Cy­to­ki­net­ic­s' long and wind­ing road to de­vel­op its lead heart drug will face an ad­comm this fall

The path Cy­to­ki­net­ics has plot­ted for its lead heart drug will face one more po­ten­tial ob­sta­cle as it ap­proach­es its PDU­FA date this fall — an ad­comm.

FDA told Cy­to­ki­net­ics it plans to con­vene its pan­el of ex­perts to dis­cuss the ap­pli­ca­tion for ome­cam­tiv mecar­bil, the biotech said Tues­day morn­ing. The date and spe­cif­ic dis­cus­sion top­ics are not yet known, but Cy­to­ki­net­ics said the agency plans to fol­low up at a lat­er date.

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