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NVO Reports New Positive Phase III Data on Mim8 in Hemophilia A
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Key Takeaways
Novo Nordisk's Mim8 was well-tolerated when patients switched directly from Hemlibra treatment.
Patients favored Mim8's pen-injector for ease of use, suggesting potential for strong treatment compliance.
Mim8 maintained clotting activity without safety issues, with no adverse events or antibody detection.
Novo Nordisk (NVO - Free Report) announced new data from the phase III FRONTIER clinical program, comprising five separate studies evaluating its investigational candidate, Mim8 (denecimig), as a prophylaxis treatment for people with hemophilia A, with or without inhibitors. The new data is from the phase IIIb FRONTIER5 study evaluating the safety of switching from previous Roche’s (RHHBY - Free Report) Hemlibra (emicizumab) prophylaxis treatment directly to Mim8 prophylaxis therapy using the Mim8 pen-injector in adults and adolescents aged 12 years and older.
NVO’s Phase III Hemophilia A Study Results in Detail
Per the data readout, it was observed that switching directly from Roche’s Hemlibra to Novo Nordisk’s Mim8 for hemophilia A, without a washout period or loading dose, was well-tolerated with no safety issues in adults and adolescents, regardless of inhibitor status. Additionally, patient-reported outcomes indicated a strong preference for the Mim8 pen-injector, which was found to be easier to use compared to the Hemlibra injection system. Subject to approval, it is likely that Mim8 will enjoy a high patient compliance rate as it significantly reduces the treatment burden compared to current treatment options.
Year to date, shares of Novo Nordisk have lost 14.2% compared with the industry’s 2.7% decline.
Image Source: Zacks Investment Research
In the study, patients received their first Mim8 maintenance dose on the scheduled day of their next Hemlibra dose. They were given a choice between weekly, biweekly or monthly Mim8 dosing, regardless of their previous regimen. Steady-state levels of Mim8 were reached by week 16, with Roche’s Hemlibra fully cleared by week 26. The switch to Mim8 resulted in a sustained rise in thrombin peak levels (helping blood to clot) without causing excessive thrombin activity, which was encouraging.
Novo Nordisk confirmed that Mim8 was overall well-tolerated in the FRONTIER5 study with no safety issues reported. There were no thromboembolic events, hypersensitivity reactions or treatment-related adverse events leading to discontinuation. Additionally, no signs of neutralising antibodies against Mim8 were detected.
Based on the encouraging findings, Novo Nordisk anticipates submitting Mim8 as a prophylaxis treatment for people with hemophilia A, with or without inhibitors, for regulatory review in 2025. Currently, the candidate is not approved by regulatory authorities anywhere in the world. The company also expects to report additional data from the phase III FRONTIER program in 2025 and 2026.
Hemophilia is a rare genetic disorder that affects the blood's ability to clot, impacting around 1.1 million people globally. Hemophilia A is caused by a deficiency in clotting Factor VIII, while hemophilia B involves Factor IX. Up to 30% of those with severe hemophilia A develop inhibitors — immune responses that reduce the effectiveness of replacement therapies.
In the past 60 days, loss per share estimates for Immunocore’s 2025 have improved from $1.50 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.68 to $1.33 during the same period. IMCR stock has gained 6.2% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 57.4%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
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NVO Reports New Positive Phase III Data on Mim8 in Hemophilia A
Key Takeaways
Novo Nordisk (NVO - Free Report) announced new data from the phase III FRONTIER clinical program, comprising five separate studies evaluating its investigational candidate, Mim8 (denecimig), as a prophylaxis treatment for people with hemophilia A, with or without inhibitors. The new data is from the phase IIIb FRONTIER5 study evaluating the safety of switching from previous Roche’s (RHHBY - Free Report) Hemlibra (emicizumab) prophylaxis treatment directly to Mim8 prophylaxis therapy using the Mim8 pen-injector in adults and adolescents aged 12 years and older.
NVO’s Phase III Hemophilia A Study Results in Detail
Per the data readout, it was observed that switching directly from Roche’s Hemlibra to Novo Nordisk’s Mim8 for hemophilia A, without a washout period or loading dose, was well-tolerated with no safety issues in adults and adolescents, regardless of inhibitor status. Additionally, patient-reported outcomes indicated a strong preference for the Mim8 pen-injector, which was found to be easier to use compared to the Hemlibra injection system. Subject to approval, it is likely that Mim8 will enjoy a high patient compliance rate as it significantly reduces the treatment burden compared to current treatment options.
Year to date, shares of Novo Nordisk have lost 14.2% compared with the industry’s 2.7% decline.
Image Source: Zacks Investment Research
In the study, patients received their first Mim8 maintenance dose on the scheduled day of their next Hemlibra dose. They were given a choice between weekly, biweekly or monthly Mim8 dosing, regardless of their previous regimen. Steady-state levels of Mim8 were reached by week 16, with Roche’s Hemlibra fully cleared by week 26. The switch to Mim8 resulted in a sustained rise in thrombin peak levels (helping blood to clot) without causing excessive thrombin activity, which was encouraging.
Novo Nordisk confirmed that Mim8 was overall well-tolerated in the FRONTIER5 study with no safety issues reported. There were no thromboembolic events, hypersensitivity reactions or treatment-related adverse events leading to discontinuation. Additionally, no signs of neutralising antibodies against Mim8 were detected.
Based on the encouraging findings, Novo Nordisk anticipates submitting Mim8 as a prophylaxis treatment for people with hemophilia A, with or without inhibitors, for regulatory review in 2025. Currently, the candidate is not approved by regulatory authorities anywhere in the world. The company also expects to report additional data from the phase III FRONTIER program in 2025 and 2026.
Hemophilia is a rare genetic disorder that affects the blood's ability to clot, impacting around 1.1 million people globally. Hemophilia A is caused by a deficiency in clotting Factor VIII, while hemophilia B involves Factor IX. Up to 30% of those with severe hemophilia A develop inhibitors — immune responses that reduce the effectiveness of replacement therapies.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
NVO’s Zacks Rank and Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Immunocore (IMCR - Free Report) and Bayer (BAYRY - Free Report) . While IMCR currently sports a Zacks Rank #1 (Strong Buy), BAYRY carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
In the past 60 days, loss per share estimates for Immunocore’s 2025 have improved from $1.50 to 86 cents. Loss per share estimates for 2026 have narrowed from $1.68 to $1.33 during the same period. IMCR stock has gained 6.2% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters and missed the mark once, delivering an average surprise of 76.18%.
BAYRY’s 2025 earnings per share estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 57.4%.
BAYRY’s earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.