Denecimig

Already boasting a positive recommendation overseas, Novo’s hemophilia A newcomer Frehemgo will have to wait a while longer before taking a crack at the U.S. market. Shortly before the weekend, Novo—which had been expecting an approval decision on its bispecific antibody by the third quarter—said the FDA had announced its review was “still ongoing,” without communicating an updated timeline for the regulatory action. The delay comes down to issues the FDA uncovered during a pre-license inspection of Novo’s Frehemgo (denecimig) manufacturing site, which occurred after Novo filed its application for approval last September, the company said in a release. Specifically, as the calendar has now turned to October and 2026’s fourth quarter begins, the FDA has informed Novo that “ongoing facility remediation activities are the cause of the extension” of its review. Novo is specifically seeking approval in adults and kids without hemophilia A, with Frehemgo winning its first green light in Saudi Arabia and a positive recommendation in the European Union last month. With the delay, the FDA hasn’t singled out any efficacy or safety data deficiencies, Novo said. The company stressed that it’s continuing to work through remediation work at the unnamed facility as it works closely with the agency on the matter. The company was also clear that the issue is expected to have a limited impact for now. The observations at the Frehemgo site aren’t impacting other Novo products already on the market, the company clarified. Additionally, the extra time taken by the FDA won’t affect Novo’s 2026 outlook, and pending an approval, the drugmaker still plans to launch its hemophilia medicine in the U.S. in the first half of next year. “Haemophilia A patients should expect more from their standard of care,” said Mike Doustdar, Novo CEO, in a statement. “As Novo prepares to bring denecimig to market, our ambition is to help make better care something they can count on,” he continued. “Novo is already in the process of addressing the FDA's requests as efficiently as possible and continuing to work closely with the Agency toward bringing denecimig to patients in the US.” Novo did not specify which of its manufacturing sites is responsible for the delay. For some time now, the company has been working through regulatory headaches at the Bloomington, Indiana facility it acquired from Catalent under a transaction following Novo Holdings’ buyout of the CDMO in late 2024. Elsewhere, regulators have already started endorsing Novo’s factor VIII-a mimetic in Saudi Arabia , as well as Europe, where the EMA’s Committee for Medicinal Products for Human Use (CHMP) last month gave a marketing recommendation to Frehemgo to prevent or reduce bleeding episodes in adults and kids with hemophilia A. Novo’s next-generation offering will come up directly against Roche’s blockbuster and hemophilia market champion Hemlibra, which generated sales of roughly $5.8 billion in 2025. In Europe specifically, Novo has said it’s planning for an initial hemophilia launch before the end of 2026, which a broader rollout across the bloc slated for 2027. Frehemgo could carve out a niche as a differentiating product for Novo, which has been heavily focused on its diabetes and obesity franchises of late, namely through its popular semaglutide-based franchise of GLP-1s.

Bagsværd, Denmark, 02 October 2026 – Novo Nordisk today announced that the US Food and Drug Administration (FDA) has informed Novo that the BLA review of denecimig for the treatment of haemophilia A, with or without inhibitors in adults and children, is still ongoing. The FDA has not communicated a new timeline for expected regulatory action on the BLA. Novo submitted a BLA for denecimig for the treatment of haemophilia A in adult and paediatric patients to the US FDA for review in September 2025, with an anticipated regulatory decision in the third quarter of 2026. Following this submission, the FDA performed a pre-license inspection of the manufacturing site and provided feedback. Today, the FDA has informed Novo that the ongoing facility remediation activities are the cause for extension of the Agency's review. “Haemophilia A patients should expect more from their standard of care,” said Mike Doustdar, president and CEO of Novo. “As Novo prepares to bring denecimig to market, our ambition is to help make better care something they can count on. Novo is already in the process of addressing the FDA's requests as efficiently as possible and continuing to work closely with the Agency toward bringing denecimig to patients in the US.” The Agency has not identified deficiencies related to the clinical efficacy or safety data of denecimig demonstrated in the FRONTIER clinical trial programme. Novo is continuing implementation of the facility remediation activities in response to the FDA's feedback and is working closely with the Agency to address the outstanding requirements. The feedback on the manufacturing site does not impact other marketed Novo products. The additional FDA review time does not have an impact on Novo's financial outlook for 2026. Pending regulatory decision, Novo aims to launch denecimig in the US in the first half of 2027. About the FRONTIER trials The FRONTIER clinical programme includes FRONTIER1-5 and investigates denecimig as a prophylactic treatment to prevent bleeding episodes across paediatric and adult populations with haemophilia A, with or without inhibitors. FRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig Marketing Authorisation Application (MAA) submission. FRONTIER2 evaluated denecimig treatment once every month and once every week in adults and adolescents 12 years of age and older; FRONTIER3 evaluated denecimig treatment once every month and once every week in children below the age of 12; FRONTIER4 was an open-label extension trial evaluating the efficacy of denecimig once every two weeks (Q2W) as well as investigating the long-term safety of denecimig across all dosing regimens (once every month, once every two weeks, and once every week) in subjects with haemophilia A, with or without inhibitors. About denecimig Denecimig is a FVIIIa mimetic bispecific antibody designed with the aim to deliver once monthly, every two weeks and weekly prophylaxis for people living with haemophilia A, with or without inhibitors. Denecimig, which is administered under the skin, ‘mimics’ the role of FVIIIa by bridging factor IXa and factor X. This action mimics the cofactor function of FVIIIa, which helps restore the body’s thrombin generation capacity, helping blood to clot. On 17 September, denecimig received a positive CHMP opinion and is currently pending marketing approval from the EMA and under review by other regulatory authorities. Novo is the global healthcare company that believes lasting health starts now. For over a century, we’ve combined leading scientific expertise with a deep understanding of people’s lives. We develop treatments and support that help millions of people make progress they can see, feel and sustain now and in the future. Every day, over 67,000 employees around the world advance our purpose to drive change for lasting health. Through our partnerships, programmes and investments, we’re working to prevent disease, expand access to treatments and reduce our environmental impact to help even more people live healthier lives. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its ADRs are listed on the New York Stock Exchange (NVO). For more information, visit novonordisk.com and follow us on Instagram , LinkedIn , TikTok , Facebook , X and YouTube . Publication of inside information pursuant to Market Abuse Regulation, Article 17. Contacts for further information Company announcement No 59 / 2026