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Hutchmed

HUTCHMED Reports the P-II/III (ESLIM-02) Trial Data on Sovleplenib for Warm Antibody Autoimmune Hemolytic Anemia at EHA 2026

Shots: HUTCHMED has reported the P-III data (n=90) from P-II/III (ESLIM-02) assessing sovleplenib in in adult patients with primary or secondary wAIHA who had relapsed or were refractory to prior ≥1L of standard treatment; NDA accepted under NMPA priority review in Apr 2026 Trial met its 1EP of improved durable response rates (66% vs 15%),…

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Novartis Reports P-III (RemIND) Trial Data on Remibrutinib for Chronic Inducible Urticaria (CIndU)

Shots: Novartis has reported the topline P-III (RemIND) trial data assessing remibrutinib (PO) vs PBO in adults with CIndU inadequately controlled by H1-antihistamines Trial showed higher CR rates at Wk. 12 across symptomatic dermographism (29.3% vs 14%), cold urticaria (56.3% vs 14.6%), & cholinergic urticaria (29.3% vs 15.8%), with responses emerging as early as Wk.…

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Otsuka Pharmaceutical Reports P-III (VISIONARY) Trial Data on Voyxact for IgA Nephropathy (IgAN)

Shots: Otsuka reported the ongoing P-III (VISIONARY) trial data assessing Voyxact (sibeprenlimab; n= 320) vs PBO (n=152) in preserving kidney function in IgAN pts over a 24mos. treatment period At 12mos., Voyxactimproved kidney function with a mean eGFR change from baseline of +0.7 vs -4.8 mL/min/1.73 m², achieving the KDIGO treatment goal of limiting annual kidney…

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Celcuity

Celcuity Reports the P-III (VIKTORIA-1) Trial Data on Gedatolisib Combination for HR+/HER2- PIK3CA Mutant Advanced Breast Cancer

Shots: Celcuity has reported the PIK3CA mutant cohort data from P-III (VIKTORIA-1) study of gedatolisib + fulvestrant ± palbociclib vs SoC in HR+/HER2- advanced breast cancer pts who progressed on or after treatment with CDK4/6 inhibitor & an aromatase inhibitor In the cohort, the gedatolisib triplet showed mPFS of 11.1 vs. 5.6mos., & an ORR…

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Astrazeneca

AstraZeneca Highlights P-III (SERENA-6) Trial Data on Camizestrant Combination for ESR1 Mutated Advanced Breast Cancer at ASCO’26

Shots: AZ's trial assessed camizestrant (n=157) vs AI (anastrozole/letrozole; n=158), both in combination with CDK4/6 inhibitor in 315 pts with LA/M HR+/HER2- advanced breast cancer harboring ESR1 mutation; filings supported by the trial are under review in the US, EU & Japan Trial showed 24mos. PFS rate of 34.9% vs 14.2% (mPFS: 16.8 vs…

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