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.

StreamHit rateAnchor ageResolved
FDA catalysts (biotech)anchored today0

Chronological record

StreamClaimStatusCommittedDeadlineResolvedSource
16FDA catalystsFDA approves FDA PDUFA Date (ACLX) on or before its PDUFA date 2026-12-01.Awaiting outcome2026-07-062026-12-01certificate
15FDA catalystsFDA approves FDA PDUFA Date (priority review) (CUBT) on or before its PDUFA date 2026-11-30.Awaiting outcome2026-07-062026-11-30certificate
14FDA catalystsThe FDA accepts the NDA Filing for NDA Filing — neladalkib (NUVL) by 2026-11-27.Awaiting outcome2026-07-062026-11-27certificate
13FDA catalystsFDA approves FDA PDUFA Date (priority review) (NUVL) on or before its PDUFA date 2026-11-27.Awaiting outcome2026-07-062026-11-27certificate
12FDA catalystsFDA approves TLX250-CDx (TLPPF) on or before its PDUFA date 2026-11-15.Awaiting outcome2026-07-062026-11-15certificate
11FDA catalystsFDA approves Drug: Ivonescimab Injection (SMMT) on or before its PDUFA date 2026-11-01.Awaiting outcome2026-07-062026-11-01certificate
10FDA catalystsFDA approves Ziftomenib (KURA) on or before its PDUFA date 2026-10-22.Awaiting outcome2026-07-062026-10-22certificate
9FDA catalystsThe FDA accepts the NDA Filing for NDA Filing - MR-141 (VTRS) by 2026-10-17.Awaiting outcome2026-07-062026-10-17certificate
8FDA catalystsXEN1101 (XENE) Phase 3 readout is positive by 2026-10-15.Awaiting outcome2026-07-062026-10-15certificate
7FDA catalystsDazucorilant 300 mg (CORT) Phase 2 readout is positive by 2026-10-15.Awaiting outcome2026-07-062026-10-15certificate
6FDA catalystsTX000045- Dose A (TECX) Phase 2 readout is positive by 2026-10-09.Awaiting outcome2026-07-062026-10-09certificate
5FDA catalystsRuxolitinib Cream (INCY) Phase 3 readout is positive by 2026-10-09.Awaiting outcome2026-07-062026-10-09certificate
4FDA catalystsFDA approves Atacicept (VERA) on or before its PDUFA date 2026-10-06.Awaiting outcome2026-07-062026-10-06certificate
3FDA catalystsPhysician's Choice medications (SOBI.ST) Phase 3 readout is positive by 2026-10-05.Awaiting outcome2026-07-062026-10-05certificate
2FDA catalystsmRNA-1189 (MRNA) Phase 2 readout is positive by 2026-10-05.Awaiting outcome2026-07-062026-10-05certificate
1FDA catalystsBivalent BNT162b2 (original/Omicron BA.4/BA.5) 3 microgram dose (BNTX) Phase 3 readout is positive by 2026-07-23.Awaiting outcome2026-07-062026-07-23certificate

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