Novo Nordisk stock popped Tuesday after the company confirmed it asked the Food and Drug Administration to approve its weight-loss pill, an oral version of Wegovy.
If approved, the Danish drugmaker would be the first to market with an oral obesity drug, leapfrogging Eli Lilly and Pfizer.
Many expected Lilly to be the first to hit the market with a weight-loss pill. Last Thursday, Lilly stock jetted 14% higher after the company said patients who received an oral version of its obesity treatment, Zepbound, lost up to 7.9% of their body weight over 40 weeks. But that study was in diabetic patients. Lilly still has to finish testing its pill in patients with obesity.
Lilly's news came less than a week after Pfizer dropped its latest-stage obesity pill after one patient experienced a potential drug-induced liver injury. This is the second big setback for that particular drug, danuglipron, and the third setback for Pfizer's efforts to develop an obesity treatment.
Novo confirmed its FDA filing in an email to Investor's Business Daily. The company reported positive Phase 3 results for oral semaglutide in May 2023. Semaglutide is the chemical backbone behind Novo's weight-loss shot, Wegovy, and diabetes treatment Ozempic.
Novo Nordisk Stock Jumps On FDA Filing
On today's stock market, Novo Nordisk stock 2.7% to 59.90. Eli Lilly stock rose 1.1%, closing at 827.07.
Specifically, Novo asked the FDA to sign off on a 25-milligram dose of semaglutide for patients who are overweight or have obesity. The company said it filed for approval "earlier this year." Semaglutide, like other drugs, mimics the GLP-1 hormone to decrease hunger signals and improve blood sugar markers.
"This is the first application and potential approval of a GLP-1 in a pill for weight loss," a spokesperson for Novo said. "Additional details, including timing, will be shared with our quarterly results on 7 May."
The market for oral weight-loss drugs could be huge. Some experts say the effectiveness of daily pills will likely trail weekly injections. But pills can be titrated easily — cut in half to lower the dosage and potential for side effects — and are easier to store in countries with less access to refrigeration.
Pills Could Bring Relief For Needle-Phobic People
Pills could also be a boon for needle-phobic patients. They could also offer a maintenance option for patients taking weekly injections that have reached their weight-loss goals.
And Novo's oral semaglutide looks to be the first to hit the market, well ahead of Eli Lilly's orforglipron. Lilly is expected to have the results of a 72-week study of orforglipron in patients with obesity in the third quarter, Leerink Partners analyst David Risinger said in a recent report.
He rates Lilly stock an outperform and doesn't have a rating on Novo Nordisk stock.
Follow Allison Gatlin on X/Twitter at @AGatlin_IBD.
