{"success":true,"data":{"pressRelease":{"id":"159742","rtpr_id":"nGNE1bnCcM-20261002","ticker":"NOVOB","exchange":"Nasdaq Copenhagen","all_tickers":["NOVOB"],"title":"REG-Novo provides update on the denecimig Biologics License Application (BLA) in the US","author":"Globe Newswire","published_at":"2026-10-02T20:53:42.099Z","article_body":"* The US Food and Drug Administration (FDA) has informed Novo that the BLA\nreview of denecimig for the treatment of haemophilia A is still ongoing. The\nFDA has not communicated a new timeline for regulatory action on the BLA \n* The FDA has informed Novo that the ongoing facility remediation activities\nare the cause for extension of the Agency's review. The FDA has not identified\nany deficiencies related to the clinical efficacy or safety data submitted in\nthe denecimig BLA\n* Novo is actively working with the FDA, addressing the Agency's requests for\nremediations related to the manufacturing facility. The extended FDA review\ntime for the denecimig BLA has no impact on Novo's financial outlook for 2026\nand pending regulatory decision, Novo aims to launch denecimig in the US in\nthe first half of 2027\nBagsværd, Denmark, 02 October 2026 – Novo Nordisk today announced that the\nUS Food and Drug Administration (FDA) has informed Novo that the BLA review of\ndenecimig for the treatment of haemophilia A, with or without inhibitors in\nadults and children, is still ongoing. The FDA has not communicated a new\ntimeline for expected regulatory action on the BLA. \n\nNovo submitted a BLA for denecimig for the treatment of haemophilia A in adult\nand paediatric patients to the US FDA for review in September 2025, with an\nanticipated regulatory decision in the third quarter of 2026. Following this\nsubmission, the FDA performed a pre-license inspection of the manufacturing\nsite and provided feedback. Today, the FDA has informed Novo that the ongoing\nfacility remediation activities are the cause for extension of the Agency's\nreview.\n\n“Haemophilia A patients should expect more from their standard of care,”\nsaid Mike Doustdar, president and CEO of Novo. “As Novo prepares to bring\ndenecimig to market, our ambition is to help make better care something they\ncan count on. Novo is already in the process of addressing the FDA's requests\nas efficiently as possible and continuing to work closely with the Agency\ntoward bringing denecimig to patients in the US.”\n\nThe Agency has not identified deficiencies related to the clinical efficacy or\nsafety data of denecimig demonstrated in the FRONTIER clinical trial\nprogramme. Novo is continuing implementation of the facility remediation\nactivities in response to the FDA's feedback and is working closely with the\nAgency to address the outstanding requirements. The feedback on the\nmanufacturing site does not impact other marketed Novo products.\n\nThe additional FDA review time does not have an impact on Novo's financial\noutlook for 2026. Pending regulatory decision, Novo aims to launch denecimig\nin the US in the first half of 2027.\n\nAbout the FRONTIER trials\nThe FRONTIER clinical programme includes FRONTIER1-5 and investigates\ndenecimig as a prophylactic treatment to prevent bleeding episodes across\npaediatric and adult populations with haemophilia A, with or without\ninhibitors.\n\nFRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig Marketing\nAuthorisation Application (MAA) submission. FRONTIER2 evaluated denecimig\ntreatment once every month and once every week in adults and adolescents 12\nyears of age and older; FRONTIER3 evaluated denecimig treatment once every\nmonth and once every week in children below the age of 12; FRONTIER4 was an\nopen-label extension trial evaluating the efficacy of denecimig once every two\nweeks (Q2W) as well as investigating the long-term safety of denecimig across\nall dosing regimens (once every month, once every two weeks, and once every\nweek) in subjects with haemophilia A, with or without inhibitors.\n\nAbout denecimig\nDenecimig is a FVIIIa mimetic bispecific antibody designed with the aim to\ndeliver once monthly, every two weeks and weekly prophylaxis for people living\nwith haemophilia A, with or without inhibitors. Denecimig, which is\nadministered under the skin, ‘mimics’ the role of FVIIIa by bridging\nfactor IXa and factor X. This action mimics the cofactor function of FVIIIa,\nwhich helps restore the body’s thrombin generation capacity, helping blood\nto clot. On 17 September, denecimig received a positive CHMP opinion and is\ncurrently pending marketing approval from the EMA and under review by other\nregulatory authorities.\n\nNovo is the global healthcare company that believes lasting health starts now.\nFor over a century, we’ve combined leading scientific expertise with a deep\nunderstanding of people’s lives. We develop treatments and support that help\nmillions of people make progress they can see, feel and sustain now and in the\nfuture. Every day, over 67,000 employees around the world advance our purpose\nto drive change for lasting health. Through our partnerships, programmes and\ninvestments, we’re working to prevent disease, expand access to treatments\nand reduce our environmental impact to help even more people live healthier\nlives. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its\nADRs are listed on the New York Stock Exchange (NVO). For more information,\nvisit novonordisk.com\n(https://www.globenewswire.com/Tracker?data=lMNAyW8SQgTgE99sXgvPXuro4tVK0ny8YGOK6w3D3n2EaV7tykxMbwZ9UOcxPGaZZcodjM_7HS47XFUGmt_5qwb0soTuOXE3VKqziwN-oos=)\nand follow us on Instagram\n(https://www.globenewswire.com/Tracker?data=MOw5ljvxvz6mw3scHR98U0sB2q0PZJ_xOv141XDdxj0wSIrOmP7TxsQO2P308dRUc7XE1U67IN6H6C72iTcLJUDEcDqNXsNXIDXpJr2Lyqk=),\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=VGWna1_PhZLd0fd74x7-Ab87hTwjB-z9fAIojHFVJRJvLZ7Agb0UFe-39PP5MBOGPSj9x9FT22Ue_Rg9drisYi4MbmhDjbRcPg_3IcHPFuKwp0JAjLZn-QJ2oHpjhfMO),\nTikTok\n(https://www.globenewswire.com/Tracker?data=ypqeR3YrHZCx03larkC1rDr4ed9ZvCzD3Vxtn1gnYCmgFtrL2hi7IhXoWfMQfBtkAaIUonuLUSrfBe2589dwvw5umBRNn3Jmaho2SThcATU=),\nFacebook\n(https://www.globenewswire.com/Tracker?data=txGqLd38HhSaiSafxYP-X535BJ86Yv0tZklTkPziA3NRrhOHTZoncOktjhiY_O3Cgwx1ta3sgXaL1tX0bzGn8RRaZVAUsQxFrbsv4I_Nb_8=),\nX\n(https://www.globenewswire.com/Tracker?data=YuXRigoi9uPJ6h_bTVYhjbpoyQjVjD4PE-F74oZ5XU-i_g_DTBkJ5cw4FVezi8Wy4XRcHfbXS_VWvsSpGl2KfA==)\nand YouTube\n(https://www.globenewswire.com/Tracker?data=D8eu8V98_vFHoFHE1QQvn0UyHDtf44fWplnvXbtCf6c2CWSZh9PvE7k_5MZFOxDqX5go0TFqPYZa3lK_aqPjx53W0v5DF5lcteoydPSYfJA=).\n\nPublication of inside information pursuant to Market Abuse Regulation, Article\n17.\n\nContacts for further information\n\n Novo Media: \n Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com Liz Skrbkova (US) +1 609 917 0632 USMediaRelations@novonordisk.com \n Novo Investors: \n Michael Novod +45 3075 6050 nvno@novonordisk.com Sina Meyer +45 3079 6656 azey@novonordisk.com \n Ida Schaap Melvold +45 3077 5649 idmg@novonordisk.com Max Ung +45 3077 6414 mxun@novonordisk.com \n Christoffer Togo Solgaard-Tullin +45 3079 1471 cftu@novonordisk.com Mads Berner Bruun +45 3075 2936 mbbz@novonordisk.com \n Frederik Taylor Pitter (US) +1 609 613 0568 fptr@novonordisk.com Alex Bruce (US) +1 640 230 0276 axeu@novonordisk.com \n\nCompany announcement No 59 / 2026\n\nAttachment\n* 261002_Denecimig FDA\n(https://ml-eu.globenewswire.com/Resource/Download/ba8d163a-634b-4af0-856a-a393b9ce5bfe)","article_body_html":"","raw_payload":{"data":{"id":"nGNE1bnCcM-20261002","title":"REG-Novo provides update on the denecimig Biologics License Application (BLA) in the US","author":"Globe Newswire","ticker":"NOVOB","created":"2026-10-02T20:53:42.099Z","tickers":["NOVOB"],"exchange":"Nasdaq Copenhagen","article_body":"* The US Food and Drug Administration (FDA) has informed Novo that the BLA\nreview of denecimig for the treatment of haemophilia A is still ongoing. The\nFDA has not communicated a new timeline for regulatory action on the BLA \n* The FDA has informed Novo that the ongoing facility remediation activities\nare the cause for extension of the Agency's review. The FDA has not identified\nany deficiencies related to the clinical efficacy or safety data submitted in\nthe denecimig BLA\n* Novo is actively working with the FDA, addressing the Agency's requests for\nremediations related to the manufacturing facility. The extended FDA review\ntime for the denecimig BLA has no impact on Novo's financial outlook for 2026\nand pending regulatory decision, Novo aims to launch denecimig in the US in\nthe first half of 2027\nBagsværd, Denmark, 02 October 2026 – Novo Nordisk today announced that the\nUS Food and Drug Administration (FDA) has informed Novo that the BLA review of\ndenecimig for the treatment of haemophilia A, with or without inhibitors in\nadults and children, is still ongoing. The FDA has not communicated a new\ntimeline for expected regulatory action on the BLA. \n\nNovo submitted a BLA for denecimig for the treatment of haemophilia A in adult\nand paediatric patients to the US FDA for review in September 2025, with an\nanticipated regulatory decision in the third quarter of 2026. Following this\nsubmission, the FDA performed a pre-license inspection of the manufacturing\nsite and provided feedback. Today, the FDA has informed Novo that the ongoing\nfacility remediation activities are the cause for extension of the Agency's\nreview.\n\n“Haemophilia A patients should expect more from their standard of care,”\nsaid Mike Doustdar, president and CEO of Novo. “As Novo prepares to bring\ndenecimig to market, our ambition is to help make better care something they\ncan count on. Novo is already in the process of addressing the FDA's requests\nas efficiently as possible and continuing to work closely with the Agency\ntoward bringing denecimig to patients in the US.”\n\nThe Agency has not identified deficiencies related to the clinical efficacy or\nsafety data of denecimig demonstrated in the FRONTIER clinical trial\nprogramme. Novo is continuing implementation of the facility remediation\nactivities in response to the FDA's feedback and is working closely with the\nAgency to address the outstanding requirements. The feedback on the\nmanufacturing site does not impact other marketed Novo products.\n\nThe additional FDA review time does not have an impact on Novo's financial\noutlook for 2026. Pending regulatory decision, Novo aims to launch denecimig\nin the US in the first half of 2027.\n\nAbout the FRONTIER trials\nThe FRONTIER clinical programme includes FRONTIER1-5 and investigates\ndenecimig as a prophylactic treatment to prevent bleeding episodes across\npaediatric and adult populations with haemophilia A, with or without\ninhibitors.\n\nFRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig Marketing\nAuthorisation Application (MAA) submission. FRONTIER2 evaluated denecimig\ntreatment once every month and once every week in adults and adolescents 12\nyears of age and older; FRONTIER3 evaluated denecimig treatment once every\nmonth and once every week in children below the age of 12; FRONTIER4 was an\nopen-label extension trial evaluating the efficacy of denecimig once every two\nweeks (Q2W) as well as investigating the long-term safety of denecimig across\nall dosing regimens (once every month, once every two weeks, and once every\nweek) in subjects with haemophilia A, with or without inhibitors.\n\nAbout denecimig\nDenecimig is a FVIIIa mimetic bispecific antibody designed with the aim to\ndeliver once monthly, every two weeks and weekly prophylaxis for people living\nwith haemophilia A, with or without inhibitors. Denecimig, which is\nadministered under the skin, ‘mimics’ the role of FVIIIa by bridging\nfactor IXa and factor X. This action mimics the cofactor function of FVIIIa,\nwhich helps restore the body’s thrombin generation capacity, helping blood\nto clot. On 17 September, denecimig received a positive CHMP opinion and is\ncurrently pending marketing approval from the EMA and under review by other\nregulatory authorities.\n\nNovo is the global healthcare company that believes lasting health starts now.\nFor over a century, we’ve combined leading scientific expertise with a deep\nunderstanding of people’s lives. We develop treatments and support that help\nmillions of people make progress they can see, feel and sustain now and in the\nfuture. Every day, over 67,000 employees around the world advance our purpose\nto drive change for lasting health. Through our partnerships, programmes and\ninvestments, we’re working to prevent disease, expand access to treatments\nand reduce our environmental impact to help even more people live healthier\nlives. Novo Nordisk's B shares are listed on Nasdaq Copenhagen (Novo-B). Its\nADRs are listed on the New York Stock Exchange (NVO). For more information,\nvisit novonordisk.com\n(https://www.globenewswire.com/Tracker?data=lMNAyW8SQgTgE99sXgvPXuro4tVK0ny8YGOK6w3D3n2EaV7tykxMbwZ9UOcxPGaZZcodjM_7HS47XFUGmt_5qwb0soTuOXE3VKqziwN-oos=)\nand follow us on Instagram\n(https://www.globenewswire.com/Tracker?data=MOw5ljvxvz6mw3scHR98U0sB2q0PZJ_xOv141XDdxj0wSIrOmP7TxsQO2P308dRUc7XE1U67IN6H6C72iTcLJUDEcDqNXsNXIDXpJr2Lyqk=),\nLinkedIn\n(https://www.globenewswire.com/Tracker?data=VGWna1_PhZLd0fd74x7-Ab87hTwjB-z9fAIojHFVJRJvLZ7Agb0UFe-39PP5MBOGPSj9x9FT22Ue_Rg9drisYi4MbmhDjbRcPg_3IcHPFuKwp0JAjLZn-QJ2oHpjhfMO),\nTikTok\n(https://www.globenewswire.com/Tracker?data=ypqeR3YrHZCx03larkC1rDr4ed9ZvCzD3Vxtn1gnYCmgFtrL2hi7IhXoWfMQfBtkAaIUonuLUSrfBe2589dwvw5umBRNn3Jmaho2SThcATU=),\nFacebook\n(https://www.globenewswire.com/Tracker?data=txGqLd38HhSaiSafxYP-X535BJ86Yv0tZklTkPziA3NRrhOHTZoncOktjhiY_O3Cgwx1ta3sgXaL1tX0bzGn8RRaZVAUsQxFrbsv4I_Nb_8=),\nX\n(https://www.globenewswire.com/Tracker?data=YuXRigoi9uPJ6h_bTVYhjbpoyQjVjD4PE-F74oZ5XU-i_g_DTBkJ5cw4FVezi8Wy4XRcHfbXS_VWvsSpGl2KfA==)\nand YouTube\n(https://www.globenewswire.com/Tracker?data=D8eu8V98_vFHoFHE1QQvn0UyHDtf44fWplnvXbtCf6c2CWSZh9PvE7k_5MZFOxDqX5go0TFqPYZa3lK_aqPjx53W0v5DF5lcteoydPSYfJA=).\n\nPublication of inside information pursuant to Market Abuse Regulation, Article\n17.\n\nContacts for further information\n\n Novo Media: \n Ambre James-Brown +45 3079 9289 globalmedia@novonordisk.com Liz Skrbkova (US) +1 609 917 0632 USMediaRelations@novonordisk.com \n Novo Investors: \n Michael Novod +45 3075 6050 nvno@novonordisk.com Sina Meyer +45 3079 6656 azey@novonordisk.com \n Ida Schaap Melvold +45 3077 5649 idmg@novonordisk.com Max Ung +45 3077 6414 mxun@novonordisk.com \n Christoffer Togo Solgaard-Tullin +45 3079 1471 cftu@novonordisk.com Mads Berner Bruun +45 3075 2936 mbbz@novonordisk.com \n Frederik Taylor Pitter (US) +1 609 613 0568 fptr@novonordisk.com Alex Bruce (US) +1 640 230 0276 axeu@novonordisk.com \n\nCompany announcement No 59 / 2026\n\nAttachment\n* 261002_Denecimig FDA\n(https://ml-eu.globenewswire.com/Resource/Download/ba8d163a-634b-4af0-856a-a393b9ce5bfe)"},"type":"article","timestamp":"2026-10-02T20:53:42.220203395Z","server_sent_at_ms":1790974422220},"received_at":"2026-10-02T20:53:42.272Z","source_url":null},"analysis":{"id":"148336","press_release_id":"159742","analysis_json":{"industry":{"label":"Pharmaceuticals","sector":"Health Care"},"redFlags":["FDA review extended with no new timeline communicated","manufacturing facility remediation issues, though FDA says they do not affect other marketed Novo products"],"eventType":"regulatory","narrative":"Novo Nordisk disclosed that the FDA's review of the denecimig BLA for haemophilia A is still ongoing past the anticipated Q3 2026 decision, with no new timeline provided.\n\nThe FDA attributed the extension to ongoing manufacturing facility remediation; no deficiencies were identified in the clinical efficacy or safety data from the FRONTIER trial programme.\n\nNovo says the delay has no impact on its 2026 financial outlook and still aims to launch denecimig in the US in the first half of 2027, pending the regulatory decision. Denecimig already received a positive CHMP opinion in September and is pending EMA approval.","sentiment":"bearish","agentHooks":{"shouldPost":true,"suggestedAngle":"Denecimig BLA slips past Q3 2026 on facility remediation -- watch for residual US launch timing risk into 2027."},"keyFigures":{"drugName":"denecimig","phaseOfTrial":"BLA review (pivotal trials FRONTIER2-4)","customDimensions":{"expected_launch":"US launch aimed for first half of 2027, pending regulatory decision","financial_outlook_impact":"none on 2026 outlook","original_decision_timing":"Q3 2026 (BLA submitted September 2025)"}},"quotedText":"The FDA has informed Novo that the ongoing facility remediation activities are the cause for extension of the Agency's review. The FDA has not identified any deficiencies related to the clinical efficacy or safety data submitted in the denecimig BLA","namedEntities":{"people":[{"name":"Mike Doustdar","role":"president and CEO of Novo Nordisk"}],"products":["denecimig","FRONTIER clinical trial programme"],"companies":[{"name":"Novo Nordisk","ticker":"NOVOB","relationship":"filer"},{"name":"US Food and Drug Administration (FDA)","relationship":"regulator"},{"name":"European Medicines Agency (EMA)","relationship":"regulator"}],"dollarAmounts":[]},"materialImpact":{"score":3,"reasoning":"FDA extended review of the denecimig BLA beyond the anticipated Q3 2026 decision with no new timeline given, citing manufacturing facility remediation. However, no clinical efficacy or safety deficiencies were identified and the 2026 financial outlook is unaffected, limiting downside."},"tickerRelevance":{"others":[{"ticker":"NVO","relevance":"ADR listing of the same issuer"}],"primary":"NOVOB"},"globalImportance":45,"audienceRelevance":60,"eventTypeSecondary":[],"importanceComponents":{"tickerTier":"mega-cap pharma","eventGravity":"regulatory delay, binary event pushed with no new date","clinicalMitigant":"no efficacy/safety deficiencies identified","householdBrandBoost":true}},"event_type":"regulatory","event_type_secondary":null,"sentiment":"bearish","material_impact_score":3,"narrative":"Novo Nordisk disclosed that the FDA's review of the denecimig BLA for haemophilia A is still ongoing past the anticipated Q3 2026 decision, with no new timeline provided.\n\nThe FDA attributed the extension to ongoing manufacturing facility remediation; no deficiencies were identified in the clinical efficacy or safety data from the FRONTIER trial programme.\n\nNovo says the delay has no impact on its 2026 financial outlook and still aims to launch denecimig in the US in the first half of 2027, pending the regulatory decision. Denecimig already received a positive CHMP opinion in September and is pending EMA approval.","key_figures":{"drugName":"denecimig","phaseOfTrial":"BLA review (pivotal trials FRONTIER2-4)","customDimensions":{"expected_launch":"US launch aimed for first half of 2027, pending regulatory decision","financial_outlook_impact":"none on 2026 outlook","original_decision_timing":"Q3 2026 (BLA submitted September 2025)"}},"named_entities":{"people":[{"name":"Mike Doustdar","role":"president and CEO of Novo Nordisk"}],"products":["denecimig","FRONTIER clinical trial programme"],"companies":[{"name":"Novo Nordisk","ticker":"NOVOB","relationship":"filer"},{"name":"US Food and Drug Administration (FDA)","relationship":"regulator"},{"name":"European Medicines Agency (EMA)","relationship":"regulator"}],"dollarAmounts":[]},"model_name":"glm-5.3-flashx","prompt_hash":"sha256:727b4b9429a443af","schema_hash":"sha256:05005c02d9cffac9","created_at":"2026-10-02T20:53:47.805Z","global_importance":45,"audience_relevance":60,"importance_components":{"tickerTier":"mega-cap pharma","eventGravity":"regulatory delay, binary event pushed with no new date","clinicalMitigant":"no efficacy/safety deficiencies identified","householdBrandBoost":true}},"durationMs":5518,"modelName":"glm-5.3-flashx"}}