Yeji
PDUFAoutcome: unknownconf 0.99

omecamtiv mecarbil — PDUFA

$CYTK · CYTOKINETICS INC · heart failure with reduced ejection fraction (HFrEF)
Event date
February 28, 2023
1194 days ago
Sponsor runway
3 mo
$129.8M liquid

Evidence

The New Drug Application (NDA) for omecamtiv mecarbil is currently under review by the FDA, with a Prescription Drug User Fee Act (PDUFA) target action date of February 28, 2023.
Source: 8-K filed 2022-12-14View on EDGAR ↗0000950170-22-026478

Comparable historical pdufas· last 5 years · same indication

TickerDrugDateOutcome
$CYTKomecamtiv mecarbil2022-11-30unknown

Recent insider activity· ±90 days

14 insiders · 0 buys · 23 sells
Exercise10b5-1
2023-05-16
Blum Robert I
President & CEO
12,500 @ $9.65$121K
Sell10b5-1
2023-05-16
Blum Robert I
President & CEO
12,500 @ $37.41$468K
Sell10b5-1
2023-05-15
HENDERSON JOHN T
Director
4,166 @ $37.77$157K
Exercise10b5-1
2023-05-15
HENDERSON JOHN T
Director
4,166 @ $6.78$28K
Sell10b5-1
2023-05-11
Malik Fady Ibraham
EVP Research & Development
1,787 @ $39.50$71K
Grant
2023-05-10
Wysenski Nancy
Director
5,000 @
Grant
2023-05-10
Wysenski Nancy
Director
10,000 @
Grant
2023-05-10
PARSHALL B LYNNE
Director
5,000 @
Grant
2023-05-10
PARSHALL B LYNNE
Director
10,000 @
Grant
2023-05-10
Kaye Edward M. MD
Director
10,000 @
Grant
2023-05-10
HENDERSON JOHN T
Director
5,000 @
Grant
2023-05-10
HENDERSON JOHN T
Director
10,000 @
Grant
2023-05-10
Harrington Robert Arthur
Director
5,000 @
Grant
2023-05-10
Harrington Robert Arthur
Director
10,000 @
Grant
2023-05-10
COSTA SANTO J
Director
5,000 @
Grant
2023-05-10
COSTA SANTO J
Director
10,000 @
Grant
2023-05-10
Bhanji Muna
Director
5,000 @
Grant
2023-05-10
Bhanji Muna
Director
10,000 @
Grant
2023-05-10
Kaye Edward M. MD
Director
5,000 @
Grant
2023-05-10
SMITH SANDFORD D
Director
5,000 @
Grant
2023-05-10
SMITH SANDFORD D
Director
10,000 @
Grant
2023-05-10
WIERENGA WENDALL
Director
5,000 @
Grant
2023-05-10
WIERENGA WENDALL
Director
10,000 @
Sell10b5-1
2023-05-03
Malik Fady Ibraham
EVP Research & Development
7,000 @ $40.00$280K
Exercise10b5-1
2023-05-03
Malik Fady Ibraham
EVP Research & Development
7,000 @ $7.96$56K
Exercise10b5-1
2023-04-28
Blum Robert I
President & CEO
12,500 @ $9.65$121K
Sell10b5-1
2023-04-28
Blum Robert I
President & CEO
12,500 @ $37.68$471K
Exercise10b5-1
2023-04-14
Blum Robert I
President & CEO
12,500 @ $9.65$121K
Sell10b5-1
2023-04-14
Blum Robert I
President & CEO
12,500 @ $35.61$445K
Sell10b5-1
2023-04-13
Malik Fady Ibraham
EVP Research & Development
4,000 @ $34.21$137K
Grant
2023-04-03
Wysenski Nancy
Director
149 @ $37.71$6K
Grant
2023-04-03
SMITH SANDFORD D
Director
298 @ $37.71$11K
Grant
2023-04-03
WIERENGA WENDALL
Director
298 @ $37.71$11K
Grant
2023-04-03
Harrington Robert Arthur
Director
298 @ $37.71$11K
Grant
2023-04-03
HENDERSON JOHN T
Director
530 @ $37.71$20K
Grant
2023-04-03
Kaye Edward M. MD
Director
298 @ $37.71$11K
Sell
2023-03-28
Blum Robert I
President & CEO
12,500 @ $35.05$438K
Exercise
2023-03-28
Blum Robert I
President & CEO
12,500 @ $9.65$121K
Exercise
2023-03-15
Blum Robert I
President & CEO
12,500 @ $9.65$121K
Sell
2023-03-15
Blum Robert I
President & CEO
12,500 @ $37.26$466K
Sell
2023-03-09
Malik Fady Ibraham
EVP Research & Development
4,000 @ $39.10$156K
Exercise
2023-03-06
Blum Robert I
President & CEO
12,500 @ $9.65$121K
Grant
2023-03-06
Wong Robert
VP, Chief Accounting Officer
6,000 @
Grant
2023-03-06
Wong Robert
VP, Chief Accounting Officer
2,464 @
Grant
2023-03-06
Wong Robert
VP, Chief Accounting Officer
9,536 @
Grant
2023-03-06
Malik Fady Ibraham
EVP Research & Development
40,000 @
Grant
2023-03-06
Malik Fady Ibraham
EVP Research & Development
2,555 @
Grant
2023-03-06
Malik Fady Ibraham
EVP Research & Development
77,445 @
Grant
2023-03-06
Jaw Ching
SVP Finance & CFO
30,000 @
Grant
2023-03-06
Jaw Ching
SVP Finance & CFO
2,555 @
+ 48 more