Verve Therapeutics Shares Tumble After FDA Hold On Trial For Elevated Cholesterol Level Candidate

  • The FDA has instituted a clinical hold on Verve Therapeutics Inc's VERV IND application to conduct a clinical trial evaluating VERVE-101 in patients with heterozygous familial hypercholesterolemia (HeFH).
  • VERVE-101 is currently being evaluated in the heart-1 Phase 1 clinical trial in New Zealand and the U.K. 
  • Verve plans to provide updates pending engagement with the FDA and intends to work closely with the FDA to resolve the hold.
  • Related: Verve's Stock Price Could Continue To Rise Through Clinical Progress - Despite Worries About "DeeperPocketed" Competition.
  • The company said that dosing in the first dose cohort of the heart-1 Clinical Trial of VERVE-101 in HeFH is complete.
  • Independent Data Safety monitoring board recommended proceeding to the second dose level in New Zealand and U.K.
  • Verve plans to report initial safety and pharmacodynamic data for all dose cohorts of the dose-escalation portion of the heart-1 study at a medical meeting in 2H of 2023.
  • The company ended Q3 with a cash balance of $550.7 million, sufficient to fund its current operating plan into 2H of 2025.
  • Price Action: VERV shares are down 30.70% at $21.67 on the last check Monday.
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