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 present Phase 4 SYNCHRONICITY trial data at the American Academy of Ophthalmology meeting on October 9, 2026. The late-breaking oral presentation during Uveitis Subspecialty Day in New Orleans will cover fluocinolone acetonide intravitreal implant in chronic non-infectious uveitis affecting the back of the eye. SYNCHRONICITY is an open-label, single-arm trial, meaning treatment is known and there is no comparison group. Principal investigator David Almeida will present.
ANI also plans an on-demand ePoster presented by Christina Y Weng on Phase 4 NEW DAY analyses conducted after the trial, comparing baseline characteristics and efficacy in rescued and non-rescued patients with diabetic macular edema. An encore SYNCHRONICITY presentation by Victor Gonzalez is planned for January 21, 2027, at Hawaiian Eye & Retina.
ANI Pharmaceuticals (ANIP) received final FDA approval for its Abbreviated New Drug Application for Everolimus Tablets for Oral Suspension in 2 mg, 3 mg and 5 mg strengths.
The product is the generic version of reference listed drug Afinitor Disperz®, expanding ANI’s U.S.-focused generics portfolio with a technically demanding formulation. The company’s CEO said this approval demonstrates ongoing execution by the R&D team and supports momentum in the commercial portfolio.
The company reiterated that it remains on track to launch at least 15 new generic products in 2026, with Everolimus Tablets for Oral Suspension contributing to that target. U.S. annual sales for Everolimus Tablets for Oral Suspension totaled approximately $123 million based on July 2026 moving annual total IQVIA data, highlighting the market size of the reference product that ANI’s generic will compete in.
ANI Pharmaceuticals (ANIP)/b) announced that President and CEO Nikhil Lalwani and members of the executive leadership team will participate in fireside chats at three September 2026 investor conferences.These are the 2026 Wells Fargo Healthcare Conference on September 10 at 1:30 p.m. ET, the Morgan Stanley 24th Annual Global Healthcare Conference on September 14 at 7:00 a.m. ET, and the H.C. Wainwright 28th Annual Global Investment Conference on September 15 at 12:00 p.m. ET. Live and archived webcasts will be available in the Investors section of the company’s website under Events and Presentations.
ANI Pharmaceuticals (Nasdaq: ANIP) appointed Henry Gosebruch to its Board of Directors, effective August 19, 2026, as the company advances its strategy to become a leading rare disease company. Gosebruch has over 30 years of experience in corporate strategy, business development and finance, including senior roles at Lakefront Biotherapeutics, Neumora Therapeutics, AbbVie and J.P. Morgan.
ANI also disclosed that director Muthusamy (Samy) Shanmugam resigned from the Board, effective immediately, while continuing in his executive positions as Head of Research and Development and Chief Operating Officer of New Jersey Operations.
ANI Pharmaceuticals (Nasdaq: ANIP) reported record second quarter 2026 net revenues of $266.0 million, up 25.9% year-over-year, driven by Rare Disease and Generics. Cortrophin Gel net revenues rose 43.5% to $117.1 million, while Generics revenues increased 9.7% to $99.1 million. ILUVIEN revenues declined 16.1% to $18.7 million and Brands declined 10.5% to $11.8 million, partially offset by $17.7 million of brand royalties and other revenues from the Harmony Agreement.
GAAP net income available to common shareholders was $24.7 million with diluted EPS of $1.05. Adjusted non-GAAP EBITDA was $71.6 million, up 32.4%, and adjusted diluted EPS was $2.21. ANI reaffirmed 2026 total net revenue guidance of $1.08–$1.14 billion and adjusted non-GAAP EBITDA of $285–$300 million, while revising Cortrophin Gel 2026 revenue guidance to $520–$540 million. The company ended June 30, 2026 with $360.2 million in cash and cash equivalents and generated $115.0 million in year-to-date operating cash flow.
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.