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- The FDA has lifted the clinical hold placed on Vertex Pharmaceuticals Inc's (NASDAQ:VRTX) Phase 1/2 trial of VX-880 for people with type 1 diabetes (T1D) with severe hypoglycemia.
- VX-880 is an investigational stem cell-derived, fully differentiated pancreatic islet cell replacement therapy.
- The FDA instituted a clinical hold on the study due to a determination of insufficient information to support dose escalation with the product.
- As a result, the Phase 1/2 trial will be reopened for screening, enrollment, and dosing at multiple sites in the U.S.
- Three patients have been dosed in the Phase 1/2 study with VX-880.
- Two patients received half the target dose of cells in Part A of the study. A third patient has received the full target dose in Part B of the study.
- Part B will evaluate safety and efficacy in five patients at the target dose before expanding to additional patients in Part C.
- Price Action: VRTX shares are up 0.58% at $289.00 during the premarket session on the last check Tuesday.
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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