February 2026 FDA PDUFA Results
5 Approvals, 3 CRLs — ODIN Called All 8 Correctly (100%)
Complete February 2026 PDUFA Scorecard
| Ticker | Drug | Indication | Date | ODIN | Score | Result | Move |
|---|---|---|---|---|---|---|---|
| ETON | ET-600 (Desmopressin) | Arginine Vasopressin Deficiency | Feb 25 | TIER_2 | 85.5% | ✓ APPROVED | +14.7% |
| REGN | Dupixent (dupilumab) | Allergic Fungal Rhinosinusitis | Feb 24 | TIER_1 | 94.8% | ✓ APPROVED | +7.3% |
| VNDA | Bysanti (milsaperidone) | Bipolar I / Schizophrenia | Feb 20 | TIER_1 | 89.7% | ✓ APPROVED | +44% |
| ASND | YUVIWEL (navepegritide) | Achondroplasia (Pediatric) | Feb 27 | TIER_1 | 88.9% | ✓ APPROVED | +6% |
| ASND | TransCon hGH Weekly | Adult Growth Hormone Deficiency | Feb 7 | TIER_1 | 95.5% | ✓ APPROVED | +19% |
| IRON | Bitopertin | Erythropoietic Protoporphyria (EPP) | Feb 13 | TIER_4 | 39.4% | ✗ CRL | -52% |
| RGNX | RGX-121 (Clemidsogene) | Hunter Syndrome (MPS II) | Feb 7 | TIER_4 | 45.0% | ✗ CRL | -21% |
| PHAR | Leniolisib (Joenja sNDA) | APDS (Children 4-11) | Feb 1 | TIER_3 | 58.0% | ✗ CRL | -28% |
February 2026 Approvals
ETON — ET-600 (Desmopressin Oral Solution)
Indication: Arginine Vasopressin Deficiency (Central Diabetes Insipidus)
Approved: February 25, 2026 | ODIN: TIER_2 (85.5%) | Move: +14.7% (T-25→T-0)
505(b)(2) NDA with Orphan Drug designation. Desmopressin oral solution for rare endocrine condition. Micro-cap ($180M mkt cap).
REGN — Dupixent (dupilumab) for AFRS
Indication: Allergic Fungal Rhinosinusitis (AFRS)
Approved: February 24, 2026 (4 days early) | ODIN: TIER_1 (94.8%) | Runup: +7.3% (T-60→T-7)
9th FDA-approved Dupixent indication. First-and-only medicine for AFRS. sBLA label expansion.
VNDA — Bysanti (milsaperidone)
Indication: Bipolar I Disorder / Schizophrenia
Approved: February 20, 2026 (1 day early) | ODIN: TIER_1 (89.7%) | Move: +44%
NCE bioequivalent to iloperidone. 100K+ patient-years safety data. Second VNDA approval in <2 months.
ASND — TransCon hGH Weekly
Indication: Adult Growth Hormone Deficiency
Approved: February 7, 2026 | ODIN: TIER_1 (95.5%) | Move: +19%
Weekly formulation, strong Phase 3 data, experienced sponsor (Ascendis Pharma).
February 2026 CRLs (ODIN Correctly Avoided)
ODIN scored all three CRL recipients below the BUY threshold, correctly signaling AVOID. Investors following ODIN avoided a combined -101% in potential losses across these three events.
IRON — Bitopertin (EPP) | CRL Feb 13 | -52%
ODIN: TIER_4 (39.4%) AVOID. FDA cited insufficient evidence of clinical benefit despite biomarker improvement.
RGNX — RGX-121 (Hunter Syndrome) | CRL Feb 7 | -21%
ODIN: TIER_4 (45.0%) AVOID. FDA cited eligibility criteria, external control comparability, and surrogate endpoint concerns.
PHAR — Leniolisib (APDS Pediatric) | CRL Feb 1 | -28%
ODIN: TIER_3 (58.0%) AVOID. Pediatric expansion CRL. ODIN flagged inexperienced sponsor + pediatric extrapolation risk.
What's Next: March 2026 PDUFAs
March 2026 has several upcoming PDUFA dates. Track all upcoming catalysts with ODIN tier predictions on the PDUFA Calendar.
ODIN's overall track record: 52 verified outcomes, 50 correct (96.2% accuracy). In 2026: 15/15 perfect on PDUFA binary predictions. View the full track record.
Never Miss a PDUFA Decision
52 verified outcomes. 96.2% accuracy. 15/15 perfect in 2026. Track every upcoming FDA catalyst.
View March 2026 PDUFAs →Disclaimer: PDUFA.BIO provides informational analysis only. This is not financial advice or investment recommendation. Past prediction accuracy does not guarantee future results. ODIN tier scores are probabilistic assessments, not certainties. Always conduct your own due diligence.