Yeji
FDA approvaloutcome: successconf 1.00

lybalvi — FDA approval

$ALKS · Alkermes plc.
Event date
May 28, 2021
1835 days ago
Sponsor runway
6 mo
$351.6M liquid

Evidence

“openFDA ORIG (TYPE 1/4) approval of LYBALVI — application NDA213378”
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

14 insiders · 2 buys · 8 sells
Buy
2021-08-23
Alva Emily Peterson
Director
1,650.165 @ $30.22$50K
Sell
2021-08-19
Brown Iain Michael
SVP, Chief Financial Officer
40,000 @ $29.99$1.20M
Exercise
2021-08-19
Brown Iain Michael
SVP, Chief Financial Officer
40,000 @ $16.55$662K
Buy
2021-08-02
MCKEON BRIAN P
Director
10,000 @ $26.43$264K
Exercise
2021-07-29
Gaffin David Joseph
EVP, CLO, Alkermes, Inc.
14,000 @ $16.55$232K
Sell
2021-07-29
Gaffin David Joseph
EVP, CLO, Alkermes, Inc.
14,000 @ $26.00$364K
Sell
2021-07-01
ANSTICE DAVID W
Director
20,000 @ $24.58$492K
Exercise
2021-07-01
ANSTICE DAVID W
Director
20,000 @ $14.60$292K
Grant
2021-06-14
snyderman nancy lynn MD
Director
15,677 @ ——
Grant
2021-06-14
Alva Emily Peterson
Director
7,585 @ ——
Grant
2021-06-14
Cooke Shane
Director
15,677 @ ——
Grant
2021-06-14
Cooke Shane
Director
7,585 @ ——
Grant
2021-06-14
Alva Emily Peterson
Director
15,677 @ ——
Grant
2021-06-14
Daglio David Angelo Jr.
Director
15,677 @ ——
Grant
2021-06-14
Daglio David Angelo Jr.
Director
7,585 @ ——
Grant
2021-06-14
Wilson Frank Anders
Director
15,677 @ ——
Grant
2021-06-14
Wilson Frank Anders
Director
7,585 @ ——
Grant
2021-06-14
ANSTICE DAVID W
Director
15,677 @ ——
Grant
2021-06-14
ANSTICE DAVID W
Director
7,585 @ ——
Grant
2021-06-14
MCKEON BRIAN P
Director
15,677 @ ——
Grant
2021-06-14
MCKEON BRIAN P
Director
7,585 @ ——
Grant
2021-06-14
GAYNOR RICHARD
Director
15,677 @ ——
Grant
2021-06-14
GAYNOR RICHARD
Director
7,585 @ ——
Grant
2021-06-14
Wysenski Nancy
Director
7,585 @ ——
Grant
2021-06-14
Wysenski Nancy
Director
15,677 @ ——
Grant
2021-06-14
DIXON WENDY L
Director
15,677 @ ——
Grant
2021-06-14
DIXON WENDY L
Director
7,585 @ ——
Grant
2021-06-14
snyderman nancy lynn MD
Director
7,585 @ ——
Sell
2021-06-10
DIXON WENDY L
Director
25,000 @ $25.00$625K
Exercise
2021-06-10
DIXON WENDY L
Director
25,000 @ $18.21$455K
Exercise
2021-06-10
Gaffin David Joseph
EVP, CLO, Alkermes, Inc.
13,500 @ $16.55$223K
Sell
2021-06-10
Gaffin David Joseph
EVP, CLO, Alkermes, Inc.
13,500 @ $25.00$338K
Grant
2021-06-09
Alva Emily Peterson
Director
532 @ ——
Grant
2021-06-09
Alva Emily Peterson
Director
1,115 @ ——
Grant
2021-06-09
Alva Emily Peterson
Director
11,387 @ ——
Grant
2021-06-09
Alva Emily Peterson
Director
22,759 @ ——
Sell
2021-06-09
Hopkinson Craig C.
EVP R&D, Chief Medical Officer
882 @ $24.60$22K
Exercise
2021-06-07
Gaffin David Joseph
EVP, CLO, Alkermes, Inc.
13,500 @ $16.55$223K
Exercise
2021-06-07
ANSTICE DAVID W
Director
5,000 @ $14.60$73K
Tax
2021-06-07
Hopkinson Craig C.
EVP R&D, Chief Medical Officer
368 @ $23.50$9K
Sell
2021-06-07
Gaffin David Joseph
EVP, CLO, Alkermes, Inc.
13,500 @ $24.00$324K
Sell
2021-06-07
ANSTICE DAVID W
Director
5,000 @ $24.00$120K
Exercise
2021-06-07
Hopkinson Craig C.
EVP R&D, Chief Medical Officer
1,250 @ ——
Exercise
2021-06-05
Nichols Christian Todd
SVP, Chief Commercial Officer
3,500 @ ——
Tax
2021-06-05
Nichols Christian Todd
SVP, Chief Commercial Officer
1,029 @ $23.08$24K
← All catalysts for $ALKS