Welcome to our dedicated page for Novartis news (Ticker: NVS), a resource for investors and traders seeking the latest updates and insights on Novartis stock.
Novartis AG (NVS) generates a steady flow of news driven by clinical milestones, regulatory decisions, strategic collaborations and financial updates across its innovative medicines portfolio. As a pharmaceutical preparation manufacturing company, Novartis regularly announces US Food and Drug Administration (FDA) approvals, late‑stage trial readouts and label changes that shape its position in immunology, cardiovascular disease, kidney disease, neuroscience and autoimmune disorders.
Recent news has highlighted multiple FDA approvals, including Rhapsido (remibrutinib), an oral Bruton's tyrosine kinase inhibitor for adults with chronic spontaneous urticaria who remain symptomatic despite H1 antihistamines; label expansion for Leqvio (inclisiran) enabling first‑line use as monotherapy with diet and exercise to reduce LDL‑C in adults with hypercholesterolemia; Vanrafia (atrasentan) for reduction of proteinuria in primary IgA nephropathy; and Fabhalta (iptacopan) as the first approved treatment for C3 glomerulopathy to reduce proteinuria. Novartis has also reported positive Phase III results for ianalumab in Sjögren’s disease and an FDA approval for Itvisma, a gene replacement therapy for spinal muscular atrophy in a broad age range.
In addition to product‑specific developments, Novartis news often covers strategic deals and pipeline expansion. Examples include agreements with Argo Biopharma for cardiovascular siRNA assets, a global license and collaboration with PTC Therapeutics for the PTC518 Huntington’s disease program, and a planned acquisition of Avidity Biosciences to strengthen its late‑stage neuroscience pipeline. The company also communicates on collaborations in radioligand therapies, such as its SSTR2‑targeting radiotherapeutic candidate partnership with Ratio Therapeutics.
Investors and followers of NVS news can expect coverage of earnings and financial reports via Form 6‑K filings, guidance updates on constant‑currency sales growth, and commentary on the expected impact of major transactions. For those tracking developments in specific diseases—such as chronic spontaneous urticaria, hidradenitis suppurativa, IgA nephropathy, C3 glomerulopathy, Sjögren’s disease, cardiovascular risk reduction and spinal muscular atrophy—the Novartis news flow provides insight into late‑stage data, regulatory timelines and commercial positioning. Bookmarking the Novartis news page on Stock Titan can help users monitor these ongoing clinical, regulatory and strategic updates.
Novartis (NYSE:NVS) has received FDA approval for Rhapsido® (remibrutinib), marking a significant breakthrough as the first oral Bruton's tyrosine kinase inhibitor (BTKi) treatment for chronic spontaneous urticaria (CSU) in adults who remain symptomatic despite antihistamine treatment.
The approval is supported by Phase III REMIX-1 and REMIX-2 clinical trials, where Rhapsido demonstrated superior efficacy in reducing itch and hives as early as Week 2, with about one-third of patients achieving complete symptom relief by Week 12. The twice-daily oral medication requires no lab monitoring and offers a new treatment approach for the 1.7 million Americans living with CSU.
The drug works by targeting BTK to inhibit histamine release and proinflammatory mediators. Novartis has submitted regulatory applications for Rhapsido across multiple countries, including the EU, Japan, and China, with priority review granted in China.
Argo Biopharma has expanded its strategic collaboration with Novartis (NYSE: NVS) through multiple cardiovascular asset agreements. The deal includes an upfront payment of $160 million to Argo, with potential milestone and option payments totaling up to $5.2 billion, plus tiered royalties.
The collaboration encompasses: 1) Novartis' option to license ex-China rights for two discovery-stage molecules targeting severe hypertriglyceridemia and mixed dyslipidemia, 2) First negotiation rights for BW-00112 (ANGPTL3) in Phase II, and 3) License with P&L sharing options for a hepatic-delivered siRNA candidate in IND-enabling studies. Additionally, Novartis expressed interest in participating in Argo's next equity financing round.
Novartis (NYSE:NVS) announced significant breakthrough in Phase III clinical trials for ianalumab in treating Sjögren's disease. Both NEPTUNUS-1 and NEPTUNUS-2 trials met their primary endpoint, demonstrating statistically significant improvements in disease activity measured by EULAR Sjögren's syndrome disease activity index (ESSDAI).
Ianalumab, which features a dual mechanism of action through B-cell depletion and BAFF-R inhibition, could become the first targeted treatment approved for Sjögren's disease. The drug demonstrated a favorable safety profile and was well-tolerated in trials. Having received FDA Fast Track Designation, Novartis plans to present detailed trial data at an upcoming medical meeting and submit to health authorities globally.
Novartis (NYSE:NVS) announced a significant FDA approval for a label update of Leqvio® (inclisiran), enabling its use as a first-line monotherapy for LDL-C reduction in adults with hypercholesterolemia. The update removes the requirement for combination with statin therapy, allowing Leqvio to be used alone with diet and exercise.
The FDA proactively requested this label update based on robust LDL-C lowering data for PCSK9-targeting therapies. This development is particularly significant as up to 80% of ASCVD patients in the US struggle to reach the LDL-C guideline-recommended target of <70 mg/dL. Leqvio's unique twice-yearly dosing regimen, administered by healthcare providers, aims to support better patient adherence and long-term cholesterol management.
Novartis (NYSE:NVS) announced that its Phase III GCAptAIN study of Cosentyx® (secukinumab) in giant cell arteritis (GCA) did not meet its primary endpoint of sustained remission at Week 52. The study evaluated Cosentyx in combination with a 26-week steroid taper versus placebo with a 52-week steroid taper in adults with newly diagnosed or relapsing GCA.
While secondary outcomes showed numerically better results for cumulative steroid dose and steroid-related toxicity compared to placebo, they did not achieve statistical superiority. The safety profile remained consistent with Cosentyx's known safety data across approved indications. Novartis plans to conduct a full evaluation of the study data and share detailed results in the future.
Novartis (NVS) has received FDA accelerated approval for Vanrafia® (atrasentan), the first selective endothelin A receptor antagonist for proteinuria reduction in adults with primary IgA nephropathy (IgAN). The approval is based on Phase III ALIGN study results showing:
- 36.1% proteinuria reduction vs placebo (P<0.0001) - Improvements visible from Week 6 and sustained through Week 36 - Favorable safety profile with no REMS requirement
IgAN affects approximately 13 per million people in the US annually, with up to 50% of patients progressing to kidney failure within 10-20 years of diagnosis. This marks Novartis's third FDA approval in its renal portfolio in under a year. Final approval may depend on additional Phase III ALIGN study data expected in 2026.
Novartis has received FDA approval for oral Fabhalta® (iptacopan) to treat adults with C3 glomerulopathy (C3G), marking the first-ever approved treatment for this condition. The approval is based on the Phase III APPEAR-C3G study, which demonstrated sustained proteinuria reduction at one year with favorable safety.
C3G is an ultra-rare kidney disease typically diagnosed around age 23, with approximately 50% of patients progressing to kidney failure within 10 years. Fabhalta is the only oral alternative complement pathway inhibitor targeting the disease's underlying cause, replacing previous reliance on supportive care and broad immunosuppression.
This marks Fabhalta's third FDA approval, following its December 2023 approval for paroxysmal nocturnal hemoglobinuria (PNH) and August 2024 accelerated approval for IgA nephropathy (IgAN). The drug is also under regulatory review in China and Japan for C3G indication.
Novartis has announced the presentation of data from 17 abstracts at the 2025 AAAAI-WAO Joint Congress and AAD Annual Meeting, showcasing its immunology portfolio developments. The presentations will feature:
- Two-year efficacy and safety analyses from Phase III SUNSHINE and SUNRISE trials of Cosentyx® (secukinumab) for hidradenitis suppurativa (HS)
- New 52-week data analyses from Phase III REMIX pivotal trials of investigational remibrutinib for chronic spontaneous urticaria (CSU), demonstrating improvements in urticaria control, sleep, and activity
The company plans to submit regulatory filings for remibrutinib as a CSU treatment in the first half of 2025. Additionally, remibrutinib is being investigated for other immune-mediated conditions, including chronic inducible urticaria, HS, and food allergy.
PTC Therapeutics (NASDAQ: PTCT) has entered into a global license and collaboration agreement with Novartis for its PTC518 Huntington's disease program. The deal includes a $1.0 billion upfront payment and potential earnings of up to $1.9 billion in development, regulatory, and sales milestones. PTC will share profits in the U.S. on a 40/60 basis and receive tiered double-digit royalties on ex-U.S. sales.
Novartis will take over global development, manufacturing, and commercialization responsibilities after completing the ongoing PIVOT-HD study's placebo-controlled portion, expected in H1 2025. Interim results from June 2024 showed PTC518 achieved durable, dose-dependent reduction in HTT protein levels and demonstrated favorable safety profiles.
Ratio Therapeutics has entered into an exclusive worldwide license and collaboration agreement with Novartis Pharma AG to develop a Somatostatin Receptor 2 (SSTR2) radiotherapeutic candidate for cancer treatment. Under the agreement, Ratio will receive upfront and potential milestone payments totaling up to $745 million, plus tiered royalties. Ratio will collaborate on preclinical activities and candidate selection, while Novartis will handle subsequent development, manufacturing, and commercialization. The partnership aims to leverage Ratio's radioligand therapy expertise and technology platforms to develop best-in-class therapy for SSTR2-expressing tumors.