Yeji
NDA/BLA filedoutcome: unknownconf 0.99

imetelstat — NDA/BLA filed

$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
August 21, 2023
1020 days ago
Sponsor runway
3 mo
$68.9M liquid

Evidence

“On August 21, 2023, Geron Corporation announced that its New Drug Application ("NDA") for the use of imetelstat for the treatment of transfusion-dependent anemia in patients with lower risk myelodysplastic syndromes has been accepted for filing by the U.S. Food and Drug Administration ("FDA").”
Source: 8-K filed 2023-08-22View on EDGAR ↗0000950170-23-043949

Comparable historical nda/bla fileds· last 5 years · same event type

TickerDrugDateOutcome
$AXSM—2025-12-31unknown
$RCKTkresladi2025-10-14unknown
$ALDXreproxalap2025-07-17unknown
$ETONet-6002025-07-08unknown
$BCRXorladeyo (berotralstat)2025-05-14unknown
$CORTrelacorilant2025-03-03unknown
$ALDXreproxalap2024-11-01unknown
$AXSMaxs-072024-09-04unknown
$RCKTkresladi2023-10-02unknown
$CRMDdefencath2023-06-21unknown

Recent insider activity· ±90 days

13 insiders · 2 buys · 0 sells
Grant
2023-09-29
Spiegel Robert J.
Director
3,390 @ ——
Grant
2023-09-29
Molineaux Susan
Director
6,191 @ ——
Grant
2023-09-25
ROBERTSON MICHELLE
EVP, CHIEF FINANCIAL OFFICER
1,350,000 @ ——
Buy
2023-08-24
O'Farrell Elizabeth G.
Director
6,579 @ $2.28$15K
Buy
2023-08-24
O'Farrell Elizabeth G.
Director
6,607 @ $2.28$15K
Grant
2023-08-15
GRETHLEIN ANDREW J
EVP, Chief Operating Officer
221,544 @ ——
Grant
2023-08-15
Feller Faye
EVP, Chief Medical Officer
20,000 @ ——
Grant
2023-08-15
Bloom Olivia Kyusuk
EVP, Chief Financial Officer
250,000 @ ——
Grant
2023-08-15
SCARLETT JOHN A
Chairman, President and CEO
500,000 @ ——
Grant
2023-08-15
Feller Faye
EVP, Chief Medical Officer
180,000 @ ——
Grant
2023-08-01
Samuels Scott Alan
EVP, Chief Legal Officer
1,350,000 @ ——
Grant
2023-06-30
Kapur Anil
EVP, Corp Strategy & CCO
7,567 @ $2.04$15K
Grant
2023-06-30
Molineaux Susan
Director
4,088 @ ——
Grant
2023-06-30
Spiegel Robert J.
Director
2,239 @ ——
Grant
2023-05-31
O'Farrell Elizabeth G.
Director
125,000 @ ——
Grant
2023-05-31
Molineaux Susan
Director
125,000 @ ——
Grant
2023-05-31
LAWLIS V BRYAN
Director
125,000 @ ——
Grant
2023-05-31
Spiegel Robert J.
Director
125,000 @ ——
Grant
2023-05-31
Bir Dawn Carter
Interim President and CEO
125,000 @ ——
Grant
2023-05-31
McDonald John F
Director
125,000 @ ——
← All catalysts for $GERN