NDA/BLA filedoutcome: unknownconf 0.99

orladeyo (berotralstat) — NDA/BLA filed

$BCRX · BIOCRYST PHARMACEUTICALS INC · Hereditary angioedema (HAE) in pediatric patients aged 2 to 11 years

Event date

May 14, 2025

388 days ago

Sponsor runway

12 mo

$238.4M liquid

Evidence

“the U.S. Food and Drug Administration ("FDA") has accepted its new drug application for the use of once-daily ORLADEYO® (berotralstat) oral granules in pediatric patients with hereditary angioedema ("HAE") aged 2 to 11 years.”

Source: 8-K filed 2025-05-14View on EDGAR ↗0001171843-25-003152

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
$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
$CRMD	defencath	2023-06-21	unknown

Recent insider activity· ±90 days

10 insiders · 0 buys · 0 sells

Grant

2025-07-24

Ghias Babar

Chief Financial Officer

305,000 @ ——

Grant

2025-07-24

Ghias Babar

Chief Financial Officer

147,000 @ ——

Grant

2025-06-12

Galson Steven K

Director

27,181 @ ——

Grant

2025-06-12

LEVIN ALAN G

Director

12,500 @ ——

Grant

2025-06-12

LEVIN ALAN G

Director

27,181 @ ——

Grant

2025-06-12

Frank Steven

Director

12,500 @ ——

Grant

2025-06-12

Frank Steven

Director

27,181 @ ——

Grant

2025-06-12

McKee Amy E

Director

27,181 @ ——

Grant

2025-06-12

Galson Steven K

Director

12,500 @ ——

Grant

2025-06-12

Hutson Nancy J

Director

27,181 @ ——

Grant

2025-06-12

SANDERS MACHELLE

Director

12,500 @ ——

Grant

2025-06-12

SANDERS MACHELLE

Director

27,181 @ ——

Grant

2025-06-12

MILANO VINCENT

Director

12,500 @ ——

Grant

2025-06-12

MILANO VINCENT

Director

27,181 @ ——

Grant

2025-06-12

McKee Amy E

Director

12,500 @ ——

Grant

2025-06-12

HEGGIE THERESA

Director

12,500 @ ——

Grant

2025-06-12

HEGGIE THERESA

Director

27,181 @ ——

Grant

2025-06-12

Hutson Nancy J

Director

12,500 @ ——

Grant

2025-05-30

Frank Steven

Director

333 @ $10.75$4K

Grant

2025-05-30

MILANO VINCENT

Director

523 @ $10.75$6K

Grant

2025-05-02

Frank Steven

Director

1,866 @ ——

Grant

2025-05-02

Frank Steven

Director

4,079 @ ——

Tax

2025-03-31

Thackray Helen M.

Chief R&D Officer

7,525 @ $7.50$56K

Grant

2025-02-28

MILANO VINCENT

Director

653 @ $8.61$6K

Date	Insider	Action	Shares	Price	Value
2025-07-24	Ghias BabarChief Financial Officer	Grant	305,000	—	—
2025-07-24	Ghias BabarChief Financial Officer	Grant	147,000	—	—
2025-06-12	Galson Steven KDirector	Grant	27,181	—	—
2025-06-12	LEVIN ALAN GDirector	Grant	12,500	—	—
2025-06-12	LEVIN ALAN GDirector	Grant	27,181	—	—
2025-06-12	Frank StevenDirector	Grant	12,500	—	—
2025-06-12	Frank StevenDirector	Grant	27,181	—	—
2025-06-12	McKee Amy EDirector	Grant	27,181	—	—
2025-06-12	Galson Steven KDirector	Grant	12,500	—	—
2025-06-12	Hutson Nancy JDirector	Grant	27,181	—	—
2025-06-12	SANDERS MACHELLEDirector	Grant	12,500	—	—
2025-06-12	SANDERS MACHELLEDirector	Grant	27,181	—	—
2025-06-12	MILANO VINCENTDirector	Grant	12,500	—	—
2025-06-12	MILANO VINCENTDirector	Grant	27,181	—	—
2025-06-12	McKee Amy EDirector	Grant	12,500	—	—
2025-06-12	HEGGIE THERESADirector	Grant	12,500	—	—
2025-06-12	HEGGIE THERESADirector	Grant	27,181	—	—
2025-06-12	Hutson Nancy JDirector	Grant	12,500	—	—
2025-05-30	Frank StevenDirector	Grant	333	$10.75	$4K
2025-05-30	MILANO VINCENTDirector	Grant	523	$10.75	$6K
2025-05-02	Frank StevenDirector	Grant	1,866	—	—
2025-05-02	Frank StevenDirector	Grant	4,079	—	—
2025-03-31	Thackray Helen M.Chief R&D Officer	Tax	7,525	$7.50	$56K
2025-02-28	MILANO VINCENTDirector	Grant	653	$8.61	$6K

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