Go­ing for broke, Tri­ci­da is slam­ming the brakes on a piv­otal tri­al ear­ly while plan­ning a run at the FDA

Two years af­ter a bit­ter set­back at the FDA, with its cash re­serves ebbing away, Tri­ci­da is ex­e­cut­ing a high-stakes gam­ble on win­ning a swift ap­proval at the FDA. A win would put them back in play with a new drug to com­mer­cial­ize. A loss, as one Wall Street an­a­lyst re­cent­ly as­sessed, would take the stock to ze­ro.

To­day Tri­ci­da $TC­DA an­nounced an “ad­min­is­tra­tive stop” for its VAL­OR-CKD tri­al af­ter watch­ing 237 pa­tients reach a pri­ma­ry end­point event — re­nal death, end-stage re­nal dis­ease, or greater than or equal to 40% re­duc­tion in es­ti­mat­ed glomeru­lar fil­tra­tion rate — in the re­nal out­comes study for their meta­bol­ic aci­do­sis and CKD drug vev­er­imer. They’ll con­tin­ue to track events in­to Q3 as they look for a top-line read­out in the near term.

Unlock this article instantly by becoming a free subscriber.

You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.

SIGN UP LOG IN BECOME A PREMIUM SUBSCRIBER