ANI achieved all-time highs in net revenue, adjusted non-GAAP EBITDA, and EPS in Q2 2025, driven by strong growth across Rare Disease and Generics units.
The company highlighted broad momentum, with Rare Disease demand accelerating, especially for Cortrophin Gel, and positive results in their retina franchise.
Management emphasized that the quarter's performance was driven by underlying demand rather than seasonality or one-time benefits, with new patient starts more than doubling year-over-year.
FDA Priority Review and Regulatory Progress for Ziftomenib
The FDA has accepted Kura's NDA for ziftomenib in relapsed/refractory NPM1-mutant AML, granting a priority review with a PDUFA date of November 30, 2025.
Management reports ongoing collaborative and constructive interactions with the FDA, emphasizing alignment with the review timeline.
Regulatory milestones include addressing information requests and preparing for pre-approval inspections, with a focus on ensuring a successful review outcome.
FDA Breakthrough Designation for DecisionDx-Melanoma and Strategic Path to FDA Approval
Castle Biosciences received FDA Breakthrough Device Designation for DecisionDx-Melanoma, signaling a significant regulatory milestone.
The company is actively progressing towards an FDA submission, with no specific public timeline disclosed.
Management expressed confidence that existing data supports FDA approval, emphasizing the importance of the breakthrough designation in accelerating regulatory pathway.