← Back to Calendar

Foundayo (orforglipron)

Eli Lilly · $LLY
Priority Review Fast Track Breakthrough Therapy NDA
PDUFA Date
April 10, 2026
Date Status
3d ago (past)
Review Type
Priority (6 mo)
90%
Baseline PoA
NDA priority review approval rate
Based on FDA historical approval rates by submission type (2015–2025)
Dynamic PoA
Coming soon
xAI Sentiment

FDA Decision

✅
✓ FDA Approved
Decision issued: April 1, 2026
FDA APPROVED April 1, 2026 — approved under the Commissioner's National Priority Voucher (CNPV) pilot program, 294 days before the standard PDUFA date of January 20, 2027. Issued 50 days after filing — fastest NME approval since 2002. Foundayo (orforglipron) is the first oral, non-peptide GLP-1 receptor agonist approved for obesity. Available via LillyDirect starting April 6, 2026, then broad retail/telehealth rollout. Price: $149-$349/month self-pay; $25/month with commercial insurance savings card.

Live Company Data NYQ

Updated just now · Data: FMP
Current Price
$939.47 +30.32%
+$218.56 today
Day: $935.54 – $963.94
Market Cap
N/A
Shares out: 893.36M
Float: 890.99M
52-Week Range
$623.78
$1133.95
Current price is at 62% of 52-week range
Avg Volume
3.15M
Beta
0.50
vs. S&P 500
Sector
Healthcare
Drug Manufacturers - General
⚠️ Financial data is for informational purposes only. Not investment advice. Prices may be delayed.
Track $LLY catalysts → get weekly FDA alerts Subscribe Free on Substack →

Indication

Obesity / overweight (oral GLP-1 receptor agonist — once-daily pill)

Key Notes

FDA APPROVED April 1, 2026 as Foundayo (orforglipron) under Commissioner's National Priority Voucher (CNPV) program — 294 days before standard PDUFA date of January 20, 2027. Fastest NME approval since 2002. Lilly's second obesity medicine after tirzepatide (Zepbound). First oral non-peptide GLP-1 agonist — no food/water restrictions, can be taken any time of day. Four positive Phase 3 ATTAIN trials. Self-pay: $149-$349/month; $25/month with commercial insurance savings card.
⚠️ Not Investment Advice: This information is provided for educational purposes only. PDUFA dates are FDA target action dates, not guaranteed approval dates. The FDA may extend the review period, issue Complete Response Letters, or take unexpected actions. Probability of approval scores are based on historical base rates and do not account for drug-specific factors. Always consult a financial advisor before making investment decisions.

Discussion

Share your analysis, research, or questions about this catalyst. No account required.

Rate limit: 5/hr per email
Loading comments...
← Back to Full Calendar