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FDA approves Novartis drug Rhapsido for symptomatic dermographism

Wed, 07 Oct 2026 12:48:37 -0400

Novartis (NYSE: NVS) announced that the U.S. Food and Drug Administration has approved Rhapsido (remibrutinib) as a treatment for adults with symptomatic dermographism (SD) inadequately controlled by H1 antihistamines.

Rhapsido is an oral, selective Bruton's tyrosine kinase inhibitor. The approval makes it the only prescription treatment with approved indications for both chronic spontaneous urticaria (CSU) and SD when antihistamines alone do not control symptoms, according to the company.

The FDA decision is based on data from the Phase III RemIND clinical trial. At Week 12, 29.3% of patients treated with Rhapsido achieved a complete response from hives compared to 14.0% in the

FDA approves Novartis drug Rhapsido for symptomatic dermographism

Wed, 07 Oct 2026 12:48:37 -0400

The FDA decision is based on data from the Phase III RemIND clinical trial. At Week 12, 29.3% of patients treated with Rhapsido achieved a complete response from hives compared to 14.0% in the

Novartis to present MS drug data at MSToronto2026 conference

Wed, 07 Oct 2026 07:35:27 -0400

Novartis (NYSE: NVS) will present 46 abstracts at MSToronto2026, the 10th Joint ACTRIMS-ECTRIMS Meeting, including Phase III trial results for its oral BTK inhibitor remibrutinib and new data on its approved therapy Kesimpta (ofatumumab).

A late-breaking oral presentation on October 23 will feature results from the Phase III REMODEL-1 and REMODEL-2 trials, which evaluated the efficacy and safety of remibrutinib versus teriflunomide in relapsing multiple sclerosis. Following the presentation, Novartis plans to host an investor conference call to discuss the data and remibrutinib's potential in MS.

A second late-breaking abstract will present data from the Phase III NEOS study, examining the efficacy

Novartis to present MS drug data at MSToronto2026 conference

Wed, 07 Oct 2026 07:35:27 -0400

A second late-breaking abstract will present data from the Phase III NEOS study, examining the efficacy

Novartis (NOVN:SW) (NVS) PT Lowered to CHF130 at Morgan Stanley

Tue, 06 Oct 2026 04:41:47 -0400

Morgan Stanley analyst Thibault Boutherin lowered the price target on Novartis (NOVN:SW) (NYSE: NVS) to CHF130.00 (from CHF135.00) while maintaining a Overweight rating.

Novartis (NOVN:SW) (NVS) PT Lowered to CHF130 at Morgan Stanley

Tue, 06 Oct 2026 04:41:47 -0400

Morgan Stanley analyst Thibault Boutherin lowered the price target on Novartis (NOVN:SW) (NYSE: NVS) to CHF130.00 (from CHF135.00) while maintaining a Overweight rating.

Novartis (NOVN:SW) (NVS) PT Lowered to CHF130 at Morgan Stanley

Tue, 06 Oct 2026 04:41:47 -0400

Morgan Stanley analyst Thibault Boutherin lowered the price target on Novartis (NOVN:SW) (NYSE: NVS) to CHF130.00 (from CHF135.00) while maintaining a Overweight rating.

Novartis (NOVN:SW) (NVS) PT Lowered to CHF130 at Morgan Stanley

Tue, 06 Oct 2026 04:41:47 -0400

Morgan Stanley analyst Thibault Boutherin lowered the price target on Novartis (NOVN:SW) (NYSE: NVS) to CHF130.00 (from CHF135.00) while maintaining a Overweight rating.

EMA panel backs Novartis Cosentyx for rheumatic condition in EU

Fri, 18 Sep 2026 11:00:37 -0400

Novartis (NYSE: NVS) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorization for Cosentyx (secukinumab) in polymyalgia rheumatica (PMR).

The opinion supports the use of Cosentyx for the treatment of PMR in adults who have had an inadequate response to steroids or who experience relapse during steroid taper.

The positive CHMP opinion is supported by results from the pivotal Replenish Phase III trial.

Following the CHMP recommendation, the European Commission is expected to issue a final decision within approximately two months, according to the company's statement.

EMA panel backs Novartis Cosentyx for rheumatic condition in EU

Fri, 18 Sep 2026 11:00:37 -0400

The opinion supports the use of Cosentyx for the treatment of PMR in adults who have had an inadequate response to steroids or who experience relapse during steroid taper.

The positive CHMP opinion is supported by results from the pivotal Replenish Phase III trial.

Following the CHMP recommendation, the European Commission is expected to issue a final decision within approximately two months, according to the company's statement.

Novartis halts ALS drug development after mid-stage trial fails

Wed, 16 Sep 2026 11:13:59 -0400

Novartis AG (NYSE: NVS) has discontinued development of an experimental drug for amyotrophic lateral sclerosis, commonly known as ALS or Lou Gehrig's disease, after a mid-stage clinical trial failed to demonstrate the treatment worked better than a placebo in slowing disease progression.

The company confirmed the decision in an emailed statement. The discontinued drug, VHB937, is a monoclonal antibody that researchers had hoped would engage the immune system to protect brain cells from damage.

ALS is a fast-progressing neurological condition that causes paralysis, difficulty swallowing, and trouble breathing.

Novartis halts ALS drug development after mid-stage trial fails

Wed, 16 Sep 2026 11:13:59 -0400

ALS is a fast-progressing neurological condition that causes paralysis, difficulty swallowing, and trouble breathing.

Selloff in this biotech stock is overdone – Mizuho

Sat, 12 Sep 2026 16:00:00 -0400

Analysts at Mizuho remain optimistic about the prospects of one biotech company whose shares fell in response to the announcement from Novartis (NYSE: NVS) that its HARBOR Phase 3 study had failed to achieve its primary endpoint.

Sarepta Therapeutics (NASDAQ: SRPT) stock was down 10% (and has been volatile since) following the announcement, amid concerns that the company’s SRP-1003 targeting myotonic dystrophy type 1 (DM1) might similarly disappoint.

The HARBOR Phase 3 trial did not demonstrate a statistically significant improvement versus placebo in video hand opening time (vHOT), a measure of hand myotonia/function. HARBOR was a pivotal, randomized, placebo-controlled study of 159

Selloff in this biotech stock is overdone – Mizuho

Sat, 12 Sep 2026 16:00:00 -0400

Selloff in this biotech stock is overdone – Mizuho

Sat, 12 Sep 2026 16:00:00 -0400

Selloff in this biotech stock is overdone – Mizuho

Sat, 12 Sep 2026 16:00:00 -0400

Novartis (NOVN:SW) (NVS) PT Lowered to CHF105 at Berenberg