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Novo's Sogroya Gains CHMP Nod for Idiopathic Short Stature in the EU
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Key Takeaways
Novo's Sogroya received a positive CHMP opinion for children with idiopathic short stature in the EU.
Phase III REAL8 data showed Sogroya was non-inferior to daily growth hormone on annualized height velocity.
Sogroya's weekly dosing may offer convenience and support adherence among pediatric patients and families.
Novo (NVO - Free Report) announced that its once-weekly growth hormone therapy Sogroya (somapacitan) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for treating children with idiopathic short stature (ISS) and persistent growth disturbance.
The non-binding recommendation will now be reviewed by the European Commission to make a final decision. If approved, Sogroya would become the first and only growth hormone treatment approved for ISS in the EU, potentially expanding Novo’s presence in the pediatric growth disorder market.
Novo’s Sogroya ISS Expansion Gains Support From REAL8 Data
ISS refers to children who are significantly shorter than their peers without an identifiable underlying medical cause. The condition affects up to 3% of children worldwide and can have social and psychological consequences, while treatment options remain limited across many countries.
The latest CHMP recommendation was supported by data from Novo’s phase III REAL8 basket clinical study, which evaluated once-weekly Sogroya across children with ISS, as well as those born small for gestational age (SGA) and children with Noonan Syndrome (NS). Data showed that Sogroya was non-inferior to once-daily growth hormone treatment in terms of mean annualized height velocity at week 52.
Year to date, NVO shares have lost 15% against the industry’s 12.3% growth.
Image Source: Zacks Investment Research
Sogroya’s once-weekly dosing could also offer a convenience advantage compared with daily growth hormone injections, potentially supporting treatment adherence among pediatric patients and their families. The drug is a long-acting human growth hormone analog that uses albumin-binding technology to extend its presence in the bloodstream.
The latest positive CHMP opinion follows a similar recommendation issued in May 2026 for Sogroya in children with short stature associated with SGA and NS. A European Commission decision covering all three indications is expected later this year.
Sogroya Adds to Novo’s Rare Disease Growth Prospects
Novo’s Sogroya is already authorized in the EU for growth hormone deficiency in adults and children aged three years and older. If approved, the label expansion to treat ISS, SGA and NS would broaden the therapy’s addressable patient population and further strengthen NVO’s position in the growth hormone market.
For Novo, the development also provides another potential growth avenue beyond its dominant GLP-1 franchise. While the short stature therapy opportunity is considerably smaller than the company’s diabetes and obesity markets, additional pediatric indications could support Sogroya’s longer-term expansion and diversify Novo’s revenue base.
Outside the EU, Sogroya is approved for growth hormone deficiency in the United States, Japan and China. Its U.S. label was expanded in 2026 to include children with short stature associated with SGA, NS and ISS.
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 86.2% 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 16.3% 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 Therapeutics have 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 73.8% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.
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Novo's Sogroya Gains CHMP Nod for Idiopathic Short Stature in the EU
Key Takeaways
Novo (NVO - Free Report) announced that its once-weekly growth hormone therapy Sogroya (somapacitan) received a positive opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) for treating children with idiopathic short stature (ISS) and persistent growth disturbance.
The non-binding recommendation will now be reviewed by the European Commission to make a final decision. If approved, Sogroya would become the first and only growth hormone treatment approved for ISS in the EU, potentially expanding Novo’s presence in the pediatric growth disorder market.
Novo’s Sogroya ISS Expansion Gains Support From REAL8 Data
ISS refers to children who are significantly shorter than their peers without an identifiable underlying medical cause. The condition affects up to 3% of children worldwide and can have social and psychological consequences, while treatment options remain limited across many countries.
The latest CHMP recommendation was supported by data from Novo’s phase III REAL8 basket clinical study, which evaluated once-weekly Sogroya across children with ISS, as well as those born small for gestational age (SGA) and children with Noonan Syndrome (NS). Data showed that Sogroya was non-inferior to once-daily growth hormone treatment in terms of mean annualized height velocity at week 52.
Year to date, NVO shares have lost 15% against the industry’s 12.3% growth.
Image Source: Zacks Investment Research
Sogroya’s once-weekly dosing could also offer a convenience advantage compared with daily growth hormone injections, potentially supporting treatment adherence among pediatric patients and their families. The drug is a long-acting human growth hormone analog that uses albumin-binding technology to extend its presence in the bloodstream.
The latest positive CHMP opinion follows a similar recommendation issued in May 2026 for Sogroya in children with short stature associated with SGA and NS. A European Commission decision covering all three indications is expected later this year.
Sogroya Adds to Novo’s Rare Disease Growth Prospects
Novo’s Sogroya is already authorized in the EU for growth hormone deficiency in adults and children aged three years and older. If approved, the label expansion to treat ISS, SGA and NS would broaden the therapy’s addressable patient population and further strengthen NVO’s position in the growth hormone market.
For Novo, the development also provides another potential growth avenue beyond its dominant GLP-1 franchise. While the short stature therapy opportunity is considerably smaller than the company’s diabetes and obesity markets, additional pediatric indications could support Sogroya’s longer-term expansion and diversify Novo’s revenue base.
Outside the EU, Sogroya is approved for growth hormone deficiency in the United States, Japan and China. Its U.S. label was expanded in 2026 to include children with short stature associated with SGA, NS and ISS.
Novo Nordisk A/S Price and Consensus
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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 86.2% 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 16.3% 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 Therapeutics have 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 73.8% year to date.
Aldeyra Therapeutics’ earnings beat estimates in each of the trailing four quarters, delivering an average surprise of 29.25%.