Novo Nordisk's FDA Submission For Obesity Pill Gets Retail Traders Buzzing Amid Fierce Eli Lilly Rivalry

Shares of Novo Nordisk A/S (NVO) climbed 0.4% on Monday and rose in extended trading after the Danish drugmaker said it had made regulatory headway with a hotly anticipated anti-obesity offering.

BioPharma Dive reported, citing a company spokesperson, that Novo had earlier this year asked the U.S. Food and Drug Administration to approve a pill version of its popular weight loss drug.

According to the report, the request came two years after the company reported positive Phase 3 results for Rybelsus, an oral formulation of semaglutide. 

On Stocktwits, message volume about Novo spiked by over 417% over the past 24 hours to late Monday, while retail sentiment remained 'bullish.'

One user said, "It looks like the bottoms are in." Novo shares have lost over 50% in the past six months, primarily due to disappointing trial results of a new weight-loss therapy called Cagrisema and another oral prospect.

Another said Novo's activity “for the past 3-4 days...seems non-normal, something is up for sure. Holding my shares tight.”

Novo's latest revelation comes as it races against U.S. rival Eli Lilly & Co (LLY) to develop a blockbuster weight loss pill.

Lilly said last week that its experimental oral GLP-1 drug, orforglipron, met its goals in a major diabetes trial. If an ongoing obesity study also succeeds, the company plans to seek regulatory approval. 

Wall Street responded with bullish calls on Lilly, while Novo Nordisk (NVO) took a hit.

On Thursday, BMO Capital downgraded Novo to 'Market Perform' from 'Outperform,' slashing its price target to $64 from $105. The firm said Lilly's commercial and clinical progress is eroding Novo's early lead in obesity treatments. 

BMO expects "softer" Q1 results from Novo and will remain on the sidelines until it sees stronger clinical and commercial execution.

Leerink echoed optimism for Lilly, noting that orforglipron's once-daily oral dosing showed comparable safety and efficacy to Novo's weekly injectable semaglutide, with no liver safety issues reported. 

The firm expects Phase 3 obesity data in Q3 2025 and a potential approval in 2026. Leerink reiterated an 'Outperform' rating on Lilly.

Novo shares have lost over 33% this year, while Lilly has risen 4.8%.

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