Novo’s once-weekly Sogroya® (somapacitan) receives positive CHMP opinion in Europe for children with idiopathic short stature (unexplained shortness)

A positive CHMP opinion for Sogroya moves Novo Nordisk closer to an EU label expansion into idiopathic short stature and two other paediatric indications.

Rhea-AI Summary

Novo Nordisk (NVO) received a positive CHMP opinion recommending once-weekly Sogroya (somapacitan) for children in Europe with idiopathic short stature (ISS) and persistent growth disturbance.

If approved, Sogroya would be the first and only growth hormone treatment authorised for ISS in the EU, adding to earlier CHMP recommendations for children born small for gestational age and with Noonan Syndrome. In the phase 3 REAL8 trial, once-weekly Sogroya was non-inferior to once-daily growth hormone for mean annualised height velocity at Week 52 in children with ISS, SGA and NS. The opinion now goes to the European Commission, with a marketing authorisation decision covering all three indications expected later in 2026. Sogroya is already approved in the EU for growth hormone deficiency in adults and in children aged 3 years and older.

Positive

• Positive CHMP opinion for once-weekly Sogroya in children with idiopathic short stature and persistent growth disturbance
• If authorised, Sogroya would be the EU's first and only approved growth hormone treatment for idiopathic short stature
• REAL8 phase 3 data show once-weekly Sogroya is non-inferior to once-daily growth hormone for mean annualised height velocity at Week 52 in ISS, SGA and NS
• European Commission marketing authorisation decision covering three paediatric indications is expected later in 2026

Negative

• None.

Market Context

The prior CHMP recommendation for FREHEMGO was followed by a 3.56% 24-hour gain, providing same-comp...

Analysis

The prior CHMP recommendation for FREHEMGO was followed by a 3.56% 24-hour gain, providing same-company regulatory context for Sogroya’s positive opinion; NVO’s 3.55% quote preceded this announcement.

Key Figures

European Commission decision: Expected later this year Treatment frequency: Once weekly Trial assessment: Week 52 +2 more

European Commission decision

Expected later this year

Marketing authorisation covering all three indications

Treatment frequency

Once weekly

Sogroya administration for children with idiopathic short stature

Trial assessment

Week 52

REAL8 clinical trial mean annualised height velocity

Comparator result

Non-inferior

Once-weekly Sogroya versus once-daily growth hormone in REAL8

ISS prevalence

Up to 3%

Children worldwide

Historical Context

1 past event · Latest: Sep 17

1 event

1. Sep 17

   CHMP recommendation

   24h Move

   +3.6%

   Positive CHMP opinion recommended EU authorisation for Novo’s haemophilia A treatment

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

chmp, ema, non-inferior, albumin-binding technology

4 terms

chmp regulatory

"The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines"

The CHMP is the European Medicines Agency’s expert panel that evaluates whether a medicine for people should be recommended for approval across the EU. Think of it as a technical review board whose positive or negative opinion strongly affects a drug maker’s ability to sell a product in the European market, shaping potential revenues, regulatory risk and investment timelines for companies developing or marketing therapies.

ema regulatory

"the European Medicines Agency (EMA) has recommended once-weekly Sogroya"

Exponential moving average (EMA) is a type of trend line that smooths a stream of recent price data while giving more weight to the newest prices, similar to how a spotlight focuses more on what's happening now than what happened long ago. Investors use EMAs to see whether a stock’s short-term direction is changing, to compare fast and slow averages for momentum signals, and to help time entries, exits, and risk controls without overreacting to random day-to-day noise.

View in glossary

non-inferior medical

"was non-inferior to once-daily growth hormone treatment for mean annualised height velocity"

Non-inferior describes a result from a clinical or comparative test showing a new product, treatment, or approach is not meaningfully worse than an existing standard by more than an agreed-upon, acceptable difference. Think of it like proving a new car model performs at least close enough to the old one on key measures so consumers won’t lose out. Investors care because non-inferiority outcomes can clear regulatory or market hurdles and preserve commercial potential without needing to beat the incumbent.

albumin-binding technology technical

"It uses albumin-binding technology, which allows the growth hormone to attach"

A drug-design approach that attaches or links therapeutic molecules to a component that binds to albumin, the most common protein in blood, so the medicine stays in circulation longer and reaches tissues more steadily. Think of albumin as a slow-moving delivery van: drugs that hitch a ride on it can require less frequent dosing and have more predictable exposure. Investors care because this can change a drug’s safety profile, dosing schedule, manufacturing complexity, and commercial appeal.

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

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If approved, Sogroya® (somapacitan) would be the first and only growth hormone treatment approved for idiopathic short stature in the EU, providing a much-needed treatment option for children and their families affected by this condition.

• The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended once-weekly Sogroya® (somapacitan) for children in Europe living with idiopathic short stature (ISS) with persistent growth disturbance.
  • ISS is a diagnosis given to children who are significantly shorter than their peers when no underlying medical cause can be found, affecting a child's confidence and well-being^1-4. This affects up to 3% of children worldwide^1,6,8.
  • Positive opinion follows the previous recommendation for Sogroya® in the treatment of short stature in children born Small for Gestational Age (SGA) and with Noonan Syndrome (NS) in Europe⁵.

Bagsværd, Denmark, 18 September 2026 – Novo Nordisk today welcomed a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA), recommending once-weekly Sogroya® for children with idiopathic short stature (ISS) with persistent growth disturbance.

“Through our research and relationships with the community, we know that 70% of families raising children with ISS and other growth disorders feel unseen, and that the impact on their child's daily life simply isn't recognised,” said Ashley Gilmer, chief executive officer of International Coalition of Organizations Supporting Endocrine Patients (ICOSEP). “This recommendation is a meaningful signal that this may be starting to change. What matters now is that recognition turns into real support of timely diagnosis, clear information, and access to care for every family who needs it.”

ISS affects up to 3% of children worldwide, yet it remains under-recognised and has limited options for managing its treatment^1,6-8. As part of the REAL8 clinical trial, Sogroya® has been assessed for the treatment of ISS and acts as a long-acting growth hormone, given as a single injection under the skin once a week^9,10. If approved, Sogroya® would be the first and only growth hormone treatment approved for ISS in the EU, providing a much-needed treatment option for children and their families living with this condition.

“For too long, treatment options for many children with growth disorders have been limited. Building on our decades of experience in growth hormone medicines, we’re committed to changing that. Today’s approval recommendation from the CHMP is a very important step forward for children and their families affected by ISS across Europe,” said Martin Holst Lange, executive vice president, chief scientific officer and head of Research & Development at Novo.

This opinion follows the CHMP recommendation of Sogroya® for the treatment of short stature in children born small for gestational age (SGA) and Noonan Syndrome (NS) in May 2026⁵. The opinion is now passed to the European Commission, whose decision on marketing authorisation, covering all three indications, is expected later this year.

About once-weekly Sogroya^® (somapacitan)

Once-weekly Sogroya® (somapacitan) is a long-acting human growth hormone analogue, given as a single injection under the skin once a week. It uses albumin-binding technology, which allows the growth hormone to attach to a protein naturally present in the blood, allowing it to remain in the body for longer¹¹.

In the EU, Sogroya® was authorised for the treatment of growth hormone deficiency in adults on 31 March 2021 and in children aged 3 years and older on 24 July 2023¹².

The REAL8 clinical trial data that supported this positive CHMP opinion showed that once-weekly Sogroya® was non-inferior to once-daily growth hormone treatment for mean annualised height velocity at Week 52 in children with idiopathic short stature, born small for gestational age and Noonan Syndrome⁹.

What is idiopathic short stature?

Idiopathic short stature is a diagnosis given to children who are significantly shorter than their peers when no underlying medical cause can be found¹. It affects up to 3% of children worldwide, yet it remains under-recognised and often overlooked – in many countries, it is not a recognised condition^1,6,7. Children with idiopathic short stature are more likely to face teasing, bullying and social exclusion as a result of their condition – experiences that can affect confidence and wellbeing into adulthood^2,3,13.

Why is idiopathic short stature difficult to diagnose and treat?
The path to a diagnosis is often long and emotionally draining for families, as it can only be identified once other causes of short stature have been ruled out¹⁴. As many children with idiopathic short stature are not referred for diagnosis until puberty is approaching, the window for effective intervention with growth hormone (GH) therapy is limited^15,16. Even after diagnosis, treatment with GH therapy is only approved for idiopathic short stature in some regions and used off-label or not at all in others, leaving many children and families without options^14,17,18.

What does it mean to be born small for gestational age?

When a baby is born small for gestational age, it means they are smaller than expected in length, weight, or head circumference^19,20. There is not always a clear cause, though being born small for gestational age has been associated with genetic factors, problems with the placenta and maternal health, including malnutrition, chronic high blood pressure and chronic infections²¹. Most children born small for gestational age reach their expected height by the age of two, but if catch-up growth has not happened by two or three years of age, a referral to a paediatric endocrinologist may be needed^22,23.

What is Noonan Syndrome?
Noonan Syndrome is a genetic condition affecting both boys and girls, occurring in around 1 in 1,000 to 2,500 births^24,25. Around half of all cases are caused by a mutation on a gene found on chromosome 12²⁵. Noonan Syndrome can have a variety of effects on a child’s health and development, including short stature, heart defects present at birth, and certain distinctive facial features²⁴.

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. For more information, visit novonordisk.com and follow us on Instagram, LinkedIn, TikTok, Facebook, X and YouTube.

Contacts for further information

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

References

1.      Wit JM, Clayton PE, Rogol AD, et al. Idiopathic short stature: definition, epidemiology, and diagnostic evaluation. Growth Horm IGF Res. 2008;18:89-110.
2.      A Juul, A Linglart, MH Rasmussen, et al. Impact of Idiopathic Short Stature (ISS) on children’s well-being. ESPE Abstracts (2024), 98, P1-68. Paper/Poster presented.
3.      Novo Nordisk Data on File. Equips: Evaluating the Quality of Life in People with Short Stature. 2025.
4.      The Magic Foundation. Psycological impact of short stature on children and adolescents [online]. Available at: magicfoundation.org/psychologicalimpact. Last accessed: August 2026.
5.      Sogroya - opinion on variation to marketing authorisation. European Medicines Agency [online]. Available at: ema.europa.eu/en/medicines/human/variation/sogroya. Last accessed: August 2026.
6.      Sharma L, Rani D, Kanchan T, et al. Short Stature StatPearls Treasure Island (FL); 2026.
7.      Novo Nordisk Data on File. Investigating the Association between Idiopathic Short Stature and Health and Well-being: a register study. 2025.
8.      Romero CJ and Rapaport R. The challenges of optimising the treatment of children diagnosed with idiopathic short stature. Ann Hum Biol. 2026;53:2621718.
9.      Once-weekly Sogroya® (somapacitan) is an efficacious and welltolerated long-acting growth hormone in children with growth disorders: results from REAL8 phase 3 basket study presented at the joint Congress of ESPE and ESE 2025. Novo Nordisk [online]. Available at: ml-eu.globenewswire.com/Resource/Download/f899ae3b-aa4e-4ef3-9498-9537d9cc424b. Last accessed: August 2026.
10.      Sogroya^® (somapacitan): SmPC [online]. Available at: ema.europa.eu/en/documents/product-information/sogroya-epar-product-information_en.pdf. Last accessed: August 2026.
11.      Johansson E, Nielsen AD, Demuth H, et al. Identification of Binding Sites on Human Serum Albumin for Somapacitan, a Long-Acting Growth Hormone Derivative. Biochemistry. 2020;59:1410-1419.
12.      An overview of Sogroya and why it is authorised in the EU. European Medicines Agency [online]. Available at: ema.europa.eu/en/documents/overview/sogroya-epar-medicine-overview_en.pdf. Last accessed: August 2026.
13.      Investigating the Association between Idiopathic Short Stature and Health and Well-being: a register study. 2025.
14.      Pedicelli S PE, Violi E, et al. Controversies in the definition and treatment of idiopathic short stature (ISS). J Clin Res Pediatr Endocrinol. 2009;1:105-115.
15.      Cohen P, Rogol AD, Deal CL, et al. Consensus statement on the diagnosis and treatment of children with idiopathic short stature: a summary of the Growth Hormone Research Society, the Lawson Wilkins Pediatric Endocrine Society, and the European Society for Paediatric Endocrinology Workshop. J Clin Endocrinol Metab. 2008;93:4210-7.
16.      Novo Nordisk Data on File. Adivo – 2023 US GHT Patient Assessment. 2025.
17.      Kemp SF and Frindik JP. Emerging options in growth hormone therapy: an update. Drug Des Devel Ther. 2011;5:411-9.
18.      Murano MC. A Disability Bioethics Reading of the FDA and EMA Evaluations on the Marketing Authorisation of Growth Hormone for Idiopathic Short Stature Children. Health Care Anal. 2020;28:266-282.
19.      Schlaudecker EP, Munoz FM, Bardaji A, et al. Small for gestational age: Case definition & guidelines for data collection, analysis, and presentation of maternal immunisation safety data. Vaccine. 2017;35:6518-6528.
20.      Lee PA, Chernausek SD, Hokken-Koelega AC, et al. International Small for Gestational Age Advisory Board consensus development conference statement: management of short children born small for gestational age, April 24-October 1, 2001. Pediatrics. 2003;111:1253-61.
21.      Liu Q, Yang H, Sun X, et al. Risk factors and complications of small for gestational age. Pak J Med Sci. 2019;35:1199-1203.
22.      Finken MJJ, van der Steen M, Smeets CCJ, et al. Children Born Small for Gestational Age: Differential Diagnosis, Molecular Genetic Evaluation, and Implications. Endocr Rev. 2018;39:851-894.
23.      Hokken-Koelega ACS, van der Steen M, Boguszewski MCS, et al. International Consensus Guideline on Small for Gestational Age: Etiology and Management From Infancy to Early Adulthood. Endocr Rev. 2023;44:539-565.
24.      Sharma L, Winters R and Corado A. Noonan Syndrome StatPearls Treasure Island (FL); 2026.
25.      Visser-van Balen H, Sinnema G and Geenen R. Growing up with idiopathic short stature: psychosocial development and hormone treatment; a critical review. Arch Dis Child. 2006;91:433-9.

Attachment

• PR260918-Sogroya-CHMP-positive

FAQ

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

What is once-weekly Sogroya and how is it administered?

Sogroya (somapacitan) is a long-acting human growth hormone analogue given as a single injection under the skin once a week. It uses albumin-binding technology that allows the growth hormone molecule to attach to a naturally occurring blood protein so it remains in the body for longer.

What did the REAL8 clinical trial show about Sogroya in children with growth disorders?

The REAL8 phase 3 trial evaluated once-weekly Sogroya in children with idiopathic short stature, those born small for gestational age and those with Noonan Syndrome. Once-weekly Sogroya was shown to be non-inferior to once-daily growth hormone treatment for mean annualised height velocity at Week 52 in these children.

For which indications is Sogroya already authorised in the EU?

In the EU, Sogroya is authorised for the treatment of growth hormone deficiency in adults and for growth hormone deficiency in children aged 3 years and older. Adult authorisation was granted on 31 March 2021, and paediatric authorisation from age 3 was granted on 24 July 2023.

What are the next regulatory steps after the positive CHMP opinion?

The positive opinion from the CHMP is being forwarded to the European Commission, which will decide on marketing authorisation for Sogroya covering idiopathic short stature, short stature in children born small for gestational age and Noonan Syndrome. A decision is expected later in 2026.