PDUFAoutcome: successconf 0.98

xphozah — PDUFA

$ARDX · ARDELYX, INC.

Event date

October 17, 2023

963 days ago

Sponsor runway

3 mo

$31.2M liquid

Evidence

“The FDA has set a user fee goal date of October 17, 2023.”

Source: 8-K filed 2023-05-17View on EDGAR ↗0001628280-23-018655

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

8 insiders · 0 buys · 29 sells

Sell10b5-1

2024-01-08

Rosenbaum David P.

Chief Development Officer

30,000 @ $6.64$199K

Sell10b5-1

2023-12-26

Renz Justin A

Chief Financial Officer

225,000 @ $6.36$1.43M

Exercise10b5-1

2023-12-26

Renz Justin A

Chief Financial Officer

75,000 @ $0.99$74K

Sell10b5-1

2023-12-18

Rosenbaum David P.

Chief Development Officer

5,675 @ $6.07$34K

Sell10b5-1

2023-12-14

Rosenbaum David P.

Chief Development Officer

7,000 @ $5.55$39K

Sell10b5-1

2023-12-11

GRAMMER ELIZABETH A

See Remarks

50,000 @ $5.08$254K

Sell10b5-1

2023-12-08

Rosenbaum David P.

Chief Development Officer

20,000 @ $5.27$105K

Sell10b5-1

2023-12-05

Rosenbaum David P.

Chief Development Officer

10,272 @ $5.00$51K

Sell10b5-1

2023-11-30

Rosenbaum David P.

Chief Development Officer

3,000 @ $4.50$14K

Sell

2023-11-20

Rodriguez Susan

Chief Commercial Officer

4,714 @ $4.36$21K

Sell

2023-11-20

Blanks Robert

See Remarks

2,835 @ $4.36$12K

Sell

2023-11-20

Rosenbaum David P.

Chief Development Officer

932 @ $4.36$4K

Sell

2023-11-20

Renz Justin A

Chief Financial Officer

2,873 @ $4.36$13K

Sell

2023-11-20

RAAB MICHAEL

President & CEO

11,368 @ $4.36$50K

Sell

2023-11-20

Felsch Robert Ora

See Remarks

1,044 @ $4.36$5K

Sell

2023-11-20

Williams Laura A

Chief Patient Officer

2,581 @ $4.36$11K

Sell

2023-11-20

Rosenbaum David P.

Chief Development Officer

2,835 @ $4.36$12K

Sell

2023-11-20

GRAMMER ELIZABETH A

See Remarks

2,384 @ $4.36$10K

Sell

2023-11-15

Williams Laura A

Chief Patient Officer

25,000 @ $4.00$100K

Sell10b5-1

2023-10-10

Rosenbaum David P.

Chief Development Officer

1,644 @ $4.00$7K

Sell10b5-1

2023-09-08

Rosenbaum David P.

Chief Development Officer

2,897 @ $4.55$13K

Sell

2023-08-21

Rosenbaum David P.

Chief Development Officer

937 @ $3.55$3K

Sell

2023-08-21

RAAB MICHAEL

President & CEO

11,419 @ $3.55$41K

Sell

2023-08-21

GRAMMER ELIZABETH A

See Remarks

2,392 @ $3.55$8K

Sell

2023-08-21

Blanks Robert

See Remarks

2,846 @ $3.55$10K

Sell

2023-08-21

Williams Laura A

Chief Patient Officer

2,591 @ $3.55$9K

Sell

2023-08-21

Rodriguez Susan

Chief Commercial Officer

4,733 @ $3.55$17K

Sell

2023-08-21

Renz Justin A

Chief Financial Officer

2,884 @ $3.55$10K

Sell

2023-08-21

Felsch Robert Ora

See Remarks

1,048 @ $3.55$4K

Sell

2023-08-21

Rosenbaum David P.

Chief Development Officer

2,846 @ $3.55$10K

Date	Insider	Action	Shares	Price	Value
2024-01-08	Rosenbaum David P.Chief Development Officer	Sell10b5-1	30,000	$6.64	$199K
2023-12-26	Renz Justin AChief Financial Officer	Sell10b5-1	225,000	$6.36	$1.43M
2023-12-26	Renz Justin AChief Financial Officer	Exercise10b5-1	75,000	$0.99	$74K
2023-12-18	Rosenbaum David P.Chief Development Officer	Sell10b5-1	5,675	$6.07	$34K
2023-12-14	Rosenbaum David P.Chief Development Officer	Sell10b5-1	7,000	$5.55	$39K
2023-12-11	GRAMMER ELIZABETH ASee Remarks	Sell10b5-1	50,000	$5.08	$254K
2023-12-08	Rosenbaum David P.Chief Development Officer	Sell10b5-1	20,000	$5.27	$105K
2023-12-05	Rosenbaum David P.Chief Development Officer	Sell10b5-1	10,272	$5.00	$51K
2023-11-30	Rosenbaum David P.Chief Development Officer	Sell10b5-1	3,000	$4.50	$14K
2023-11-20	Rodriguez SusanChief Commercial Officer	Sell	4,714	$4.36	$21K
2023-11-20	Blanks RobertSee Remarks	Sell	2,835	$4.36	$12K
2023-11-20	Rosenbaum David P.Chief Development Officer	Sell	932	$4.36	$4K
2023-11-20	Renz Justin AChief Financial Officer	Sell	2,873	$4.36	$13K
2023-11-20	RAAB MICHAELPresident & CEO	Sell	11,368	$4.36	$50K
2023-11-20	Felsch Robert OraSee Remarks	Sell	1,044	$4.36	$5K
2023-11-20	Williams Laura AChief Patient Officer	Sell	2,581	$4.36	$11K
2023-11-20	Rosenbaum David P.Chief Development Officer	Sell	2,835	$4.36	$12K
2023-11-20	GRAMMER ELIZABETH ASee Remarks	Sell	2,384	$4.36	$10K
2023-11-15	Williams Laura AChief Patient Officer	Sell	25,000	$4.00	$100K
2023-10-10	Rosenbaum David P.Chief Development Officer	Sell10b5-1	1,644	$4.00	$7K
2023-09-08	Rosenbaum David P.Chief Development Officer	Sell10b5-1	2,897	$4.55	$13K
2023-08-21	Rosenbaum David P.Chief Development Officer	Sell	937	$3.55	$3K
2023-08-21	RAAB MICHAELPresident & CEO	Sell	11,419	$3.55	$41K
2023-08-21	GRAMMER ELIZABETH ASee Remarks	Sell	2,392	$3.55	$8K
2023-08-21	Blanks RobertSee Remarks	Sell	2,846	$3.55	$10K
2023-08-21	Williams Laura AChief Patient Officer	Sell	2,591	$3.55	$9K
2023-08-21	Rodriguez SusanChief Commercial Officer	Sell	4,733	$3.55	$17K
2023-08-21	Renz Justin AChief Financial Officer	Sell	2,884	$3.55	$10K
2023-08-21	Felsch Robert OraSee Remarks	Sell	1,048	$3.55	$4K
2023-08-21	Rosenbaum David P.Chief Development Officer	Sell	2,846	$3.55	$10K

← All catalysts for $ARDX