Ravulizumab-CWVZ

After disappointing Wall Street for most of 2026, Roche’s eye disease drug Vabysmo met analysts’ expectations for the first time this year. But the company may have bigger fish to fry heading into 2027. The bispecific antibody of VEGF-A and Ang-2 brought in 1.14 billion Swiss francs ($1.38 billion) in third-quarter sales, up 10% sequentially and topping consensus estimates by 2%. The beat comes as Vabysmo hit a milestone, having treated 1.5 million patients globally, Roche’s pharmaceuticals chief Teresa Graham told investors during a call Thursday. Vabysmo is a key driver in the 9% year-over-year sales growth at constant exchange rates for Roche’s ophthalmology franchise, as the drug continues market share gains, Graham said. Vabysmo is approved in the U.S. for wet age-related macular degeneration, diabetic macular edema and retinal vein occlusion. “By now, Vabysmo has established itself as the preferred first-line treatment, including in the U.S.,” she said. After stellar growth initially, Vabysmo suddenly lost momentum toward the end of 2025. Between the second-quarter 2025 and the second-quarter 2026, sales of the drug actually declined 1%. Roche previously attributed the deceleration to a reset of the U.S. branded VEGF market after the closure of certain charity copay programs. “I think the U.S. has re-baselined,” Graham said on Thursday’s call. “We are expecting to remain in that low single-digit growth for Vabysmo in terms of sales." “It’s probably important to note though that volume growth in the U.S. is much higher—there’s a contracting effect that takes effect here,” she continued. “And then, when you look ex-U.S., there is actually significant growth for Vabysmo, and more opportunity for growth and penetration to come outside of the U.S.” The Roche exec maintained that the current consensus peak sales outlook of 6 billion Swiss francs is “very reasonable,” and that Vabysmo is on track to achieve that. As the Vabysmo market stabilizes, Roche and investors are turning their attention to several potential blockbuster launches. The company’s oral SERD drug giredestrant is gearing up for an FDA decision by the end of November. For 2027, Roche is expecting FDA approvals for its KRAS G12C inhibitor divarasib in non-small cell lung cancer, for BTK inhibitor fenebrutinib in multiple sclerosis and sefaxersen in IgA nephropathy, among others. As Graham put it, Roche’s regulatory and launch teams will be “exceptionally busy” in the next few months. None of those will be easy rollouts. For giredestrant , the company is targeting a first-in-class adjuvant nod for early breast cancer, but as one analyst noted on the call, many doctors remain skeptical and are waiting for overall survival data to be convinced. The phase 3 lidERA trial supporting Roche’s filing will have another overall survival data cutoff toward the first half of 2027, Graham noted. As for another criticism around lidERA’s lack of involvement of a CDK4/6 inhibitor, Graham said that a single-arm sub-study in combination with Eli Lilly’s Verzenio is expected to read out this year. Roche recently also announced two new studies in the adjuvant setting, including an investigator-initiated study using a ctDNA-guided approach and a phase 1/3 testing giredestrant alongside Pfizer’s CDK4 candidate atirmociclib. For divarasib , Roche will need to compete with existing KRAS inhibitors, Amgen’s Lumakras and Bristol Myers Squibb’s Krazati. After seeing “strong” phase 3 data, to be presented at the European Society for Medical Oncology 2026 Congress this weekend, Roche has increased divarasib’s peak sales guidance to between 2 billion and 3 billion Swiss francs, Roche’s CEO Thomas Schinecker said on the call. In the BTK field, Roche’s fenebrutinib is on a collision course with Novartis’ Rhapsido in MS. It’s also not entirely clear how the oral BTK space will play out against antibody drugs such as Roche’s top-selling Ocrevus, although Graham argued fenebrutinib “will ultimately just crack up a whole new market segment,” rather than chipping away Ocrevus’ market. As for IgAN, the space has become crowded with multiple options across various mechanisms of action, including a new FDA nod Wednesday for AstraZeneca’s complement inhibitor Ultomiris. Despite the upcoming launches, one analyst on the call questioned Roche’s ability to maintain the same level of revenue growth in 2027, pointing to “growth pressures or slowdowns on a number of products.” In the first nine months of 2026, Roche’s pharmaceuticals division ginned up 36.2 billion Swiss francs ($44 billion) on the strength of a 7% year-over-year increase at constant exchange rates, and the entire group’s 46.5 billion Swiss francs marked 6% growth. “I can only say that we’re confident that we can maintain a similar momentum that we have,” Schinecker said on the call, adding that profit margins are expected to be “at least stable.”

AstraZeneca's Alexion rare disease unit said Thursday the FDA — under accelerated approval — greenlit a fifth indication for Ultomiris (ravulizumab), this time for reducing proteinuria in adults with primary immunoglobulin A nephropathy (IgAN) at risk of progression."As the first and only C5 inhibitor approved for the reduction of proteinuria in adults with IgAN, Ultomiris offers a new treatment option for people living with this serious disease," said Alexion CEO Marc Dunoyer.The latest approval, granted through priority review, was backed by data from a prespecified interim analysis of the late-stage I CAN trial, wherein Ultomiris reduced 24-hour urine protein creatinine ratio (UPCR) by 46.6% from baseline at week 34 versus 5.6% for placebo, yielding a notable placebo-adjusted treatment effect of 43.4%.The company Ultomiris' traditional FDA approval remains contingent on confirmation of a clinical benefit in terms of slowing kidney function decline — assessed via change in estimated glomerular filtration rate (eGFR) from baseline at week 106 in the I CAN trial.Besides IgAN, Ultomiris — which racked up $4.7 billion in sales last year — has been cleared in the US for the treatment of paroxysmal nocturnal haemoglobinuria, atypical haemolytic uraemic syndrome, generalised myasthenia gravis and neuromyelitis optica spectrum disorder. The drug, however, recently missed its mark in a late-stage study of haematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).The IgAN treatment landscape has exploded lately, with six more FDA approvals in the last five years, namely Calliditas Therapeutics’ Tarpeyo (budesonide), Travere Therapeutics’ Filspari (sparsentan), Novartis’ Fabhalta (iptacopan) and Vanrafia (atrasentan), Vanda Pharmaceuticals’ Voyxact (sibeprenlimab) and Vera Therapeutics’ Trutakna (atacicept-vymj).