NDA/BLA filedoutcome: unknownconf 0.90

xphozah — NDA/BLA filed

$ARDX · ARDELYX, INC.

Event date

May 17, 2023

1116 days ago

Sponsor runway

3 mo

$31.2M liquid

Evidence

“the U.S. Food and Drug Administration (the "FDA") has accepted its resubmission of a New Drug Application ("NDA") for XPHOZAH® (tenapanor) for the control of serum phosphate in adult patients with chronic kidney disease on dialysis who have had an inadequate response or intolerance to a phosphate binder therapy.”

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

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

16 insiders · 0 buys · 21 sells

Sell

2023-06-27

Williams Laura A

Chief Patient Officer

25,000 @ $3.35$84K

Exercise10b5-1

2023-06-23

Blanks Robert

See Remarks

33,333 @ $3.42$114K

Sell10b5-1

2023-06-23

Blanks Robert

See Remarks

33,333 @ $3.63$121K

Grant

2023-06-15

Cadoret-Manier Onaiza

Director

49,237 @ ——

Grant

2023-06-15

Bhanji Muna

Director

49,237 @ ——

Grant

2023-06-15

Cadoret-Manier Onaiza

Director

12,755 @ ——

Grant

2023-06-15

Bertrand William C JR

Director

16,581 @ ——

Grant

2023-06-15

Bazemore Robert B

Director

49,237 @ ——

Grant

2023-06-15

Bertrand William C JR

Director

49,237 @ ——

Grant

2023-06-15

Rodgers Richard J

Director

49,237 @ ——

Grant

2023-06-15

Block Geoffrey A.

Director

49,237 @ ——

Grant

2023-06-15

Lundberg Jan M

Director

12,755 @ ——

Grant

2023-06-15

MOTT DAVID M

Director

49,237 @ ——

Grant

2023-06-15

Lundberg Jan M

Director

49,237 @ ——

Grant

2023-06-15

Rodgers Richard J

Director

18,494 @ ——

Grant

2023-06-15

MOTT DAVID M

Director

25,510 @ ——

Sell

2023-05-23

RAAB MICHAEL

President & CEO

11,357 @ $3.65$41K

Sell

2023-05-23

GRAMMER ELIZABETH A

See Remarks

2,384 @ $3.65$9K

Sell

2023-05-23

Blanks Robert

See Remarks

2,835 @ $3.65$10K

Sell

2023-05-23

Williams Laura A

Chief Patient Officer

2,583 @ $3.65$9K

Sell

2023-05-23

Rodriguez Susan

Chief Commercial Officer

4,711 @ $3.65$17K

Sell

2023-05-23

Renz Justin A

Chief Financial Officer

2,873 @ $3.65$10K

Sell

2023-05-23

Felsch Robert Ora

See Remarks

1,046 @ $3.65$4K

Sell

2023-05-23

Rosenbaum David P.

Chief Development Officer

2,835 @ $3.65$10K

Sell

2023-05-23

Rosenbaum David P.

Chief Development Officer

934 @ $3.65$3K

Sell

2023-03-29

Rosenbaum David P.

Chief Development Officer

3,000 @ $4.63$14K

Sell

2023-02-21

Rosenbaum David P.

Chief Development Officer

1,114 @ $3.00$3K

Sell

2023-02-21

Felsch Robert Ora

See Remarks

3,214 @ $3.00$10K

Sell

2023-02-21

GRAMMER ELIZABETH A

See Remarks

2,914 @ $3.00$9K

Sell

2023-02-21

RAAB MICHAEL

President & CEO

13,449 @ $3.00$40K

Sell

2023-02-21

Rosenbaum David P.

Chief Development Officer

3,394 @ $3.00$10K

Sell

2023-02-21

Renz Justin A

Chief Financial Officer

3,439 @ $3.00$10K

Sell

2023-02-21

Rodriguez Susan

Chief Commercial Officer

5,586 @ $3.00$17K

Sell

2023-02-21

Blanks Robert

See Remarks

3,394 @ $3.00$10K

Sell

2023-02-21

Williams Laura A

Chief Patient Officer

3,187 @ $3.00$10K

Date	Insider	Action	Shares	Price	Value
2023-06-27	Williams Laura AChief Patient Officer	Sell	25,000	$3.35	$84K
2023-06-23	Blanks RobertSee Remarks	Exercise10b5-1	33,333	$3.42	$114K
2023-06-23	Blanks RobertSee Remarks	Sell10b5-1	33,333	$3.63	$121K
2023-06-15	Cadoret-Manier OnaizaDirector	Grant	49,237	—	—
2023-06-15	Bhanji MunaDirector	Grant	49,237	—	—
2023-06-15	Cadoret-Manier OnaizaDirector	Grant	12,755	—	—
2023-06-15	Bertrand William C JRDirector	Grant	16,581	—	—
2023-06-15	Bazemore Robert BDirector	Grant	49,237	—	—
2023-06-15	Bertrand William C JRDirector	Grant	49,237	—	—
2023-06-15	Rodgers Richard JDirector	Grant	49,237	—	—
2023-06-15	Block Geoffrey A.Director	Grant	49,237	—	—
2023-06-15	Lundberg Jan MDirector	Grant	12,755	—	—
2023-06-15	MOTT DAVID MDirector	Grant	49,237	—	—
2023-06-15	Lundberg Jan MDirector	Grant	49,237	—	—
2023-06-15	Rodgers Richard JDirector	Grant	18,494	—	—
2023-06-15	MOTT DAVID MDirector	Grant	25,510	—	—
2023-05-23	RAAB MICHAELPresident & CEO	Sell	11,357	$3.65	$41K
2023-05-23	GRAMMER ELIZABETH ASee Remarks	Sell	2,384	$3.65	$9K
2023-05-23	Blanks RobertSee Remarks	Sell	2,835	$3.65	$10K
2023-05-23	Williams Laura AChief Patient Officer	Sell	2,583	$3.65	$9K
2023-05-23	Rodriguez SusanChief Commercial Officer	Sell	4,711	$3.65	$17K
2023-05-23	Renz Justin AChief Financial Officer	Sell	2,873	$3.65	$10K
2023-05-23	Felsch Robert OraSee Remarks	Sell	1,046	$3.65	$4K
2023-05-23	Rosenbaum David P.Chief Development Officer	Sell	2,835	$3.65	$10K
2023-05-23	Rosenbaum David P.Chief Development Officer	Sell	934	$3.65	$3K
2023-03-29	Rosenbaum David P.Chief Development Officer	Sell	3,000	$4.63	$14K
2023-02-21	Rosenbaum David P.Chief Development Officer	Sell	1,114	$3.00	$3K
2023-02-21	Felsch Robert OraSee Remarks	Sell	3,214	$3.00	$10K
2023-02-21	GRAMMER ELIZABETH ASee Remarks	Sell	2,914	$3.00	$9K
2023-02-21	RAAB MICHAELPresident & CEO	Sell	13,449	$3.00	$40K
2023-02-21	Rosenbaum David P.Chief Development Officer	Sell	3,394	$3.00	$10K
2023-02-21	Renz Justin AChief Financial Officer	Sell	3,439	$3.00	$10K
2023-02-21	Rodriguez SusanChief Commercial Officer	Sell	5,586	$3.00	$17K
2023-02-21	Blanks RobertSee Remarks	Sell	3,394	$3.00	$10K
2023-02-21	Williams Laura AChief Patient Officer	Sell	3,187	$3.00	$10K

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