Abelacimab

Novartis has axed two late-stage programs in cancer-related blood clots after observing “inferior efficacy” in a clinical trial. The move marks a setback for a candidate that Novartis out-licensed in 2019, then paid $925 million upfront to get back in 2025. Novartis is still pursuing abelacimab for its lead indication: atrial fibrillation. Abelacimab is part of a new class of anticoagulants called factor XI inhibitors, which are designed to prevent blood clots while reducing the bleeding risks associated with traditional blood thinners. The drug was in three Phase 3 trials, two of which were focused on cancer-related thrombosis. Novartis confirmed to Endpoints News on Monday that both cancer studies have been terminated, after an independent data review committee said abelacimab demonstrated “inferior efficacy” to Bristol Myers Squibb’s blockbuster blood thinner Eliquis in a trial called ASTER . A company spokesperson said the other trial, called MAGNOLIA , was cut short “following further strategic review.” The latter trial compared abelacimab to Pfizer’s blood thinner Fragmin. The third study in atrial fibrillation remains ongoing. Novartis said in its February earnings presentation that it hopes to file for regulatory review in 2028. The trial is enrolling patients who are unsuitable for oral anticoagulants. CEO Vas Narasimhan said in a November earnings call that he expects there will be a “substantial market opportunity” in that setting for abelacimab, which is administered as a monthly injection. Endpoints is fielding the next Biopharma Sentiment Index (BPSI) — a concise, three-minute survey that distills thousands of industry views into a clear quarterly benchmark. This year is pivotal for biopharma, and we need your perspective on where things are going. Take the survey here.

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. '