A major shareholder in Novartis has called for a shake-up of the Swiss drugmaker's board to improve corporate governance after its shares suffered a record fall this week following back-to-back trial setbacks.
NVS' del-desiran fails the HARBOR study's primary endpoint, adding to recent pipeline setbacks as investors await next steps.
Dyne Therapeutics remains a Buy despite a 16% selloff triggered by Novartis' DM1 trial failure, which heightened platform-wide clinical risk perceptions. The Novartis HARBOR trial failure challenges the core RNA-targeting therapeutic thesis, raising doubts about translating biomarker gains into functional benefit for DYN's DM1 and DMD programs. DYN's lead asset, z-rostudirsen, faces regulatory and confirmatory risks, with FDA approval likely but long-term value now more uncertain due to functional outcome concerns.
Biopharma stocks are dominating the unusual options volume list today, after a high-profile clinical trial failure from Novartis AG (NYSE:NVS) sent shockwaves through the sector.
Novartis AG (ADR) (NYSE:NVS) shares fell as much as 10% after the company's del-desiran failed to meet the primary endpoint in its pivotal Phase 3 HARBOR study evaluating the drug in myotonic dystrophy type 1. The study did not show a statistically significant improvement over placebo on video hand opening time, a novel measure of hand myotonia that served as the trial's primary endpoint.
U.S.-listed shares of Novartis are slumping Tuesday morning following disappointing clinical trial results from the Swiss drugmaker.
Novartis shares plunged after late-stage failures of pelacarsen and del-desiran, impacting its long-term growth outlook. Despite setbacks, Novartis reiterated 2025-2030 revenue growth guidance of 5-6% CAGR, aided by Rhapsido's phase 3 success in RMS. Rhapsido's positive data in relapsing multiple sclerosis offer partial offset, with potential for $3 billion+ in annual peak sales.
Novartis shares fell sharply on Tuesday after the Swiss drugmaker said its experimental treatment for myotonic dystrophy failed in a late-stage clinical trial, marking another setback for a pipeline that investors had been counting on to drive future growth. The stock fell about 10% following the announcement and has now lost more than 14% over the past five trading sessions.
The drug candidate was one of three therapies the Swiss pharmaceutical company added to its pipeline through its $12 billion acquisition of Avidity Biosciences.
Novartis' pelacarsen study failed to cut cardiovascular events, clouding prospects for the drug and highlighting portfolio challenges.
The company said the late-stage study for its pelacarsen drug missed its primary objective of reducing the risk of cardiovascular events like death, heart attack and stroke compared with placebo.
Shares of Novartis fell 3.3% on Monday morning after its cholesterol drug failed in a closely watched study, casting fresh doubt on the therapeutic approach and raising the stakes for the Swiss drugmaker's upcoming data for a gene therapy.