Abelacimab

Dive Brief:Bayers experimental blood thinner asundexianmet its main goal in a closely watched Phase 3 stroke prevention trial, reducing the recurrence of a stroke in people who took the therapy along with standard treatments. The trial compared treatment with a combination of asundexian and an antiplatelet therapy against a placebo and the same antiplatelet treatment.The German-based company didnt release detailed data, stating that researchers will disclose them at an upcoming medical meeting while company executives discuss them with regulators ahead of possible approval applications.Results of the trial lifted optimism for asundexian'sdrug class, called Factor XIa inhibitors, following a series of clinical setbacks. Most recently, a rival drug missed its main goal in a trial of people whod had a recent heart attack.Dive Insight:The spotlight has been on Factor XIa inhibitors as the next big innovation in cardiovascular medicine, with drugmakers and researchers hoping they will prove safer and more effective than aging franchises like Bristol Myers Squibbs Eliquis. These drugs, which include asundexian,Bristol Myers and Johnson & Johnsons milvexian and Novartis abelacimab, block a protein involved in forming blood clots but is believed to be less essential in stopping bleeding.The balancing act in preventing stroke or any acute cardiovascular episode due to blood vessel blockages is in suppressing clotting without raising the risk that people will have uncontrolled bleeding incidents. In people who have irregular heartbeats, Eliquis is able to do just that better than an older drug called warfarin or aspirin.In treating people whove already had one stroke that wasnt caused by an irregular heartbeat, in a setting called secondary prevention, doctors use one or two drugs to thin the blood, known as antiplatelet medications. The drugs used include aspirin, clopidogrel, AstraZenecas Brilinta and Eli Lillys Effient.In the trial called Oceanic Stroke, Bayer aimed to measure whether adding asundexianto the mix would help, testing it against a placebo in over 12,000 people. The company said the experimental drug reduced the risk of ischemic stroke compared to placebo and added that its addition didnt increase the risk of major bleeding episodes.Bayers German-listed shares rose more than 12% following the news, changing hands at about 31 euros apiece. Two years ago, Bayer terminated a head-to-head trial of asundexianagainst Eliquis in people with irregular heartbeats, an early Phase 3 readout that cast some doubt over the promise of Factor XIa inhibitors.Milvexiansfailure in acute coronary syndrome earlier this month didnt boost optimism, but the asundexianresults may reverse some of the doubt.After a string of class setbacks, this is a needed win, wrote Cantor Fitzgerald analyst Carter Gould, who covers Bristol Myers, in a note to clients.Bristol Myers and J&J are expecting milvexiansPhase 3 trials in people with irregular heartbeats, as well as secondary stroke prevention, in the fourth quarter of 2026. Bristol Myers shares rose 5% in morning trading. '

Novartis said it has shifted the range of its mid-term growth target due to higher peak sales projections for some of its key medicines, as well as other growth drivers in its pipeline. The Swiss drugmaker now expects a compound annual growth rate of 5% to 6% from 2025 to 2030. Last month, Novartis said it expected a 6% annual growth rate from 2024 to 2029. During a call with the media Thursday morning, CEO Vas Narasimhan said he is confident Novartis will hit the new goal due to “three buckets of items.” The first consists of Novartis’ “in-line brands,” which continue to deliver “a really strong performance,” Narasimhan said. These include its breast cancer drug Kisqali, for which the company has upped peak sales guidance from at least $8 billion to at least $10 billion. New-to-brand prescriptions of Kisqali are about 70% in some ex-US markets, Narasimhan said. Another key medicine that should support Novartis’ growth is the chronic myeloid leukemia drug Scemblix. The company raised its peak sales guidance from at least $3 billion to at least $4 billion. “We see market shares [for Scemblix] really above 60% in the third-line setting, above 40% in the second-line setting, and climbing above 20% in the first-line setting in the markets that we’ve launched,” Narasimhan said. The second bucket comprises ongoing or upcoming launches that are “going to be very important to drive that growth,” Narasimhan said. In September, Novartis secured an FDA approval for its BTK inhibitor Rhapsido in chronic spontaneous urticaria. The company is currently launching the drug in the US and also testing it against Sanofi and Regeneron’s Dupixent in a Phase 3 trial that’s set to read out in 2027. In August, Novartis reported Phase 3 success for its Sjögren’s disease drug candidate ianalumab, and announced plans to file with the FDA. The drug has fast-track designation, meaning it could be eligible for a speedier review process. Narasimhan also spotlighted its “pipeline that we’ve built up with 30 plus high value assets.” At least 10 of those assets were acquired or licensed over the past two years, according to the release. Novartis’ list of future growth drivers is “fairly familiar,” Jefferies analysts wrote in a same-day note, adding that it includes ianalumab and the cholesterol drug pelacarsen. But the analysts highlighted that the company is now touting three new candidates as potential blockbusters: abelacimab for thrombosis; farabursen for autosomal dominant polycystic kidney disease; and pacibekitug for inflammatory diseases.