Novo Nordisk haemophilia drug wins EU panel backing

Rhea-AI Filing Summary

Novo Nordisk A/S (NVO) announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) has issued a positive opinion recommending EU marketing authorisation for FREHEMGO® (denecimig) to treat haemophilia A, with or without inhibitors, in adults and children.

FREHEMGO is a next-generation factor VIIIa mimetic bispecific antibody intended for routine prophylaxis to prevent or reduce bleeding episodes, with flexible once-monthly, once-every-two-weeks and weekly dosing in a pre-filled pen. Across the phase 3 FRONTIER programme, denecimig showed consistently low mean annualised bleeding rates, generally below 1, and a substantial proportion of participants experienced zero treated bleeds. A FRONTIER 5 study reported no new safety signals after switching from emicizumab and showed a clear preference for the denecimig device. Denecimig remains under review by the EMA and other regulators, and a Biologics License Application has been submitted to the US FDA.

Positive

• EMA CHMP issues positive opinion for FREHEMGO® in haemophilia A, supporting potential EU approval of denecimig as a flexible, low-bleed prophylactic option for adults and children with or without inhibitors.

Negative

• None.

Key Figures

Mean annualised bleeding rate: Generally below 1 Dosing frequencies: Once monthly, once every two weeks, once weekly Haemophilia experience: Over 40 years +2 more

5 metrics

Mean annualised bleeding rate Generally below 1 Across the reported phase 3 FRONTIER programme population treated with denecimig

Dosing frequencies Once monthly, once every two weeks, once weekly Prophylactic regimens evaluated in FRONTIER2, FRONTIER3 and FRONTIER4 for denecimig

Haemophilia experience Over 40 years Novo Nordisk’s stated commitment in haemophilia treatment

Company history Over 100 years Novo Nordisk’s duration combining scientific expertise with patient understanding

Employees Over 67,000 Number of Novo Nordisk employees worldwide

Key Terms

factor VIIIa mimetic, bispecific antibody, annualised bleeding rate, prophylaxis, +2 more

6 terms

factor VIIIa mimetic medical

"FREHEMGO® is a next-generation factor VIIIa mimetic bispecific antibody"

bispecific antibody medical

"FREHEMGO® is a next-generation factor VIIIa mimetic bispecific antibody"

A bispecific antibody is a specially designed protein that can attach to two different targets at the same time. Think of it as a custom-made connector that brings two things together—such as a disease cell and an immune system component—helping the body fight illnesses more effectively. For investors, understanding bispecific antibodies is important because they represent innovative therapies that could lead to new treatments and potentially lucrative market opportunities.

annualised bleeding rate medical

"denecimig significantly reduced annualised bleeding rate compared to prior clotting factor prophylaxis"

prophylaxis medical

"designed as a routine prophylaxis to prevent or reduce the frequency of bleeding episodes"

Prophylaxis is a medical prevention strategy — a drug, vaccine, device, or procedure given to stop a disease or condition before it starts. For investors, prophylactic products matter because they can create steady, large markets and reduce long‑term healthcare costs; regulatory approval or broader adoption can change demand forecasts much like a new safety feature that becomes standard across an entire industry.

Marketing Authorisation Application regulatory

"FRONTIER2, FRONTIER3 and FRONTIER4 formed the basis of the denecimig Marketing Authorisation Application"

A marketing authorisation application is the formal package a drug or medical-device maker submits to a health regulator to get permission to sell a product. Think of it as an application for a sales license: regulators review safety, effectiveness and manufacturing quality before granting permission. Investors watch these submissions because approval unlocks revenue and reduces development risk, while rejection or delays can materially affect a company’s value and timeline.

Biologics License Application regulatory

"submitted denecimig for review to the US Food and Drug Administration through a Biologics License Application"

A biologics license application is a formal request submitted to regulatory authorities seeking approval to market a new biological medicine, such as vaccines or treatments made from living organisms. It is a comprehensive review process that evaluates the safety, effectiveness, and manufacturing quality of the product. For investors, receiving approval signals that a biological therapy can be sold to the public, potentially leading to revenue growth and market success.

FAQ

AI-generated questions and answers. How Rhea-AI works. Not financial advice.

What did Novo Nordisk (NVO) announce about FREHEMGO in Europe?

Novo Nordisk reported that the EMA’s CHMP adopted a positive opinion recommending marketing authorisation for FREHEMGO® (denecimig) to treat haemophilia A, with or without inhibitors, in both adults and children, pending final EMA approval.

What is FREHEMGO (denecimig) that Novo Nordisk (NVO) is developing?

FREHEMGO® (denecimig) is a factor VIIIa mimetic bispecific antibody given under the skin as prophylaxis to prevent or reduce bleeding episodes in people with haemophilia A, including those with inhibitors, using monthly, every two weeks or weekly dosing in a pre-filled pen.

What efficacy results for denecimig did Novo Nordisk (NVO) highlight?

Novo Nordisk stated that across the phase 3 FRONTIER programme, denecimig produced consistently low mean annualised bleeding rates, generally below 1, with a substantial proportion of participants experiencing zero treated bleeds compared with prior prophylaxis or on-demand treatment.

What safety and switching data were reported for denecimig by NVO?

In the FRONTIER 5 trial, Novo Nordisk reported no new safety signals when patients switched directly from emicizumab to denecimig prophylaxis and noted a clear preference among participants for the denecimig device.

What are the dosing options for FREHEMGO mentioned by Novo Nordisk (NVO)?

FREHEMGO® is designed to offer once-monthly, once-every-two-weeks and once-weekly prophylactic dosing in a pre-filled pen, aiming to provide strong bleed protection with flexible treatment frequencies for people with haemophilia A.

Has Novo Nordisk (NVO) pursued US approval for denecimig?

Yes. Novo Nordisk stated that in September 2025 it submitted denecimig to the US Food and Drug Administration through a Biologics License Application, which is under review.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Available on EDGAR 09/17/2026 - 12:21 PM Accepted by SEC EDGAR 09/17/2026 - 12:21 PM Learn about SEC filing dates

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

________________

FORM 6-K

________________

REPORT OF FOREIGN PRIVATE ISSUER

Pursuant to Rule 13a-16 or 15d-16

of the Securities Exchange Act of 1934

September 17, 2026

________________

NOVO NORDISK A/S

 (Exact name of Registrant as specified in its charter)

Novo Allé 1

DK- 2880, Bagsvaerd

Denmark

(Address of principal executive offices)

________________

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F

Form 20-F ☒           Form 40-F ☐

 

 

CHMP recommends EU approval of FREHEMGO® (denecimig), the first factor VIIIa mimetic offering monthly, once every two weeks and weekly dosing in a pre-filled pen, for the treatment of haemophilia A

· FREHEMGO® (denecimig) has been recommended by CHMP for approval in the EU for the treatment of haemophilia A (congenital FVIII deficiency), with or without inhibitors for adults and children

· FREHEMGO® is the first FVIIIa mimetic to offer once-monthly, once-every-two-weeks and once-weekly prophylaxis in a single-use pre-filled pen

· Novo expects to launch FREHEMGO® in the first European countries in Q4 2026 and broadly across the EU starting early 2027

Bagsværd, Denmark, 17 September 2026 – Novo Nordisk today announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending marketing authorisation for FREHEMGO® (denecimig) to treat haemophilia A (HA), with or without inhibitors, in adults and children.

FREHEMGO® is a next-generation factor VIIIa mimetic bispecific antibody, designed as a routine prophylaxis to prevent or reduce the frequency of bleeding episodes in people living with HA, with or without inhibitors.

The CHMP recommendation is based on the FRONTIER trial programme. In the pivotal FRONTIER 2 trial, denecimig significantly reduced annualised bleeding rate compared to prior clotting factor prophylaxis and on-demand treatment in people with HA, with or without inhibitors. In children younger than 12 years, results from FRONTIER 3 were consistent with the efficacy observed in adolescents and adults.^1-2 Across the FRONTIER programme, denecimig has demonstrated consistently low mean annualised bleeding rates, generally below 1 in the reported phase 3 population, and with a substantial proportion of participants experiencing zero treated bleeds.^1-3 Furthermore, in the FRONTIER 5 trial, no new safety signals were identified following direct switching from emicizumab to denecimig prophylaxis. The study also showed a clear preference for the denecimig device.⁴

¹ NCT5053139; Mancuso ME, Chan AKC, Shanmukhaiah C, et al. N Engl J Med. 2026; doi: 10.1056/NEJMoa2517384

² NCT05306418

³ NCT05685238

⁴ NCT05878938; Hermans C, Benson G, Matino D, et al. J Thromb Haemost. 2026; doi: 10.1016/j.jtha.2026.09.004

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“The recommendation by the CHMP for approval of FREHEMGO® builds on Novo’s commitment of over 40 years in haemophilia and marks an important advancement for people living with haemophilia A, with or without inhibitors”, said Mike Doustdar, president and CEO of Novo. “The combination of strong bleed protection, flexible dosing frequency and a prefilled pen offers a differentiated treatment option that can reduce treatment burden and give people with haemophilia A greater freedom in managing their disease.”

In September 2025, Novo submitted denecimig for review to the US Food and Drug Administration (FDA) through a Biologics License Application (BLA).

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 FREHEMGO® (denecimig)

FREHEMGO® (denecimig) is an 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. FREHEMGO®, 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. FREHEMGO® is currently pending marketing approval from the EMA and 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.

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Publication of inside information pursuant to Market Abuse Regulation, Article 17.

Contacts for further information
Novo Media:
Ambre James-Brown	Liz Skrbkova (US)
+45 3079 9289	+1 609 917 0632
globalmedia@novonordisk.com	USMediaRelations@novonordisk.com
Novo Investors:
Michael Novod	Sina Meyer
+45 3075 6050	+45 3079 6656
nvno@novonordisk.com	azey@novonordisk.com
Christoffer Togo Solgaard-Tullin
+45 3079 1471
cftu@novonordisk.com
Ida Schaap Melvold	Mads Berner Bruun
+45 3077 5649	+45 3075 2936
idmg@novonordisk.com	mbbz@novonordisk.com
Frederik Taylor Pitter (US)	Alex Bruce (US)
+1 609 613 0568	+1 640 230 0276
fptr@novonordisk.com	axeu@novonordisk.com

Novo Nordisk A/S Investor Relations	Novo Allé 1 2880 Bagsværd Denmark	Telephone: +45 4444 8888	www.novonordisk.com CVR no: 24 25 67 90
			Company announcement No 55 / 2026

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf of the undersigned, thereunto duly authorized.

Date: September 17, 2026   NOVO NORDISK A/S   Maziar Mike Doustdar Chief Executive Officer