HUTCHMED Reports P-III Trial Data on Orpathys + Tagrisso for Previously Untreated MET-Overexpressing EGFRm NSCLC

Shots: The P-III (SANOVO) trial assessed Orpathys (300 or 200mg, BID) + Tagrisso (80mg, QD) vs Tagrisso in 326 treatment-naïvepts with locally advanced or metastatic NSCLC harboring EGFR mutations (exon 19 deletion or L858R) & MET overexpression The combination significantly improved PFS in both high-MET and ITT populations, while also showing encouraging OS benefit; follow-up…

ByRidhi Rastogi1 day ago

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Novartis Reports P-III (REMODEL-1/-2) Trial Data on Remibrutinib for Relapsing Multiple Sclerosis

Shots: Novartis has reported topline data from P-III (REMODEL-1/-2) trials assessing remibrutinib (100mg) vs teriflunomide in ~2,000 adults with relapsing multiple sclerosis (RMS) Remibrutinib met the 1EP, significantly reducing annualized relapse rate (ARR), plus trial showed clinically meaningful reductions in key 2EPs related to disability progression, with a positive trend in 3mCDP & nominally significant…

ByRidhi Rastogi1 day ago

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Arrowhead Reports P-III (SHASTA-3 & 4) Trial Data on Redemplo (Plozasiran) for Severe Hypertriglyceridemia at ESC’26

Shots: P-III (SHASTA-3 & 4) trials, assessing Redemplo (25mg, SC, Q3M) vs PBO in sHTG adults (n=757), met their 1 & 2EPs, showing median TG reductions of 79% & 81%, respectively, at 12mos. In pts with TG ≥880mg/dL, median TG reductions were 85% in both trials At 12mos., Redemplo enabled 91% & 93% pts in…

ByRidhi Rastogi2 days ago

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Daiichi Sankyo Doses First Patient in the P-I Trial with DS1025 for Advanced Solid Tumors

Shots: Daiichi Sankyo has dosed the first patient in the P-I trial with DS1025 for the treatment of advanced or metastatic solid tumors with disease progression on or after ≥1 prior line of standard therapy The P-I trial of DS1025 will evaluate safety, tolerability, PK & preliminary efficacy above-mentioned pts (n=~45), assessing safety & tolerability,…

ByRidhi RastogiAugust 28, 2026

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AstraZeneca and Amgen Report P-III (CROSSING) Trial Data on Tezspire for Eosinophilic Esophagitis

Shots: Amgen & AstraZeneca have reported the top-line P-III (CROSSING) trial results assessing Tezspire at one of two doses (tezepelumab-ekko; SC, Q4W) vs PBO in pts living with eosinophilic esophagitis (EoE) Trial showed improvements across co-1EPs (histologic remission, and the frequency & severity of dysphagia) & key 2EPs at Wk. 24 which were sustained through Wk. 52; data…

ByRidhi RastogiAugust 27, 2026

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Akeso and Summit Report P-III (HARMONi-GI1) Trial Data on Ivonescimab + CT for 1L Advanced Biliary Tract Cancer

Shots: Akeso and Summit have reported interim analysis from the P-III (AK112-309/HARMONi-GI1) trial assessing ivonescimab + CT vs durvalumab + CT for the 1L treatment of advanced biliary tract cancer (BTC) Trial met its 1EP of OS, plus achieved all key 2EPs of PFS & ORR; data will be presented at the academic conference & published…

ByRidhi RastogiAugust 26, 2026

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VarmX Enrolls First Patient in P-III (EquilibriX-S) Trial of VMX‑C001 in Urgent Surgery

Shots: VarmX has enrolled the first pt in the global registrational P-III (EquilibriX-S) study assessing VMX-C001 vs usual pharmacologic care in pts receiving FXa inhibitors who require urgent surgery/procedures EquilibriX-S, a randomized, controlled trial is expected to recruit pts across >20 countries and assess whether a single IV dose of VMX-C001 rapidly restores hemostasis, with…

ByDipanshu DixitAugust 21, 2026

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Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

Shots: The P-III (LUCIDITY) trial assessed avexitide (90mg, SC, QD) vs PBO in 78 adults with Post-Bariatric Hypoglycemia (PBH) following Roux-en-Y gastric bypass (RYGB) surgery Trial met its 1EP, showing a 55% reduction in the composite rate of Level 2 & Level 3 hypoglycemic events through Wk. 16. All 2EPs were also met, with consistent, highly…

ByRidhi RastogiAugust 18, 2026

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argenx Reports Topline P-III (ALKIVIA) Trial Data on Vyvgart Hytrulo in Autoimmune Myositis

Shots: The P-II/III (ALKIVIA) trial assessed Vyvgart Hytrulo (SC, QW) vs PBO PH20 (SC) for the treatment of pts (n=264) with autoimmune myositis across immune-mediated necrotizing myopathy (IMNM), dermatomyositis (DM) & PM The study met its 1EP, with Vyvgart Hytrulo delivering a 15.4-point greater improvement in mean TIS at Wk. 52 in IMNM & DM pts…

ByRidhi RastogiAugust 17, 2026

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Daiichi Sankyo and AstraZeneca Report P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2 Mutant Non-Squamous NSCLC

Shots: Daiichi Sankyo & AZ have reported P-III (DESTINY-Lung04) trial data assessing Enhertu (5.4mg/kg) vs SoC (Pt-pemetrexed doublet CT + Keytruda) in 454 pts with unresectable, locally advanced or metastatic, nsq-NSCLC harboring a HER2 exon 19 or 20 mutation Trial showed that Enhertu improved PFS as 1L treatment, with trial continuing to evaluate 2EPs incl. OS;…

ByRidhi RastogiAugust 17, 2026

HUTCHMED Reports P-III Trial Data on Orpathys + Tagrisso for Previously Untreated MET-Overexpressing EGFRm NSCLC

Novartis Reports P-III (REMODEL-1/-2) Trial Data on Remibrutinib for Relapsing Multiple Sclerosis

Arrowhead Reports P-III (SHASTA-3 & 4) Trial Data on Redemplo (Plozasiran) for Severe Hypertriglyceridemia at ESC’26

Daiichi Sankyo Doses First Patient in the P-I Trial with DS1025 for Advanced Solid Tumors

AstraZeneca and Amgen Report P-III (CROSSING) Trial Data on Tezspire for Eosinophilic Esophagitis

Akeso and Summit Report P-III (HARMONi-GI1) Trial Data on Ivonescimab + CT for 1L Advanced Biliary Tract Cancer

VarmX Enrolls First Patient in P-III (EquilibriX-S) Trial of VMX‑C001 in Urgent Surgery

Amylyx Pharmaceuticals Reports Topline P-III (LUCIDITY) Trial Data on Avexitide in Post-Bariatric Hypoglycemia

argenx Reports Topline P-III (ALKIVIA) Trial Data on Vyvgart Hytrulo in Autoimmune Myositis

Daiichi Sankyo and AstraZeneca Report P-III (DESTINY-Lung04) Trial Data on Enhertu for HER2 Mutant Non-Squamous NSCLC

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