PDUFAoutcome: unknownconf 0.98

imetelstat — PDUFA

$GERN · GERON CORP · transfusion-dependent anemia in adult patients with low- to intermediate-1 risk myelodysplastic syndromes who have failed to respond, or have lost response to, or are ineligible for erythropoiesis-stimulating agents

Event date

June 16, 2024

720 days ago

Sponsor runway

3 mo

$68.9M liquid

Evidence

“its New Drug Application ("NDA") for the use of imetelstat for the treatment of transfusion-dependent anemia in adult patients with low-to-intermediate-1 risk myelodysplastic syndromes who have failed to respond or have lost response to or are ineligible for erythropoiesis-stimulating agents, was accepted by the United States Food and Drug Administration ("FDA") for review and assigned a Prescription Drug User Fee Act ("PDUFA") action date of June 16, 2024.”

Source: 8-K filed 2024-01-30View on EDGAR ↗0000950170-24-008536

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 · 5 sells

Grant

2024-09-09

Ziegler James

EVP, Chief Commercial Officer

1,600,000 @ ——

Sell

2024-07-08

GRETHLEIN ANDREW J

EVP, Chief Operating Officer

674,348 @ $4.56$3.07M

Exercise

2024-07-08

GRETHLEIN ANDREW J

EVP, Chief Operating Officer

674,348 @ $1.72$1.16M

Exercise

2024-07-08

GRETHLEIN ANDREW J

EVP, Chief Operating Officer

452,804 @ ——

Exercise

2024-07-08

GRETHLEIN ANDREW J

EVP, Chief Operating Officer

221,544 @ ——

Grant

2024-06-28

Spiegel Robert J.

Director

1,916 @ ——

Exercise

2024-06-10

Kapur Anil

EVP, Corp Strategy & CCO

421,875 @ $1.06$447K

Sell

2024-06-10

Kapur Anil

EVP, Corp Strategy & CCO

421,875 @ $4.64$1.96M

Exercise

2024-06-10

Feller Faye

EVP, Chief Medical Officer

112,500 @ $1.06$119K

Exercise

2024-06-10

Feller Faye

EVP, Chief Medical Officer

20,000 @ $1.06$21K

Exercise

2024-06-10

Feller Faye

EVP, Chief Medical Officer

155,400 @ $1.29$201K

Sell

2024-06-10

Feller Faye

EVP, Chief Medical Officer

287,900 @ $4.63$1.33M

Grant

2024-06-06

SCARLETT JOHN A

Chairman, President and CEO

1,000,000 @ ——

Grant

2024-06-06

Feller Faye

EVP, Chief Medical Officer

50,000 @ ——

Grant

2024-06-06

Samuels Scott Alan

EVP, Chief Legal Officer

250,000 @ ——

Grant

2024-06-06

ROBERTSON MICHELLE

EVP, CHIEF FINANCIAL OFFICER

250,000 @ ——

Grant

2024-06-06

GRETHLEIN ANDREW J

EVP, Chief Operating Officer

452,804 @ ——

Grant

2024-06-06

Kapur Anil

EVP, Corp Strategy & CCO

250,000 @ ——

Grant

2024-06-06

Feller Faye

EVP, Chief Medical Officer

200,000 @ ——

Exercise

2024-06-04

SCARLETT JOHN A

Chairman, President and CEO

600,000 @ $2.54$1.52M

Sell

2024-06-04

SCARLETT JOHN A

Chairman, President and CEO

600,000 @ $4.00$2.40M

Sell10b5-1

2024-05-15

LAWLIS V BRYAN

Director

35,000 @ $3.75$131K

Exercise10b5-1

2024-05-15

LAWLIS V BRYAN

Director

35,000 @ $1.94$68K

Grant

2024-05-09

O'Farrell Elizabeth G.

Director

180,000 @ ——

Grant

2024-05-09

McDonald John F

Director

180,000 @ ——

Grant

2024-05-09

Spiegel Robert J.

Director

180,000 @ ——

Grant

2024-05-09

Bir Dawn Carter

Interim President and CEO

180,000 @ ——

Grant

2024-05-09

LAWLIS V BRYAN

Director

180,000 @ ——

Grant

2024-05-09

Molineaux Susan

Director

180,000 @ ——

Grant

2024-05-09

Aggarwal Gaurav

Director

180,000 @ ——

Grant

2024-03-29

Spiegel Robert J.

Director

2,462 @ ——

Date	Insider	Action	Shares	Price	Value
2024-09-09	Ziegler JamesEVP, Chief Commercial Officer	Grant	1,600,000	—	—
2024-07-08	GRETHLEIN ANDREW JEVP, Chief Operating Officer	Sell	674,348	$4.56	$3.07M
2024-07-08	GRETHLEIN ANDREW JEVP, Chief Operating Officer	Exercise	674,348	$1.72	$1.16M
2024-07-08	GRETHLEIN ANDREW JEVP, Chief Operating Officer	Exercise	452,804	—	—
2024-07-08	GRETHLEIN ANDREW JEVP, Chief Operating Officer	Exercise	221,544	—	—
2024-06-28	Spiegel Robert J.Director	Grant	1,916	—	—
2024-06-10	Kapur AnilEVP, Corp Strategy & CCO	Exercise	421,875	$1.06	$447K
2024-06-10	Kapur AnilEVP, Corp Strategy & CCO	Sell	421,875	$4.64	$1.96M
2024-06-10	Feller FayeEVP, Chief Medical Officer	Exercise	112,500	$1.06	$119K
2024-06-10	Feller FayeEVP, Chief Medical Officer	Exercise	20,000	$1.06	$21K
2024-06-10	Feller FayeEVP, Chief Medical Officer	Exercise	155,400	$1.29	$201K
2024-06-10	Feller FayeEVP, Chief Medical Officer	Sell	287,900	$4.63	$1.33M
2024-06-06	SCARLETT JOHN AChairman, President and CEO	Grant	1,000,000	—	—
2024-06-06	Feller FayeEVP, Chief Medical Officer	Grant	50,000	—	—
2024-06-06	Samuels Scott AlanEVP, Chief Legal Officer	Grant	250,000	—	—
2024-06-06	ROBERTSON MICHELLEEVP, CHIEF FINANCIAL OFFICER	Grant	250,000	—	—
2024-06-06	GRETHLEIN ANDREW JEVP, Chief Operating Officer	Grant	452,804	—	—
2024-06-06	Kapur AnilEVP, Corp Strategy & CCO	Grant	250,000	—	—
2024-06-06	Feller FayeEVP, Chief Medical Officer	Grant	200,000	—	—
2024-06-04	SCARLETT JOHN AChairman, President and CEO	Exercise	600,000	$2.54	$1.52M
2024-06-04	SCARLETT JOHN AChairman, President and CEO	Sell	600,000	$4.00	$2.40M
2024-05-15	LAWLIS V BRYANDirector	Sell10b5-1	35,000	$3.75	$131K
2024-05-15	LAWLIS V BRYANDirector	Exercise10b5-1	35,000	$1.94	$68K
2024-05-09	O'Farrell Elizabeth G.Director	Grant	180,000	—	—
2024-05-09	McDonald John FDirector	Grant	180,000	—	—
2024-05-09	Spiegel Robert J.Director	Grant	180,000	—	—
2024-05-09	Bir Dawn CarterInterim President and CEO	Grant	180,000	—	—
2024-05-09	LAWLIS V BRYANDirector	Grant	180,000	—	—
2024-05-09	Molineaux SusanDirector	Grant	180,000	—	—
2024-05-09	Aggarwal GauravDirector	Grant	180,000	—	—
2024-03-29	Spiegel Robert J.Director	Grant	2,462	—	—

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