Novo Nordisk Caught Between FDA Tailwind and a Brutal Revenue Outlook

FDA proposal to curb cheap copycats boosts Novo Nordisk shares 4.8%, but pricing pressure, competition, and a grim 2026 forecast keep the stock near 52-week lows.

A surprise regulatory proposal out of Washington has handed Novo Nordisk a rare moment of relief, but the Danish drugmaker’s longer-term picture remains clouded by pricing pressure, intensifying competition, and a grim 2026 forecast.

FDA Proposal Could Curb Cheap Copycats

The US Food and Drug Administration has put forward a plan to remove several active ingredients — including semaglutide, tirzepatide, and liraglutide — from its 503B bulk substances list. That list currently allows compounding pharmacies to produce cheaper, custom-made versions of branded drugs. Semaglutide is the engine behind Novo Nordisk’s blockbuster obesity and diabetes treatments Ozempic and Wegovy.

The agency argues there is no clinical need for such compounding, a move that, if finalized, would eliminate a key source of price competition. Compounded versions are often sold at a steep discount to the originals.

The market wasted no time reacting. Novo Nordisk shares climbed roughly 4.8% on Thursday to €36.20, making it the strongest performer on the Copenhagen exchange and hitting its highest level in more than two months.

But the Bigger Picture Is Bleak

That rally, however, needs context. The stock is still down nearly 19% year-to-date and roughly 38% over the past 12 months. The 52-week high of €70.13 — set in June 2025 — remains a distant memory.

The structural headwinds are formidable. Novo Nordisk expects revenue and operating profit to fall by 5% to 13% in 2026, measured at constant exchange rates. The primary culprit: declining net prices in the US, where Medicare Part D negotiations and most-favored-nation clauses are squeezing margins.

Competition is also heating up. Eli Lilly secured FDA approval for Foundayo, an oral GLP-1 drug, in early April. While early sales data have been mixed, the mere presence of another player in the oral GLP-1 space adds pressure on Novo Nordisk’s own pipeline. A market once dominated by two players is growing increasingly crowded.

Analyst Sentiment Sours

The shifting landscape has rattled Wall Street. The average price target for Novo Nordisk has been cut by more than 21% over the past three months, and the consensus rating now sits at “Hold.” Several institutional investors have trimmed their positions, signaling waning patience for a quick turnaround.

On the technical side, the relative strength index has dipped to around 25, a level that typically suggests oversold conditions. Whether that signals a bottom or simply reflects the depth of the selloff will likely become clearer when first-quarter results are released in early May.

Buyback Program Chugs Along

Amid the turmoil, Novo Nordisk has continued its share repurchase program. The current tranche is capped at 3.8 billion Danish kroner and runs until May 4, 2026. As of April 24, the company had bought back roughly 13.4 million B-shares at an average price of 256.48 kroner, for a total of around 3.4 billion kroner. The broader program authorizes up to 15 billion kroner over 12 months.

What’s Next

The FDA’s proposal is far from a done deal. A public comment period is open until June 29, 2026, after which the agency will make a final decision. For Novo Nordisk, a favorable outcome would be a structural win — fewer cheap alternatives means greater pricing power in the booming obesity and diabetes market.

But nearer term, all eyes are on the Q1 report due in early May. Investors will be watching for signs of how Wegovy’s US sales momentum is holding up, particularly for the oral formulation. One potential bright spot: Medicare is expected to expand coverage for obesity drugs by mid-2026, which could significantly broaden patient access to Wegovy. Whether that will be enough to offset the pricing headwinds is the question the market will be weighing on reporting day.