Novartis (NYSE: NVS) is the Basel-headquartered pharmaceutical major whose peptide-relevant coverage anchors on the Pluvicto (lutetium-177 vipivotide tetraxetan) and Lutathera (lutetium-177 dotatate) peptide-radioconjugate franchise, plus a growing set of Phase 3 and commercial programs across oncology, cardiovascular, and neuroscience.
On Tuesday September 1, 2026, Novartis announced that both the REMODEL-1 and REMODEL-2 Phase 3 trials of remibrutinib (an oral selective Bruton's tyrosine kinase inhibitor) met their primary endpoints in relapsing multiple sclerosis, with statistically significant reductions in annualized relapse rate versus teriflunomide and a clean liver-safety profile across the 4,500-plus-patient program. Novartis shares rose more than 4% on the news, and full REMODEL data will be presented at MSToronto2026 (ECTRIMS-ACTRIMS joint meeting) October 21-23.
On Friday September 4, 2026, Novartis announced that the pelacarsen Phase 3 Lp(a)HORIZON trial (partnered with Ionis and Royalty Pharma) did not meet its primary endpoint of reducing major adverse cardiovascular events in patients with elevated lipoprotein(a) plus established cardiovascular disease, despite achieving substantial Lp(a) reduction. The 8,000-patient trial was the largest test to date of the Lp(a)-as-causal-cardiovascular-risk-factor hypothesis, and the miss reshapes the framework for Amgen olpasiran, Silence Therapeutics zerlasiran, and Lilly lepodisiran programs. Two days earlier, on Wednesday September 2, Novartis signed an option and license agreement worth up to $3.22 billion with Korean biotech Alteogen for the ALT-B4 (berahyaluronidase alfa) subcutaneous-conversion platform.
Other recent moves: the $1.4 billion Tourmaline Bio acquisition brought pacibekitug (an anti-IL-6 monoclonal antibody) into the pipeline, and Novartis has stated Phase 3 commitment to the cardiovascular risk reduction indication despite Novo Nordisk's ZEUS ziltivekimab Phase 3 miss at ESC 2026. The $12 billion Avidity Biosciences acquisition brought a portfolio of RNAi drug-delivery-to-muscle-tissue programs (facioscapulohumeral muscular dystrophy, DM1 myotonic dystrophy, Duchenne). The peptide-radioligand franchise continues to expand with new manufacturing sites in Indianapolis, Zaragoza, Ivrea, and New Jersey.
On Friday September 18, 2026, the CHMP adopted a positive opinion for Cosentyx (secukinumab) in adults with polymyalgia rheumatica (PMR) who have had an inadequate response to steroids or who relapse during steroid taper. Novartis says Cosentyx would be the first IL-17A inhibitor licensed in Europe for PMR. The opinion rests on the Phase III REPLENISH trial, which met all primary and secondary endpoints in both the 300 mg and 150 mg arms; Cosentyx doubled sustained remission rates and reduced steroid use versus placebo, with no new safety signals. A European Commission decision is expected within about two months.
Stories here cover Novartis trial readouts, franchise commercial performance, and platform integration. See [[remibrutinib]], [[pluvicto]], and [[pacibekitug]] for adjacent threads.
BoomRay Pharmaceuticals, a radioligand developer based in Suzhou, China, said on September 22, 2026 that Novartis took an exclusive worldwide license to an undisclosed preclinical radioligand therapy asset. BoomRay can receive up to $900 million, including an upfront payment and development, regulatory, and sales milestones, plus royalties on net sales; the upfront amount, target, isotope, and indication were not disclosed. Novartis global oncology head Shiva Malek said the asset complements the company's radioligand portfolio, which includes the peptide-based Lutathera and the PSMA-targeted Pluvicto. The license was announced one day after the Telix–ITM merger.
Novartis announced on Friday, September 18, 2026 that the CHMP adopted a positive opinion for Cosentyx (secukinumab) to treat polymyalgia rheumatica (PMR) in adults who have had an inadequate response to steroids or who relapse during steroid taper. Novartis says Cosentyx would be the first IL-17A inhibitor licensed in Europe for PMR. The opinion is based on the global Phase III REPLENISH trial, run in 27 countries, in which all primary and secondary endpoints were met across both the 300 mg and 150 mg arms; Cosentyx doubled sustained remission rates and delivered steroid-sparing effects versus placebo, with no new safety signals. The data were published in the New England Journal of Medicine, and the European Commission is expected to decide within about two months.
Novartis (NYSE: NVS) initiated clinical holds on all rap-cel (YTB323, an autologous CD19-directed CAR-T cell therapy) autoimmune trials on August 24, 2026 following three fatal cases of immune effector cell-associated hemophagocytic syndrome, a rare life-threatening inflammatory reaction. Affected trials cover lupus (systemic lupus erythematosus), myasthenia gravis, multiple sclerosis, systemic sclerosis, idiopathic inflammatory myopathies, and additional autoimmune indications. Bristol Myers Squibb (NYSE: BMY) voluntarily paused enrollment in its own zola-cel (zolacabtagene autoleucel, another autologous CD19 CAR-T) autoimmune trials after detecting transient and reversible inflammatory events during routine safety surveillance; BMS had halted the enrollment in June 2026 after cases of brain inflammation but did not publicly disclose the pause until three months later. Novartis and BMS were the leading commercial-scale CAR-T-in-autoimmune-disease players; the paired pauses are a substantial setback for the category, which had been the hottest cell-therapy expansion area of 2026 after Kyverna, Cabaletta Bio, and multiple academic centers reported dramatic clinical responses in refractory lupus and neurological autoimmune disease.
Novartis (NYSE: NVS) announced Friday September 4, 2026 that the pelacarsen Phase 3 Lp(a)HORIZON trial did not meet its primary endpoint of reducing major adverse cardiovascular events (a composite of cardiovascular death, non-fatal myocardial infarction, non-fatal stroke, and urgent coronary revascularization requiring hospitalization) versus placebo in patients with elevated lipoprotein(a) plus established cardiovascular disease on guideline-directed background therapy including lipid-lowering and antihypertensive medications. Pelacarsen (an antisense oligonucleotide targeting hepatic APO(a) production, licensed from Ionis Pharmaceuticals in 2019) did achieve substantial lower Lp(a) levels versus placebo. The trial enrolled roughly 8,000 patients globally over 6 years and represents the largest and most consequential test to date of the Lp(a)-as-causal-cardiovascular-risk-factor hypothesis. The miss substantially raises the bar for Amgen's olpasiran (RNAi, Phase 3 OCEAN(a) ongoing), Silence Therapeutics's zerlasiran (RNAi), and Lilly's lepodisiran (RNAi) — all of which are testing similar Lp(a)-lowering-plus-cardiovascular-outcome frameworks. Ionis and Royalty Pharma both hold economic interests in pelacarsen.
Alteogen (KOSDAQ: 196170) announced Wednesday September 2, 2026 an option and license agreement with Novartis (NYSE: NVS) for the development and commercialization of subcutaneous formulations of multiple Novartis products using Alteogen's ALT-B4 (berahyaluronidase alfa) enabled by the proprietary Hybrozyme technology. Terms: up to $3.22 billion in aggregate potential value including option exercise fees, development and commercial milestone payments, plus royalties on net sales. ALT-B4 temporarily depolymerizes hyaluronan in the extracellular matrix, enabling co-administered biologics to disperse and absorb subcutaneously rather than requiring intravenous infusion. The transaction is Alteogen's fourth Hybrozyme deal in 2026 following prior agreements with Merck KGaA, Sanofi, and one undisclosed global pharma. The technology approach mirrors Halozyme Therapeutics's ENHANZE platform (used in Roche's SC Herceptin, Rituxan, and Ocrevus, plus Bristol Myers Squibb's SC Opdivo and Johnson & Johnson's SC Darzalex), and the SC-conversion category has become an anchor commercial strategy for pharma companies looking to extend patent life and improve patient convenience on established IV biologics.
Novartis (NYSE: NVS) shares rose more than 4% Tuesday September 1 and continued climbing Wednesday September 2, 2026 following the twin REMODEL-1 and REMODEL-2 Phase 3 wins of remibrutinib (an oral BTK inhibitor) in relapsing multiple sclerosis, which met both primary endpoints versus teriflunomide with a clean liver-safety profile across the 4,500+ patient program. Investor focus now turns to two additional Novartis growth-vehicle programs: pacibekitug (an anti-IL-6 monoclonal antibody acquired in the $1.4 billion Tourmaline Bio acquisition earlier in 2026) advancing into Phase 3 for cardiovascular risk reduction despite Novo Nordisk's ZEUS ziltivekimab Phase 3 miss at ESC 2026 last weekend; and the ongoing integration of the $12 billion Avidity Biosciences acquisition centered on RNAi drug delivery to muscle tissue for facioscapulohumeral muscular dystrophy, DM1 myotonic dystrophy, and Duchenne muscular dystrophy programs. Novartis Q3 2026 earnings release is scheduled for late October.
Novartis (NYSE: NVS) announced Tuesday September 1, 2026 that the twin REMODEL-1 and REMODEL-2 Phase 3 trials of remibrutinib (an oral, selective, high-efficacy Bruton's tyrosine kinase inhibitor) met both primary endpoints in relapsing multiple sclerosis, with remibrutinib demonstrating statistically significant superiority versus teriflunomide (Aubagio) in reducing annualized relapse rate (ARR) and inflammatory brain MRI lesions. Key secondary endpoints related to disability progression trended in favor of remibrutinib, with nominal significance in 6-month confirmed disability progression (6mCDP) in a preplanned pooled analysis. Safety was clean: no liver-safety signal and no cases meeting Hy's Law criteria across a broader remibrutinib development program that has now enrolled more than 4,500 participants across neurologic and immune-mediated indications. Full REMODEL-1/-2 data will be presented at MSToronto2026 (ECTRIMS-ACTRIMS joint meeting, October 21-23, Toronto). Regulatory submissions will follow. The readout positions remibrutinib as a potential oral option in a category currently anchored by injectable anti-CD20 therapies (Ocrevus, Kesimpta, Briumvi) plus Sanofi's Aubagio and the sphingosine-1-phosphate receptor modulators.
Novartis (NYSE: NVS) reiterated at ESC Congress 2026 Saturday August 29 that it will advance the Phase 3 program for pacibekitug (an anti-IL-6 monoclonal antibody acquired from Tourmaline Bio through the $1.4 billion acquisition completed earlier in 2026) for cardiovascular risk reduction in inflammation-driven disease, notwithstanding the Phase 3 ZEUS trial failure of Novo Nordisk's ziltivekimab announced the same weekend. Novartis's stance is that ZEUS was underpowered in the specific ASCVD-plus-CKD-plus-inflammation subgroup rather than a class-level miss for IL-6 blockade, and that pacibekitug's differentiated pharmacokinetic profile (longer half-life and less frequent dosing) plus the differently-selected patient population in the planned Phase 3 will allow the mechanism to prove out. The commitment is a $1.4 billion acquisition-scale bet against the base-rate signal from ZEUS and continues the pattern of large pharma anti-inflammatory cardiovascular pipeline commitment following the earlier successful CANTOS canakinumab (IL-1β) proof of concept.
PeptiDream Inc. (TSE: 4587), the Kawasaki-based peptide discovery platform company, announced the appointment of three new Executive Vice Presidents. The leadership restructure accompanies the company's multi-year deal-book growth and the increasing preclinical-to-clinical progression of its partnered peptide programs. Company background: PeptiDream operates the Peptide Discovery Platform System (PDPS), a proprietary technology for designing constrained cyclic peptides. PDPS uses genetic-code reprogramming to generate trillion-scale diverse libraries of non-standard peptides (containing modified amino acids not found in natural proteins), which are then screened to identify molecules that bind target proteins with high affinity and specificity. Applications span oncology (peptide-drug conjugates, radioligand-conjugated peptides), immunology (novel immune-modulating peptides), and rare disease peptide drug development. Partnership book: PeptiDream has active collaborations with Novartis (multiple targets), Merck (peptide-radioligand programs), Genentech/Roche (immuno-oncology), AbbVie (multiple targets), Bristol Myers Squibb, Eli Lilly (including the recent obesity-adjacent partnership), and multiple mid-cap biopharmaceutical companies. The constrained cyclic peptide modality PeptiDream specializes in sits between traditional linear peptides (subject to protease degradation and short half-lives) and small-molecule drugs (limited target diversity), and has grown as a distinct drug modality throughout the 2020s as GLP-1 and other peptide successes have expanded the industry's willingness to invest in peptide chemistry platforms.
Vertex Pharmaceuticals' (NASDAQ: VRTX) povetacicept, a BAFF/APRIL-blocking fusion protein for primary IgA nephropathy, has US FDA acceptance of its Biologics License Application with a PDUFA target action date of November 30, 2026. Povetacicept works through the same mechanism as Vera Therapeutics' TRUTAKNA (atacicept-vymj), targeting the BAFF and APRIL cytokines that drive plasma-cell antibody production. Phase 3 topline data reported in March 2026 showed a 49.8% reduction in urine protein-creatinine ratio (UPCR) at 36 weeks in povetacicept-treated patients versus placebo (versus 45.7% for TRUTAKNA in the ORIGIN Phase 3). BioSpace analysis published this weekend characterizes the Vertex program as derisked following the Vera TRUTAKNA approval on July 7 and the Novartis Fabhalta traditional approval on July 17 — both marketing campaigns will build IgAN awareness and educate nephrologists on the treatment landscape before povetacicept reaches market, and both approvals validate the FDA's willingness to green-light novel IgAN mechanisms on accelerated pathways. Povetacicept, if approved, would become the first commercialized therapy in Vertex's emerging nephrology franchise.
Novartis (SIX: NOVN) announced Friday July 17, 2026 that the FDA has granted traditional approval for Fabhalta (iptacopan) to slow kidney function decline in adults with primary immunoglobulin A nephropathy (IgAN) at risk of disease progression. Fabhalta is a first-in-class complement Factor B inhibitor (small molecule); the traditional approval converts the August 2024 FDA accelerated approval (which was based on proteinuria reduction) into a full label supported by kidney-function outcomes. The Phase 3 APPLAUSE-IgAN trial showed a 3.02 mL/min/1.73 m² per year difference in estimated glomerular filtration rate (eGFR) slope in the iptacopan arm versus placebo, translating to a 48% slower kidney-function decline. The approval extends the primary IgA nephropathy competitive set that Vera Therapeutics entered on July 7, 2026 when Trutakna (atacicept-vymj), a BAFF/APRIL-targeting peptide-and-Fc fusion protein, received FDA accelerated approval based on a 45.7% versus 6.8% reduction in urine protein-to-creatinine ratio in the Phase 3 ORIGIN trial. IgA nephropathy affects approximately 130,000-150,000 Americans and is the most common primary glomerular disease worldwide; roughly 40% of patients progress to end-stage renal disease within 20 years without effective treatment.
Novartis announced Monday July 6, 2026 that it has entered into a definitive agreement to acquire UK biotech Myricx Bio for up to $1.5 billion ($1.1 billion cash upfront plus potential milestone payments) to advance next-generation ADC payload innovation. Myricx Bio developed a first-in-class N-myristoyltransferase inhibitor (NMTi) payload platform. NMT is an enzyme that maintains the function of certain proteins inside cells, and cancer cells rely on it to grow and survive; blocking NMT with a payload delivered via ADC disrupts those processes directly inside tumor cells. Myricx's two lead assets target B7-H3 and HER2 across multiple solid-tumor settings. The transaction is expected to close in H2 2026 subject to customary closing conditions including regulatory approvals. The deal extends the payload-and-linker chemistry infrastructure that peptide-drug conjugates (PDCs), ADCs, and adjacent bioconjugate modalities share. Novo Holdings (through its portfolio company backing of Myricx) and Sofinnova Partners were among the pre-deal investors. Endpoints News framed the transaction as another 2026 signal that payload innovation, not antibody targeting alone, is driving competitive differentiation in the next-generation ADC race.
Novartis (which acquired Avidity Biosciences in February 2026) announced June 11 that the biomarker cohort of the Phase 1/2 FORTITUDE trial of delpacibart braxlosiran (del-brax, AOC 1020) met its primary and key secondary endpoints, with reductions in KHDC1L (cDUX target) and creatine kinase indicating strong target engagement and reduced muscle damage in adults with FSHD. The data validate the dosing regimen now being used in the Phase 3 FORWARD trial enrolling 200 patients across the US and Europe. Del-brax is an antibody-oligonucleotide conjugate aimed at aberrant DUX4 expression, the same conjugate-modality family as the peptide-oligonucleotide conjugates from PepGen (PGN-EDODM1 for DM1) and Vertex (VX-670).
A DelveInsight market analysis published April 20 projects 7.3% CAGR growth in the pheochromocytoma and paraganglioma treatment market through 2036, driven by SSTR2 analogs and peptide receptor radionuclide therapies including Novartis's Lutathera (lutetium-177 dotatate). PRRT remains one of the few FDA-approved peptide therapeutics for rare neuroendocrine tumors, binding SSTR2 to deliver targeted radiation.