Yeji
PDUFAoutcome: unknownconf 0.99

aficamten — PDUFA

$CYTK · CYTOKINETICS INC · obstructive hypertrophic cardiomyopathy (oHCM)
Event date
December 26, 2025
162 days ago
Sponsor runway
3 mo
$129.8M liquid

Evidence

The Prescription Drug User Fee Act ("PDUFA") target action date for the NDA for aficamten remains December 26, 2025.
Source: 8-K filed 2025-09-16View on EDGAR ↗0001193125-25-204991

Comparable historical pdufas· last 5 years · same event type

60% hit rate (3/5)
TickerDrugDateOutcome
$RCKTkresladi2026-03-28success
$RYTMimcivree2026-03-20success
$ALDXreproxalap2025-12-16unknown
$BCRXorladeyo2025-12-12success
$OMERnarsoplimab2025-09-25unknown
$BCRXorladeyo (berotralstat)2025-09-12unknown
$ETONet-4002025-05-28unknown
$ALDXreproxalap2025-04-02failure
$IONSolezarsen2024-12-19unknown
$RCKTkresladi2024-06-30failure

Recent insider activity· ±90 days

12 insiders · 0 buys · 42 sells
Sell10b5-1
2026-03-18
Callos Andrew
EVP, Chief Commercial Officer
1,930 @ $62.07$120K
Sell
2026-03-17
Callos Andrew
EVP, Chief Commercial Officer
2,916 @ $62.15$181K
Sell
2026-03-17
Malik Fady Ibraham
EVP Research & Development
7,636 @ $62.15$475K
Sell
2026-03-17
Malik Fady Ibraham
EVP Research & Development
4,397 @ $62.15$273K
Sell
2026-03-17
Callos Andrew
EVP, Chief Commercial Officer
5,626 @ $62.15$350K
Sell
2026-03-17
Blum Robert I
President & CEO
12,673 @ $62.15$788K
Sell
2026-03-17
Blum Robert I
President & CEO
23,928 @ $62.15$1.49M
Sell
2026-03-17
Lee Sung
EVP, Chief Financial Officer
4,935 @ $62.15$307K
Sell10b5-1
2026-03-16
Callos Andrew
EVP, Chief Commercial Officer
1,709 @ $61.03$104K
Grant
2026-03-15
Blum Robert I
President & CEO
1,665 @
Grant
2026-03-15
Blum Robert I
President & CEO
111,864 @
Grant
2026-03-15
Callos Andrew
EVP, Chief Commercial Officer
20,646 @
Grant
2026-03-15
Callos Andrew
EVP, Chief Commercial Officer
13,320 @
Grant
2026-03-15
Callos Andrew
EVP, Chief Commercial Officer
1,665 @
Grant
2026-03-15
Callos Andrew
EVP, Chief Commercial Officer
29,480 @
Grant
2026-03-15
Hessekiel Jeffrey
Chief Legal & Admin Officer
20,646 @
Grant
2026-03-15
Hessekiel Jeffrey
Chief Legal & Admin Officer
8,325 @
Grant
2026-03-15
Hessekiel Jeffrey
Chief Legal & Admin Officer
22,820 @
Grant
2026-03-15
Lee Sung
EVP, Chief Financial Officer
20,646 @
Grant
2026-03-15
Lee Sung
EVP, Chief Financial Officer
1,665 @
Grant
2026-03-15
Lee Sung
EVP, Chief Financial Officer
29,480 @
Grant
2026-03-15
Malik Fady Ibraham
EVP Research & Development
27,306 @
Grant
2026-03-15
Malik Fady Ibraham
EVP Research & Development
1,665 @
Grant
2026-03-15
Malik Fady Ibraham
EVP Research & Development
39,527 @
Grant
2026-03-15
Blum Robert I
President & CEO
75,258 @
Sell
2026-03-09
Callos Andrew
EVP, Chief Commercial Officer
2,582 @ $60.72$157K
Sell
2026-03-09
Malik Fady Ibraham
EVP Research & Development
2,907 @ $60.72$177K
Sell
2026-03-09
Blum Robert I
President & CEO
7,931 @ $60.72$482K
Exercise10b5-1
2026-03-05
Callos Andrew
EVP, Chief Commercial Officer
11,000 @ $39.13$430K
Sell10b5-1
2026-03-05
Callos Andrew
EVP, Chief Commercial Officer
15,000 @ $61.87$928K
Sell10b5-1
2026-03-05
Callos Andrew
EVP, Chief Commercial Officer
11,000 @ $61.88$681K
Exercise10b5-1
2026-03-05
Callos Andrew
EVP, Chief Commercial Officer
15,000 @ $23.26$349K
Sell10b5-1
2026-03-02
PARSHALL B LYNNE
Director
5,000 @ $61.21$306K
Exercise10b5-1
2026-03-02
Callos Andrew
EVP, Chief Commercial Officer
886 @ $37.63$33K
Sell10b5-1
2026-03-02
Callos Andrew
EVP, Chief Commercial Officer
886 @ $61.62$55K
Exercise10b5-1
2026-02-05
Callos Andrew
EVP, Chief Commercial Officer
15,000 @ $23.26$349K
Sell10b5-1
2026-02-05
Callos Andrew
EVP, Chief Commercial Officer
15,000 @ $61.93$929K
Exercise10b5-1
2026-02-02
Callos Andrew
EVP, Chief Commercial Officer
886 @ $37.63$33K
Sell10b5-1
2026-02-02
Callos Andrew
EVP, Chief Commercial Officer
886 @ $62.10$55K
Grant
2026-01-15
Daly James M
Director
197 @ $63.44$12K
Grant
2026-01-15
Wysenski Nancy
Director
98 @ $63.44$6K
Grant
2026-01-15
WIERENGA WENDELL
Director
98 @ $63.44$6K
Grant
2026-01-15
Kaye Edward M. MD
Director
197 @ $63.44$12K
Grant
2026-01-15
HENDERSON JOHN T
Director
334 @ $63.44$21K
Grant
2026-01-15
Harrington Robert Arthur
Director
197 @ $63.44$12K
Exercise10b5-1
2026-01-05
Callos Andrew
EVP, Chief Commercial Officer
15,000 @ $23.26$349K
Sell10b5-1
2026-01-05
Callos Andrew
EVP, Chief Commercial Officer
15,000 @ $60.28$904K
Sell10b5-1
2026-01-02
Callos Andrew
EVP, Chief Commercial Officer
913 @ $62.09$57K
Exercise10b5-1
2026-01-02
Callos Andrew
EVP, Chief Commercial Officer
885 @ $37.63$33K
Sell10b5-1
2026-01-02
Callos Andrew
EVP, Chief Commercial Officer
885 @ $63.16$56K
+ 61 more