Novo Nordisk announced that the U.S. Food and Drug Administration approved three new pediatric indications for its once‑weekly growth hormone therapy, Sogroya (somapacitan‑beco). The approvals cover idiopathic short stature, small for gestational age with no catch‑up growth by age two, and growth failure associated with Noonan syndrome, and the drug will be available in 5 mg, 10 mg, and 15 mg strengths.
The new indications broaden Sogroya’s therapeutic reach beyond its existing approvals for adults with growth hormone deficiency and for children aged 2.5 years and older with growth failure due to inadequate endogenous growth hormone. By offering a once‑weekly dosing schedule, the drug addresses a key adherence challenge in pediatric growth therapy and expands the patient population eligible for treatment, potentially increasing the company’s addressable market in the rare endocrine disorder segment.
"Daily injections have defined the growth disorder treatment paradigm for more than 40 years. Our scientific leadership and focus on advancing care in rare diseases led us to the development of Sogroya® – a once‑weekly growth hormone therapy – which may help address the challenge of daily injections while offering patients and families a therapeutic option that delivers efficacy and safety. These new approvals expand the patient populations that can be helped by Sogroya® and reflect our strategic focus on delivering meaningful, evidence‑based innovation for children living with growth disorders," said Nicky Kelepouris, Rare Endocrine Disorders‑US Medical Lead.
"Families and healthcare professionals now have the option to consider a once‑weekly growth hormone as treatment with 313 injection free days per year for their children 2.5 years and older with ISS, NS, and born SGA. Sogroya® is an effective alternative to daily injections that supports children’s growth goals and may help fit into their routine," added Dr. Aristides Maniatis, founder of Rocky Mountain Pediatric Endocrinology and investigator in the REAL8 trial.
Sogroya’s approval history shows a steady expansion: first approved in 2020 for adults, then in 2023 for pediatric growth failure, and now in 2026 for three additional indications. The drug’s albumin‑binding technology extends its half‑life, enabling the once‑weekly regimen that differentiates it from other long‑acting growth hormone products and positions it as the broadest‑approved LAGH therapy in the market.
Novo Nordisk’s Q4 2025 earnings beat analyst expectations, driven by strong demand in core segments, but the company issued a cautious 2026 outlook that forecasts a 5% to 13% decline in sales and operating profit at constant exchange rates. The guidance reflects pricing headwinds, patent expirations, and Medicaid coverage losses, and it has tempered investor enthusiasm for the Sogroya approval, which, while a positive development for the drug line, is unlikely to offset the broader financial headwinds facing the company.
Investors reacted to the approval with a focus on the company’s 2026 guidance. The positive regulatory milestone was viewed as a strategic win for Novo Nordisk’s rare endocrine portfolio, but the broader guidance signals that the approval will not dramatically alter the company’s near‑term financial trajectory.
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