| Date | Ticker | Company | Drug | Type | Phase | PoA | Mkt Size | Notes |
|---|---|---|---|---|---|---|---|---|
|
2026-04-28 Today |
INSM | PDUFA | Phase 2 | — | $6B | For NTM lung disease. sNDA filing. Extracted from SEC filing: 8-K | ||
|
2026-06-05 in 177 days |
ARVN | PDUFA | — | 85% | $10B | JUN 5 2026 38 days 💊 PDUFA (vepdegestrant (ARV-471)) $ARVN Arvinas / Pfizer · NDA ESR1-mut | ||
|
2026-06-08 in 180 days |
ABBV | PDUFA | — | 90% | $6B | JUN 8 2026 41 days 💊 PDUFA (cendakimab) $ABBV AbbVie / Arena Pharma · NDA Eosinophilic eso | ||
|
2026-06-16 in 188 days |
SNY | PDUFA | Phase 3 | — | $8B | For hemophilia. BLA filing. Extracted from SEC filing: 6-K | ||
|
2026-06-18 in 190 days |
IMCR | PDUFA | Phase 3 | — | $8B | For unresectable or metastatic uveal melanoma. BLA filing. Extracted from SEC filing: 8-K | ||
|
2026-06-28 in 200 days |
MNKD | PDUFA | Phase 3 | — | $8B | For Type 1 diabetes. NDA filing. Extracted from SEC filing: 8-K | ||
|
2026-06-30 in 202 days |
AZN | PDUFA | — | 85% | $12B | JUN 30 2026 63 days 💊 PDUFA (camizestrant (AZD9833)) $AZN AstraZeneca · NDA HR+/HER2- adva | ||
|
2026-06-30 in 202 days |
AZN | PDUFA | — | 92% | $8B | JUN 30 2026 63 days 💊 PDUFA Truqap (supplemental) (capivasertib (Truqap) + abir...) $AZN A | ||
|
2026-07-07 in 279 days |
VERA | PDUFA | — | 88% | $8B | JUL 7 2026 70 days 💊 PDUFA (atacicept) $VERA Vera Therapeutics · BLA IgA nephropathy (IgAN | ||
|
2026-07-25 in 297 days |
BIIB | PDUFA | — | 92% | $15B | JUL 25 2026 88 days 💊 PDUFA Leqembi (lecanemab) $BIIB Eisai / Biogen · sNDA Subcutaneous f | ||
|
2026-08-01 in 373 days |
MRNA | PDUFA | Phase 3 | — | $8B | For Influenza vaccine. FDA reversed its Refusal-to-File decision on Moderna's mRNA-1010 fl | ||
|
2026-08-05 in 377 days |
MRNA | PDUFA | Phase 3 | — | $15B | For influenza. The FDA reversed its earlier Refusal-to-File decision and agreed to review | ||
|
2026-08-25 in 397 days |
RHHBY | PDUFA | Phase 2 | — | $15B | NDA filing. AI-extracted from news: FDA Accepts Bristol Myers Squibb (BMY) NDA for Iberdom | ||
|
2026-10-29 in 601 days |
MRK | PDUFA | Phase 2 | — | $12B | For Adults with Active Psoriatic Arthritis If the sBLA is approved. sbla filing. AI-extra | ||
|
2026-10-30 in 602 days |
CYTK | PDUFA | — | 92% | $8B | OCT 30 2026 185 days 💊 PDUFA MYQORZO (supplemental) (aficamten (MAPLE-HCM sNDA)) $CYTK Cyt | ||
|
2026-11-01 in 673 days |
SMMT | PDUFA | Phase 3 | — | $8B | Extracted from: Summit gets November PDUFA date for its PD-1xVEGF bispecific | ||
|
2026-12-01 in 773 days |
MRK | PDUFA | Phase 3 | — | $8B | For Renal cell carcinoma (RCC). Exelixis presented data on Zanzalintinib for renal cell ca | ||
|
2026-12-27 in 799 days |
CNTA | PDUFA | NDA | — | $15B | For epilepsy. NDA submitted. AI-extracted from: Praxis tees up another approval filing; Ge | ||
|
2027-01-01 in 9673 days |
EXEL | PDUFA | Phase 3 | — | $6B | For advanced hepatocellular carcinoma. sNDA filing. Extracted from SEC filing: 8-K | ||
|
2027-02-12 in 9784 days |
OCUL | PDUFA | NDA | — | $12B | For wet-AMD. NDA submitted. AI-extracted from: Ocular: 'Buy' As AXPAXLI Program For Wet-AM | ||
|
2027-02-17 in 9789 days |
MLTX | PDUFA | NDA | — | $8B | For inflammatory arthritis. BLA submitted. AI-extracted from: MoonLake has 'confidence' ah | ||
|
2027-03-01 in 9873 days |
GSK | PDUFA | Phase 2 | — | $15B | For multiple myeloma. BLA filing. Extracted from SEC filing: 6-K | ||
|
2027-03-04 in 9876 days |
XENE | PDUFA | Phase 3 | — | $15B | For epilepsy. NDA submitted. AI-extracted from: Xenon gets Phase 3 win with epilepsy drug, | ||
|
2027-04-04 in 9976 days |
CFOO | PDUFA | NDA | — | $12B | For Unresectable or Metastatic HER2-Positive Adult Breast Cancer. BLA accepted. AI-extract |