SYNBIOMATICA

Daily briefings

Editor’s Briefing: November 9, 2026

In Short. Vir’s hepatitis delta combination met its Phase 3 goal of clearing virus and normalizing a liver enzyme. Argenx agreed to buy Unnatural Products for up to $1.15bn, and a drug lowering the blood particle Lp(a) did not cut heart events.

Vir’s hepatitis delta combination clears virus in a Phase 3 trial

CHRONIC HEPATITIS DELTA is a severe viral liver disease that occurs only in people who carry hepatitis B and can progress quickly to cirrhosis and liver failure. On Sunday Vir Biotechnology reported first results from ECLIPSE 1, a pivotal Phase 3 trial of monthly injected elebsiran, a small interfering RNA that lowers hepatitis B surface antigen, plus tobevibart, a monoclonal antibody against that antigen (Vir release). The trial randomized 124 adults to the combination or delayed treatment. Among 83 patients on the combination, 44% met the primary endpoint of undetectable hepatitis delta virus RNA plus a normal level of a liver-damage enzyme, alanine aminotransferase, at week 48, versus 0% of 41 patients on delayed treatment at week 12. At week 48, 79% of the 83 treated patients had undetectable virus. Vir plans a U.S. filing in mid-2027 after two further Phase 3 trials report in early 2027.

Argenx agrees to buy Unnatural Products for up to $1.15bn

Argenx builds antibody medicines for immune diseases and owns a minority stake in Unnatural Products, a Santa Cruz, California biotech that designs ring-shaped protein fragments, called macrocyclic peptides, meant to hit targets that are hard to drug with antibodies or small molecules. On Monday it said it would buy the remaining shares for $550m in cash upfront and up to $595m more if development and regulatory milestones are met, for total potential consideration of up to $1.15bn (argenx release). The companies have worked together for more than two years. After closing, expected by year-end subject to customary conditions, Unnatural Products will keep operating from Santa Cruz as argenx’s peptide discovery site. Karen Massey, argenx’s chief executive, said the deal adds peptide capabilities that complement antibody engineering, including paths to oral or long-acting medicines.

Pelacarsen cuts Lp(a) but not heart events in full Lp(a)HORIZON data

Lipoprotein(a), or Lp(a), is a cholesterol particle whose level is largely set by genes and is linked to higher risk of heart attack and stroke. Pelacarsen, a Novartis drug made of short synthetic genetic material that blocks Lp(a) production in the liver, was tested in the Phase 3 Lp(a)HORIZON outcomes trial in 8,322 adults with established cardiovascular disease and Lp(a) of at least 70 mg/dL. On Saturday results were presented at the American Heart Association Scientific Sessions and published in the New England Journal of Medicine (Cleveland Clinic). After a median 4.7 years, the primary composite of cardiovascular death, heart attack, stroke or urgent coronary revascularization occurred in 12.3% of patients on monthly pelacarsen 80 mg and 12.1% on placebo. After one year Lp(a) fell 78.4% with pelacarsen and 3.2% with placebo. Anaphylaxis occurred in 19 pelacarsen patients and none on placebo.

Valneva’s Shigella vaccine meets a Phase 2 infection-challenge goal

Shigellosis is a diarrheal disease caused by Shigella bacteria. An estimated 165 million infections occur worldwide each year, and no licensed vaccine exists. On Monday Valneva reported results from two Phase 2 studies of S4V2, a tetravalent bioconjugate vaccine candidate that links bacterial sugars to a carrier protein (Valneva release). In Kenya, 110 infants aged nine months received two doses of S4V2 or a meningococcal control, and antibodies against the bacteria’s surface sugars rose for all four targeted strains versus control. In a U.S. controlled human infection model of about 120 adults, volunteers received two doses of S4V2 or placebo and were then challenged with Shigella sonnei 53G. The trial met its primary endpoint with a statistically significant reduction in S. sonnei shigellosis among vaccinated participants versus placebo. Valneva did not publish exact case counts and said further efficacy analysis is ongoing.

Abeona’s gene therapy for a rare skin disease posts early sales

Recessive dystrophic epidermolysis bullosa, or RDEB, is an inherited blistering disease in which wounds form because the skin lacks working collagen VII. ZEVASKYN (prademagene zamikeracel) is a gene therapy made from a patient’s own cells, sold by Abeona for RDEB wounds. On Monday Abeona reported third-quarter results (Abeona release). Net ZEVASKYN revenue was $13.5m, up 18% from $11.4m in the prior quarter. Fifteen treatments have been completed since launch, including six in the third quarter. The qualified treatment-center network now has eight sites, four of which have treated patients. A Medicare add-on payment for ZEVASKYN took effect on October 1.

Sources

  1. BioSpace (Novartis Zolgensma tumor reports)
  2. Biodesix Q3 results (SEC exhibit 99.1)
  3. Eton Pharmaceuticals Q3 results (SEC exhibit 99.1)
  4. Natera Q3 results (SEC exhibit 99.1)
  5. Precision BioSciences pricing release (SEC exhibit 99.1)