Welcome to our dedicated page for ANI Pharmaceuticals news (Ticker: ANIP), a resource for investors and traders seeking the latest updates and insights on ANI Pharmaceuticals stock.
ANI Pharmaceuticals, Inc. reports developments as a diversified biopharmaceutical company that develops, manufactures, and commercializes therapeutics through Rare Disease, Generics, and Brands businesses. Its Rare Disease portfolio includes Purified Cortrophin® Gel and ophthalmology products such as ILUVIEN® and YUTIQ®, while its generics portfolio includes products launched through FDA-approved abbreviated new drug applications.
ANI news commonly covers quarterly and annual financial results, guidance updates, product revenue trends, FDA approvals, generic product launches, clinical data publications, investor presentations, and capital allocation actions. Company updates also describe activity in ophthalmology, rheumatology, nephrology, neurology, and pulmonology, along with manufacturing and commercialization execution in the United States.
ANI Pharmaceuticals (Nasdaq: ANIP) announced FDA approval and the launch of Pimozide Tablets 1 mg and 2 mg on April 20, 2026. The product is a generic of Orap and carries 180‑day competitive generic therapy (CGT) exclusivity. U.S. annual sales for pimozide total approximately $3.1 million based on February 2026 MAT IQVIA data.
The company said the launch brings a limited‑competition generic to market to serve customers and patients while the exclusive period restricts other generic entrants for 180 days.
ANI Pharmaceuticals (Nasdaq: ANIP) launched Carbamazepine Extended-Release Capsules in 100 mg, 200 mg and 300 mg strengths on April 13, 2026.
The product is a generic version of the reference listed drug Carbatrol. ANI said the launch targets a limited competition segment and cited U.S. annual sales of approximately $65 million based on February 2026 MAT IQVIA data.
ANI Pharmaceuticals (Nasdaq: ANIP) announced FDA final approval and launch of Isosorbide Mononitrate Tablet USP, 10 mg and 20 mg on April 8, 2026. The product is the generic of reference listed drug Monoket. The company said the launch targets limited‑competition markets and reflects its R&D and operational capabilities.
ANI Pharmaceuticals (Nasdaq: ANIP) announced publication (April 7, 2026) of the NEW DAY randomized Phase 4 trial of ILUVIEN (fluocinolone acetonide 0.19 mg) in Ophthalmology. The report presents safety and efficacy data for ILUVIEN as a baseline therapy for diabetic macular edema in previously steroid-treated patients.
The publication includes key safety findings: intraocular pressure elevations and high cataract incidence versus sham, and notes ILUVIEN's approved indication for DME in selected patients.
ANI Pharmaceuticals (Nasdaq: ANIP) reported record Q4 2025 net revenue of $247.1M (+29.6% YoY) and full‑year revenue of $883.4M (+43.8% YoY). Cortrophin Gel drove Rare Disease growth with Q4 revenue of $111.4M (+87.6%) and full‑year $347.8M (+75.6%).
The company posted Q4 GAAP EPS $1.18 and adjusted non‑GAAP diluted EPS $2.33, record adjusted EBITDA of $65.4M Q4 and $229.8M full year, and reaffirmed 2026 guidance targeting >$1B revenue and adjusted EBITDA $275M–$290M.
ANI Pharmaceuticals (Nasdaq: ANIP) announced that CEO Nikhil Lalwani and executive leaders will present at three investor conferences in March 2026: Raymond James (Mar 3), Leerink Partners Global Healthcare (Mar 10), and Barclays Global Healthcare (Mar 11).
Live and archived webcasts will be available via the company’s Investors section, with replays accessible for 90 days.
ANI Pharmaceuticals (Nasdaq: ANIP) will release its fourth quarter and full year 2025 financial results on Friday, February 27, 2026, before the market opens. A conference call and live webcast at 8:00 a.m. ET will discuss the results, with replay available for 12 months.
Executives on the call include President and CEO Nikhil Lalwani, SVP Finance and CFO Stephen P. Carey, and Head of Rare Disease Chris Mutz. The webcast and replay will be available under Investors > Events and Presentations at www.anipharmaceuticals.com. Dial-in details include toll-free U.S. access and Conference ID 5230834.
ANI Pharmaceuticals (Nasdaq: ANIP) reported preliminary, unaudited full year 2025 results and provided full year 2026 guidance on Jan 12, 2026. ANI expects 2025 total net revenues, adjusted non-GAAP EBITDA, and adjusted non-GAAP diluted EPS to be within or above prior guidance ranges of $854M–$873M, $221M–$228M, and $7.37–$7.64, respectively. Cortrophin Gel net revenues were approximately $347.8M in 2025 (up 76% YoY) and $111.4M in Q4 2025 (up 88% YoY). 2026 guidance: $1,055M–$1,115M total net revenues; Cortrophin Gel $540M–$575M; adjusted non-GAAP EBITDA $275M–$290M; adjusted non-GAAP diluted EPS $8.83–$9.34. ANI expects Rare Disease to be ~60% of 2026 revenue, plans a ~90-person Rare Disease expansion, and will present at the J.P. Morgan Healthcare Conference on Jan 13, 2026.
ANI Pharmaceuticals (Nasdaq: ANIP) announced that CEO Nikhil Lalwani will present at the 44th Annual J.P. Morgan Healthcare Conference on January 13, 2026 at 3:00 p.m. PT / 6:00 p.m. ET.
The presentation will be available via a live webcast and an archived replay on the company website under Investors > Events and Presentations. The replay will be accessible for 30 days.
ANI Pharmaceuticals (Nasdaq: ANIP) announced on December 2, 2025 the formation of the FutureVision Advisory Council to guide its ophthalmology and retina franchise within the Rare Disease business.
The council comprises seven retina and three uveitis specialists, co‑led by Arshad M. Khanani, MD (Principal Retina Advisor and Chair) and Peter Y. Chang, MD (Principal Uveitis Advisor and Chair). The council will advise on strategic advancement of current products, including ILUVIEN and Cortrophin Gel, and on development priorities to support patient care.