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- Omeros Corporation (NASDAQ:OMER) has submitted to the FDA its response to Complete Response Letter for narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
- The response comprises a comprehensive briefing package drafted in close collaboration with external clinical, regulatory, and legal experts addressing the points raised by the FDA.
- Omeros concurrently requested a Type A meeting with FDA to resolve any outstanding items.
- Related Link: Omeros Stock Falls As FDA Asks For More Clinical Narsoplimab Data In HSCT-TMA.
- Narsoplimab is the first drug candidate submitted to FDA for approval in HSCT-TMA.
- It has Breakthrough Therapy and Orphan designations in both HSCT-TMA and IgA nephropathy.
- Related: Omeros' Narsoplimab Shows Improved, Stabilized Renal Function At Three Years.
- Price Action: OMER shares are up 1.94% at $5.26 during after-hours trading on Wednesday.
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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