PDUFAoutcome: unknownconf 0.95

PDUFA

$ARDX · ARDELYX, INC.

Event date

July 29, 2021

1773 days ago

Sponsor runway

3 mo

$31.2M liquid

Evidence

“In April 2021, the FDA extended the PDUFA date for the NDA to July 29, 2021 as a result of the Company's submission of additional data analyses requested by the FDA.”

Source: 8-K filed 2021-07-19View on EDGAR ↗0001628280-21-014021

Comparable historical pdufas· last 5 years · same event type

75% hit rate (3/4)

Ticker	Drug	Date	Outcome
$RCKT	kresladi	2026-03-28	success
$RYTM	imcivree	2026-03-20	success
$CYTK	aficamten	2025-12-26	unknown
$ALDX	reproxalap	2025-12-16	unknown
$BCRX	orladeyo	2025-12-12	success
$OMER	narsoplimab	2025-09-25	unknown
$BCRX	orladeyo (berotralstat)	2025-09-12	unknown
$ETON	et-400	2025-05-28	unknown
$ALDX	reproxalap	2025-04-02	failure
$IONS	olezarsen	2024-12-19	unknown

Recent insider activity· ±90 days

14 insiders · 0 buys · 10 sells

Grant

2021-10-08

Rosenbaum David P.

Chief Development Officer

60,000 @ ——

Grant

2021-10-08

Blanks Robert

See Remarks

250,000 @ ——

Grant

2021-10-08

Rosenbaum David P.

Chief Development Officer

150,000 @ ——

Grant

2021-10-08

Rodriguez Susan

Chief Commercial Officer

150,000 @ ——

Grant

2021-10-08

RAAB MICHAEL

President & CEO

300,000 @ ——

Grant

2021-10-08

Renz Justin A

Chief Financial Officer

250,000 @ ——

Grant

2021-10-08

GRAMMER ELIZABETH A

See Remarks

250,000 @ ——

Sell

2021-08-20

Renz Justin A

Chief Financial Officer

631 @ $1.32$833

Sell

2021-08-20

RAAB MICHAEL

President & CEO

2,573 @ $1.32$3K

Sell

2021-08-20

GRAMMER ELIZABETH A

See Remarks

526 @ $1.32$694

Sell

2021-08-20

Blanks Robert

See Remarks

631 @ $1.32$833

Sell

2021-08-20

Rodriguez Susan

Chief Commercial Officer

630 @ $1.32$832

Sell

2021-08-20

Jacobs Jeffrey W

Chief Scientific Officer

741 @ $1.32$978

Sell

2021-08-20

Rosenbaum David P.

Chief Development Officer

631 @ $1.32$833

Sell

2021-08-20

Rosenbaum David P.

Chief Development Officer

176 @ $1.32$232

Exercise

2021-08-03

Jacobs Jeffrey W

Chief Scientific Officer

10,000 @ $0.54$5K

Tax

2021-08-03

Jacobs Jeffrey W

Chief Scientific Officer

5,613 @ $1.64$9K

Exercise

2021-08-03

RAAB MICHAEL

President & CEO

267,892 @ $0.54$145K

Tax

2021-08-03

RAAB MICHAEL

President & CEO

150,343 @ $1.64$247K

Grant

2021-06-16

Rodgers Richard J

Director

9,917 @ ——

Grant

2021-06-16

Rodgers Richard J

Director

32,765 @ ——

Grant

2021-06-16

Bazemore Robert B

Director

32,765 @ ——

Grant

2021-06-16

Bertrand William C JR

Director

32,765 @ ——

Grant

2021-06-16

Bertrand William C JR

Director

8,891 @ ——

Grant

2021-06-16

MOTT DAVID M

Director

32,765 @ ——

Grant

2021-06-16

Cadoret-Manier Onaiza

Director

32,765 @ ——

Grant

2021-06-16

Lundberg Jan M

Director

7,181 @ ——

Grant

2021-06-16

Lundberg Jan M

Director

32,765 @ ——

Grant

2021-06-16

Block Geoffrey A.

Director

32,765 @ ——

Sell

2021-06-15

Jacobs Jeffrey W

Chief Scientific Officer

7,500 @ $7.29$55K

Exercise

2021-06-15

Jacobs Jeffrey W

Chief Scientific Officer

7,500 @ $0.54$4K

Sell

2021-05-28

Rosenbaum David P.

Chief Development Officer

3,062 @ $7.22$22K

Date	Insider	Action	Shares	Price	Value
2021-10-08	Rosenbaum David P.Chief Development Officer	Grant	60,000	—	—
2021-10-08	Blanks RobertSee Remarks	Grant	250,000	—	—
2021-10-08	Rosenbaum David P.Chief Development Officer	Grant	150,000	—	—
2021-10-08	Rodriguez SusanChief Commercial Officer	Grant	150,000	—	—
2021-10-08	RAAB MICHAELPresident & CEO	Grant	300,000	—	—
2021-10-08	Renz Justin AChief Financial Officer	Grant	250,000	—	—
2021-10-08	GRAMMER ELIZABETH ASee Remarks	Grant	250,000	—	—
2021-08-20	Renz Justin AChief Financial Officer	Sell	631	$1.32	$833
2021-08-20	RAAB MICHAELPresident & CEO	Sell	2,573	$1.32	$3K
2021-08-20	GRAMMER ELIZABETH ASee Remarks	Sell	526	$1.32	$694
2021-08-20	Blanks RobertSee Remarks	Sell	631	$1.32	$833
2021-08-20	Rodriguez SusanChief Commercial Officer	Sell	630	$1.32	$832
2021-08-20	Jacobs Jeffrey WChief Scientific Officer	Sell	741	$1.32	$978
2021-08-20	Rosenbaum David P.Chief Development Officer	Sell	631	$1.32	$833
2021-08-20	Rosenbaum David P.Chief Development Officer	Sell	176	$1.32	$232
2021-08-03	Jacobs Jeffrey WChief Scientific Officer	Exercise	10,000	$0.54	$5K
2021-08-03	Jacobs Jeffrey WChief Scientific Officer	Tax	5,613	$1.64	$9K
2021-08-03	RAAB MICHAELPresident & CEO	Exercise	267,892	$0.54	$145K
2021-08-03	RAAB MICHAELPresident & CEO	Tax	150,343	$1.64	$247K
2021-06-16	Rodgers Richard JDirector	Grant	9,917	—	—
2021-06-16	Rodgers Richard JDirector	Grant	32,765	—	—
2021-06-16	Bazemore Robert BDirector	Grant	32,765	—	—
2021-06-16	Bertrand William C JRDirector	Grant	32,765	—	—
2021-06-16	Bertrand William C JRDirector	Grant	8,891	—	—
2021-06-16	MOTT DAVID MDirector	Grant	32,765	—	—
2021-06-16	Cadoret-Manier OnaizaDirector	Grant	32,765	—	—
2021-06-16	Lundberg Jan MDirector	Grant	7,181	—	—
2021-06-16	Lundberg Jan MDirector	Grant	32,765	—	—
2021-06-16	Block Geoffrey A.Director	Grant	32,765	—	—
2021-06-15	Jacobs Jeffrey WChief Scientific Officer	Sell	7,500	$7.29	$55K
2021-06-15	Jacobs Jeffrey WChief Scientific Officer	Exercise	7,500	$0.54	$4K
2021-05-28	Rosenbaum David P.Chief Development Officer	Sell	3,062	$7.22	$22K

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