NDA/BLA filedconf 0.70

NDA/BLA filed

$SVRA · Savara Inc

Event date

Date TBD

Sponsor runway

18 mo

$202.8M liquid

Evidence

“Upon preliminary review, the FDA determined that the BLA submitted in March 2025 was not sufficiently complete to permit substantive review and requested additional data related to Chemistry, Manufacturing, and Controls (CMC).”

Source: Press release · 2025-05-27View press release ↗

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 · 0 sells

Exercise

2026-03-18

Lowrance David L

Chief Financial Officer

80,684 @ $1.51$122K

Tax

2026-03-18

Lowrance David L

Chief Financial Officer

24,174 @ $5.04$122K

Exercise

2026-03-18

Lowrance David L

Chief Financial Officer

75,000 @ $1.59$119K

Tax

2026-03-18

Lowrance David L

Chief Financial Officer

23,661 @ $5.04$119K

Exercise

2026-03-18

Lowrance David L

Chief Financial Officer

130,650 @ $1.23$161K

Tax

2026-03-18

Lowrance David L

Chief Financial Officer

31,885 @ $5.04$161K

Exercise

2026-03-18

Lowrance David L

Chief Financial Officer

43,063 @ $1.11$48K

Tax

2026-03-18

Lowrance David L

Chief Financial Officer

9,485 @ $5.04$48K

Exercise

2026-03-18

Lowrance David L

Chief Financial Officer

12,500 @ $4.45$56K

Tax

2026-03-18

Lowrance David L

Chief Financial Officer

11,037 @ $5.04$56K

Exercise

2026-03-18

Lowrance David L

Chief Financial Officer

24,850 @ $3.35$83K

Tax

2026-03-18

Lowrance David L

Chief Financial Officer

16,518 @ $5.04$83K

Date	Insider	Action	Shares	Price	Value
2026-03-18	Lowrance David LChief Financial Officer	Exercise	80,684	$1.51	$122K
2026-03-18	Lowrance David LChief Financial Officer	Tax	24,174	$5.04	$122K
2026-03-18	Lowrance David LChief Financial Officer	Exercise	75,000	$1.59	$119K
2026-03-18	Lowrance David LChief Financial Officer	Tax	23,661	$5.04	$119K
2026-03-18	Lowrance David LChief Financial Officer	Exercise	130,650	$1.23	$161K
2026-03-18	Lowrance David LChief Financial Officer	Tax	31,885	$5.04	$161K
2026-03-18	Lowrance David LChief Financial Officer	Exercise	43,063	$1.11	$48K
2026-03-18	Lowrance David LChief Financial Officer	Tax	9,485	$5.04	$48K
2026-03-18	Lowrance David LChief Financial Officer	Exercise	12,500	$4.45	$56K
2026-03-18	Lowrance David LChief Financial Officer	Tax	11,037	$5.04	$56K
2026-03-18	Lowrance David LChief Financial Officer	Exercise	24,850	$3.35	$83K
2026-03-18	Lowrance David LChief Financial Officer	Tax	16,518	$5.04	$83K

← All catalysts for $SVRA