FDA approvaloutcome: successconf 1.00

baclofen — FDA approval

$ANIP · ANI PHARMACEUTICALS INC

Event date

June 8, 2023

1094 days ago

Sponsor runway

cash-flow +

$311.2M liquid

Evidence

“openFDA ORIG (UNKNOWN) approval of BACLOFEN — application ANDA217252”

Source ↗

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

15 insiders · 0 buys · 25 sells

Sell10b5-1

2023-09-01

Gassert Chad

SVP - CORP. DEV. & STRATEGY

20,000 @ $64.70$1.29M

Sell

2023-08-29

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

25,000 @ $63.37$1.58M

Sell

2023-08-28

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

25,000 @ $63.06$1.58M

Exercise

2023-08-23

Marken James G.

SVP OPS & PROD DEV

1,667 @ $33.00$55K

Sell

2023-08-23

Marken James G.

SVP OPS & PROD DEV

3,932 @ $63.00$248K

Exercise

2023-08-23

Gutwerg Ori

SVP, GENERICS

13,502 @ $31.49$425K

Sell

2023-08-23

Gutwerg Ori

SVP, GENERICS

2,059 @ $62.39$128K

Exercise

2023-08-23

Marken James G.

SVP OPS & PROD DEV

3,750 @ $40.59$152K

Sell

2023-08-23

Gutwerg Ori

SVP, GENERICS

13,502 @ $62.39$842K

Grant

2023-08-21

Leonard Matthew J

Director

7,583 @ ——

Sell

2023-08-16

MERIDIAN VENTURE PARTNERS II LP

10%+ Owner

200,000 @ $58.50$11.70M

Sell10b5-1

2023-08-15

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

22,110 @ $61.60$1.36M

Sell

2023-08-15

Lalwani Nikhil

PRESIDENT & CEO

11,616 @ $61.13$710K

Exercise

2023-08-15

Lalwani Nikhil

PRESIDENT & CEO

11,616 @ $29.00$337K

Sell

2023-08-14

CAREY STEPHEN P.

SVP & CFO

17,639 @ $61.37$1.08M

Sell10b5-1

2023-08-14

Pera Antonio R

Director

3,000 @ $60.37$181K

Sell10b5-1

2023-08-14

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

27,890 @ $61.15$1.71M

Sell

2023-08-11

Lalwani Nikhil

PRESIDENT & CEO

56,666 @ $57.75$3.27M

Sell10b5-1

2023-08-01

Gassert Chad

SVP - CORP. DEV. & STRATEGY

20,000 @ $51.06$1.02M

Sell10b5-1

2023-07-21

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

11,500 @ $52.56$604K

Sell10b5-1

2023-07-20

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

6,000 @ $51.52$309K

Sell10b5-1

2023-07-19

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

5,969 @ $51.48$307K

Tax

2023-07-18

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

1,743 @ $51.89$90K

Sell10b5-1

2023-07-18

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

6,700 @ $51.84$347K

Sell10b5-1

2023-07-17

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

9,831 @ $51.06$502K

Sell10b5-1

2023-07-14

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

10,000 @ $50.43$504K

Sell10b5-1

2023-07-03

Gassert Chad

SVP - CORP. DEV. & STRATEGY

20,000 @ $53.43$1.07M

Sell10b5-1

2023-06-22

Gassert Chad

SVP - CORP. DEV. & STRATEGY

20,000 @ $51.32$1.03M

Sell10b5-1

2023-06-22

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

13,500 @ $51.38$694K

Sell10b5-1

2023-06-21

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

11,843 @ $51.95$615K

Sell10b5-1

2023-06-20

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

14,657 @ $51.93$761K

Grant

2023-05-23

TANNENBAUM RENEE P

Director

6,865 @ ——

Grant

2023-05-23

Thoma Jeanne

Director

6,865 @ ——

Grant

2023-05-23

HAUGHEY THOMAS

Director

6,865 @ ——

Grant

2023-05-23

NASH DAVID

Director

6,865 @ ——

Grant

2023-05-23

Walsh Patrick D

Director

6,865 @ ——

Grant

2023-05-23

Pera Antonio R

Director

6,865 @ ——

Tax

2023-04-10

CAREY STEPHEN P.

SVP & CFO

4,534 @ $38.50$175K

Tax

2023-04-10

Marken James G.

SVP OPS & PROD DEV

2,289 @ $38.50$88K

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

Date	Insider	Action	Shares	Price	Value
2023-09-01	Gassert ChadSVP - CORP. DEV. & STRATEGY	Sell10b5-1	20,000	$64.70	$1.29M
2023-08-29	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell	25,000	$63.37	$1.58M
2023-08-28	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell	25,000	$63.06	$1.58M
2023-08-23	Marken James G.SVP OPS & PROD DEV	Exercise	1,667	$33.00	$55K
2023-08-23	Marken James G.SVP OPS & PROD DEV	Sell	3,932	$63.00	$248K
2023-08-23	Gutwerg OriSVP, GENERICS	Exercise	13,502	$31.49	$425K
2023-08-23	Gutwerg OriSVP, GENERICS	Sell	2,059	$62.39	$128K
2023-08-23	Marken James G.SVP OPS & PROD DEV	Exercise	3,750	$40.59	$152K
2023-08-23	Gutwerg OriSVP, GENERICS	Sell	13,502	$62.39	$842K
2023-08-21	Leonard Matthew JDirector	Grant	7,583	—	—
2023-08-16	MERIDIAN VENTURE PARTNERS II LP10%+ Owner	Sell	200,000	$58.50	$11.70M
2023-08-15	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	22,110	$61.60	$1.36M
2023-08-15	Lalwani NikhilPRESIDENT & CEO	Sell	11,616	$61.13	$710K
2023-08-15	Lalwani NikhilPRESIDENT & CEO	Exercise	11,616	$29.00	$337K
2023-08-14	CAREY STEPHEN P.SVP & CFO	Sell	17,639	$61.37	$1.08M
2023-08-14	Pera Antonio RDirector	Sell10b5-1	3,000	$60.37	$181K
2023-08-14	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	27,890	$61.15	$1.71M
2023-08-11	Lalwani NikhilPRESIDENT & CEO	Sell	56,666	$57.75	$3.27M
2023-08-01	Gassert ChadSVP - CORP. DEV. & STRATEGY	Sell10b5-1	20,000	$51.06	$1.02M
2023-07-21	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	11,500	$52.56	$604K
2023-07-20	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	6,000	$51.52	$309K
2023-07-19	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	5,969	$51.48	$307K
2023-07-18	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Tax	1,743	$51.89	$90K
2023-07-18	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	6,700	$51.84	$347K
2023-07-17	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	9,831	$51.06	$502K
2023-07-14	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	10,000	$50.43	$504K
2023-07-03	Gassert ChadSVP - CORP. DEV. & STRATEGY	Sell10b5-1	20,000	$53.43	$1.07M
2023-06-22	Gassert ChadSVP - CORP. DEV. & STRATEGY	Sell10b5-1	20,000	$51.32	$1.03M
2023-06-22	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	13,500	$51.38	$694K
2023-06-21	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	11,843	$51.95	$615K
2023-06-20	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Sell10b5-1	14,657	$51.93	$761K
2023-05-23	TANNENBAUM RENEE PDirector	Grant	6,865	—	—
2023-05-23	Thoma JeanneDirector	Grant	6,865	—	—
2023-05-23	HAUGHEY THOMASDirector	Grant	6,865	—	—
2023-05-23	NASH DAVIDDirector	Grant	6,865	—	—
2023-05-23	Walsh Patrick DDirector	Grant	6,865	—	—
2023-05-23	Pera Antonio RDirector	Grant	6,865	—	—
2023-04-10	CAREY STEPHEN P.SVP & CFO	Tax	4,534	$38.50	$175K
2023-04-10	Marken James G.SVP OPS & PROD DEV	Tax	2,289	$38.50	$88K
2023-03-28	Marken James G.SVP OPS & PROD DEV	Tax	524	$38.62	$20K
2023-03-28	CAREY STEPHEN P.SVP & CFO	Tax	1,420	$38.62	$55K
2023-03-23	Marken James G.SVP OPS & PROD DEV	Tax	2,452	$37.82	$93K
2023-03-23	CAREY STEPHEN P.SVP & CFO	Tax	4,224	$37.82	$160K
2023-03-23	Lalwani NikhilPRESIDENT & CEO	Tax	17,455	$37.82	$660K

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