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Cogent Biosciences Reports Recent Business Highlights and Third Quarter 2026 Financial Results

Globe Newswire•05/11/2026•16:01 ET
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Key Highlights

  • ➤$791.1 million cash balance expected to fund operations into late 2028
  • ➤GIST bezuclastinib PDUFA action date set for November 30, 2026
  • ➤AdvSM bezuclastinib NDA accepted; PDUFA target action date June 29, 2027
  • ➤Third-quarter net loss widened to $111.4 million from $80.9 million
  • ➤G&A expenses rose to $42.1 million amid bezuclastinib commercial launch preparations

Expert Statements

Andrew Robbins, President and Chief Executive Officer of Cogent Biosciences

“With our commercial team in place, we are prepared to execute on the anticipated launch of bezuclastinib in GIST”

Andrew Robbins, President and Chief Executive Officer of Cogent Biosciences

“In parallel, our team is preparing for potential approvals in NonAdvanced and Advanced Systemic Mastocytosis and we expect to file INDs for our JAK2 and KRAS pipeline programs this quarter.”

Andrew Robbins, President and Chief Executive Officer of Cogent Biosciences

“Backed by a strong balance sheet and a world-class team, we are well positioned to continue our vision of creating best-in-class therapies for patients fighting rare, mutationally driven diseases.”

Preparing for anticipated bezuclastinib launch in GIST; PDUFA action date November 30, 2026

NonAdvSM PDUFA target action date December 30, 2026; AdvSM PDUFA target action date June 29, 2027

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