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CHMP Backs EU Approval of Novo Nordisk's Wegovy Pill for Obesity
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Key Takeaways
Novo Nordisk's Wegovy pill won CHMP backing for EU approval in weight management.
The Wegovy pill showed 16.6% mean weight loss in OASIS 4 when treatment was adhered to.
CHMP also backed Wegovy 7.2 mg in a single-dose pen, with an EU launch expected in Q3 2026.
Novo Nordisk (NVO - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for Wegovy pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and support long-term weight management. The opinion also includes the SELECT study data in the label, showing that Wegovy reduces the risk of major adverse cardiovascular events.
Per NVO, Wegovy pill is the first oral GLP-1 RA therapy to receive a positive CHMP recommendation for weight management in the EU. Data from the OASIS study program and the SELECT study support the positive opinion.
In the OASIS 4 study, treatment with the Wegovy pill led to a mean weight loss of 16.6% among adults with obesity or overweight and at least one comorbidity when treatment was adhered to. The result was broadly comparable to injectable Wegovy 2.4 mg, with about one-third of patients achieving weight loss of 20% or more.
Per Novo Nordisk, the safety and tolerability profile of the Wegovy pill was consistent with prior semaglutide studies in weight management. The company also highlighted more than 50 million patient-years of real-world safety data for semaglutide and noted that the proposed label includes no drug–drug restrictions with concomitant medications.
Year to date, Novo Nordisk shares have lost 11.6% against the industry’s 2.3% growth.
Image Source: Zacks Investment Research
The positive opinion moves the Wegovy pill closer to becoming the first oral GLP-1 treatment approved for weight management in the EU. Novo Nordisk expects to launch the medicine in the first markets outside the United States in the second half of 2026.
NVO’s blockbuster weight-loss injection, Wegovy, is already approved worldwide to reduce major cardiovascular events, ease HFpEF symptoms and relieve osteoarthritis-related knee pain in obesity. Its label has also been expanded to treat metabolic dysfunction-associated steatohepatitis.
The FDA approved the Wegovy pill in late December, and it was subsequently launched in early January. Per Novo Nordisk, demand for convenient and effective obesity treatments is already evident in the United States, where more than one million Americans began using the Wegovy pill within four months of launch.
CHMP Backs NVO’s Higher-Dose Wegovy in a Single-Dose Pen
In a separate press release, Novo Nordisk announced that the EMA’s CHMP has also adopted a positive opinion recommending marketing authorization for a Wegovy 7.2 mg (once-weekly injectable semaglutide 7.2 mg) dose delivered through a single-dose pen for people living with obesity.
The higher-dose formulation is already available in the EU for adults with obesity as three separate 2.4 mg injections. The single-dose pen recommendation is supported by results from the STEP UP study program, where semaglutide 7.2 mg injected once weekly delivered a mean weight loss of 20.7% in obesity patients, with roughly one-third achieving weight loss of 25% or more.
In the STEP UP T2D study, which enrolled patients with obesity and type II diabetes, semaglutide 7.2 mg demonstrated a mean weight loss of 14.1%. Novo Nordisk said the safety and tolerability profile was consistent with prior semaglutide weight-management studies.
Wegovy 7.2 mg in a single-dose pen is already approved in the United States and the United Kingdom, with the U.S. version marketed as Wegovy HD. Novo Nordisk expects to launch Wegovy 7.2 mg in a single-dose pen in the EU in the third quarter of 2026.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 76.8% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV shares have risen 4.6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. On the other hand, its 2026 EPS is currently pegged at 11 cents. IMCR shares have lost 16.9% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.
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CHMP Backs EU Approval of Novo Nordisk's Wegovy Pill for Obesity
Key Takeaways
Novo Nordisk (NVO - Free Report) announced that the Committee for Medicinal Products for Human Use (CHMP) under the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorization for Wegovy pill (once-daily oral semaglutide 25 mg) to reduce excess body weight and support long-term weight management. The opinion also includes the SELECT study data in the label, showing that Wegovy reduces the risk of major adverse cardiovascular events.
Per NVO, Wegovy pill is the first oral GLP-1 RA therapy to receive a positive CHMP recommendation for weight management in the EU. Data from the OASIS study program and the SELECT study support the positive opinion.
In the OASIS 4 study, treatment with the Wegovy pill led to a mean weight loss of 16.6% among adults with obesity or overweight and at least one comorbidity when treatment was adhered to. The result was broadly comparable to injectable Wegovy 2.4 mg, with about one-third of patients achieving weight loss of 20% or more.
Per Novo Nordisk, the safety and tolerability profile of the Wegovy pill was consistent with prior semaglutide studies in weight management. The company also highlighted more than 50 million patient-years of real-world safety data for semaglutide and noted that the proposed label includes no drug–drug restrictions with concomitant medications.
Year to date, Novo Nordisk shares have lost 11.6% against the industry’s 2.3% growth.
Image Source: Zacks Investment Research
The positive opinion moves the Wegovy pill closer to becoming the first oral GLP-1 treatment approved for weight management in the EU. Novo Nordisk expects to launch the medicine in the first markets outside the United States in the second half of 2026.
NVO’s blockbuster weight-loss injection, Wegovy, is already approved worldwide to reduce major cardiovascular events, ease HFpEF symptoms and relieve osteoarthritis-related knee pain in obesity. Its label has also been expanded to treat metabolic dysfunction-associated steatohepatitis.
The FDA approved the Wegovy pill in late December, and it was subsequently launched in early January. Per Novo Nordisk, demand for convenient and effective obesity treatments is already evident in the United States, where more than one million Americans began using the Wegovy pill within four months of launch.
CHMP Backs NVO’s Higher-Dose Wegovy in a Single-Dose Pen
In a separate press release, Novo Nordisk announced that the EMA’s CHMP has also adopted a positive opinion recommending marketing authorization for a Wegovy 7.2 mg (once-weekly injectable semaglutide 7.2 mg) dose delivered through a single-dose pen for people living with obesity.
The higher-dose formulation is already available in the EU for adults with obesity as three separate 2.4 mg injections. The single-dose pen recommendation is supported by results from the STEP UP study program, where semaglutide 7.2 mg injected once weekly delivered a mean weight loss of 20.7% in obesity patients, with roughly one-third achieving weight loss of 25% or more.
In the STEP UP T2D study, which enrolled patients with obesity and type II diabetes, semaglutide 7.2 mg demonstrated a mean weight loss of 14.1%. Novo Nordisk said the safety and tolerability profile was consistent with prior semaglutide weight-management studies.
Wegovy 7.2 mg in a single-dose pen is already approved in the United States and the United Kingdom, with the U.S. version marketed as Wegovy HD. Novo Nordisk expects to launch Wegovy 7.2 mg in a single-dose pen in the EU in the third quarter of 2026.
Novo Nordisk A/S Price and Consensus
Novo Nordisk A/S price-consensus-chart | Novo Nordisk A/S Quote
NVO’s Zacks Rank & Stocks to Consider
Novo Nordisk currently carries a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Liquidia Corporation (LQDA - Free Report) , Indivior Pharmaceuticals (INDV - Free Report) and Immunocore (IMCR - Free Report) . While LQDA and INDV sport a Zacks Rank #1 (Strong Buy) each at present, IMCR currently has a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Over the past 60 days, estimates for Liquidia Corporation’s 2026 EPS have increased from $1.50 to $2.97. Over the same period, EPS estimates for 2027 have also increased from $2.91 to $4.81. LQDA shares have rallied 76.8% year to date.
Liquidia Corporation’searnings beat estimates in three of the trailing four quarters and missed in the remaining one, with the average surprise being 54.40%.
Over the past 60 days, estimates for Indivior Pharmaceuticals’ 2026 earnings per share have increased from $3.10 to $3.35. Over the same period, EPS estimates for 2027 have risen to $3.69 from $3.47. INDV shares have risen 4.6% year to date.
Indivior Pharmaceuticals’ earnings beat estimates in each of the trailing four quarters, with the average surprise being 65.44%.
Over the past 60 days, estimates for Immunocore’s 2026 loss per share have narrowed from 97 cents to 16 cents. On the other hand, its 2026 EPS is currently pegged at 11 cents. IMCR shares have lost 16.9% year to date.
Immunocore’s earnings beat estimates in three of the trailing four quarters, while missing the same on the remaining occasion, with the average surprise being 46.66%.