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 Giri4 days ago

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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 Rastogi5 days ago

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Novartis and Alteogen Partner for ALT-B4 to Advance SC Formulations of Multiple Products

Shots: Alteogen has entered into an option & license agreement with Novartis for the development & commercialization of SC products leveraging ALT-B4 powered by Alteogen's Hybrozyme tech As per the deal, Novartis can obtain exclusive rights to develop & commercialize SC formulations of multiple products using Alteogen’s ALT-B4, with Alteogen eligible for ~$3.223B in option…

ByRidhi RastogiSeptember 3, 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

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Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Shots: The US FDA has approved Pluvicto (lutetium Lu 177 vipivotide tetraxetan) with an androgen receptor pathway inhibitor (ARPI) for pts with PSMA+ metastatic androgen pathway modulation-naive/sensitive (mAPMN/S) prostate cancer Approval was based on the P-III (PSMAddition) trial, which showed Pluvicto + ARPI & ADT reduced the risk of progression or death by 28% vs SoC…

ByRidhi RastogiAugust 3, 2026

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Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Shots: The US FDA has granted traditional approval to Fabhalta (iptacopan) for slowing kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression Approval was based on the P-III (APPLAUSE-IgAN) trial, where Fabhalta slowed eGFR decline by 48% vs PBO over 2yrs., with an annualized mean change from baseline…

ByRidhi RastogiJuly 17, 2026

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Novartis to Acquire Myricx Bio for ~$1.5B

Shots: Novartis has entered into an agreement to acquire Myricx Bio, strengthening Novartis’ oncology pipeline & advancing next-generation targeted drug conjugates with novel payload mechanisms Myricx is developing ADCs, using NMT inhibitor (NMTi) payloads designed to disrupt key cancer cell processes, with preclinical data showing broad activity across solid tumors, incl. TOPO-1-resistant models As per…

ByRidhi RastogiJuly 6, 2026

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Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Shots: The EC has approved Novartis' Itvisma (onasemnogene abeparvovec) for the treatment of pts (≥2yrs.) living with 5q spinal muscular atrophy (SMA) harboring a confirmed bi-allelic mutation in the SMN1 gene Approval was based on the P-III (STEER) trial & supportive P-IIIb (STRENGTH) & P-I/II (STRONG) studies, where STEER showed a 2.39-point improvement in the…

ByRidhi RastogiJuly 2, 2026

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Antares Therapeutics Inks ~$1.9B Deal with Novartis for Undruggable Oncology Targets

Shots: Antares Therapeutics has entered into a strategic collaboration with Novartis to discover, develop & commercialize small molecule therapies against undruggable oncology targets Antares will lead research & apply its discovery engine to a select number of historically undruggable targets until option exercise, while continuing to advance its wholly owned & partnered precision medicine pipeline…

ByRidhi RastogiJune 25, 2026

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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.…

ByRidhi RastogiJune 12, 2026

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

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

Novartis and Alteogen Partner for ALT-B4 to Advance SC Formulations of Multiple Products

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

Novartis Reports the US FDA Approval of Pluvicto for mHSPC

Novartis Reports the US FDA’s Traditional Approval of Fabhalta to Treat Primary IgAN

Novartis to Acquire Myricx Bio for ~$1.5B

Novartis’ Itvisma Receives the EC Approval for Spinal Muscular Atrophy

Antares Therapeutics Inks ~$1.9B Deal with Novartis for Undruggable Oncology Targets

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

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