Pseudominds
$NVO Here’s why I think $100/share is coming.
Wegovy Pill vs Foundayo — Global Approval & Launch Status
One thing I think investors are overlooking is how large Novo’s international regulatory head start currently is in oral obesity.
Wegovy pill — Novo Nordisk
Approved / authorized:
🇺🇸 United States — FDA approved Dec. 2025; launched Jan. 5, 2026
🇦🇪 UAE — approved and launched June 2026
🇬🇧 United Kingdom — approved June 2026; launched early July
🇪🇺 European Union — European Commission authorization granted July 15, 2026, covering all 27 EU member states.
Commercially available today in at least:
🇺🇸 U.S.
🇦🇪 UAE
🇬🇧 UK
🇩🇪 Germany — launched Sept. 1 and became the first EU country to commercially launch oral Wegovy.
Novo has said more selected international launches are coming. Mexico has been discussed as an upcoming market, but I would not count it as commercially launched yet without a confirmed regulatory/launch notice.
Regulatory footprint:
Because one centralized EU authorization applies across the 27-member EU, Wegovy pill is now authorized across roughly 30 jurisdictions:
27 EU countries + U.S. + UK + UAE
Commercial launch is occurring country by country.
⸻
Foundayo — Eli Lilly
Approved:
🇺🇸 United States — FDA approved April 1, 2026; launched immediately afterward.
🇦🇪 UAE — approved April 2026 and now available.
🇲🇽 Mexico — approved for obesity and type 2 diabetes; Lilly said commercial launch would occur later in 2026.
🇸🇦 Saudi Arabia — approved Aug. 2; the Saudi regulator currently lists Foundayo with “Marketing Status: Marketed.”
🇬🇧 United Kingdom — approved Aug. 10 and commercially launched Aug. 24 through private prescription.
European Union:
❌ Foundayo is NOT yet EU-approved.
As recently as the September EMA meeting, orforglipron was still in the regulatory process at the “list of outstanding issues” stage.
That means Lilly still needs to clear the CHMP process and receive European Commission authorization before it can broadly commercialize Foundayo across the EU.
⸻
Current comparison
Wegovy pill
✅ U.S.
✅ UK
✅ UAE
✅ Entire EU regulatory authorization
✅ Germany already commercially launched
➡️ Additional international markets coming
Foundayo
✅ U.S.
✅ UK
✅ UAE
✅ Saudi Arabia
✅ Mexico approved, launch pending/rolling out
❌ EU approval still pending
⸻
Why this matters
The U.S. competition receives almost all the attention, but internationally Novo currently has a meaningful first-mover advantage.
Wegovy pill is already authorized throughout the entire EU, while Lilly is still going through the EU regulatory process.
That gives Novo an opportunity to establish:
• doctors
• patients
• pharmacy inventory
• payer relationships
• brand recognition
• recurring prescriptions
before Foundayo enters many European markets.
Novo does not need to wait for another EMA approval to enter France, Spain, Italy, Denmark, Sweden and other EU countries. The EU-wide authorization already exists; commercial launches now depend primarily on country-level pricing, access, distribution and Novo’s rollout decisions.
Reuters confirmed on Sept. 30 that Wegovy pill was already available in the U.S., UK, Germany and UAE, with further international launches expected.
So right now the global oral race is not simply:
Wegovy vs Foundayo in America.
It is also:
How many countries can Novo establish Wegovy pill in before Lilly receives the regulatory approvals necessary to follow?
That international head start could become strategically important if obesity pills evolve into a mass-market global therapy.
My NVO thesis for 2028 is increasingly about global oral leadership, not necessarily retaking U.S. injectable leadership. Lilly may ultimately win the injectable obesity market, perhaps around 65–70/30, but Novo has an opportunity to reverse that relationship in oral obesity globally. Wegovy pill launched first, produced one of the strongest pharmaceutical launches in U.S. history, and Novo is now using its regulatory and manufacturing lead to expand internationally before Foundayo reaches many of those markets. If Novo can establish Wegovy oral as the incumbent global obesity pill, maintain a large injectable franchise, successfully commercialize CagriSema and return the company to sustainable double-digit growth, today’s ~9–10× earnings valuation could prove far too pessimistic. My personal 2028 scenario is approximately $100/share—not because Lilly fails, but because the obesity market becomes large enough for Lilly to win and Novo to win simultaneously.
Data current through Oct. 5, 2026. This is factual/research commentary, not financial advice.
Not financial advice, my personal opinions.
17
