Yeji
PDUFAoutcome: unknownconf 0.95

axs-05 — PDUFA

$AXSM · Axsome Therapeutics, Inc. · major depressive disorder
Event date
August 22, 2021
1749 days ago
Sponsor runway
44 mo
$305.1M liquid

Evidence

the U.S. Food and Drug Administration informed the Company in a teleconference on August 20, 2021, that its review of the new drug application for AXS-05 for the treatment of major depressive disorder would not be completed by the Prescription Drug User Fee Act target action date of August 22, 2021.
Source: 8-K filed 2021-08-23View on EDGAR ↗0001564590-21-045336

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

5 insiders · 9 buys · 0 sells
Buy
2021-11-19
JEFFS ROGER
Director
3,950 @ $37.30$147K
Buy
2021-11-18
Coleman Mark
Director
409 @ $35.07$14K
Buy
2021-11-18
Pizzie Nick
Chief Financial Officer
142 @ $35.20$5K
Buy
2021-11-18
Coleman Mark
Director
1,021 @ $35.10$36K
Buy
2021-11-18
Pizzie Nick
Chief Financial Officer
527 @ $35.50$19K
Buy
2021-11-18
Pizzie Nick
Chief Financial Officer
141 @ $35.43$5K
Buy
2021-11-18
Pizzie Nick
Chief Financial Officer
145 @ $34.30$5K
Buy
2021-11-17
Saad Mark E
Director
100 @ $34.40$3K
Buy
2021-11-17
Saad Mark E
Director
3,000 @ $34.53$104K
Grant
2021-11-12
Jacobson Mark L.
Chief Operating Officer
41,638 @
Grant
2021-11-12
Pizzie Nick
Chief Financial Officer
36,086 @
Grant
2021-06-04
Coleman Mark
Director
7,325 @
Grant
2021-06-04
JEFFS ROGER
Director
7,325 @
Grant
2021-06-04
Saad Mark E
Director
7,325 @