$72.670
+0.109 (+0.15%)Zum Schluss
ANIP-News
ANIP-Events
ANI Pharmaceuticals Launches Duloxetine Delayed-Release Capsules
ANI Pharmaceuticals announced the launch of Duloxetine Delayed-Release Capsules 20, 30 and 60 mg. ANI's Duloxetine Delayed-Release Capsules are the generic version of the reference listed drug, or RLD, Cymbalta. U.S. annual sales for Duloxetine Delayed-Release Capsules totaled approximately $247M.
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 Reports Q2 Revenue of $266M, Exceeding Expectations
Reports Q2 revenue $266M, consensus $260.13M. "In the second quarter, we delivered outstanding financial results, while we implemented the largest Rare Disease sales force expansion in our history," said Nikhil Lalwani, President and CEO of ANI. "Leading indicators from our gout expansion for Cortrophin Gel are very positive, with the team rapidly delivering a large funnel of new patient cases, with significant breadth and depth of prescribing. The encouraging initial trends we are seeing from the gout expansion, and the continued momentum in our existing specialties, further support our conviction in Cortrophin Gel's sizable multi-year growth opportunity. We are reaffirming our full year 2026 total net revenue guidance of $1,080 - $1,140 million and adjusted non-GAAP EBITDA of $285 - $300 million. Based on our results in the first half of 2026, we are modestly adjusting our Cortrophin Gel net revenue guidance to $520 - $540 million, reflecting 50-55% growth for the full year. Our solid track record of commercial execution and prudent capital allocation combined with our strong balance sheet position us well for continued shareholder value creation."
Company Adjusts FY26 EBITDA Outlook to $285M-$300M
Backs FY26 adjusted EBITDA view $285M-$300M.
Diese Seite dient nur der Recherche und ist keine Anlageberatung. Modelle können falsch liegen. Vergangene Wertentwicklung ist kein Indikator für die Zukunft.