Novo Nordisk (NYSE: NVO) shares climbed 2.7% on Thursday after the UK’s Medicines and Healthcare products Regulatory Agency approved the oral Wegovy pill for chronic weight management in adults.
The MHRA authorization covers oral semaglutide 25mg as an adjunct to a reduced-calorie diet and increased physical activity in adults with obesity or overweight and at least one weight-related condition.
The approval makes the United Kingdom the first country in Europe to authorize a daily GLP-1 weight-loss pill, offering patients a non-injectable alternative to weekly obesity treatments.
Commercial availability via private prescription is expected within weeks, expanding patient access significantly across one of Europe’s largest healthcare markets.
The UK milestone represents the third country to authorize the Wegovy pill, following earlier approvals in the United States and the United Arab Emirates.
Investors viewed the oral therapy as strategically important because it broadens Novo Nordisk’s obesity portfolio beyond injectables, targeting patients who are reluctant to use injections.
The positive regulatory news overshadowed a cybersecurity incident disclosed by Novo Nordisk on the same day, in which unauthorized access to a limited number of internal IT systems was reported.
The company stated that certain non-public data, including personal information, had been copied externally without authorization, prompting the engagement of external cybersecurity experts and notification of relevant authorities.
Novo Nordisk also implemented containment measures, including temporarily taking some internal systems offline, though the company stated its core business operations have not been affected.
The MHRA approval was supported by data from the phase III OASIS development program, a global initiative comprising four studies enrolling approximately 1,300 patients with obesity.
A key 64-week study called OASIS 4, evaluating 307 adults with obesity or overweight with one or more comorbidities, showed patients achieved a mean weight reduction of 16.6% when treatment was adhered to.
One in three patients in OASIS 4 achieved 20% or greater weight reduction, a result comparable to injectable Wegovy 2.4 mg, reinforcing confidence in the oral therapy’s clinical profile.
Novo Nordisk noted that no currently available oral GLP-1 therapy matches the level of weight loss achieved with the Wegovy pill in clinical studies, underscoring its competitive positioning.
The company highlighted that obesity affects approximately 15 million people in the United Kingdom, with the prevalence of overweight and obesity among adults projected to reach 71% by 2040.
Novo Nordisk expects to launch the Wegovy pill in other select markets in the second half of 2026, providing additional commercial runway for the oral therapy’s global rollout.
Despite Thursday’s gain, NVO shares remain down 13.6% year to date, underperforming the broader industry, which has grown 4.5% over the same period.
Novo Nordisk currently carries a Zacks Rank of 3, or Hold, while peers Liquidia Corporation (NASDAQ: LQDA), Indivior Pharmaceuticals (NASDAQ: INDV), and Immunocore (NASDAQ: IMCR) each carry a Zacks Rank of 1, or Strong Buy.
LQDA shares have rallied 107.7% year to date, supported by rising EPS estimates, while INDV has gained 6.3% year to date with its 2026 EPS estimate climbing from $3.33 to $4.05 over the past 60 days.
