PDUFAoutcome: successconf 0.99

defencath — PDUFA

$CRMD · CorMedix Inc.

Event date

November 15, 2023

934 days ago

Sponsor runway

cash-flow +

$178.1M liquid

Evidence

“the FDA considers the resubmission as a complete Class 2 response with a six-month review and has assigned a Prescription Drug User Fee Act target action date of November 15, 2023”

Source: 8-K filed 2023-06-21View on EDGAR ↗0001213900-23-050240

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

7 insiders · 4 buys · 0 sells

Grant

2024-01-12

David Matthew T

Chief Financial Officer

100,000 @ ——

Tax

2024-01-12

Hurlburt Elizabeth

Chief Operating Officer

4,603 @ $3.47$16K

Grant

2024-01-12

Hurlburt Elizabeth

Chief Operating Officer

100,000 @ ——

Grant

2024-01-12

Todisco Joseph

Chief Executive Officer

266,667 @ ——

Grant

2024-01-12

Mistry Erin

EVP, Chief Commercial Officer

50,000 @ ——

Tax

2024-01-12

Mistry Erin

EVP, Chief Commercial Officer

4,389 @ $3.47$15K

Grant

2024-01-12

Mistry Erin

EVP, Chief Commercial Officer

100,000 @ ——

Grant

2024-01-12

David Matthew T

Chief Financial Officer

50,000 @ ——

Tax

2024-01-12

David Matthew T

Chief Financial Officer

5,216 @ $3.47$18K

Grant

2024-01-12

Hurlburt Elizabeth

Chief Operating Officer

50,000 @ ——

Grant

2024-01-12

Todisco Joseph

Chief Executive Officer

133,333 @ ——

Tax

2024-01-12

Todisco Joseph

Chief Executive Officer

13,781 @ $3.47$48K

Buy

2023-12-15

DUNTON ALAN W

Director

3,000 @ $3.30$10K

Buy

2023-12-14

DUNTON ALAN W

Director

3,000 @ $3.45$10K

Grant

2023-12-12

Zelnick Kaufman Beth

Chief Legal Officer

200,000 @ ——

Grant

2023-12-12

Zelnick Kaufman Beth

Chief Legal Officer

50,000 @ ——

Buy

2023-11-17

Mistry Erin

EVP, Chief Commercial Officer

1,000 @ $4.00$4K

Exercise

2023-11-16

Lefkowitz Steven W

Director

15,000 @ $2.25$34K

Buy

2023-09-08

Todisco Joseph

Chief Executive Officer

10,000 @ $3.71$37K

Date	Insider	Action	Shares	Price	Value
2024-01-12	David Matthew TChief Financial Officer	Grant	100,000	—	—
2024-01-12	Hurlburt ElizabethChief Operating Officer	Tax	4,603	$3.47	$16K
2024-01-12	Hurlburt ElizabethChief Operating Officer	Grant	100,000	—	—
2024-01-12	Todisco JosephChief Executive Officer	Grant	266,667	—	—
2024-01-12	Mistry ErinEVP, Chief Commercial Officer	Grant	50,000	—	—
2024-01-12	Mistry ErinEVP, Chief Commercial Officer	Tax	4,389	$3.47	$15K
2024-01-12	Mistry ErinEVP, Chief Commercial Officer	Grant	100,000	—	—
2024-01-12	David Matthew TChief Financial Officer	Grant	50,000	—	—
2024-01-12	David Matthew TChief Financial Officer	Tax	5,216	$3.47	$18K
2024-01-12	Hurlburt ElizabethChief Operating Officer	Grant	50,000	—	—
2024-01-12	Todisco JosephChief Executive Officer	Grant	133,333	—	—
2024-01-12	Todisco JosephChief Executive Officer	Tax	13,781	$3.47	$48K
2023-12-15	DUNTON ALAN WDirector	Buy	3,000	$3.30	$10K
2023-12-14	DUNTON ALAN WDirector	Buy	3,000	$3.45	$10K
2023-12-12	Zelnick Kaufman BethChief Legal Officer	Grant	200,000	—	—
2023-12-12	Zelnick Kaufman BethChief Legal Officer	Grant	50,000	—	—
2023-11-17	Mistry ErinEVP, Chief Commercial Officer	Buy	1,000	$4.00	$4K
2023-11-16	Lefkowitz Steven WDirector	Exercise	15,000	$2.25	$34K
2023-09-08	Todisco JosephChief Executive Officer	Buy	10,000	$3.71	$37K

← All catalysts for $CRMD