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NDA/BLA filedconf 0.95

livmarli — NDA/BLA filed

$MIRM · Mirum Pharmaceuticals, Inc.
Event date
Date TBD
Sponsor runway
5 mo
$386.3M liquid

Evidence

“Sandoz, Inc. ("Sandoz"), providing notification to the Company that Sandoz has submitted an Abbreviated New Drug Application ("ANDA") to the U.S. Food and Drug Administration ("FDA"), seeking approval of a generic version of Livmarli ® (maralixibat)”
Source: 8-K filed 2025-12-19View on EDGAR ↗0001193125-25-326822

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
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$GERNimetelstat2023-08-21unknown

Recent insider activity· ±90 days

1 insider · 0 buys · 1 sells
Exercise10b5-1
2026-05-15
Ramasastry Saira
Director
2,000 @ $23.51$47K
Sell10b5-1
2026-05-15
Ramasastry Saira
Director
2,000 @ $109.47$219K
← All catalysts for $MIRM