Cy­to­Dyn shares slammed as BLA fil­ing for leron­limab in HIV hits a wall

In a press re­lease is­sued in ear­ly June an­nounc­ing a BLA ac­knowl­edg­ment let­ter from the FDA, Cy­to­Dyn CEO Nad­er Pourhas­san said he is hope­ful about get­ting a PDU­FA date for its lead drug, leron­limab, on Ju­ly 10.

In­stead, they re­ceived a refuse-to-file let­ter to­day.

The com­pa­ny said the agency is just look­ing for “cer­tain in­for­ma­tion need­ed to com­plete a sub­stan­tive re­view.” No clin­i­cal tri­als are nec­es­sary; all that’s need­ed is ad­di­tion­al analy­sis and a meet­ing with the FDA.

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