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.
Transition to Clinical-Stage Biotech with First Clinical Trials
AbCellera achieved a major milestone by receiving Health Canada authorization to initiate its first two clinical trials for ABCL635 and ABCL575.
Dosing has begun in the Phase I trial for ABCL635, targeting moderate to severe vasomotor symptoms, marking a shift from platform to clinical-stage biotech.
A second Phase I trial for ABCL575 was also initiated, with dosing expected to start shortly, expanding the company's clinical pipeline.
The company added a third program, ABCL688, into IND-enabling studies, indicating ongoing pipeline expansion and transition into more advanced clinical development.
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.
Strategic Focus on Phase III Readouts and Clinical Progress
The company is actively progressing towards multiple pivotal Phase III trials, including in myelofibrosis and endometrial cancer, with top-line data expected in 2026.
There is a strong emphasis on the potential of selinexor in combination with ruxolitinib to redefine the standard of care for myelofibrosis, with an estimated peak revenue potential of up to $1 billion annually in the U.S.
Management highlighted the significance of recent enrollment milestones, such as closing new patient screening for the SENTRY trial in myelofibrosis, which is a key step in their clinical development strategy.
The company is leveraging its clinical data to support regulatory and commercial ambitions, emphasizing the potential for selinexor to address unmet needs in diseases with limited treatment options.