Combined FDA GLP-1 Proposal Boosts LLY, NVO, and HIMS Stock

Eli Lilly and Company NYSE: LLY and Novo Nordisk A/S NYSE: NVO there are two weight loss drugs and diabetes that are in completely different areas. Since the beginning of 2025, LLY is up almost 30%, while NVO is down more than 30%.
Eli Lilly and Company Today
Eli Lilly and Company
- 52 week interval
- $623.78
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$1,133.95
- Dividend Yield
- 0.71%
- The P/E ratio
- 34.82
- Target Value
- $1,217.59
This comes as Eli Lilly has taken major market share from Novo. In its most recent quarter, Eli Lilly posted 56% year-over-year (YOY) revenue growth. For the full year 2026, the midpoint of Lilly’s guidance implies growth of 28% YOY.
Meanwhile, Novo expects its fixed income sales to fall 5% to 13% YOY in 2026, a big step down from 36% growth in 2023. The biggest difference in their revenue growth is due to Lilly’s GLP-1 tirzepatide. Called Mounjaro and Zepbound, the drug induces about 47% more weight loss than Novo’s semaglutide.
Despite their battle, the companies recently received news that they can both be happy about. The Food and Drug Administration proposed to exclude tirzepatide and semaglutide from its 503B bulk list. Here’s what that means for Lilly and Novo going forward.
FDA Looks to Stop 503B Good Merger—Lilly and Novo Score
When an approved drug is in short supply, the FDA allows 503A compounding pharmacies and 503B dispensing facilities to compound copies of the drug. After the FDA added tirzepatide and semaglutide to the shortage list in 2022, companies like Hims & Hers Health are building businesses around GLP-1s. Hims has used 503A and 503B agencies to acquire drugs in the past.
His Life and Hers Today
His & Her Life
- 52 week interval
- $13.74
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$70.43
- The P/E ratio
- 51.47
- Target Value
- $31.86
The shortage of both drugs ended between 2024 and 2025, but Hims worked in a legal gray area to continue selling. According to Pharmacy Times, the passage of this proposal will “close any future way” for 503B institutions to cover these drugs, “even if there is a new shortage name.” In other words, there would be no turning back.
For Lilly and Novo, this would be a clear victory. Computers have taken away the need for drugs that we would go to. The proposal would remove the ability of 503B institutions to do this in the future. In 503A, that future opportunity still exists, although it is technically prohibited to sell these drugs under that condition, since the shortage is over. However, Hims clearly shows that regulators are not fully enforcing this.
Notably, Novo’s shares rose 4.8% on the day of the announcement on April 30, indicating that investors saw it as a reasonable piece of good news. Lilly rose 9.8% on the day, and although the announcement coincided with the company’s impressive earnings report, the news may also have contributed to Lilly’s big gain.
Hims Gains as Investors Weigh Compounding Regulation
For His and His, the benefit is very different but still valid. The company recently signed an agreement with Novo, allowing it to legally sell semaglutide and oral semaglutide. With this proposal, the group of compounders that Hims competes with is weakened.
With its Novo deal, Hims can sell sealed (AKA unbundled versions) of the company’s GLP-1s. This means that the FDA’s proposal should not limit Hims’ ability to sell Novo’s drugs. However, it could affect the ability of other compounders to do the same in the future, putting Hims in a strong position.
In a statement sent to Reuters, a spokesperson for Hims & Hers said the company does not expect this proposal to have an impact on its business. Hims noted that “there are no GLP-1s covered by 503B facilities accessible through our platform.” Its shares rose about 3.2% on the day of the proposal.
Hims can still continue to sell Lilly’s drugs. However, this company does not have the same type of agreement as it does with Novo. Finding Lilly’s drugs through Hims works as a referral arrangement, directing users to Lilly. Hims’ announcement states, “Access to Zepbound and Foundayo does not imply a partnership or association with Eli Lilly and Company.”
Because of this, it is unlikely that Hims will receive a direct financial benefit from Lilly’s drug donation. However, Hims may be able to gain or retain members who would otherwise look to other telehealth platforms to access Lilly’s treatment.
Lilly continues to dominate the GLP-1 Arena
Overall, Eli Lilly and Novo should get more protection for their important GLP-1 drugs. The proposal is not final yet. However, since it came from the decision maker itself (the FDA), it is likely to be struck down.
Hims is an under-the-radar winner from the proposal side of semaglutide, given his formal relationship with Novo.
However, among these names, Eli Lilly is clearly in the strongest position. The company has shown that it does not need to make a deal with Hims like Novo did. Instead, it takes all the damage from its top-notch weight loss and diabetes drugs.
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