NDA/BLA filedconf 0.75

Volixibat — NDA/BLA filed

$MIRM · Mirum Pharmaceuticals, Inc. · Intrahepatic Cholestasis of Pregnancy

Event date

Date TBD

Sponsor runway

5 mo

$386.3M liquid

Evidence

“The Company has a pre-New Drug Application ("NDA") meeting for volixibat in PSC scheduled with the U.S. Food and Drug Administration ("FDA") in summer 2026, with a planned NDA submission in the second half of 2026.”

Source: 8-K filed 2026-05-04View on EDGAR ↗0001193125-26-202609

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

Ticker	Drug	Date	Outcome
$AXSM	—	2025-12-31	unknown
$RCKT	kresladi	2025-10-14	unknown
$ALDX	reproxalap	2025-07-17	unknown
$ETON	et-600	2025-07-08	unknown
$BCRX	orladeyo (berotralstat)	2025-05-14	unknown
$CORT	relacorilant	2025-03-03	unknown
$ALDX	reproxalap	2024-11-01	unknown
$AXSM	axs-07	2024-09-04	unknown
$RCKT	kresladi	2023-10-02	unknown
$GERN	imetelstat	2023-08-21	unknown

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

Date	Insider	Action	Shares	Price	Value
2026-05-15	Ramasastry SairaDirector	Exercise10b5-1	2,000	$23.51	$47K
2026-05-15	Ramasastry SairaDirector	Sell10b5-1	2,000	$109.47	$219K

← All catalysts for $MIRM