Progress and Expectations for BLA Approval of Avance Nerve Graft in September 2025
The BLA remains on track with key milestones completed, including the late cycle FDA meeting, pre-licensing inspection, and sponsor inspection.
Management expects BLA approval in September 2025, which will secure 12 years of market exclusivity and establish Avance Nerve Graft as the only implantable biologic for peripheral nerve repair.
The process involves ongoing discussions on labeling and quality system modifications, with no issues or observations reported from FDA inspections so far.
Market Dynamics and Competitive Landscape in Hypert cortisolism and Diabetes
Management discussed the expanding hypercortisolism market, with more players increasing noise and market activity, which they view positively.
The potential launch of a competitor's drug later this year could increase market awareness and demand for cortisol testing and treatment.
In the diabetes space, there are approximately 15 million patients who should have rescue glucagon, but only about 1 million currently do, indicating significant growth opportunities.
Gvoke's collaboration with American Regent for VialDx is expected to enhance market penetration in the coming years.
FIRDAPSE generated $84.8 million in net product revenue in Q2 2025, up $7.5 million from Q2 2024, with a reaffirmed full-year guidance of $355-$360 million.
The growth was impacted in 2024 by the Change Healthcare cybersecurity breach, which shifted volume from Q1 to Q2, but the impact was fully resolved by June 2024.
Year-to-date, FIRDAPSE revenue increased 16.9% over the first half of 2024, indicating strong underlying demand and market durability.
Management emphasizes high prescription approval rates above 90% and low discontinuation rates below 20%, supporting sustained performance.
The company is actively expanding education efforts supported by updated NCCN guidelines, targeting undiagnosed cancer-associated LEMS patients, with an opportunity to reach a high-potential underserved population.
Accelerated Adoption of Guardant360 Tissue ASP Achieving 2028 Target Three Years Early
Guardant360 Tissue ASP reached approximately $2,000 in Q2, surpassing the 2028 target three years ahead of schedule.
Major upgrade in April expanded the panel to include RNA and methylome analysis, with 40% fewer slides than industry norm, serving as a key differentiator.
Impact of FDA Inspection Delay on EYLEA HD and BLA for Odronextamab
EYLEA HD regulatory application delays caused by FDA site inspection at Catalent Indiana LLC, which was not specific to EYLEA HD.
Novo Nordisk expects to file a comprehensive response next week, anticipating an expeditious resolution.
BLA for odronextamab, a bispecific antibody for follicular lymphoma, was impacted by the same site inspection, resulting in a Complete Response Letter (CRL) issued earlier this week.
Management remains optimistic about resolving these issues quickly based on Novo's communication and progress with third-party fillers.
Dafinchi
