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Merck Reports the P-IIb/III (BRUNELLO) Trial Data on Remigromig for Diabetic Macular Edema

Shots: Merck has reported the P-IIb/III (BRUNELLO) trial data assessing remigromig (MK-3000, formerly EYE103;0.5 & 0.8mg, IVT, Q4W) vs 0.5mg ranibizumab (Q4W) in 984 adults with diabetic macular edema (DME)  At 52 wks., both remigromig doses demonstrated non-inferiority to 0.5mg ranibizumab in mean change from baseline in best-corrected visual acuity in pts with DME, with…
September 25, 2026

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NEWS

Astellas Reports First Patient Dosing in P-III Study of Setidegrasib in Previously Treated KRAS G12D-Mutated NSCLC

Shots: Astellas has dosed the first patient in a P-III study assessing setidegrasib vs docetaxel in ~356 pts with KRAS G12D-mutated locally advanced (unresectable) or metastatic NSCLC who progressed on or after initial Pt-based CT & checkpoint inhibitor therapy The P-III study in previously treated NSCLC builds on P-I data published in The NEJM in Mar…
September 24, 2026

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NEWS

Ionis and Roche Report Interim P-III (IMAgINATION) Trial Data on Sefaxersen in IgA Nephropathy (IgAN)

Shots: Ionis & Roche have reported interim P-III (IMAgINATION) trial results assessing sefaxersen (QM, SC) in 459 adults with IgAN for 105wks., after which eligible pts may switch to open-label treatment IMAgINATION met its 1EP, showing improvements in proteinuria reduction at 37wks., as measured by 24hr. UPCR; data to be presented in future & shared with…
September 23, 2026

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Amgen
NEWS

Amgen Reports Topline P-III (OASIZ 301) Trial Data on Dazodalibep for Systemic Sjögren’s Disease

Shots: Amgen has reported topline P-III (OASIZ 301) trial results evaluating dazodalibep vs PBO in adults (n=~621) with Sjögren's disease with mod. to sev. systemic disease activity (ESSDAI ≥ 5) Trial met its 1EP, showing statistically significant & clinically meaningful improvement at Wk. 48, as measured by the ESSDAI, with benefits seen as early as…
September 23, 2026

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Roche
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Roche Reports the P-III (CELESTIMO) Trial Data on Lunsumio in Follicular Lymphoma

Shots: Roche has reported the P-III (CELESTIMO) trial assessing Lunsumio (mosunetuzumab) + lenalidomide vs MabThera + lenalidomide in pts with r/r follicular lymphoma who have received ≥1L of prior systemic therapy Trial met its 1EP, showing a statistically significant & clinically meaningful improvement in PFS, while OS data remained immature at the interim analysis; the…
September 17, 2026

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Arrowhead Pharmaceuticals
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Arrowhead Reports Topline P-I/IIa Trial Data on ARO-DIMER-PA for Mixed Hyperlipidemia

Shots: Arrowhead has reported P-I/IIa (ARO-DIMER-PA-1001) study data assessing the safety, tolerability, PK, PD, & effects on LDL-C and TGs of single-dose (part 1) & multiple doses (part 2) of ARO-DIMER-PA in ~78 adults with mixed hyperlipidemia ARO-DIMER-PA single doses produced dose-dependent mean maximal reductions in serum PCSK9 of 72% & APOC3 of 88%, along with…
September 17, 2026

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