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- 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.
Crypto Whales Are Loading Up — Are You?
New research shows the biggest crypto buyers are back. And this time? They could hold for the possibility that Bitcoin will surpass $100,000 in 2024. You don’t want to miss the next massive crypto bull run like we saw in 2020 and 2021. To know exactly what’s going on and what to buy… Get Access To Benzinga’s Best Crypto Research and Investments For Only $1.
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