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Pharma & Biotech Daily is a short, AI-generated, human-supervised briefing on whats important in pharma and biotech.Each weekday we condense key news on pipelines, deals, regulation and strategy into a quick audio update for people who build, run and invest in life sciences.Produced by OWITH.ai, a boutique AI & data studio. Sponsor the show: https://sponsor.owith.ai Language: en-us Genres: Business, Investing, News, Tech News Contact email: Get it Feed URL: Get it iTunes ID: Get it |
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Vir Hepatitis Delta Phase 3 Win, argenx $1.15B Peptide Deal | Pharma and Biotech Daily
Episode 794
Monday, 9 November, 2026
Vir Biotechnology reports a pivotal Phase 3 win in chronic hepatitis delta, and argenx agrees to buy Unnatural Products for up to 1.15 billion dollars to add oral macrocyclic peptides. Also: TG Therapeutics raises Briumvi guidance, Xenon's azetukalner filing and X-NOVA2 timing, and Atea's path to a hepatitis C filing. Good morning from Pharma and Biotech Daily, the briefing on what matters in pharma and biotech. It's Tuesday, November 10. Vir Biotechnology has a pivotal win in hepatitis delta, and argenx is paying up to one point one five billion dollars to bring oral peptides into its antibody business. We begin with Vir. At the Liver Meeting in Denver, Vir said in a press release that its Phase three ECLIPSE 1 trial met its primary endpoint. Patients with chronic hepatitis delta received monthly injections of two drugs, the small interfering RNA elebsiran and the antibody tobevibart. After forty eight weeks, forty four percent reached the combined goal of undetectable virus plus a normal liver enzyme level, against none in the group whose treatment was delayed. Seventy nine percent had undetectable virus, and the rate was even higher in patients with cirrhosis. Only one severe treatment related side effect was reported, a temporary drop in white blood cells, and no patient stopped treatment. Two more Phase three studies read out early next year, including a head to head test against bulevirtide, with an FDA submission planned for mid twenty twenty seven. Next, a deal. The immunology company argenx will acquire Unnatural Products, a Santa Cruz biotech that designs macrocyclic peptides meant to be taken as pills against targets antibodies struggle to reach. According to the companies' announcement, argenx pays five hundred fifty million dollars upfront, with contingent value rights that lift the total to about one point one five billion. The two have already worked together for more than two years. Unnatural Products will keep running from Santa Cruz as a dedicated discovery hub, and closing is expected by year end. For argenx, whose franchise rests on injected antibodies, the purchase is a clear bet that oral and long acting formats will matter in immunology. On the commercial side, TG Therapeutics lifted its outlook for Briumvi, its multiple sclerosis antibody known generically as ublituximab. In its quarterly report, the company said United States net sales reached two hundred thirty two point six million dollars in the third quarter, up about fifty two percent from a year earlier. The company now expects Briumvi sales of nine hundred fifteen to nine hundred twenty million dollars this year and total revenue of roughly one billion dollars. It is also working to make the drug easier to give: a Phase three study supports a single starting infusion, with a possible launch in mid twenty twenty seven, and data from an under the skin version are due around the turn of the year. In neuroscience, Xenon Pharmaceuticals confirmed that its application for azetukalner in focal seizures has been with the FDA since September. Its quarterly update did not mention an FDA acceptance or a decision date. Its Phase three depression study, X-NOVA2, has finished enrolling about three hundred sixty patients, and topline results are expected in December. Xenon ended September with about one point one five billion dollars in cash and says that funds operations into twenty twenty nine. With a regulatory review under way and a large readout weeks away, Xenon heads into a decisive stretch on a strong balance sheet. Finally, hepatitis C. Atea Pharmaceuticals is preparing an FDA filing for its combination of bemnifosbuvir and ruzasvir in mid twenty twenty seven. In the North American Phase three trial reported in July, the regimen proved statistically non inferior to Gilead's Epclusa, with cure rates of about ninety four and ninety five percent respectively, according to the company's quarterly update. A second Phase three study, C-FORWARD, has enrolled more than eight hundred eighty patients in seventeen countries and reads out early next year. Atea held about one hundred ninety one million dollars at the end of September and, on November sixth, drew sixty five million dollars from a credit facility with Hercules Capital. It now expects its money to last into mid twenty twenty eight. The common thread today is viral liver disease and the pursuit of simpler treatment, from monthly shots in hepatitis delta to shorter infusions and pills elsewhere. That's the briefing for today. Pharma and Biotech Daily is produced by OWITH.ai. See you tomorrow. Sources: https://www.biospace.com/press-releases/vir-biotechnology-announces-primary-endpoint-met-in-pivotal-phase-3-eclipse-1-trial-for-elebsiran-and-tobevibart-in-chronic-hepatitis-delta https://www.biospace.com/press-releases/unnatural-products-to-be-acquired-by-argenx-for-up-to-1-15-billion-to-advance-next-generation-medicines https://www.biospace.com/press-releases/tg-therapeutics-reports-third-quarter-2026-financial-results-and-raises-full-year-revenue-guidance https://www.globenewswire.com/news-release/2026/11/09/3398912/33485/en/xenon-reports-q3-2026-financial-results-and-provides-business-update.html https://www.globenewswire.com/news-release/2026/11/09/3398942/0/en/atea-pharmaceuticals-reports-third-quarter-2026-financial-results-and-provides-business-update.html Pharma and Biotech Daily is produced by OWITH.ai. Script and voice are AI generated from the public sources listed above. 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