FDA approvaloutcome: successconf 1.00

nitazoxanide — FDA approval

$ANIP · ANI PHARMACEUTICALS INC

Event date

February 3, 2025

488 days ago

Sponsor runway

cash-flow +

$311.2M liquid

Evidence

“openFDA ORIG (UNKNOWN) approval of NITAZOXANIDE — application ANDA214844”

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

9 insiders · 0 buys · 16 sells

Sell10b5-1

2025-04-14

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

400 @ $68.96$28K

Tax

2025-03-23

Lalwani Nikhil

PRESIDENT & CEO

17,455 @ $64.26$1.12M

Tax

2025-03-23

CAREY STEPHEN P.

SVP & CFO

6,210 @ $64.26$399K

Sell10b5-1

2025-03-19

Davis Krista

SVP, CHIEF HR OFFICER

1,866 @ $65.00$121K

Sell10b5-1

2025-03-13

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

400 @ $63.33$25K

Tax

2025-03-07

CAREY STEPHEN P.

SVP & CFO

5,150 @ $60.62$312K

Sell10b5-1

2025-03-07

Davis Krista

SVP, CHIEF HR OFFICER

1,000 @ $60.86$61K

Tax

2025-03-07

Lalwani Nikhil

PRESIDENT & CEO

17,060 @ $60.62$1.03M

Tax

2025-03-07

Gutwerg Ori

SVP, GENERICS

3,314 @ $60.62$201K

Tax

2025-03-07

Mutz Christopher

HEAD OF RARE DISEASE

2,874 @ $60.62$174K

Sell

2025-03-05

Gutwerg Ori

SVP, GENERICS

5,084 @ $60.00$305K

Exercise

2025-03-05

Gutwerg Ori

SVP, GENERICS

300 @ $31.49$9K

Sell

2025-03-05

Gutwerg Ori

SVP, GENERICS

300 @ $60.03$18K

Tax

2025-02-28

Mutz Christopher

HEAD OF RARE DISEASE

1,275 @ $61.89$79K

Tax

2025-02-28

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

1,099 @ $61.89$68K

Tax

2025-02-28

Rowland Thomas Andrew

SVP, HEAD - ESTABLISHED BRANDS

627 @ $61.89$39K

Tax

2025-02-28

Gutwerg Ori

SVP, GENERICS

1,570 @ $61.89$97K

Tax

2025-02-28

Lalwani Nikhil

PRESIDENT & CEO

12,216 @ $61.89$756K

Tax

2025-02-28

CAREY STEPHEN P.

SVP & CFO

1,861 @ $61.89$115K

Tax

2025-02-28

Davis Krista

SVP, CHIEF HR OFFICER

1,099 @ $61.89$68K

Sell10b5-1

2025-02-21

Davis Krista

SVP, CHIEF HR OFFICER

1,000 @ $60.20$60K

Tax

2025-02-15

Mutz Christopher

HEAD OF RARE DISEASE

1,184 @ $58.92$70K

Tax

2025-02-15

Gutwerg Ori

SVP, GENERICS

1,167 @ $58.92$69K

Tax

2025-02-14

Davis Krista

SVP, CHIEF HR OFFICER

1,196 @ $58.92$70K

Tax

2025-02-14

Gutwerg Ori

SVP, GENERICS

1,426 @ $58.92$84K

Tax

2025-02-14

Rowland Thomas Andrew

SVP, HEAD - ESTABLISHED BRANDS

582 @ $58.92$34K

Tax

2025-02-14

Mutz Christopher

HEAD OF RARE DISEASE

1,473 @ $58.92$87K

Tax

2025-02-14

Lalwani Nikhil

PRESIDENT & CEO

7,799 @ $58.92$460K

Tax

2025-02-14

CAREY STEPHEN P.

SVP & CFO

1,730 @ $58.92$102K

Tax10b5-1

2025-02-14

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

1,434 @ $58.92$84K

Sell10b5-1

2025-02-13

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

400 @ $59.54$24K

Grant

2025-02-12

Mutz Christopher

HEAD OF RARE DISEASE

24,808 @ ——

Grant

2025-02-12

Mutz Christopher

HEAD OF RARE DISEASE

16,538 @ ——

Grant

2025-02-12

Gassert Chad

SVP - CORP. DEV. & STRATEGY

14,362 @ ——

Grant10b5-1

2025-02-12

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

16,974 @ ——

Grant

2025-02-12

Davis Krista

SVP, CHIEF HR OFFICER

8,704 @ ——

Grant

2025-02-12

Rowland Thomas Andrew

SVP, HEAD - ESTABLISHED BRANDS

7,834 @ ——

Grant

2025-02-12

CAREY STEPHEN P.

SVP & CFO

24,808 @ ——

Grant

2025-02-12

CAREY STEPHEN P.

SVP & CFO

16,538 @ ——

Grant

2025-02-12

Gutwerg Ori

SVP, GENERICS

15,668 @ ——

Grant

2025-02-12

Gassert Chad

SVP - CORP. DEV. & STRATEGY

9,574 @ ——

Grant

2025-02-12

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

14,362 @ ——

Grant

2025-02-12

Shanmugam Muthusamy

HEAD OF R&D, COO-NOVITIUM OPS

9,574 @ ——

Grant

2025-02-12

Gutwerg Ori

SVP, GENERICS

10,444 @ ——

Grant

2025-02-12

Davis Krista

SVP, CHIEF HR OFFICER

13,057 @ ——

Grant

2025-02-12

Rowland Thomas Andrew

SVP, HEAD - ESTABLISHED BRANDS

5,222 @ ——

Grant

2025-02-12

Lalwani Nikhil

PRESIDENT & CEO

91,399 @ ——

Grant

2025-02-12

Lalwani Nikhil

PRESIDENT & CEO

60,932 @ ——

Grant10b5-1

2025-02-12

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

11,316 @ ——

Sell10b5-1

2025-01-13

Cook Meredith

SR. VP, GENERAL COUNSEL & SEC.

400 @ $53.92$22K

+ 9 more

Date	Insider	Action	Shares	Price	Value
2025-04-14	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Sell10b5-1	400	$68.96	$28K
2025-03-23	Lalwani NikhilPRESIDENT & CEO	Tax	17,455	$64.26	$1.12M
2025-03-23	CAREY STEPHEN P.SVP & CFO	Tax	6,210	$64.26	$399K
2025-03-19	Davis KristaSVP, CHIEF HR OFFICER	Sell10b5-1	1,866	$65.00	$121K
2025-03-13	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Sell10b5-1	400	$63.33	$25K
2025-03-07	CAREY STEPHEN P.SVP & CFO	Tax	5,150	$60.62	$312K
2025-03-07	Davis KristaSVP, CHIEF HR OFFICER	Sell10b5-1	1,000	$60.86	$61K
2025-03-07	Lalwani NikhilPRESIDENT & CEO	Tax	17,060	$60.62	$1.03M
2025-03-07	Gutwerg OriSVP, GENERICS	Tax	3,314	$60.62	$201K
2025-03-07	Mutz ChristopherHEAD OF RARE DISEASE	Tax	2,874	$60.62	$174K
2025-03-05	Gutwerg OriSVP, GENERICS	Sell	5,084	$60.00	$305K
2025-03-05	Gutwerg OriSVP, GENERICS	Exercise	300	$31.49	$9K
2025-03-05	Gutwerg OriSVP, GENERICS	Sell	300	$60.03	$18K
2025-02-28	Mutz ChristopherHEAD OF RARE DISEASE	Tax	1,275	$61.89	$79K
2025-02-28	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Tax	1,099	$61.89	$68K
2025-02-28	Rowland Thomas AndrewSVP, HEAD - ESTABLISHED BRANDS	Tax	627	$61.89	$39K
2025-02-28	Gutwerg OriSVP, GENERICS	Tax	1,570	$61.89	$97K
2025-02-28	Lalwani NikhilPRESIDENT & CEO	Tax	12,216	$61.89	$756K
2025-02-28	CAREY STEPHEN P.SVP & CFO	Tax	1,861	$61.89	$115K
2025-02-28	Davis KristaSVP, CHIEF HR OFFICER	Tax	1,099	$61.89	$68K
2025-02-21	Davis KristaSVP, CHIEF HR OFFICER	Sell10b5-1	1,000	$60.20	$60K
2025-02-15	Mutz ChristopherHEAD OF RARE DISEASE	Tax	1,184	$58.92	$70K
2025-02-15	Gutwerg OriSVP, GENERICS	Tax	1,167	$58.92	$69K
2025-02-14	Davis KristaSVP, CHIEF HR OFFICER	Tax	1,196	$58.92	$70K
2025-02-14	Gutwerg OriSVP, GENERICS	Tax	1,426	$58.92	$84K
2025-02-14	Rowland Thomas AndrewSVP, HEAD - ESTABLISHED BRANDS	Tax	582	$58.92	$34K
2025-02-14	Mutz ChristopherHEAD OF RARE DISEASE	Tax	1,473	$58.92	$87K
2025-02-14	Lalwani NikhilPRESIDENT & CEO	Tax	7,799	$58.92	$460K
2025-02-14	CAREY STEPHEN P.SVP & CFO	Tax	1,730	$58.92	$102K
2025-02-14	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Tax10b5-1	1,434	$58.92	$84K
2025-02-13	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Sell10b5-1	400	$59.54	$24K
2025-02-12	Mutz ChristopherHEAD OF RARE DISEASE	Grant	24,808	—	—
2025-02-12	Mutz ChristopherHEAD OF RARE DISEASE	Grant	16,538	—	—
2025-02-12	Gassert ChadSVP - CORP. DEV. & STRATEGY	Grant	14,362	—	—
2025-02-12	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Grant10b5-1	16,974	—	—
2025-02-12	Davis KristaSVP, CHIEF HR OFFICER	Grant	8,704	—	—
2025-02-12	Rowland Thomas AndrewSVP, HEAD - ESTABLISHED BRANDS	Grant	7,834	—	—
2025-02-12	CAREY STEPHEN P.SVP & CFO	Grant	24,808	—	—
2025-02-12	CAREY STEPHEN P.SVP & CFO	Grant	16,538	—	—
2025-02-12	Gutwerg OriSVP, GENERICS	Grant	15,668	—	—
2025-02-12	Gassert ChadSVP - CORP. DEV. & STRATEGY	Grant	9,574	—	—
2025-02-12	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Grant	14,362	—	—
2025-02-12	Shanmugam MuthusamyHEAD OF R&D, COO-NOVITIUM OPS	Grant	9,574	—	—
2025-02-12	Gutwerg OriSVP, GENERICS	Grant	10,444	—	—
2025-02-12	Davis KristaSVP, CHIEF HR OFFICER	Grant	13,057	—	—
2025-02-12	Rowland Thomas AndrewSVP, HEAD - ESTABLISHED BRANDS	Grant	5,222	—	—
2025-02-12	Lalwani NikhilPRESIDENT & CEO	Grant	91,399	—	—
2025-02-12	Lalwani NikhilPRESIDENT & CEO	Grant	60,932	—	—
2025-02-12	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Grant10b5-1	11,316	—	—
2025-01-13	Cook MeredithSR. VP, GENERAL COUNSEL & SEC.	Sell10b5-1	400	$53.92	$22K

+ 9 more transactions

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