Gilead Sciences targets 200 treatment centers for potential anito-cel launch. November 10, 2026 Key points. * Gilead's Kite unit is preparing for a potential anito-cel launch in multiple myeloma, with a U.S. regulatory decision expected on December 23. It plans to begin in patients who have received at least three prior lines of treatment. * Kite expects to work with 200 authorized U.S. treatment centers, with 80% expected to come on board within six months and 90% of payers to cover the therapy within a year. The company says it has manufacturing capacity for launch and aims to achieve brand leadership within 18 months. * Kite plans to present updated trial data, including safety and efficacy results, at the American Society of Hematology meeting. An earlier-line application could come as soon as 2027, pending results from the iMMagine-3 study. * Five stocks to consider instead of Gilead Sciences. Gilead Sciences NASDAQ: GILD is preparing for a potential launch of its multiple myeloma cell therapy anito-cel, with plans to build on the treatment-center relationships and manufacturing capabilities established by its existing CAR-T products, a company executive said. Cindy Perettie, executive vice president of Gilead's Kite unit, said the company expects to have 200 authorized treatment centers in the U.S. for anito-cel. The drug has a December 23 regulatory decision date, she confirmed during a discussion hosted by Wolfe biopharma analyst Alex Hammond. Perettie described anito-cel as Kite's next major growth driver, while noting that its existing lymphoma therapies, YESCARTA and TECARTUS, continue to face competition. Gilead's initial planned launch is in patients who have received at least three prior lines of treatment. Launch targets and manufacturing. Although Kite works with the 200 centers today, Perettie said it cannot complete contracts to add anito-cel until the product has a label. Centers will also need to add the ordering system to their electronic medical records and put the treatment on their formularies, while payer reimbursement will be another factor in uptake. Kite expects 80% of the authorized centers to come on board within six months and 90% of payers to reimburse the therapy within the first year. Perettie said the company's goal is to achieve brand leadership within 18 months. "The things that were barriers in the past," including manufacturing slot availability, should not be hurdles in the future, she said. Kite has enough manufacturing capacity to support YESCARTA, TECARTUS and anito-cel beyond its initial launch and into earlier treatment settings, according to Perettie. She said Kite's commercial products currently have turnaround times of two to three weeks, which the company expects to match for anito-cel. Kite has reported 97% manufacturing reliability for YESCARTA and TECARTUS and had published a 99% figure for anito-cel, although she cautioned that the latter could change as volumes increase. Data and earlier-line opportunity. Perettie said Kite plans to present updated iMMagine-1 trial data at the American Society of Hematology meeting, including efficacy, safety and progression-free survival results with a minimum of 18 months of follow-up. She cautioned that the progression-free survival data remain immature beyond that period. More than 400 patients have received anito-cel across the phase 1, iMMagine-1 and iMMagine-3 studies, she said. Perettie said the rate of grade 3 cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome remained below 1%, and that Kite continues to have confidence in the treatment's safety profile. The iMMagine-3 study, which is evaluating anito-cel in earlier lines of treatment, completed enrollment in June ahead of schedule. Perettie said 2027 is the earliest the company could submit for an earlier-line indication. The trial has co-primary endpoints involving minimal residual disease and complete response rates, as well as progression-free survival. Perettie said the company sees safety and the ability to treat patients in community settings as important to expanding CAR-T use in earlier lines. Most of Kite's current authorized centers are academic institutions, though about 25 are community practices, she said. Autoimmune research and pipeline. Beyond multiple myeloma, Perettie said Kite is studying cell therapies in autoimmune diseases. She said patient deaths reported elsewhere in the field were unfortunate, but that Kite had not observed the same outcome in its programs. The company has a CD19/CD20 program with basket trials in rheumatology and neurology, and anito-cel is being studied in myasthenia gravis and myositis. The phase 1 myasthenia gravis study is nearly fully enrolled, she said. Kite is also building an in vivo cell therapy portfolio and studying candidates for lymphoma and solid tumors, including hepatocellular cancer and glioblastoma. Perettie said anito-cel remains the principal near-term growth opportunity. About Gilead Sciences (NASDAQ:GILD). Gilead Sciences, Inc. is a biopharmaceutical company that discovers, develops and commercializes medicines for serious diseases. Founded in 1987 and headquartered in Foster City, California, the company focuses on antiviral therapies, including treatments and preventive medicines for HIV and medicines for viral hepatitis. Its products include Biktarvy for HIV and Epclusa for hepatitis C. Gilead also develops medicines in areas such as oncology and inflammatory diseases. Its portfolio includes Veklury (remdesivir), an antiviral medicine used to treat COVID-19. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. Before you consider Gilead Sciences, you'll want to hear this. MarketBeat keeps track of Wall Street's top-rated and best performing research analysts and the stocks they recommend to their clients on a daily basis. MarketBeat has identified the five stocks that top analysts are quietly whispering to their clients to buy now before the broader market catches on... and Gilead Sciences wasn't on the list. While Gilead Sciences currently has a Moderate Buy rating among analysts, top-rated analysts believe these five stocks are better buys. Robotics and automation are rapidly becoming essential infrastructure across healthcare, manufacturing, logistics, and many other industries. "Physical AI" is coming. 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Vir, A Gilead rival, shoots to two-year high on its 'clean win' in hepatitis D treatment. * ALLISON GATLIN * Updated 04:17 PM ET 11/09/2026 Vir stock catapulted to a nearly two-year high Monday on a "clean win" for its hepatitis D treatment. After 48 weeks, patients who received Vir Biotechnology's (VIR) tobevibart and elebsiran showed improvements across the board. Every patient showed a virological response, meaning the levels of virus in their body declined. Nearly eight in 10 patients, 79%, had undetectable levels of the hepatitis D virus after treatment. More than half of patients reached normal liver enzymes. Importantly, 44% of patients reached normal liver enzymes and had undetectable levels of the virus. That topped expectations for 30% to 40%, Needham analyst Joseph Stringer said in a report, describing the results as a "clean win." "We view VIR's ECLIPSE-1 data as an important validation of its (hepatitis D) combination regimen and we're more optimistic on VIR's ability to differentiate vs competitors on depth of virologic suppression," Leerink Partners analyst Roanna Ruiz said in a report. On today's stock market, Vir stock surged 11.8% to 13.65, hitting its highest point since January 2025. Vir stock broke out of a flat base with a buy point at 11.94 on Oct. 9, MarketSurge shows. Later, the stock dropped as much as 17% below its entry, triggering a sell rule. Savvy investors are encouraged to cut their losses when a stock drops 7% to 8% below its entry. Its stock has a strong Relative Strength Rating of 97, meaning it has performed in the top 3% of all stocks over the past 12 months. 'Best-In-Disease profile' The study suggests Vir Biotech has a "best-in-disease profile" with tobevibart and elebsiran, Stringer said. The latter was developed with Alnylam Pharmaceuticals (ALNY). Alnylam stock ticked more than 1% higher Monday to 157.77. He noted Vir's rivals include Hepcludex from Gilead Sciences (GILD) and the experimental drug, brelovitug, from Mirum Pharmaceuticals (MIRM). IBD newsletters. Get exclusive IBD analysis and actionable news daily. In clinical testing, 86% of patients responded to treatment with Mirum's drug. A smaller 17% reached undetectable levels of the hepatitis D virus, liver enzymes normalized for 63%, and 56% of patients had a virologic response plus normal liver enzymes. "In all, VIR's results are compelling and show the dual siRNA plus mAb approach may be the more effective strategy for clearing (hepatitis D) RNA," Ruiz said. Elebsiran is a small interfering RNA drug, or siRNA. It works by silencing specific disease-causing genes. Tobevibart is a monoclonal antibody, or mAb. Ruiz reiterated her outperform rating on Vir stock. Follow Allison Gatlin on X/Twitter at @AGatlin_IBD. YOU MAY ALSO LIKE:

A Motley Fool columnist has named five biotech stocks to hold long term, despite the industry's volatility and regulatory risks: Vertex Pharmaceuticals, Amgen, Gilead Sciences, Exelixis, and Regeneron Pharmaceuticals. Vertex leads the cystic fibrosis market and is moving into kidney disease. Amgen had 17 products with double-digit sales growth in the third quarter, and 17 medicines with annual revenue runs of at least $1 billion. It has raised its dividend every year since 2011. Gilead is expanding beyond HIV into oncology, and has raised its payouts by 74.5% over a decade. Exelixis, much smaller than the others, relies on its cancer drug Cabometyx, which may face US generic competition by early 2030. Regeneron is recovering from Eylea competition, helped by a new Eylea formulation and Dupixent.