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NDA/BLA filedoutcome: unknownconf 0.85

axs-07 — NDA/BLA filed

$AXSM · Axsome Therapeutics, Inc. · acute treatment of migraine
Event date
September 4, 2024
640 days ago
Sponsor runway
44 mo
$305.1M liquid

Evidence

“the U.S. Food and Drug Administration has acknowledged the resubmission of the Company's New Drug Application for AXS-07 for the acute treatment of migraine.”
Source: 8-K filed 2024-09-04View on EDGAR ↗0000950170-24-103098

Comparable historical nda/bla fileds· last 5 years · same event type

TickerDrugDateOutcome
$AXSM—2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown
$CRMDdefencath2023-06-21unknown

Recent insider activity· ±90 days

5 insiders · 0 buys · 2 sells
Exercise
2024-11-19
Coleman Mark
Director
33,410 @ $5.94$198K
Exercise10b5-1
2024-09-11
Saad Mark E
Director
11,016 @ $3.67$40K
Sell10b5-1
2024-09-11
Saad Mark E
Director
11,016 @ $91.31$1.01M
Exercise10b5-1
2024-08-09
Jacobson Mark L.
Chief Operating Officer
47,739 @ $4.04$193K
Sell10b5-1
2024-08-09
Jacobson Mark L.
Chief Operating Officer
47,739 @ $84.26$4.02M
Grant
2024-06-07
Coleman Mark
Director
5,799 @ ——
Grant
2024-06-07
Mahony Susan
Director
5,799 @ ——
Grant
2024-06-07
JEFFS ROGER
Director
5,799 @ ——
Grant
2024-06-07
Saad Mark E
Director
5,799 @ ——
← All catalysts for $AXSM