PDUFA Calendar 2026 · Monthly Breakdown
PDUFA Dates February 2026: FDA Approval Decisions
February 2026 features 7 FDA PDUFA target action dates across CNS, oncology, immunology, and rare disease. Two events have already resolved: VNDA Bysanti was approved and RGNX RGX-121 received a CRL. The remaining decisions are expected by month-end.
ODIN Highlight
VNDA Bysanti — ODIN TIER_1 (89.7%) → APPROVED Feb 20 → Stock +44% AH. Read the full VNDA case study →
All February 2026 PDUFA Dates
| Date | Ticker | Drug | Indication | ODIN | Outcome |
|---|---|---|---|---|---|
| Feb 8 | RGNX | RGX-121 (clemidsogene lanparvovec) | MPS II (Hunter Syndrome) | TIER_3 | ✗ CRL |
| Feb 20 | VNDA | Bysanti (milsaperidone) | Schizophrenia / Bipolar-I | TIER_1 (89.7%) | ✓ APPROVED |
| Feb 25 | OTSKF | INQOVI + Venetoclax | Acute Myeloid Leukemia | TIER_2 | Pending |
| Feb 25 | ETON | ET-600 | Pediatric Indication | TIER_2 | Pending |
| Feb 28 | REGN | Dupixent (dupilumab) | Allergic Fungal Rhinosinusitis | TIER_1 | Pending |
| Feb 28 | ASND | Navepegritide (TransCon CNP) | Achondroplasia | TIER_1 | ✓ APPROVED |
| Feb 28 | BMRN | Palynziq (pegvaliase) | PKU Expansion | TIER_2 | Pending |
Key February 2026 Events
VNDA Bysanti — Approved Feb 20 (ODIN TIER_1)
Vanda Pharmaceuticals' Bysanti (milsaperidone) was approved one day ahead of its PDUFA date for schizophrenia and bipolar-I disorder. This first-in-class M4 receptor partial agonist received strong ODIN scoring based on robust Phase 3 data, Priority Review designation, and an unmet need in psychiatry. VNDA surged +44% in after-hours trading. Full analysis →
RGNX RGX-121 — CRL Issued Feb 9 (ODIN TIER_3)
RegenXBio's gene therapy for MPS II (Hunter Syndrome) received a Complete Response Letter. ODIN had scored this TIER_3 (mixed odds) citing manufacturing complexity and a limited efficacy dataset. The CRL highlights the challenge of gene therapy regulatory pathways.
REGN Dupixent — Feb 28 (ODIN TIER_1)
Regeneron's supplemental BLA for Dupixent (dupilumab) in allergic fungal rhinosinusitis. As an sBLA expansion of an already-approved blockbuster franchise, this carries lower regulatory risk. ODIN scores it TIER_1.
ASND Navepegritide — Feb 28 (ODIN TIER_1)
Ascendis Pharma's TransCon CNP (navepegritide) for achondroplasia. A first-in-class C-type natriuretic peptide therapy targeting the root cause of the most common form of dwarfism.
February 2026 Scorecard
Resolved: 2 of 7 events
Approved: 1 (VNDA Bysanti) — ODIN correctly predicted TIER_1
CRL: 1 (RGNX RGX-121) — ODIN correctly flagged TIER_3
Pending: 5 events remaining (Feb 25-28)
Frequently Asked Questions
How many PDUFA dates are in February 2026?
7 confirmed FDA target action dates spanning CNS, oncology, immunology, endocrinology, and rare disease.
Was VNDA Bysanti approved?
Yes — approved Feb 20, one day early. ODIN scored 89.7% TIER_1. Stock +44% AH. Case study →
What happened to RGX-121?
CRL issued Feb 9. ODIN had scored it TIER_3 (mixed odds) due to gene therapy manufacturing complexity.