Novartis Reports del-desiran P-III HARBOR Study Data in Myotonic Dystrophy Type 1

Shots: Novartis announced that the P-III HARBOR study of delpacibart etedesiran (del-desiran) in people with myotonic dystrophy type 1 (DM1) did not meet its 1EP of video hand opening time (vHOT) Del-desiran showed evidence of clinical activity in 2EPs and exploratory analyses, while safety findings were generally consistent with previously reported data; Novartis is evaluating…

ByPrince GiriSeptember 8, 2026

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Upstream Bio Reports P-II VALIANT Data for Verekitug in Severe Asthma

Shots: Upstream Bio presented results from the P-II VALIANT study evaluating verekitug in 478 adults with severe asthma, with the study meeting its 1EP of reducing the annualized asthma exacerbation rate (AAER) across all dose regimens. Verekitug 100 mg dosed every 12 wks. reduced AAER by 56% vs. PBO (p<0.001) and also improved lung function…

ByPrince GiriSeptember 8, 2026

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Nyxoah Implants First Patient in BREATHE US Post-Approval Study of Genio System

Shots: Nyxoah announced the first patient implantation in BREATHE, its US post-approval study evaluating the long-term safety and effectiveness of the Genio System in adults with moderate to severe obstructive sleep apnea (OSA) The prospective, multicenter study plans to implant up to 229 pts. across up to 25 US centres, with follow-up for up to…

ByPrince GiriSeptember 8, 2026

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Novo Nordisk Reports the P-III (STEP Young) Trial Data on Semaglutide to Treat Children Living with Obesity

Shots: Novo Nordisk has reported the P-III (STEP Young) trial data assessing semaglutide (1.7 or 2.4mg based on weight at start of trial; QW, SC) vs PBO in 165 children (6 to <12yrs.) with obesity, both in combination with a reduced-calorie diet & increased physical activity Trial met its 1EP of superior BMI reduction at…

ByRidhi RastogiSeptember 7, 2026

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Novartis Reports the P-III (Lp(a)HORIZON) Trial Data on Pelacarsen in Patients with Elevated Lp(a) and Established CV Disease

Shots: Novartis has reported the topline P-III (Lp(a)HORIZON) trial data assessing pelacarsen vs PBO on the incidence of 4-point major adverse CV events (MACE) in 8,323 pts with elevated Lp(a) & established CVD Pelacarsen did not meet its 1EP of reducing major CV events, despite lowering Lp(a) levels in pts receiving guideline-directed lipid-lowering & antihypertensive…

ByRidhi RastogiSeptember 7, 2026

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AbbVie Reports the Topline P-III (CERVINO) Trial Data on Etentamig for R/R Multiple Myeloma

Shots: AbbVie has reported the P-III (CERVINO) trial assessing etentamig (Q4W) vs standard available therapies in pts with R/R MM who have received ≥2 prior lines of therapy, incl. exposure to a proteasome inhibitor, an immunomodulatory drug & an anti-CD38 mAb At the mFU of 11.4mos. (n=393 pts; median 3 prior lines), trial met its dual 1EPs…

ByRidhi RastogiSeptember 4, 2026

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Teva Reports Topline P-IIa Trial Results on TEV ‘408 in Celiac Disease

Shots: Teva has reported topline P-IIa trial results assessing TEV ‘408 in adults with celiac disease on a gluten-free diet (GFD) with minimal intestinal damage; additional analyses are underway The trial met its 1EP, showing prevention of gluten-induced intestinal damage at Wk. 8 following a single SC dose & improving Vh:Cd ratio, with least squares (LS)…

ByRidhi RastogiSeptember 3, 2026

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Akeso and Summit Report P-III (HARMONi-2) Trial Data on Ivonescimab for PD-L1-Positive Advanced NSCLC

Shots: Akeso and Summit has reported the P-III (HARMONi-2/AK112-303) trial data assessing ivonescimab monotx. vs Keytruda in Chinese pts with locally advanced or metastatic NSCLC whose tumors have positive PD-L1 expression Trial showed improvement in OS (2EP), with results to be presented in future. In the primary analysis, trial met it 1EP of improved PFS,…

ByRidhi RastogiSeptember 3, 2026

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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 RastogiSeptember 1, 2026

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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 RastogiSeptember 1, 2026

Novartis Reports del-desiran P-III HARBOR Study Data in Myotonic Dystrophy Type 1

Upstream Bio Reports P-II VALIANT Data for Verekitug in Severe Asthma

Nyxoah Implants First Patient in BREATHE US Post-Approval Study of Genio System

Novo Nordisk Reports the P-III (STEP Young) Trial Data on Semaglutide to Treat Children Living with Obesity

Novartis Reports the P-III (Lp(a)HORIZON) Trial Data on Pelacarsen in Patients with Elevated Lp(a) and Established CV Disease

AbbVie Reports the Topline P-III (CERVINO) Trial Data on Etentamig for R/R Multiple Myeloma

Teva Reports Topline P-IIa Trial Results on TEV ‘408 in Celiac Disease

Akeso and Summit Report P-III (HARMONi-2) Trial Data on Ivonescimab for PD-L1-Positive Advanced NSCLC

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

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