Novo Nordisk NVO introduced that it has submitted a regulatory submitting in search of label growth for a better dose of its blockbuster weight problems drug, Wegovy (injectable semaglutide).
The FDA submitting seeks approval for a 7.2 mg dose of the drug, which Novo Nordisk claims supplies an possibility for “better weight reduction potential” than what’s presently being provided by the out there doses (0.25 mg, 0.5 mg, 1 mg, 1.7 mg and a pair of.4 mg).
For this submitting, Novo Nordisk is in search of an extra-fast evaluation by the FDA’s Commissioner’s Nationwide Precedence Voucher (CNPV) pilot program. This program is designed to considerably fast-track the evaluation of medicine and biologics addressing critical or life-threatening ailments with excessive unmet medical wants, lowering the usual evaluation interval from 10-12 months (6-8 months in case the drug is granted precedence evaluation designation) to only 1-2 months. The CNPV voucher was granted to the corporate by the company earlier this month.
How Efficient is NVO’s Larger-Dose Wegovy?
The submitting is supported by information from the part III STEP UP research, which confirmed that contributors who took a 7.2 mg dose of Wegovy for 72 weeks achieved a mean weight lack of 20.7% in contrast with 2.4% with placebo and 17.5% with a 2.4 mg Wegovy dose.
Novo Nordisk additionally reported further analyses from the research, which confirmed that 33.2% of people that took the 7.2 mg dose achieved a weight lack of at the very least 25% in contrast with 16.7% of contributors within the 2.4mg dose group. No sufferers within the placebo arm met this criterion.
An identical regulatory submitting is presently below evaluation with the EMA, additionally supported by information from the STEP UP research. A closing choice is predicted within the first quarter of 2026.
NVO Inventory Efficiency
12 months to this point, shares of Novo Nordisk have plunged over 43% towards the business‘s 19% development.
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Key Developments Round NVO’s Weight problems Medication
This week has been blended for Novo Nordisk, which reported a number of key updates round its pipeline. Whereas the corporate’s investigational oral weight problems tablet known as amycretin achieved vital weight reduction and HbA1c discount in sort 2 diabetes (T2D), two late-stage research on Rybelsus (oral semaglutide) failed to point out superiority over placebo in lowering development of Alzheimer’s illness (AD).
Earlier this week, the Facilities for Medicare & Medicaid Providers introduced that it has negotiated worth reductions for 15 medicine that will likely be relevant from 2027. Certainly one of these 15 medicine is Novo Nordisk’s semaglutide merchandise, which will likely be bought at a negotiated worth of $274 per 30 days, a 71% low cost to its 2024 record worth.
Past Wegovy, semaglutide can be marketed as Ozempic (for T2D). Just lately, the corporate secured approval for an oral model of semaglutide, which is marketed below the identify Rybelsus within the T2D indication.
Competitors Heating Up within the Weight problems Area
In response to analysis performed by Goldman Sachs, the weight problems market in the USA is predicted to achieve $100 billion by 2030. Novo Nordisk and Eli Lilly LLY presently dominate this area.
Wegovy instantly competes with Eli Lilly’s tirzepatide drugs Zepbound. Like Novo Nordisk, LLY additionally generates a considerable portion of its revenues from gross sales of this drug.
NVO and LLY are racing to introduce oral weight-loss tablets. Novo Nordisk has already submitted a regulatory submitting with the FDA in search of approval for an oral model of Wegovy, with a closing choice anticipated earlier than this yr’s finish. Aside from amycretin, NVO can be growing one other next-generation candidate in its weight problems pipeline known as CagriSema (a mixture of semaglutide and cagrilintide).
Eli Lilly is investing broadly in next-generation medicine and is presently growing a spread of oral and injectable drugs with totally different mechanisms of motion. This contains two late-stage candidates, orforglipron, a once-daily oral GLP-1 small molecule and retatrutide, a GGG tri-agonist. LLY stays on monitor to submit regulatory filings for orforglipron in weight problems earlier than this yr’s finish, organising the timeline for a possible launch subsequent yr. Like Novo Nordisk, Eli Lilly additionally secured a CNPV from the FDA for orforglipron earlier this month.
A number of different corporations, together with Viking Therapeutics VKTX, are additionally advancing weight problems candidates. In June, VKTX began two late-stage research evaluating the subcutaneous formulation of its investigational weight problems drug, VK2735. Whereas one in every of these research not too long ago accomplished enrolment at a fast tempo, Viking Therapeutics expects to finish enrolment within the different research by the primary quarter of 2026.
Earlier this month, Pfizer PFE closed the acquisition of weight problems drug developer Metsera for round $10 billion, after a heated bidding warfare towards Novo Nordisk. The Metsera acquisition has introduced Pfizer again into the profitable weight problems area by including the latter’s 4 novel clinical-stage incretin and amylin applications, that are anticipated to generate billions of {dollars} in peak gross sales.
Novo Nordisk A/S Value
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NVO’s Zacks Rank
Novo Nordisk presently carries a Zacks Rank #3 (Maintain). You’ll be able to see the whole record of at present’s Zacks #1 Rank (Robust Purchase) shares right here.
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