- PhaseBio Pharmaceuticals Inc (NASDAQ:PHAS) remains on track to complete the bentracimab biologics license application (BLA) filing around mid-2022 for bleeding risks associated with using ticagrelor antiplatelet drug.
- A pre-BLA filing meeting with FDA will take place in the coming months. Needham analyst says that based on prior FDA guidance, the interim results from the first ~100 patients of the REVERSE-IT trial could support accelerated approval.
- But the agency recommended that the initial ~100 patients should consist of an equal split between patients with uncontrolled/life-threatening bleeding and requiring urgent surgery/ invasive procedure.
- FDA stated that an imbalance would be a review issue.
- Though the interim results from the ph 3 REVERSE-IT trial of bentracimab met its co-primary endpoints, the interim evaluation mainly consisted of patients requiring urgent surgery/invasive procedures.
- Analyst Serge Belanger believes the interim REVERSE-IT results support approval and assumes a 2H 2023 launch.
- If FDA requires the full REVERSE-IT dataset, it could likely delay a potential approval by 12-16 mths or provide a partial approval (only for patients requiring urgent surgery/invasive procedures).
- PHAS estimates that in the U.S., 500,000 patients (~10% market share) undergo Brilinta therapy, which is expected to reach around 2 million (or 25-35% market share) by 2029 once the product loses patent in 2024.
- Assuming bentracimab pricing between $10k-$20k/dose, the addressable target market for the product represents an opportunity in the range of $750 million-$1.5 billion.
- Price Action: PHAS shares are trading at $1.24 during the market session on the last check Monday.
