Verve Slides as FDA Seeks Data Before Allowing Gene-Therapy Trial

Angelica Peebles, Bloomberg News

An automated machine works on purification of potential hepatitis C virus drug candidate at the Gilead Sciences Inc. lab in Foster City, California, U.S. Photographer: David Paul Morris , Bloomberg

(Bloomberg) -- Verve Therapeutics Inc. shares fell the most in five months, pulling down shares of rival drugmakers, after the biotechnology company said US regulators requested additional information before allowing a test of its gene therapy to begin.

The Food and Drug Administration wants more information around potency, unintended changes in patients’ DNA and the risk those alterations could be passed down to offspring, Verve said Monday in a regulatory filing. The FDA also suggested Verve add tighter contraceptive requirements and lengthen the time between treatment doses and wants to see data from trials taking place outside the US.

Verve disclosed the hold last month after filing an application in October to start human testing of the treatment in the US. The rare-disease therapy aims to alter a cholesterol-raising gene to prevent heart attacks, and Verve is already testing it in New Zealand and the UK. The drugmaker said it plans to share initial safety and pharmacodynamic data in the second half of next year.

While analysts said the FDA’s feedback could have been harsher, it still shook investors who are anxiously watching the burgeoning field that aims to make permanent changes in human DNA in order to treat -- and potentially cure -- disease. Shares of Verve fell 13% as of noon in New York.

Other firms developing gene-editing treatments also fell: Intellia Therapeutics Inc. slipped as much as 8%, Editas Medicine Inc. lost as much as 4%, and Prime Medicine Inc. fell as much as 9%. Beam Therapeutics Inc., which licenses its editing system to Verve, tumbled as much as 6.5%.