Yeji
PDUFAoutcome: failureconf 0.95

axs-07 — PDUFA

$AXSM · Axsome Therapeutics, Inc. · acute treatment of migraine
Event date
April 30, 2022
1498 days ago
Sponsor runway
44 mo
$305.1M liquid

Evidence

“the Company expects to receive a Complete Response Letter with respect to this NDA on or about the Prescription Drug User Fee Act target action date of April 30, 2022.”
Source: 8-K filed 2022-04-25View on EDGAR ↗0000950170-22-006038

Comparable historical pdufas· last 5 years · same event type

75% hit rate (3/4)
TickerDrugDateOutcome
$RCKTkresladi2026-03-28success
$RYTMimcivree2026-03-20success
$CYTKaficamten2025-12-26unknown
$ALDXreproxalap2025-12-16unknown
$BCRXorladeyo2025-12-12success
$OMERnarsoplimab2025-09-25unknown
$BCRXorladeyo (berotralstat)2025-09-12unknown
$ETONet-4002025-05-28unknown
$ALDXreproxalap2025-04-02failure
$IONSolezarsen2024-12-19unknown

Recent insider activity· ±90 days

6 insiders · 0 buys · 0 sells
Grant
2022-06-03
JEFFS ROGER
Director
16,976 @ ——
Grant
2022-06-03
Saad Mark E
Director
16,976 @ ——
Grant
2022-06-03
Coleman Mark
Director
16,976 @ ——
Exercise
2022-03-15
Coleman Mark
Director
3,496 @ $1.30$5K
Grant
2022-03-04
JEFFS ROGER
Director
2,347 @ ——
Grant
2022-03-04
Pizzie Nick
Chief Financial Officer
77,872 @ ——
Grant
2022-03-04
Pizzie Nick
Chief Financial Officer
41,176 @ ——
Grant
2022-03-04
Coleman Mark
Director
2,798 @ ——
Grant
2022-03-04
TABUTEAU HERRIOT
Chief Executive Officer
209,655 @ ——
Grant
2022-03-04
Saad Mark E
Director
2,337 @ ——
Grant
2022-03-04
TABUTEAU HERRIOT
Chief Executive Officer
110,861 @ ——
Grant
2022-03-04
Jacobson Mark L.
Chief Operating Officer
89,405 @ ——
Grant
2022-03-04
Jacobson Mark L.
Chief Operating Officer
47,990 @ ——
← All catalysts for $AXSM