; QD, PO) ) in treatment-naïve adults with HIV-1 infection (n=537) Trial met its primary efficacy hypothesis, with DOR/ISL showing non-inferiority to BIC/FTC/TAF in achieving HIV-1 RNA <50 copies/mL at Wk. 48, & also achieved its…
November 20, 2025

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