Yahoo Finance

Novo Nordisk A/S (NYSE:NVO) on Monday presented data from the phase 3 REAL8 basket study investigating once-weekly Sogroya (somapacitan) in four different but related growth disorder indications, including small for gestational age (SGA), Turner syndrome (TS), Noonan syndrome (NS), and idiopathic short stature (ISS) under one trial protocol.

In REAL8, pre-pubertal children with NS, TS, or ISS were randomized to receive either once-weekly Sogroya (somapacitan) 0.24 mg/kg/week or once-daily somatropin 0.050 mg/kg/day.

Children born SGA were randomized to receive either somapacitan 0.24 mg/kg/week, a low dose of somatropin 0.035 mg/kg/day, or a high dose of somatropin 0.067 mg/kg/day.

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The trial showed that once-weekly Sogroya was non-inferior to the once-daily growth hormone Norditropin (somatropin) in improving yearly growth rate (as measured by height velocity or HV at Week 52).

In addition, once-weekly Sogroya was superior to daily growth hormone in children with NS and to lower doses of daily growth hormone in children born SGA.

REAL8 data showed that Sogroya was well-tolerated, with no safety or tolerability issues identified compared to once-daily growth hormone.

Results from the Turner syndrome (TS) sub-study of REAL8 will be available later this year.

The REAL8 trial achieved its primary endpoints for the first three sub-studies, demonstrating that once-weekly Sogroya was non-inferior to once-daily growth hormone treatment at Week 52 across the three indications presented:

• In children born SGA, Sogroya demonstrated superior estimated mean HV when compared with a lower dose (0.035 mg/kg/day) of somatropin (11.0 vs 9.4 cm/year) and non-inferior estimated mean HV when compared with a higher dose (0.067 mg/kg/day) of somatropin (11.0 vs 11.1 cm/year).

• Sogroya demonstrated superior estimated mean HV in children with NS compared with somatropin (10.4 vs 9.2 cm/year).

• Sogroya demonstrated non-inferior estimated mean HV in children with ISS compared with daily somatropin (10.5 vs 10.5 cm/year).

• In April 2025, based on the data from REAL8 and REAL9, the three indications (SGA, NS, and ISS) were submitted for regulatory review in both the EU and the U.S.

Price Action: NVO stock is down 3.00% to $63.80 during the premarket session at the last check on Monday.

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