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iStock, happy_lark Hibsago’s approval—a functional cure for certain patients with a hepatitis B infection—further validates Ionis Pharmaceuticals’ antisense platform, which has already generated two other new drug approvals this year. The FDA has given the go-ahead to GSK and Ionis Pharmaceuticals’ antisense oligonucleotide bepirovirsen for the treatment of chronic hepatitis B virus infection, giving some patients the chance to potentially get off long-term medication. Bepiroversen, to be marketed under the brand name Hibsago, can help patients achieve undetectable levels of the virus in the blood after six months—serving as a functional cure, according to GSK’s announcement on Tuesday. GSK has forecasted peak worldwide sales of over £2 billion ($2.67 billion) for the drug, Reuters reported in May. BMO Capital Markets was more conservative in their estimate, projecting peak risk-unadjusted sales of $659 million in a Tuesday afternoon investor note. Ionis will receive 10–12% tiered royalties on GSK’s sales—about $163 million, by BMO’s estimate—a “relatively modest” contribution to the company’s commercial business, the analysts wrote. But the approval “adds meaningful validation” of Ionis’ antisense oligonucleotide (ASO) platform after recent setbacks to the overall class, BMO continued. The firm pointed to the Phase 3 failure of Ionis’ AstraZeneca-partnered ASO Wainua in transthyretin-mediated amyloid cardiomyopathy (ATTR-CM) this summer and the September miss of Ultragenyx’s investigational ASO in Angelman syndrome. Rare diseases Ionis Paves Its Own Path as Initial Tryngolza Launch Defies Expectations Long an R&D company that partnered off assets, RNAi biotech Ionis Pharmaceuticals shifted in 2025 to bring two medicines to market alone. Analysts are already impressed—and there’s more to come in 2026. February 18, 2026 · 3 min read · Annalee Armstrong Read more Hibsago marks Ionis’ third ASO approval this year, following the September victory of Zanvastro for Alexander disease and the June clearance of Tryngolza to lower blood lipid levels and pancreatitis risk in patients with severe hypertriglyceridemia. “While [Hibsago’s] approval was generally anticipated, we view this as another indication of the capabilities for the ASO platform Ionis has built,” BMO wrote. Hibsago is given via subcutaneous injection every six months, and patients have the option to self-administer the drug after the first dose. It is indicated for use in combination with nucleos(t)ide analog reverse transcriptase inhibitors (NRTI) and is approved for adult patients who have no liver scarring, according to GSK. Patients must have also been on NRTI treatment for at least six months and meet certain biomarker thresholds, as determined by an FDA-approved test. Alongside Hibsago’s approval, the agency cleared Roche’s Elecsys HBsAg II quant II RxDx assay as a diagnostic device to identify patients with chronic hepatitis B who are eligible for treatment. The assay is also meant to help monitor patients while undergoing treatment. Originally developed by Ionis, Hibsago was licensed by GSK in August 2019 with $25 million upfront plus up to $262 million in milestones. The antisense therapy targets the genetic material of the hepatitis B virus and tags it for destruction. This mechanism prevents the virus’ replication, while also boosting the immune system’s capabilities to fight off the infection. The FDA previously granted Hibsago breakthrough and priority review designations. Hibsago’s approval was supported by data from the Phase 3 B-Well studies. The program consists of two late-stage studies, B-Well 1 and B-Well 2 , which together enrolled more than 1,800 adults with chronic hepatitis B who had been exposed to NRTI treatment. Participants were given either Hibsago or placebo. Both trials primarily assessed for functional cure, defined as having no detectable levels of the virus for 24 weeks after ending all hepatitis B medication. Infectious disease GSK, Ionis’ hepatitis B functional cure effectively eliminates virus in nearly 20% of patients The antisense oligonucleotide was even more effective in patients with relatively low viral activity. More than one-quarter of these individuals had undetectable levels of the virus in the blood for at least six months after stopping treatment. May 28, 2026 · 2 min read · Tristan Manalac Read more Detailed findings from the B-Well studies presented in May showed that Hibsago resulted in a 19% functional cure response rate. None of the patients on placebo hit functional cure. In a key secondary analysis, GSK focused on patients with low baseline levels of the virus’ surface antigen. Hibsago treatment elicited a 26% functional cure rate in this subgroup, the pharma said on Tuesday. “Hibsago provides a new treatment approach that gives some patients the possibility of maintaining control of the virus after all chronic HBV treatment has ended,” Wendy Carter, acting director of the FDA’s Office of Infectious Diseases under the Center for Drugs of Evaluation and Research, said in an agency release . “This approval represents an important advance for people living with this serious disease.” As for safety, the FDA added a boxed warning on the Hibsago logo warning of serious liver reactions and low platelet counts, which the regulator said could aggravate the likelihood of potentially life-threatening bleeding. Other warnings for the drug include serious inflammatory side effects and declining kidney function.

Across the pond, European regulators handed down a pair of pivotal approval recommendations this week, making way for a new front in Novo and Eli Lilly’s oral GLP-1 showdown and endorsing Revolution Medicines’ potential pancreatic cancer game changer, which has received some investor scrutiny of late following the recent release of FDA review documents in the U.S. Both decisions—which cover Lilly’s oral GLP-1 treatment Foundayo and RevMed’s RAS inhibitor Rasonque—came by way of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), which has recommended six new drugs for approval and jockeyed for five label extensions in its latest wave of regulatory action. CHMP’s approval recommendations are not the end of the road for a drug application in the European Union, with the decisions still subject to final sign-off by the European Commission. However, formal approval often follows the human medicines committees’ blessing. The marketing recommendation for Lilly’s Foundayo, which leverages the orally delivered GLP-1 molecule orforglipron, addresses both obesity and Type 2 diabetes for adults, coming on the heels of the weight management-only EU endorsement that Novo received for its rival Wegovy pill back in May. Novo has long sold a separate version of oral semaglutide for diabetes under the brand name Rybelsus, which the medicine still carries in Europe. Novo retired the Rybelsus brand in the U.S. and relaunched a slight reformulation of oral semaglutide in Type 2 diabetes under the Ozempic pill moniker earlier this year. The new EU endorsement for Foundayo, meanwhile, applies to treatment of obesity or overweight in adults with at least one weight-related health problem. In diabetes, Foundayo can either be taken alone when metformin isn’t a good fit for patients, or together with other diabetes meds, the CHMP explained in a Friday release. The CHMP based its obesity green light on a pair of studies that found patients on Foundayo lost around 5% to 11% of their body weight after 72 weeks, dependent upon the exact dose received, versus a range of 2% to 2.5% on placebo. And in the four primary studies of Foundayo in Type 2 diabetes, Lilly’s GLP-1 tablet was linked to A1C reductions of around 1.2 to 1.9 percentage points—again dose-dependent—compared to a 0.4-to-0.8 percentage-point decline on placebo. Lilly also pitted its pill against AstraZeneca’s SGLT2 inhibitor Farxiga and Novo’s oral semaglutide at the 7- and 14-mg doses in Type 2 diabetes, coming out on top in those comparisons as well. Aside from the likely pent-up patient demand for another oral weight loss option in the EU, investors and industry watchers will be closely monitoring Foundayo’s performance in the transatlantic market. After gaining a notable market advantage over Novo’s bread-and-butter obesity injectable Wegovy with its own Zepbound in recent years, Lilly has struggled to gain a lead after launching second to Novo in the oral obesity drug space earlier this year. The other banner endorsement from the CHMP this week came for RevMed’s Rasonque as a second-line monotherapy in patients with metastatic pancreatic adenocarcinoma, rounding out a similar green light from the FDA in late August. Should Rasonque snare the European Commission’s blessing, it will become the first broad RAS-targeted treatment for this specific patient population in the EU, RevMed said in an Oct. 15 release. As in the case of the recent U.S. nod, RevMed leaned on its landmark RASolute 302 trial to support its approval ambitions in Europe. RevMed reported that Rasonque had doubled overall survival in the phase 3 study back in April and then revealed at ASCO that the RAS inhibitor had doubled progression-free survival , too, prompting a standing ovation from the conference’s sizeable audience. “Today’s positive CHMP opinion marks a major step toward making Rasonque available to eligible adults with metastatic pancreatic cancer in the European Union,” Mark Goldsmith, M.D., Ph.D., RevMed’s CEO, said in a statement. As major hopes ride on Rasonque, the drug faced some unexpected investor unease earlier this month with the release of FDA review documents, which led to questions about the drug’s positioning in a key KRAS subgroup. The shareholder jitters, which pressured RevMed’s stock last week, largely revolved around the medicine’s lower posted objective response rate in patients with KRAS G12D mutations, which represent the most common subtype of KRAS mutations in pancreatic cancer. Still, multiple analyst shops flagged the stock movement as an overreaction, with the team at Leerink Partners noting last week that the subgroup analysis “doesn’t change anything for Rasonque.” In a statement to Fierce, a RevMed representative stressed that overall survival remains “the gold standard endpoint in oncology and is what matters most to patients and physicians, particularly in pancreatic cancer.” Moreover, the analysts pointed to apparent other benefits in Rasonque despite lower ORR numbers in G12D and another subgroup of patients. Beyond Rasonque and Foundayo, other drugs to win favor with CHMP this week included Ascendis’ Yuviwel for pediatric achondroplasia and Orphelia Pharma’s glioblastoma multiforme and malignant glioma med Kizfizo, which has orphan drug status in the U.S.—plus endorsements for two separate biosimilar referencing Roche’s Lucentis (ranibizumab) and the neutropenia med filgrastim. The regulatory body also put its weight behind label extensions for AstraZeneca’s avian influenza vaccine, as well as Novo’s insulin icodec-semaglutide combo for Type 2 diabetes, Kyinsu, plus Johnson & Johnson’s Talvey, Ionis’ Tryngolza and Pfizer’s Tukysa.