Yeji
FDA approvaloutcome: successconf 1.00

fesoterodine fumarate — FDA approval

$ANIP · ANI PHARMACEUTICALS INC
Event date
January 4, 2023
1249 days ago
Sponsor runway
cash-flow +
$311.2M liquid

Evidence

“openFDA ORIG (UNKNOWN) approval of FESOTERODINE FUMARATE — application ANDA204504”
Source ↗

Comparable historical fda approvals· last 5 years · same event type

100% hit rate (10/10)
TickerDrugDateOutcome
$INCYzynyz2026-05-18success
$INCYjakafi xr2026-05-01success
$AXSMauvelity2026-04-30success
$INCYzynyz2026-03-30success
$BIIBspinraza2026-03-27success
$CORTlifyorli2026-03-25success
$RYTMimcivree2026-03-19success
$ASNDyuviwel2026-02-27success
$BMRNpalynziq2026-02-27success
$ETONdesmoda2026-02-25success

Recent insider activity· ±90 days

10 insiders · 0 buys · 1 sells
Tax
2023-03-28
Marken James G.
SVP OPS & PROD DEV
524 @ $38.62$20K
Tax
2023-03-28
CAREY STEPHEN P.
SVP & CFO
1,420 @ $38.62$55K
Tax
2023-03-23
Marken James G.
SVP OPS & PROD DEV
2,452 @ $37.82$93K
Tax
2023-03-23
CAREY STEPHEN P.
SVP & CFO
4,224 @ $37.82$160K
Tax
2023-03-23
Lalwani Nikhil
PRESIDENT & CEO
17,455 @ $37.82$660K
Tax
2023-03-07
Marken James G.
SVP OPS & PROD DEV
509 @ $44.23$23K
Tax
2023-03-07
CAREY STEPHEN P.
SVP & CFO
2,639 @ $44.23$117K
Tax
2023-03-07
Gutwerg Ori
SVP, GENERICS
586 @ $44.23$26K
Tax
2023-03-07
Gutwerg Ori
SVP, GENERICS
1,756 @ $44.23$78K
Tax
2023-03-07
Lalwani Nikhil
PRESIDENT & CEO
9,397 @ $44.23$416K
Tax
2023-03-07
Lalwani Nikhil
PRESIDENT & CEO
4,265 @ $44.23$189K
Tax
2023-03-07
CAREY STEPHEN P.
SVP & CFO
864 @ $44.23$38K
Tax
2023-03-07
Mutz Christopher
HEAD OF RARE DISEASE
1,426 @ $44.23$63K
Tax
2023-03-07
Mutz Christopher
HEAD OF RARE DISEASE
476 @ $44.23$21K
Tax
2023-03-07
Marken James G.
SVP OPS & PROD DEV
1,951 @ $44.23$86K
Grant
2023-02-28
Davis Krista
SVP, CHIEF HR OFFICER
8,104 @ ——
Grant
2023-02-28
Cook Meredith
SR. VP, GENERAL COUNSEL & SEC.
8,104 @ ——
Grant
2023-02-28
Marken James G.
SVP OPS & PROD DEV
13,026 @ ——
Grant
2023-02-28
Marken James G.
SVP OPS & PROD DEV
8,684 @ ——
Grant
2023-02-28
Gutwerg Ori
SVP, GENERICS
17,369 @ ——
Grant
2023-02-28
Gutwerg Ori
SVP, GENERICS
11,578 @ ——
Grant
2023-02-28
Gassert Chad
SVP - CORP. DEV. & STRATEGY
17,369 @ ——
Grant
2023-02-28
Gassert Chad
SVP - CORP. DEV. & STRATEGY
11,578 @ ——
Grant
2023-02-28
Shanmugam Muthusamy
HEAD OF R&D, COO-NOVITIUM OPS
17,369 @ ——
Grant
2023-02-28
Shanmugam Muthusamy
HEAD OF R&D, COO-NOVITIUM OPS
11,578 @ ——
Grant
2023-02-28
Mutz Christopher
HEAD OF RARE DISEASE
17,369 @ ——
Grant
2023-02-28
Mutz Christopher
HEAD OF RARE DISEASE
11,578 @ ——
Grant
2023-02-28
Lalwani Nikhil
PRESIDENT & CEO
95,530 @ ——
Grant
2023-02-28
Lalwani Nikhil
PRESIDENT & CEO
63,686 @ ——
Grant
2023-02-28
CAREY STEPHEN P.
SVP & CFO
16,210 @ ——
Grant
2023-02-28
Davis Krista
SVP, CHIEF HR OFFICER
12,158 @ ——
Grant
2023-02-28
Cook Meredith
SR. VP, GENERAL COUNSEL & SEC.
12,158 @ ——
Grant
2023-02-28
CAREY STEPHEN P.
SVP & CFO
24,316 @ ——
Tax
2023-02-15
Mutz Christopher
HEAD OF RARE DISEASE
1,292 @ $45.04$58K
Tax
2023-02-15
Gutwerg Ori
SVP, GENERICS
1,275 @ $45.04$57K
Sell
2022-12-01
MERIDIAN VENTURE PARTNERS II LP
10%+ Owner
200,000 @ $38.50$7.70M
← All catalysts for $ANIP