NVO Stock up on Plans to Advance Obesity Candidate Amycretin
Novo Nordisk NVO announced plans to advance amycretin, for weight management, into late-stage development. Amycretin is being developed for subcutaneous and oral administration.
Shares of this Denmark-based company gained 2.95% on June 12, following the announcement.
Oral amycretin is a novel, unimolecular co-agonist of both GLP-1 and amylin receptors being developed by Novo Nordisk to provide an efficacious and convenient treatment for obesity and type 2 diabetes in adults.
NVO decided to advance the candidate into phase III based on feedback received from regulatory authorities following end-of-phase II interactions for subcutaneous and oral amycretin in weight management.
A phase I study evaluated the single-ascending dose and multiple-ascending doses for oral amycretin, up to 2 times 50 mg, in people with overweight or obesity, with a total treatment duration of up to 12 weeks.
A phase Ib/IIa study investigated the safety, tolerability, pharmacokinetics, and proof-of-concept of once-weekly subcutaneous amycretin in people with overweight or obesity. The trial was a combined single ascending dose, multiple ascending dose and dose-response trial investigating three different maintenance doses with a total treatment duration of up to 36 weeks.
The phase III program on amycretin is planned to be initiated during the first quarter of 2026.
Buoyed by the stupendous success of its blockbuster semaglutide products, Wegovy (obesity) and Ozempic (diabetes), NVO is now developing several next-generation candidates in its pipeline, especially targeting the lucrative U.S. market.
CagriSema, a fixed-dose combination of a long-acting amylin analogue and Wegovy, is the most advanced candidate in Novo Nordisk's obesity pipeline.
Novo Nordisk will present full results from the phase III REDEFINE 1 and 2 studies on CagriSema shortly.
Management stated that the REDEFINE 1 and 2 studies will provide insights into the transformational potential of CagriSema.
The FDA accepted Novo Nordisk's regulatory application, seeking the approval of oral semaglutide 25 mg for obesity, for review. A final decision from the regulatory body is expected around the turn of the year.
Year to date, Novo Nordisk's shares have lost 4.7% against the industry's growth of 2.9%.
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The stock price was under pressure at the start of the year due to recent market challenges. Stiff competition in the obesity market from its arch-rival, Eli Lilly LLY, along with pipeline and regulatory setbacks, weighed on the share price. We note that NVO's semaglutide drugs have only been off the FDA's supply shortage list since February 2025.
Eli Lilly markets its tirzepatide medicines as Mounjaro for T2D and Zepbound for obesity. Like NVO, LLY is also evaluating several next-generation weight loss candidates. LLY, too, has achieved stupendous success for its obesity drugs.
Nonetheless, NVO stock has witnessed some recovery this week.
Novo Nordisk gained 5% on June 10, following a report that activist hedge fund Parvus Asset Management is building a stake in the company.
Per the Financial Times, this London-based hedge fund is raising its stake in NVO to influence the appointment of the company's new chief executive officer (CEO).
Last month, shares of the company dipped after it announced that CEO Lars Fruergaard Jørgensen would step down from his position following a mutual agreement with the company's board.
Novo Nordisk currently carries a Zacks Rank #3 (Hold). A couple of better-ranked large-cap pharma stocks are Novartis NVS and Bayer BAYRY, both carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here.
The Zacks Consensus Estimate for Novartis' 2025 earnings per share (EPS) has risen from $8.46 to $8.74 over the past 60 days. EPS estimates for 2026 have jumped 35 cents to $9.02 during this timeframe. The stock has risen 27% so far this year.
BAYRY's 2025 EPS estimate has increased from $1.19 to $1.25 for 2025 over the past 60 days, while that for 2026 has gone up from $1.28 to $1.31 over the same timeframe. Year to date, shares of Bayer have surged 65.1%.
BAYRY's earnings beat estimates in one of the trailing four quarters, matched twice and missed on the remaining occasion, the average negative surprise being 13.91%.
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