FDA approvalconf 0.98

lybalvi — FDA approval

$ALKS · Alkermes plc.

Event date

June 1, 2021

1831 days ago

Sponsor runway

6 mo

$351.6M liquid

Evidence

“On June 1, 2021, Alkermes plc issued a press release announcing that the U.S. Food and Drug Administration has approved LYBALVI TM (olanzapine and samidorphan) for the treatment of adults with schizophrenia and for the treatment of adults with bipolar I disorder, as a maintenance monotherapy or for the acute treatment of manic or mixed episodes, as monotherapy or an adjunct to lithium or valproate.”

Source: 8-K filed 2021-06-01View on EDGAR ↗0001564590-21-030940

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

100% hit rate (10/10)

Ticker	Drug	Date	Outcome
$INCY	zynyz	2026-05-18	success
$INCY	jakafi xr	2026-05-01	success
$AXSM	auvelity	2026-04-30	success
$INCY	zynyz	2026-03-30	success
$BIIB	spinraza	2026-03-27	success
$CORT	lifyorli	2026-03-25	success
$RYTM	imcivree	2026-03-19	success
$ASND	yuviwel	2026-02-27	success
$BMRN	palynziq	2026-02-27	success
$ETON	desmoda	2026-02-25	success

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

Date	Insider	Action	Shares	Price	Value
2021-08-23	Alva Emily PetersonDirector	Buy	1,650.165	$30.22	$50K
2021-08-19	Brown Iain MichaelSVP, Chief Financial Officer	Sell	40,000	$29.99	$1.20M
2021-08-19	Brown Iain MichaelSVP, Chief Financial Officer	Exercise	40,000	$16.55	$662K
2021-08-02	MCKEON BRIAN PDirector	Buy	10,000	$26.43	$264K
2021-07-29	Gaffin David JosephEVP, CLO, Alkermes, Inc.	Exercise	14,000	$16.55	$232K
2021-07-29	Gaffin David JosephEVP, CLO, Alkermes, Inc.	Sell	14,000	$26.00	$364K
2021-07-01	ANSTICE DAVID WDirector	Sell	20,000	$24.58	$492K
2021-07-01	ANSTICE DAVID WDirector	Exercise	20,000	$14.60	$292K
2021-06-14	snyderman nancy lynn MDDirector	Grant	15,677	—	—
2021-06-14	Alva Emily PetersonDirector	Grant	7,585	—	—
2021-06-14	Cooke ShaneDirector	Grant	15,677	—	—
2021-06-14	Cooke ShaneDirector	Grant	7,585	—	—
2021-06-14	Alva Emily PetersonDirector	Grant	15,677	—	—
2021-06-14	Daglio David Angelo Jr.Director	Grant	15,677	—	—
2021-06-14	Daglio David Angelo Jr.Director	Grant	7,585	—	—
2021-06-14	Wilson Frank AndersDirector	Grant	15,677	—	—
2021-06-14	Wilson Frank AndersDirector	Grant	7,585	—	—
2021-06-14	ANSTICE DAVID WDirector	Grant	15,677	—	—
2021-06-14	ANSTICE DAVID WDirector	Grant	7,585	—	—
2021-06-14	MCKEON BRIAN PDirector	Grant	15,677	—	—
2021-06-14	MCKEON BRIAN PDirector	Grant	7,585	—	—
2021-06-14	GAYNOR RICHARDDirector	Grant	15,677	—	—
2021-06-14	GAYNOR RICHARDDirector	Grant	7,585	—	—
2021-06-14	Wysenski NancyDirector	Grant	7,585	—	—
2021-06-14	Wysenski NancyDirector	Grant	15,677	—	—
2021-06-14	DIXON WENDY LDirector	Grant	15,677	—	—
2021-06-14	DIXON WENDY LDirector	Grant	7,585	—	—
2021-06-14	snyderman nancy lynn MDDirector	Grant	7,585	—	—
2021-06-10	DIXON WENDY LDirector	Sell	25,000	$25.00	$625K
2021-06-10	DIXON WENDY LDirector	Exercise	25,000	$18.21	$455K
2021-06-10	Gaffin David JosephEVP, CLO, Alkermes, Inc.	Exercise	13,500	$16.55	$223K
2021-06-10	Gaffin David JosephEVP, CLO, Alkermes, Inc.	Sell	13,500	$25.00	$338K
2021-06-09	Alva Emily PetersonDirector	Grant	532	—	—
2021-06-09	Alva Emily PetersonDirector	Grant	1,115	—	—
2021-06-09	Alva Emily PetersonDirector	Grant	11,387	—	—
2021-06-09	Alva Emily PetersonDirector	Grant	22,759	—	—
2021-06-09	Hopkinson Craig C.EVP R&D, Chief Medical Officer	Sell	882	$24.60	$22K
2021-06-07	Gaffin David JosephEVP, CLO, Alkermes, Inc.	Exercise	13,500	$16.55	$223K
2021-06-07	ANSTICE DAVID WDirector	Exercise	5,000	$14.60	$73K
2021-06-07	Hopkinson Craig C.EVP R&D, Chief Medical Officer	Tax	368	$23.50	$9K
2021-06-07	Gaffin David JosephEVP, CLO, Alkermes, Inc.	Sell	13,500	$24.00	$324K
2021-06-07	ANSTICE DAVID WDirector	Sell	5,000	$24.00	$120K
2021-06-07	Hopkinson Craig C.EVP R&D, Chief Medical Officer	Exercise	1,250	—	—
2021-06-05	Nichols Christian ToddSVP, Chief Commercial Officer	Exercise	3,500	—	—
2021-06-05	Nichols Christian ToddSVP, Chief Commercial Officer	Tax	1,029	$23.08	$24K

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