ANI Pharmaceuticals, Inc.

ANI Pharmaceuticals Announces the Launch of Duloxetine Delayed-Release Capsules

ANI Pharmaceuticals launched Duloxetine Delayed-Release Capsules in 20, 30 and 60 mg strengths, the generic version of the reference listed drug Cymbalta. U.S. annual sales for the product totaled approximately $247 million based on August 2026 moving annual total IQVIA data, and the company describes it as a limited-competition market where it can support stable supply. The launch adds an incremental revenue stream to ANI's Generics business, complementing its Rare Disease and Brands segments.

•13d ago

ANI Pharmaceuticals Announces Positive Phase 4 Open-Label, Single-Arm SYNCHRONICITY Clinical Trial Results Presented as Late Breaking Oral Presentation at the American Academy of Ophthalmology 2026 Annual Meeting

ANI Pharmaceuticals announced positive 6- and 24-month results from its Phase 4 SYNCHRONICITY trial of ILUVIEN in chronic non-infectious posterior segment uveitis, presented as a late-breaking oral at the AAO 2026 meeting. The open-label, single-arm study (n=108) met both co-primary endpoints at 6 months with statistical significance: +3.6 letters BCVA gain (p=0.0077) and -157.5 microns CST reduction (p<0.0001), with gains maintained at 24 months (+5.5 letters; -171.2 microns). 79.6% of study eyes had no inflammation recurrence over 24 months, and safety was consistent with prior trials of the implant. The data support physician uptake of ILUVIEN following the 2025 FDA label expansion to chronic NIU-PS, though all analyses were descriptive with nominal p-values.

•20d ago

ANI Pharmaceuticals Announces the FDA Approval of Everolimus Tablets for Oral Suspension

ANI Pharmaceuticals received final FDA approval of its ANDA for Everolimus Tablets for Oral Suspension in 2mg, 3mg and 5mg strengths, the generic version of Afinitor Disperz. The addressable U.S. market is approximately $123 million in annual sales based on July 2026 IQVIA moving annual total data. CEO Nikhil Lalwani highlighted the approval as evidence of R&D execution on technically demanding formulations, with the company still on track to launch at least 15 new generics this year.

•1mo ago

ANI Pharmaceuticals Appoints Henry Gosebruch to Board of Directors 

ANI Pharmaceuticals appointed Henry Gosebruch to its Board of Directors effective August 19, 2026, bringing over 30 years of biopharmaceutical strategy and M&A experience. Gosebruch previously served as CEO of Lakefront Biotherapeutics and held strategy leadership roles at AbbVie and J.P. Morgan, where he oversaw more than 100 transactions. Concurrently, director Muthusamy Shanmugam resigned from the board to focus on his executive role as Head of R&D and COO of New Jersey Operations.

•2mo ago

ANI Pharmaceuticals Reports Record Second Quarter 2026 Financial Results

ANI Pharmaceuticals reported record Q2 revenue of $266.0 million, up 25.9% year-over-year, driven by a 43.5% increase in Cortrophin Gel sales to $117.1 million. Adjusted non-GAAP EBITDA rose 32.4% to $71.6 million, while adjusted EPS reached $2.21, reflecting strong operational performance and margin expansion. The company reaffirmed its full-year 2026 guidance for total revenue and EBITDA, while adjusting Cortrophin Gel expectations to $520-$540 million, and authorized a new $100 million share repurchase program.

•2mo ago

ANI Pharmaceuticals Announces Positive Six-Month Topline Data from the Phase 4 Open-Label, Single-Arm SYNCHRONICITY Trial Evaluating Fluocinolone Acetonide Intravitreal Implant in Patients with Chronic Non-Infectious Uveitis

ANI Pharmaceuticals reported positive topline data from the Phase 4 SYNCHRONICITY trial for its Fluocinolone Acetonide Intravitreal Implant, meeting both co-primary endpoints with statistical significance. The trial demonstrated a mean improvement of +3.6 letters in best corrected visual acuity and a mean reduction of -157.5 microns in central subfield thickness at six months in the intent-to-treat population. Safety data were consistent with prior trials, with 29% of patients experiencing treatment-related adverse events, most commonly ocular hypertension and cataracts, while 7% required surgical intervention for IOP lowering.

•3mo ago