| Date | Ticker | Company | Drug | Type | Phase | PoA | Mkt Size | Notes |
|---|---|---|---|---|---|---|---|---|
|
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 | ||
|
2026-06-30 in 202 days |
AZN | PDUFA | — | 85% | $12B | JUN 30 2026 63 days 💊 PDUFA (camizestrant (AZD9833)) $AZN AstraZeneca · NDA HR+/HER2- adva | ||
|
2026-07-25 in 297 days |
BIIB | PDUFA | — | 92% | $15B | JUL 25 2026 88 days 💊 PDUFA Leqembi (lecanemab) $BIIB Eisai / Biogen · sNDA Subcutaneous f | ||
|
2026-08-05 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 | ||
|
2026-12-27 in 799 days |
CNTA | PDUFA | NDA | — | $15B | For epilepsy. NDA submitted. AI-extracted from: Praxis tees up another approval filing; Ge | ||
|
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 | ||
|
2027-03-01 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 |