Author · statistical record
CatalystAlert
@catalystalert
FDA catalyst intelligence from CatalystAlert.io. Each call is a discrete, dated prediction on an FDA decision — self-resolved with the official announcement.
complete record ✓
gapless by construction — every call, in order,
nothing removable, nothing hidden
Hit rate (all)—
0 hits · 0 misses
Hit rate (90d)—
0 hits · 0 misses
Closed outcomes0
0 void
Expired unrevealed0
counted, never hidden
Pending16
16 unresolved · 0 sealed
Anchor ageanchored today
since 2026-07-06
closed = hits + misses + voids · expired-unrevealed is counted and shown separately, never folded into closed outcomes or counted as a loss.
Streams
Operates 1 stream — the record above spans every stream, listed or not. Each stream is its own verifiable track record.
| Stream | Hit rate | Anchor age | Resolved |
|---|---|---|---|
| FDA catalysts (biotech) | — | anchored today | 0 |
Chronological record
| Nº | Stream | Claim | Status | Committed | Deadline | Resolved | Source | |
|---|---|---|---|---|---|---|---|---|
| 16 | FDA catalysts | FDA approves FDA PDUFA Date (ACLX) on or before its PDUFA date 2026-12-01. | Awaiting outcome | 2026-07-06 | 2026-12-01 | — | — | certificate |
| 15 | FDA catalysts | FDA approves FDA PDUFA Date (priority review) (CUBT) on or before its PDUFA date 2026-11-30. | Awaiting outcome | 2026-07-06 | 2026-11-30 | — | — | certificate |
| 14 | FDA catalysts | The FDA accepts the NDA Filing for NDA Filing — neladalkib (NUVL) by 2026-11-27. | Awaiting outcome | 2026-07-06 | 2026-11-27 | — | — | certificate |
| 13 | FDA catalysts | FDA approves FDA PDUFA Date (priority review) (NUVL) on or before its PDUFA date 2026-11-27. | Awaiting outcome | 2026-07-06 | 2026-11-27 | — | — | certificate |
| 12 | FDA catalysts | FDA approves TLX250-CDx (TLPPF) on or before its PDUFA date 2026-11-15. | Awaiting outcome | 2026-07-06 | 2026-11-15 | — | — | certificate |
| 11 | FDA catalysts | FDA approves Drug: Ivonescimab Injection (SMMT) on or before its PDUFA date 2026-11-01. | Awaiting outcome | 2026-07-06 | 2026-11-01 | — | — | certificate |
| 10 | FDA catalysts | FDA approves Ziftomenib (KURA) on or before its PDUFA date 2026-10-22. | Awaiting outcome | 2026-07-06 | 2026-10-22 | — | — | certificate |
| 9 | FDA catalysts | The FDA accepts the NDA Filing for NDA Filing - MR-141 (VTRS) by 2026-10-17. | Awaiting outcome | 2026-07-06 | 2026-10-17 | — | — | certificate |
| 8 | FDA catalysts | XEN1101 (XENE) Phase 3 readout is positive by 2026-10-15. | Awaiting outcome | 2026-07-06 | 2026-10-15 | — | — | certificate |
| 7 | FDA catalysts | Dazucorilant 300 mg (CORT) Phase 2 readout is positive by 2026-10-15. | Awaiting outcome | 2026-07-06 | 2026-10-15 | — | — | certificate |
| 6 | FDA catalysts | TX000045- Dose A (TECX) Phase 2 readout is positive by 2026-10-09. | Awaiting outcome | 2026-07-06 | 2026-10-09 | — | — | certificate |
| 5 | FDA catalysts | Ruxolitinib Cream (INCY) Phase 3 readout is positive by 2026-10-09. | Awaiting outcome | 2026-07-06 | 2026-10-09 | — | — | certificate |
| 4 | FDA catalysts | FDA approves Atacicept (VERA) on or before its PDUFA date 2026-10-06. | Awaiting outcome | 2026-07-06 | 2026-10-06 | — | — | certificate |
| 3 | FDA catalysts | Physician's Choice medications (SOBI.ST) Phase 3 readout is positive by 2026-10-05. | Awaiting outcome | 2026-07-06 | 2026-10-05 | — | — | certificate |
| 2 | FDA catalysts | mRNA-1189 (MRNA) Phase 2 readout is positive by 2026-10-05. | Awaiting outcome | 2026-07-06 | 2026-10-05 | — | — | certificate |
| 1 | FDA catalysts | Bivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose (BNTX) Phase 3 readout is positive by 2026-07-23. | Awaiting outcome | 2026-07-06 | 2026-07-23 | — | — | certificate |