PDUFA Calendar 2026 · Monthly Breakdown
PDUFA Dates March 2026: FDA Approval Decisions
March 2026 features 6 FDA PDUFA target action dates headlined by Eli Lilly's orforglipron — potentially the first oral GLP-1 receptor agonist for type 2 diabetes. Other highlights include GSK's linerixibat, Lantheus' diagnostic imaging agent, and BMS's TYK2 inhibitor expansion.
Catalyst to Watch
LLY Orforglipron (Mar 25) — First oral GLP-1 for T2D. Addressable market >$100B. ODIN TIER_1. If approved, this is the most commercially significant PDUFA of Q1 2026.
All March 2026 PDUFA Dates
| Date | Ticker | Drug | Indication | TA | ODIN |
|---|---|---|---|---|---|
| Mar 6 | BMY | Deucravacitinib (Sotyktu) | Psoriatic Arthritis | Immunology | TIER_1 |
| Mar 20 | RYTM | Imcivree (setmelanotide) | Hypothalamic Obesity | Endocrinology | TIER_2 |
| Mar 24 | GSK | Linerixibat | Cholestatic Pruritus (PBC) | Hepatology | TIER_1 |
| Mar 25 | LLY | Orforglipron | Type 2 Diabetes (Oral GLP-1) | Endocrinology | TIER_1 |
| Mar 28 | RCKT | Kresladi (marnetegragene autotemcel) | Leukocyte Adhesion Deficiency-I | Gene Therapy | TIER_2 |
| Mar 29 | LNTH | Ga68-edotreotide | GEP-NETs Imaging | Oncology | TIER_1 |
Key March 2026 Events
LLY Orforglipron — Mar 25 (ODIN TIER_1)
Eli Lilly's orforglipron could become the first oral GLP-1 receptor agonist approved for type 2 diabetes. The oral formulation addresses the key patient barrier to the GLP-1 class (injection phobia) and targets a market projected to exceed $100 billion. Strong Phase 3 data showed significant HbA1c reduction and weight loss comparable to injectable GLP-1s.
GSK Linerixibat — Mar 24 (ODIN TIER_1)
GSK's linerixibat is an ileal bile acid transporter (IBAT) inhibitor for cholestatic pruritus associated with primary biliary cholangitis (PBC). Phase 3 data showed significant improvement in pruritus scores. The unmet need in PBC pruritus supports the regulatory case.
BMY Deucravacitinib — Mar 6 (ODIN TIER_1)
Bristol-Myers Squibb's Sotyktu (deucravacitinib) sBLA for psoriatic arthritis. As the first TYK2 inhibitor seeking this indication, it would expand the Sotyktu franchise. Already approved for plaque psoriasis, this is an sBLA with established safety data.
LNTH Ga68-edotreotide — Mar 29 (ODIN TIER_1)
Lantheus' novel diagnostic PET imaging agent for gastroenteropancreatic neuroendocrine tumors (GEP-NETs). If approved, it would complement the existing Lutathera therapy pathway for NETs. Full LNTH analysis →
RCKT Kresladi — Mar 28 (ODIN TIER_2)
Rocket Pharmaceuticals' gene therapy (marnetegragene autotemcel) for leukocyte adhesion deficiency type I (LAD-I). This is a resubmission following a prior CRL, with the FDA accepting the refiled BLA.
Frequently Asked Questions
What are the biggest March 2026 PDUFA dates?
LLY orforglipron (Mar 25), GSK linerixibat (Mar 24), LNTH Ga68-edotreotide (Mar 29), and BMY deucravacitinib (Mar 6).
What is orforglipron?
Eli Lilly's oral GLP-1 for type 2 diabetes. If approved, it would be the first non-injectable GLP-1 on the market, targeting a >$100B addressable market.
How many PDUFA dates are in March 2026?
6 confirmed FDA target action dates spanning immunology, endocrinology, hepatology, oncology, and gene therapy.