ANI Pharmaceuticals, Inc., a specialty pharmaceutical company, develops, manufactures, and markets branded and generic prescription pharmaceuticals in the United States and Canada. It focuses on producing controlled substances, oncology products, hormones and steroids, and other formulations. The company manufactures oral solid dose products; semi-solids, liquids, and topicals; and potent products, as well as performs contract manufacturing for other pharmaceutical companies. It markets its products through retail pharmacy chains, wholesalers, distributors and mail order pharmacies, and group purchasing organizations. The company was founded in 2001 and is headquartered in Baudette, Minnesota.
IPO Year:
Exchange: NASDAQ
Website: anipharmaceuticals.com
| Date | Price Target | Rating | Analyst |
|---|---|---|---|
| 7/10/2025 | $84.00 | Buy | H.C. Wainwright |
| 3/14/2025 | $80.00 | Buy | Jefferies |
| 3/12/2025 | $85.00 | Overweight | Analyst |
| 12/11/2024 | $80.00 | Outperform | Leerink Partners |
| 10/11/2024 | $68.00 | Overweight | Piper Sandler |
| 3/15/2024 | $80.00 | Overweight | CapitalOne |
| 8/22/2023 | $60.00 → $73.00 | Buy | H.C. Wainwright |
| 3/1/2023 | $55.00 | Buy | Guggenheim |
| 9/7/2022 | $50.00 | Buy | H.C. Wainwright |
| 11/2/2021 | $60.00 → $65.00 | Outperform | Raymond James |
Analyst ratings in real time. Analyst ratings have a very high impact on the underlying stock. See them live in this feed.
H.C. Wainwright initiated coverage of ANI Pharma with a rating of Buy and set a new price target of $84.00
Jefferies initiated coverage of ANI Pharma with a rating of Buy and set a new price target of $80.00
Analyst initiated coverage of ANI Pharma with a rating of Overweight and set a new price target of $85.00
Leerink Partners initiated coverage of ANI Pharma with a rating of Outperform and set a new price target of $80.00
Piper Sandler initiated coverage of ANI Pharma with a rating of Overweight and set a new price target of $68.00
CapitalOne initiated coverage of ANI Pharma with a rating of Overweight and set a new price target of $80.00
H.C. Wainwright reiterated coverage of ANI Pharma with a rating of Buy and set a new price target of $73.00 from $60.00 previously
Guggenheim initiated coverage of ANI Pharma with a rating of Buy and set a new price target of $55.00
H.C. Wainwright initiated coverage of ANI Pharma with a rating of Buy and set a new price target of $50.00
Raymond James reiterated coverage of ANI Pharmaceuticals with a rating of Outperform and set a new price target of $65.00 from $60.00 previously
Live FDA approvals issued by the Food and Drug Administration and FDA breaking news
Submission status for ANI PHARMS INC's drug HYDROCODONE BITARTRATE AND IBUPROFEN (SUPPL-6) with active ingredient HYDROCODONE BITARTRATE; IBUPROFEN has changed to 'Approval' on 03/04/2021. Application Category: ANDA, Application Number: 077454, Application Classification: Labeling
Submission status for ANI PHARMS INC's drug OXYCODONE AND ASPIRIN (SUPPL-30) with active ingredient ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE has changed to 'Approval' on 03/04/2021. Application Category: ANDA, Application Number: 040255, Application Classification: Labeling
Submission status for ANI PHARMS INC's drug EZETIMIBE AND SIMVASTATIN (SUPPL-10) with active ingredient EZETIMIBE; SIMVASTATIN has changed to 'Approval' on 02/23/2021. Application Category: ANDA, Application Number: 201890, Application Classification: Labeling
Submission status for ANI PHARMS INC's drug TEMOZOLOMIDE (SUPPL-9) with active ingredient TEMOZOLOMIDE has changed to 'Approval' on 01/04/2021. Application Category: ANDA, Application Number: 203490, Application Classification: Labeling
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4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
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4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
4 - ANI PHARMACEUTICALS INC (0001023024) (Issuer)
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PRINCETON, N.J., May 27, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) (ANI or the Company) today announced that Nikhil Lalwani, Chief Executive Officer, will participate in a fireside chat at the 2026 Jefferies Global Healthcare Conference as follows: Date:Wednesday, June 3, 2026 Time:3:45 p.m. ET Webcast:Click Here The live and archived webcast will be accessible from the Company's website at www.anipharmaceuticals.com, under the Investors section under Events and Presentations. The replay of the webcast will be accessible for 90 days. About ANI ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) is a diversified biopharmaceutical company committed to its mission of "Serving Pa
Quarterly net revenues of $237.5 million, an increase of 20.5% year-over-yearPurified Cortrophin® Gel net revenues of $75.1 million, an increase of 42.1% year-over-yearQuarterly GAAP net income available to common shareholders of $29.5 million; Quarterly adjusted non-GAAP EBITDA of $63.0 million, an increase of 24.1% year-over-yearDiluted GAAP income per share of $1.28 and adjusted non-GAAP diluted earnings per share of $2.05Raised 2026 total net revenue guidance to $1,080 million to $1,140 million, adjusted non-GAAP EBITDA to $285 million to $300 million, and adjusted non-GAAP diluted earnings per share to $9.19 to $9.69; reaffirmed 2026 Cortrophin Gel net revenue guidance of $540 million t
PRINCETON, N.J., April 24, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that the Company will release its first quarter 2026 financial results on Friday, May 8, 2026, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease will host a webcast and conference call to discuss the results. To view the webcast, please click here. Links to access the webcast and conference call will also be available on the "Events & Presentations" page of the Company's website at https://www.anipharmaceuticals.com,
PRINCETON, N.J., April 20, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the launch of Pimozide Tablets 1 mg and 2 mg. ANI's Pimozide Tablets is the generic version of the reference listed drug (RLD) Orap®. "We are proud to announce the launch of Pimozide Tablets with 180-Day CGT exclusivity. We are excited to bring limited competition products to market and continue to provide generic alternatives to our customers and patients," stated Nikhil Lalwani, President and Chief Executive Officer of ANI. U.S. annual sales for Pimozide Tablets total approximately $3.1 million, based on February 2026 moving annual total (MAT) IQVIA data. A
PRINCETON, N.J., April 13, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the launch of Carbamazepine Extended-Release Capsules, 100 mg, 200 mg and 300 mg. ANI's Carbamazepine Extended-Release Capsules are the generic version of the reference listed drug (RLD) Carbatrol®. "Continuing to strengthen our Generics portfolio through strategic product launches remains a key priority for us," stated Nikhil Lalwani, President and Chief Executive Officer of ANI. "The launch of Carbamazepine Extended-Release Capsules, another limited competition product, highlights our continued commitment to improving patient access to essential medicines whil
PRINCETON, N.J., April 08, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that following final approval from the U.S. Food and Drug Administration (FDA) for its Abbreviated New Drug Application (ANDA), the Company launched Isosorbide Mononitrate Tablet USP, 10 mg and 20 mg. ANI's Isosorbide Mononitrate Tablet USP is the generic version of the reference listed drug (RLD) Monoket®. "We are pleased to announce FDA approval and launch of Isosorbide Mononitrate Tablet USP, which highlights our efforts to bring limited-competition products to market and ensure that our high-quality products are readily accessible to our customers and patien
PRINCETON, N.J., April 07, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced publication of the results from the NEW DAY clinical trial involving ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in appropriate patients with diabetic macular edema in Ophthalmology, the journal of the American Academy of Ophthalmology. The company previously announced results from the NEW DAY trial in July 2025. ILUVIEN is a corticosteroid indicated for the treatment of diabetic macular edema (DME) in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in
Record quarterly and full year net revenues of $247.1 million and $883.4 million, up 29.6% and 43.8% year-over-year, respectivelyTotal Rare Disease quarterly and full year net revenue of $131.3 million and $422.6 million, up 50.8% and 84.1% year-over-year, respectively Quarterly and full year Purified Cortrophin® Gel net revenues of $111.4 million and $347.8 million, up 87.6% and 75.6% year-over-year, respectivelyQuarterly and full year ILUVIEN® and YUTIQ® net revenues of $19.8 million and $74.9 million, respectively(1) Quarterly and full year GAAP net income available to common shareholders of $27.5 million and $77.2 million, respectivelyRecord quarterly and full year adjusted non-GAAP EBIT
PRINCETON, N.J., Feb. 24, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that Nikhil Lalwani, President and Chief Executive Officer, along with members of the Company's executive leadership team, will present at the following investor conferences: Raymond James & Associates' 47th Annual Institutional Investors Conference on Tuesday, March 3, 2026, at 7:30am ETLeerink Partners Global Healthcare Conference on Tuesday, March 10, 2026, at 3:00pm ETBarclays 28th Annual Global Healthcare Conference on Wednesday, March 11, 2026, at 3:00pm ET The live and archived webcasts will be accessible from the Company's website at www.anipharmaceutica
PRINCETON, N.J., Feb. 13, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that the Company will release its fourth quarter and full year 2025 financial results on Friday, February 27, 2026, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease will host a conference call to discuss the results as follows: DateFriday, February 27, 2026Time8:00 a.m. ETToll free (U.S.)800-274-8461Conference ID5230834Webcast (live and replay) www.anipharmaceuticals.com, under the "Investors" section The live and arc
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Live Leadership Updates
Long time industry leader, Chairman of the Board Patrick Walsh replaces CEO Bill Humphries DURHAM, N.C., Jan. 13, 2025 /PRNewswire/ -- Alcami Corporation ("Alcami"), a leading contract development and manufacturing organization (CDMO), today announced the resignation of Bill Humphries. Alcami's Board Chair and former Chief Executive Officer Patrick Walsh will serve as Interim CEO, ensuring the continuation of smooth operations and a strong client-centric approach from a proven industry veteran. "On behalf of the Board, I'd like to express gratitude to Bill for his leadership
-- Mr. Leonard is an accomplished leader with 35 years of pharmaceuticals and healthcare experience -- Mr. Leonard has significant expertise in pharmacy benefits management, health insurance, and specialty and retail pharmacy -- BAUDETTE, Minn., Aug. 23, 2023 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced the addition of Matthew J. Leonard, R.Ph. to its Board of Directors. Mr. Leonard brings more than 35 years of experience as an accomplished leader and innovator within the pharmaceutical industry. This appointment is effective immediately. "We are delighted to add Matthew (Matt) Leonard to our Board of Directors. With his deep leadershi
ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) ("ANI" or the "Company") today announced that Krista L. Davis will join the Company as Chief Human Resources Officer, effective September 12. Ms. Davis brings to the Company over 20 years of executive leadership experience in human resources, talent management, and organizational development. "Ms. Davis is an important addition to our leadership team and will bring strategic and innovative thought leadership to our priority people and organizational issues. Krista has a long track record of driving organizational effectiveness and delivering results across industries and cultures, most recently with Novartis, where she led global human resources for
ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) (ANI or the Company) today announced that Meredith W. Cook will join the Company as SVP, General Counsel and Corporate Secretary, effective July 18. Ms. Cook brings over 20 years of legal and leadership experience in specialty and generics pharmaceuticals, including in corporate governance, mergers and acquisitions (M&A), strategic transactions, and intellectual property (IP). "We are delighted to welcome Ms. Cook to our leadership team. Meredith is an accomplished attorney with demonstrated leadership and expertise in the pharmaceutical industry and will no doubt play an important role in the Company's continued growth. Her guidance and perspectives
-- Dr. Tannenbaum's successful track record in driving commercial excellence to contribute as Company executes Purified Cortrophin GelTM launch -- ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) (ANI or the Company) today announced the addition of Renee P. Tannenbaum, Pharm.D., MBA, to its Board of Directors. Dr. Tannenbaum has over 35 years of management experience in the pharmaceutical industry. This appointment is effective immediately and increases ANI's Board of Directors to nine members. "We are honored to bring Dr. Tannenbaum's vast biopharmaceutical commercial experience and expertise to our Board of Directors. With her many accomplishments and proven track record of developing and implem
-- ANI Pharmaceuticals appoints Mary Pao, M.D., Ph.D., as Chief Medical Officer, Rare Disease, and Elizabeth Powell, J.D., as Chief Compliance Officer and Head of Legal, Rare Disease -- -- Dr. Pao and Ms. Powell, collectively, bring four decades of pharmaceutical industry experience to their roles in support of the commercialization of Purified Cortrophin™ Gel (repository corticotropin injection USP) -- -- Rare Disease Business Unit leadership hires build on recent Cortrophin Gel milestones -- ANI Pharmaceuticals, Inc. (NASDAQ:ANIP) (ANI or the Company) today announced two additions to its Rare Disease Business Unit leadership team. Mary Pao, M.D., Ph.D., has been appointed Chief Medical
Live finance-specific insights
Quarterly net revenues of $237.5 million, an increase of 20.5% year-over-yearPurified Cortrophin® Gel net revenues of $75.1 million, an increase of 42.1% year-over-yearQuarterly GAAP net income available to common shareholders of $29.5 million; Quarterly adjusted non-GAAP EBITDA of $63.0 million, an increase of 24.1% year-over-yearDiluted GAAP income per share of $1.28 and adjusted non-GAAP diluted earnings per share of $2.05Raised 2026 total net revenue guidance to $1,080 million to $1,140 million, adjusted non-GAAP EBITDA to $285 million to $300 million, and adjusted non-GAAP diluted earnings per share to $9.19 to $9.69; reaffirmed 2026 Cortrophin Gel net revenue guidance of $540 million t
PRINCETON, N.J., April 24, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that the Company will release its first quarter 2026 financial results on Friday, May 8, 2026, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease will host a webcast and conference call to discuss the results. To view the webcast, please click here. Links to access the webcast and conference call will also be available on the "Events & Presentations" page of the Company's website at https://www.anipharmaceuticals.com,
Record quarterly and full year net revenues of $247.1 million and $883.4 million, up 29.6% and 43.8% year-over-year, respectivelyTotal Rare Disease quarterly and full year net revenue of $131.3 million and $422.6 million, up 50.8% and 84.1% year-over-year, respectively Quarterly and full year Purified Cortrophin® Gel net revenues of $111.4 million and $347.8 million, up 87.6% and 75.6% year-over-year, respectivelyQuarterly and full year ILUVIEN® and YUTIQ® net revenues of $19.8 million and $74.9 million, respectively(1) Quarterly and full year GAAP net income available to common shareholders of $27.5 million and $77.2 million, respectivelyRecord quarterly and full year adjusted non-GAAP EBIT
PRINCETON, N.J., Feb. 13, 2026 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that the Company will release its fourth quarter and full year 2025 financial results on Friday, February 27, 2026, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease will host a conference call to discuss the results as follows: DateFriday, February 27, 2026Time8:00 a.m. ETToll free (U.S.)800-274-8461Conference ID5230834Webcast (live and replay) www.anipharmaceuticals.com, under the "Investors" section The live and arc
For full year 2025, total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS expected to be within or above guidance ranges of $854 million to $873 million, $221 million to $228 million and $7.37 to $7.64, respectivelyRare Disease business delivered exceptional growth with full year 2025 Purified Cortrophin® Gel net revenues of $347.8 million, up 76% year-over-year, and ILUVIEN and YUTIQ net revenues of $74.9 million, based on preliminary, unaudited resultsProvides full year 2026 financial guidance, which includes: Total net revenues of $1,055 million to $1,115 millionCortrophin Gel net revenues of $540 million to $575 millionAdjusted non-GAAP EBITDA of $275 million t
Record quarterly net revenues of $227.8 million, an increase of 53.6% year-over-yearPurified Cortrophin® Gel net revenues of $101.9 million, an increase of 93.8% year-over-yearRecord quarterly adjusted non-GAAP EBITDA of $59.6 million, an increase of 69.8% year-over-yearDiluted GAAP income per share of $1.13 and record adjusted non-GAAP diluted earnings per share of $2.04Raised 2025 total net revenue guidance to $854.0 million to $873.0 million, adjusted non-GAAP EBITDA to $221.0 million to $228.0 million, and adjusted non-GAAP diluted earnings per share of $7.37 to $7.64Rare Disease net revenues expected to represent approximately 50% of total Company net revenues in 2025, including revised
PRINCETON, N.J., Oct. 24, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced that the Company will release its third quarter 2025 financial results on Friday, November 7, 2025, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, and Chris Mutz, Head of Rare Disease will host a conference call to discuss the results as follows: DateFriday, November 7, 2025Time8:30 a.m. ETToll free (U.S.)800-267-6316Conference ID5120265Webcast (live and replay) www.anipharmaceuticals.com, under the "Investors" section A replay of the conference call
Generated record quarterly net revenues of $211.4 million, representing year-over-year growth of 53.1% on a reported basis and 37.0% on an organic basisTotal Rare Disease quarterly net revenues of $104.0 million, which includes: Purified Cortrophin® Gel net revenues of $81.6 million, an increase of 66.0% year-over-year, andILUVIEN® and YUTIQ® net revenues of $22.3 million Generics quarterly net revenues of $90.3 million, an increase of 22.1% year-over-year Delivered record quarterly adjusted non-GAAP EBITDA of $54.1 million, an increase of 62.8% year-over-yearDiluted GAAP income per share of $0.36 and record adjusted non-GAAP diluted earnings per share of $1.80Increased 2025 guidance
PRINCETON, N.J., Aug. 01, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. ("ANI" or the "Company") (NASDAQ:ANIP) today announced that the Company will release its second quarter 2025 financial results on Friday, August 8, 2025, prior to the market open. Nikhil Lalwani, President and Chief Executive Officer, Stephen P. Carey, Senior Vice President, Finance, and Chief Financial Officer, Chris Mutz, Head of Rare Disease, and Mary Pao, M.D., Ph.D., Chief Medical Officer, will host a conference call to discuss the results as follows: DateFriday, August 8, 2025 Time8:30 a.m. ET Toll free (U.S.)800-343-4136 Conference ID5034065 Webcast (live and replay)www.anipharmaceuticals.com, under
Trial evaluated number of supplemental injections needed for the treatment of DME for patients on ILUVIEN versus the aflibercept arm Study Enrolled Treatment-Naïve, or Almost Naïve, Patients with DME Results presented by Michael A. Singer, M.D. in a paper-on-demand presentation at the American Society of Retina Specialists (ASRS) Annual Scientific Meeting Conference call scheduled for today at 8:30 am ET PRINCETON, N.J., July 23, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (NASDAQ:ANIP) today announced results from the NEW DAY clinical trial of ILUVIEN® (fluocinolone acetonide intravitreal implant), 0.19 mg (ILUVIEN) for use in patients with diabetic macula
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