Swiss multinational pharmaceutical corporation based in Basel, Switzerland; one of the world's largest pharmaceutical companies, manufacturing cancer treatments, vaccines, and other medications.
Clinical Trials
1143
41 active
Approvals
80
Total approvals
Agencies
1
Regulatory bodies
Founded
1996
Not yet recruiting
32
2.8%
No Longer Available
1
0.1%
Terminated
30
2.6%
Recruiting
58
5.1%
Approved For Marketing
1
0.1%
Withdrawn
38
3.3%
Active, not recruiting
9
0.8%
Unknown
1
0.1%
Completed
971
85.0%
- The EMA's CHMP has adopted a positive opinion recommending Cosentyx (secukinumab) for adults with polymyalgia rheumatica who respond inadequately to steroids or relapse during taper. - If approved by the European Commission, secukinumab would become the first IL-17A inhibitor licensed in Europe for polymyalgia rheumatica, a disease with few advanced options. - The recommendation rests on the pivotal Phase III REPLENISH trial, in which all primary and secondary endpoints were met in both the 300mg and 150mg arms. - REPLENISH showed Cosentyx doubled sustained remission rates and delivered steroid-sparing effects versus placebo, with no new safety signals in PMR patients.
- Novartis will pay $125 million upfront to acquire full ownership of Sironax's blood-brain barrier-crossing drug delivery platform. - Sironax retains rights to develop, manufacture and commercialize certain assets using the platform and will fund three early-stage programs with the proceeds. - The deal follows a 2024 option agreement under which Sironax was eligible for up to $175 million in upfront and milestone payments. - Sironax's lead asset SIR2501, holding FDA fast track designation, targets nerve cell damage in ALS and chemotherapy-induced peripheral neuropathy.
- Novartis exercised its exclusive option to acquire full global rights to Sironax's proprietary brain delivery platform, triggering a $125 million payment to Sironax upon closing. - The platform uses proprietary brain delivery modules designed to transport monoclonal antibodies, peptides, proteins, gene therapies and other large biologics across the blood-brain barrier. - Sironax retains rights to develop, manufacture and commercialize selected assets using the platform and will use proceeds to advance three Phase 1b/2 programs. - The pipeline includes SIR2501, a first-in-class allosteric SARM1 inhibitor with FDA Fast Track designation for chemotherapy-induced peripheral neuropathy, plus SIR4156 and SIR9900.
- Novartis halted eight studies of rapcabtagene autoleucel on August 24 after three patients developed serious immune effector cell-associated hemophagocytic syndrome, with all three dying from complications. - The paused program includes phase II trials in systemic lupus erythematosus, lupus nephritis, systemic sclerosis, ANCA-associated vasculitis and idiopathic inflammatory myopathies, plus phase I/II studies in other autoimmune indications. - Bristol Myers Squibb separately paused enrollment in autoimmune trials of zolacabtagene autoleucel after observing transient and reversible inflammatory events during routine safety monitoring.
- Novartis discontinued development of VHB937 (lifonebart) after the Phase 2 ASTRALS trial in early-stage ALS missed both primary and secondary endpoints. - The 251-patient trial tested the TREM2-stabilizing monoclonal antibody or placebo for 40 weeks, with no numerical data released by the company. - The setback adds to a difficult pipeline stretch for Novartis, following Phase 3 misses for pelacarsen and del-desiran and halted rap-cel studies. - Detailed ASTRALS findings are scheduled for presentation at the 37th International Symposium on ALS/MND in Amsterdam on December 9-11, 2026.
- Novartis received Egyptian Drug Authority approval for Kisqali as adjuvant treatment of HR-positive, HER2-negative stage II and III early breast cancer at high risk of recurrence. - The cyclin-dependent kinase inhibitor is indicated in combination with an aromatase inhibitor for adult patients, expanding use earlier in the treatment journey. - Breast cancer accounts for roughly 37% of all female cancer cases in Egypt, with one of the highest incidence rates in the WHO Eastern Mediterranean Region. - Novartis Egypt is working with authorities on patient access and physician education, complementing national screening efforts that have reached over 70 million women since 2019.
- The FDA approved Curium's Bexlutry (lutetium Lu 177 dotatate), the first generic radioligand therapy, for adults with somatostatin receptor-positive gastroenteropancreatic neuroendocrine tumors. - Bexlutry was cleared via the 505(b)(2) pathway as a radioligand equivalent to Novartis' Lutathera, relying on published evidence and bridging data rather than a new pivotal trial. - The approval follows Curium's June 2026 patent litigation victory over Novartis subsidiary Advanced Accelerator Applications, clearing the path for immediate launch. - Curium has agreed to merge with Lantheus in a transaction valued at up to approximately USD 8 billion, potentially expanding radiopharmaceutical capabilities.
- Vera Therapeutics reported that Trutakna met all prespecified endpoints in the final ORIGIN 3 analysis of 428 adults with primary IgA nephropathy at risk of progression. - Annualized eGFR slope through 104 weeks was -0.6 mL/min/1.73m2/year with Trutakna versus -5.6 with placebo, a 5.0 mL/min/1.73m2/year treatment effect (p<0.0001). - Composite kidney disease progression events occurred in 11 Trutakna patients versus 38 on placebo, a 76% risk reduction (hazard ratio 0.24; 95% CI 0.12, 0.48). - Vera plans to submit a supplemental BLA in Q4 2026 for full approval, with more than 350 patient start forms generated in the first ten weeks of launch.
- The FDA approved Curium's Bexlutry, the first generic radioligand therapy, a copycat of Novartis' Lutathera that delivers radioactive lutetium to SSTR-positive neuroendocrine tumors. - The approval covers foregut, midgut and hindgut SSTR-positive neuroendocrine cancers and followed Curium's victory in a patent dispute with Novartis. - Arrowhead's dual-acting RNA interference therapy Aro-Dimer-Pa cut PCSK9 and APOC3 protein levels by 72% and 88% after a single dose in an early-stage trial. - Corbus reported CRB-913 produced up to 5 percentage points more weight loss than placebo at 12 weeks, but psychiatric side effects drove treatment discontinuations.
- Santa Ana Bio has dosed the first cohort in a first-in-human Phase 1 trial of SAB01, a bispecific antibody that co-engages KIT and Siglec-6 to selectively deplete mast cells. - The randomized, double-blind, placebo-controlled single ascending dose study (NCT07815561) evaluates subcutaneous and intravenous SAB01 in healthy adults, with primary objectives of safety, pharmacokinetics, and pharmacodynamics. - SAB01 is designed to uncouple mast cell depletion from broad KIT inhibition, potentially avoiding toxicities such as hematopoietic stem cell and melanocyte effects seen with existing KIT-targeted antibodies. - The Phase 1 start marks Santa Ana Bio's first entry into the clinic, while its CD40-targeted glucocorticoid antibody-drug conjugate SAB05 advances through IND-enabling studies toward a 2027 clinic entry.
