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ANIP News
ANIP Events
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
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.
ANI Pharmaceuticals Plans to Appeal to Delaware Supreme Court
ANI Pharmaceuticals announced that Judge Sheldon K. Rennie, on July 16, denied ANI's post-trial motions for a new trial and judgment as a matter of law. ANI intends to appeal to the Delaware Supreme Court and continue to seek to recover the value of the assets it sold to CG Oncology under the 2010 Agreement between the parties. "ANI respectfully disagrees with the Court's decision and intends to vigorously pursue its legal rights, including to receive a 5% running royalty on future worldwide sales of cretostimogene grenadenorepvec, by appealing to the Delaware Supreme Court," said Nikhil Lalwani, President and CEO at ANI.
ANI Pharmaceuticals Reports Positive Data from Fluocinolone Acetonide Trial
ANI Pharmaceuticals announced positive topline data from its Phase 4, open-label, single-arm Synchronicity clinical trial of Fluocinolone Acetonide Intravitreal Implant in patients with chronic non-infectious uveitis affecting the posterior segment of the eye. Both co-primary endpoints assessing 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 at 6 months in the intent-to-treat population were met with statistical significance. Patients in the ITT population had a mean change in baseline BCVA of +3.6 letters gained at 6 months. Patients in the ITT population had a mean change in baseline CST of -157.5 microns at 6 months. The most common adverse events seen in SYNCHRONICITY were consistent with prior trials of the fluocinolone acetonide intravitreal implant. In the safety population, 29% of patients experienced treatment-related treatment-emergent adverse events; the most common were ocular hypertension in 6% of patients and cataract in 5% of patients. Separately, 18% of patients experienced an IOP increase of greater than or equal to25 mmHg, and 7% of patients required any laser or surgical IOP-lowering intervention. Detailed results and additional analyses will be presented at medical conferences in 4Q 2026.
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