Crispr Therapeutics Shares Rally Premarket After Favorable FDA Panel Meeting

By Colin Kellaher

Shares of Crispr Therapeutics jumped nearly 20% in premarket trading Wednesday following a U.S. Food and Drug Administration advisory committee meeting on the proposed gene-editing drug exa-cel from Crispr and partner Vertex Pharmaceuticals that analysts believe paves the way for FDA approval.

Crispr and Vertex are seeking FDA approval of exa-cel in sickle-cell disease, an inherited blood disorder, and a green light would make exa-cel the first approved drug using the gene-editing technology known as Crispr.

The FDA often turns to advisory committees to obtain advice from experts who work outside of the government when a scientific, technical or policy question arises, such as whether an unapproved product is safe and effective.

The advisory committee meeting on Tuesday, which unusually didn't include a vote on exa-cel, focused on the drug's potential off-target effects.

In a research note, analysts at Citigroup said the overwhelming consensus from the discussion was that benefit/risk for exa-cel is exceedingly favorable, and that they expect an FDA approval with off-target monitoring language.

Analysts at Truist and Mizuho also said they expect an approval from the FDA, which has set a Dec. 8 target action date.

Trading in Crispr shares was halted Tuesday while the advisory committee held its all-day meeting. The shares, which closed Monday at $38.93, were recently up 19% to $46.30 in premarket trading.

Write to Colin Kellaher at colin.kellaher@wsj.com

(END) Dow Jones Newswires

November 01, 2023 06:14 ET (10:14 GMT)

Copyright (c) 2023 Dow Jones & Company, Inc.