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Novo's Denecimig Gets CHMP Nod for Hemophilia A in the European Union
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Key Takeaways
Novo's denecimig earned a positive CHMP opinion for hemophilia A prophylaxis in adults and children.
Denecimig offers weekly, every-two-week or monthly dosing via a subcutaneous prefilled pen.
FRONTIER studies showed low bleeding rates, with many patients experiencing no treated bleeds.
Novo (NVO - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of denecimig (Mim8) for the treatment of hemophilia A, with or without inhibitors, in adults and children.
Denecimig is a next-generation factor VIIIa (FVIIIa) mimetic bispecific antibody designed to prevent or reduce bleeding episodes through routine prophylactic treatment. The therapy is designed to offer flexible dosing options, including once-monthly, every-two-week and weekly administration. It is administered subcutaneously and is being developed as a prefilled pen, which could provide greater convenience compared with conventional treatment approaches.
Upon approval, Novo expects to launch denecimig in the first European countries in the fourth quarter of 2026, followed by a broader rollout across the European Union beginning in early 2027. The company will market the drug under the brand name Frehemgo.
The candidate is also under regulatory review in the United States for routine prophylaxis in adults and children with hemophilia A, with or without inhibitors. Novo submitted the biologics license application to the FDA in September 2025.
Year to date, shares of Novo have lost 12.3% against the industry’s 14.3% growth.
Image Source: Zacks Investment Research
CHMP Nod to NVO’s Denecimig Based on FRONTIER Data
The positive opinion by CHMP is supported by data from the FRONTIER clinical program, which comprises five studies evaluating denecimig as a prophylactic treatment for hemophilia A across pediatric and adult populations, with or without inhibitors.
In the FRONTIER 2 study, denecimig significantly reduced annualized bleeding rates. Results from the FRONTIER 3 study in children younger than 12 years were consistent with those seen in adolescents and adults. In the reported phase III population across the program, denecimig demonstrated low annualized bleeding rates, with many patients experiencing no treated bleeds. In FRONTIER 5, no new safety concerns were identified when participants switched directly from emicizumab to denecimig and participants showed a preference for the denecimig administration device.
Novo already markets Alhemo for the treatment of hemophilia A and B in patients with or without inhibitors. Alhemo is administered through a prefilled subcutaneous pen and is designed to reduce reliance on intravenous infusions.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 88.3% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 14.7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.4% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
View the Zacks #1 Rank List
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Novo's Denecimig Gets CHMP Nod for Hemophilia A in the European Union
Key Takeaways
Novo (NVO - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has issued a positive opinion recommending the approval of denecimig (Mim8) for the treatment of hemophilia A, with or without inhibitors, in adults and children.
Denecimig is a next-generation factor VIIIa (FVIIIa) mimetic bispecific antibody designed to prevent or reduce bleeding episodes through routine prophylactic treatment. The therapy is designed to offer flexible dosing options, including once-monthly, every-two-week and weekly administration. It is administered subcutaneously and is being developed as a prefilled pen, which could provide greater convenience compared with conventional treatment approaches.
Upon approval, Novo expects to launch denecimig in the first European countries in the fourth quarter of 2026, followed by a broader rollout across the European Union beginning in early 2027. The company will market the drug under the brand name Frehemgo.
The candidate is also under regulatory review in the United States for routine prophylaxis in adults and children with hemophilia A, with or without inhibitors. Novo submitted the biologics license application to the FDA in September 2025.
Year to date, shares of Novo have lost 12.3% against the industry’s 14.3% growth.
Image Source: Zacks Investment Research
CHMP Nod to NVO’s Denecimig Based on FRONTIER Data
The positive opinion by CHMP is supported by data from the FRONTIER clinical program, which comprises five studies evaluating denecimig as a prophylactic treatment for hemophilia A across pediatric and adult populations, with or without inhibitors.
In the FRONTIER 2 study, denecimig significantly reduced annualized bleeding rates. Results from the FRONTIER 3 study in children younger than 12 years were consistent with those seen in adolescents and adults. In the reported phase III population across the program, denecimig demonstrated low annualized bleeding rates, with many patients experiencing no treated bleeds. In FRONTIER 5, no new safety concerns were identified when participants switched directly from emicizumab to denecimig and participants showed a preference for the denecimig administration device.
Novo already markets Alhemo for the treatment of hemophilia A and B in patients with or without inhibitors. Alhemo is administered through a prefilled subcutaneous pen and is designed to reduce reliance on intravenous infusions.
NVO's Zacks Rank & Stocks to Consider
Novo currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Precigen (PGEN - Free Report) , currently sporting a Zacks Rank #1 (Strong Buy), and AC Immune (ACIU - Free Report) and Aldeyra Therapeutics (ALDX - Free Report) , carrying a Zacks Rank #2 (Buy) each. You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Precigen’s 2026 bottom line have improved from a loss of 2 cents to earnings per share of 25 cents. Over the same period, earnings estimates for 2027 have risen from 25 cents to 86 cents. PGEN shares have increased 88.3% year to date.
Precigen’s earnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 108.96%.
Over the past 60 days, estimates for AC Immune’s 2026 loss per share have narrowed from 84 cents to 60 cents. Over the same period, earnings estimates for 2027 remained unchanged at 17 cents. ACIU shares have lost 14.7% year to date.
AC Immune’s earnings beat estimates in each of the trailing four quarters, with the average surprise being 33.25%.
Over the past 60 days, loss per share estimates for Aldeyra Therapeuticshave narrowed from 43 cents to 39 cents for 2026. Over the same period, estimates for 2027 loss per share have narrowed from 22 cents to 16 cents. ALDX shares have plunged 73.4% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.