Welcome to our dedicated page for Ani Pharmaceutic news (Ticker: ANIP), a resource for investors and traders seeking the latest updates and insights on Ani Pharmaceutic 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) will release its second quarter 2026 financial results on Friday, August 7, 2026, at 8:00 a.m. ET. President and CEO Nikhil Lalwani, CFO Stephen P. Carey, and Head of Rare Disease Chris Mutz will host a webcast and conference call to discuss the results.
According to ANI Pharmaceuticals, webcast and call access links will be posted on the “Events & Presentations” page in the Investors section of its website, and a replay will be available for up to one year.
Summary not available.
ANI Pharmaceuticals (Nasdaq: ANIP) reported positive six‑month topline results from SYNCHRONICITY, a Phase 4, open‑label, single‑arm U.S. trial of fluocinolone acetonide intravitreal implant 0.18 mg in 108 patients with chronic non‑infectious uveitis affecting the posterior segment (NIU‑PS).
Both co‑primary endpoints were met with statistical significance: mean best corrected visual acuity (BCVA) improved by +3.6 ETDRS letters (from 62.5 to 65.8; p<0.0077) and mean central subfield thickness (CST) decreased by 157.5 microns (from 505.7 to 348.8; p<0.0001) at month 6 in the intent‑to‑treat population.
In the safety population, 29% experienced treatment‑related adverse events, most commonly ocular hypertension (6%) and cataract (5%). Separately, 18% had intraocular pressure increases ≥25 mmHg and 7% required laser or surgical IOP‑lowering interventions. Detailed data will be presented in 4Q 2026.
ANI Pharmaceuticals (Nasdaq: ANIP) announced that CEO Nikhil Lalwani will participate in a fireside chat at the 2026 Jefferies Global Healthcare Conference on Wednesday, June 3, 2026 at 3:45 p.m. ET. A live and archived webcast will be available on the company’s investor relations website for 90 days.
ANI Pharmaceuticals (Nasdaq: ANIP) reported Q1 2026 net revenue of $237.5M (+20.5% YoY) and adjusted non-GAAP EBITDA of $63.0M (+24.1% YoY). Cortrophin Gel net revenue was $75.1M (+42.1% YoY). GAAP diluted EPS was $1.28; adjusted non-GAAP diluted EPS was $2.05. The company raised 2026 guidance to $1.08B–$1.14B revenue and $285M–$300M adjusted EBITDA, and authorized a $100M share repurchase program.
Q1 liquidity included $311.2M cash and $625.0M principal debt; management cited Rare Disease growth and continued generics contribution.
ANI Pharmaceuticals (Nasdaq: ANIP) will release its first quarter 2026 financial results on Friday, May 8, 2026, prior to market open.
A webcast and conference call with CEO Nikhil Lalwani, CFO Stephen P. Carey, and Head of Rare Disease Chris Mutz will discuss the results; a replay will remain accessible for up to one year. Webcast links are on the Investors > Events & Presentations page.
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.