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Novo Nordisk is trading sharply higher after the FDA approved the Wegovy pill for weight loss, making it the first oral GLP-1 receptor agonist approved for chronic weight management. The Wegovy pill delivered weight loss comparable to injectable Wegovy 2.4 mg in the OASIS-4 trial, while reaffirming the well-known safety and tolerability profile of semaglutide.
- Novo Nordisk plans to launch in the US in early Jan 2026 and has submitted oral semaglutide 25 mg once daily to the EMA and other regulators in 2H25.
- Oral dosing is a major advantage, as daily tablets are easier to administer, improve patient compliance, and are cheaper to manufacture than injectables.
- Pricing is expected to start at $149 per month for the initial 1.5 mg dose for cash-paying patients, including Medicare and Medicaid. As doses increase, monthly costs could rise to roughly $399 for cash-paying patients and up to ~$500 without insurance.
- Eli Lilly (LLY) has filed for FDA approval of its oral obesity drug orforglipron, with a potential decision as early as spring 2026.
- The approval is timely for NVO shareholders, as the stock has struggled in 2025. Novo Nordisk has significantly cut full year guidance multiple times during 2025, notably in July and again in November, citing increasing competition from LLY in the weight-loss market (Wegovy/Ozempic vs. Zepbound). The stock has also been pressured by the loss of the Metsera bidding war to Pfizer (PFE), which further strengthened competition in the obesity market.
Briefing.com Analyst Insight:
The FDA approval of the Wegovy pill is a meaningful positive catalyst for Novo Nordisk, as it expands the GLP-1 franchise into a far more patient-friendly format that could significantly broaden adoption. Oral delivery should improve compliance and expand access, particularly among needle-averse patients, while also offering potential cost advantages over injectables. That said, competition is quickly heating up, with Eli Lilly and Pfizer both emerging as formidable threats in the obesity market. While today's news helps stabilize sentiment after a challenging period for NVO, long-term upside will depend on execution, pricing power at higher doses, and the company's ability to defend share as rival oral GLP-1s reach the market.