ANI Pharmaceuticals, Inc. (ANIP) News & EventsANIPANI Pharmaceuticals, Inc.

ANI Pharmaceuticals Presents SYNCHRONICITY Trial Data

ANI Pharmaceuticals announced that both 6-month and 24-month data from SYNCHRONICITY, its Phase 4, open-label, single-arm clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye were presented in a late-breaking oral presentation during Uveitis Subspecialty Day 2026 on October 9, 2026 by Dr. David R.P. Almeida, MD, MBA, PhD, President and CEO of Erie Retina Research, and Principal Investigator in SYNCHRONICITY, at the American Academy of Ophthalmology 2026 Meeting in New Orleans. The trial met both co-primary endpoints with statistical significance in the intent-to-treat population at 6 months: mean change from baseline in best corrected visual acuity letter score as measured by ETDRS and mean change from baseline in central subfield thickness as measured by SD-OCT. Mean Change from Baseline in BCVA Letter Score at Month 6: Patients in the ITT population had a mean change from baseline BCVA of +3.6 letters gained at 6 months. Mean Change from Baseline in CST at Month 6: Patients in the ITT population also had a mean change from baseline CST of -157.5 microns at 6 months.

ANI Pharmaceuticals Receives FDA Final Approval for Everolimus Tablets

ANI Pharmaceuticals announced that it received final approval from the FDA for its Abbreviated New Drug Application, or ANDA, for Everolimus Tablets for Oral Suspension 2mg, 3mg and 5mg. ANI's Everolimus Tablets for Oral Suspension are the generic version of the reference listed drug, or RLD, Afinitor Disperz. U.S. annual sales for Everolimus Tablet for Oral Suspension totaled approximately $123M, based on July 2026 moving annual total IQVIA data.

ANI Pharmaceuticals Maintains FY26 Adjusted EPS View of $9.19-$9.69

ANI Pharmaceuticals backs FY26 adjusted EPS view $9.19-$9.69, consensus $9.42