Vertex (NASDAQ:VRTX) Pharmaceuticals Incorporated (NASDAQ: VRTX) shares are trading lower by 3.42% to $263.88 during Monday’s pre-market session after the company announced VX-880 Phase 1/2 has been placed on clinical hold by the FDA due to “a determination that there is insufficient information to support dose escalation with the product.”
Vertex Pharmaceuticals says, across the program, VX-880 has been generally well tolerated to date. There have been no serious adverse events (SAEs) considered related to VX-880. The majority of adverse events (AEs) were mild or moderate in all patients treated to date. The safety profile was generally consistent with the immunosuppressive regimen used in the study and the perioperative period.
"We are surprised by the clinical hold placed on the study. The results from the first two patients treated with half the target dose establish proof-of-concept by demonstrating that VX-880 can restore glucose-regulated insulin production and improve glycemic control. Indeed, achievement of insulin independence by the first patient is a landmark milestone. Further, the totality of the safety and efficacy data for all three patients dosed to date gives us high confidence in our benefit-risk assessment of VX-880 and its potentially transformative profile," said Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer at Vertex.
"We are committed to working with the FDA to understand and address their questions, so that the trial can resume at U.S. sites as soon as possible."
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Vertex Pharmaceuticals is a global biotechnology company that discovers and develops small-molecule drugs for the treatment of serious diseases.
According to data from Benzinga Pro, Vertex Pharmaceuticals has a 52-week high of $292.75 and a 52-week low of $176.36.
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