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NOVARTIS AGBullish
Novartis announced that the Phase III HARBOR study of del-desiran for myotonic dystrophy type 1 (DM1) failed to meet its primary endpoint of vHOT. The company is evaluating the full dataset to determine the next development steps while maintaining its 2025-2030 sales CAGR guidance of 5-6%.…more
NOVARTIS AG
Novartis announced that its Phase III Lp(a)HORIZON trial for pelacarsen failed to meet its primary endpoint of reducing the risk of major adverse cardiovascular events (MACE) in patients with elevated Lp(a) and established cardiovascular disease. While the study of 8,323 participants showed that pelacarsen successfully lowered Lp(a) levels, it did not demonstrate a reduction in cardiovascular death, non-fatal myocardial infarction, or stroke compared to placebo.…more
NOVARTIS AG
Novartis announced that its Phase III REMODEL-1/-2 trials for remibrutinib in relapsing multiple sclerosis (RMS) met the primary endpoint by significantly reducing the annualized relapse rate (ARR) compared to teriflunomide. The drug also demonstrated a clinically meaningful delay in disability progression and a favorable safety profile, leading Novartis to plan global regulatory submissions.…more
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Novartis Reports Positive Phase III Results for Remibrutinib in Multiple Sclerosis…more
Novartis announced that its drug candidate remibrutinib significantly reduced the annualized relapse rate in Phase III trials for relapsing multiple sclerosis. These results demonstrate the drug's efficacy and safety, supporting its potential for future regulatory approval.…more
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Novartis announced that its Phase III NATALEE study showed Kisqali reduces the risk of death by approximately 20% in patients with stage II and III HR+/HER2- early breast cancer. This clinical data strengthens the drug's position as a key treatment option for high-risk recurrence patients.…more
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Novartis' rapcabtagene autoleucel has been granted Orphan Drug Designation by the FDA for the treatment of idiopathic inflammatory myopathies. This status provides the company with development incentives and regulatory support for the therapy.…more
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