Tricida CEO Gerrit Klaerner

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.

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