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Celcuity Wins FDA Approval for REVTORPYK; NCCN Recommends Second-Line Use

Aug 13, 2026, 4:19 PM EDT1 sourcesAI-analyzed
Why it may matterVerify against the original reporting

Regulatory approval combined with NCCN guidance and an upcoming sNDA submission strengthens revenue visibility and potential multiple expansion; near-term launch catalysts often trigger price appreciation for biotech names with a single marketed asset.

AI summary

What happened, with direct paths to the underlying reporting

Celcuity announced FDA approval of REVTORPYK (gedatolisib) for HR+/HER2- breast cancer and NCCN Category 1 endorsement for second-line use. Positive phase 3 VIKTORIA-1 data in PIK3CA mutant and wild-type cohorts supports a Q3 2026 sNDA filing, with late-Q3 2026 launch planned. The company also raised $557.2 million in convertible notes, providing a runway into 2029 while expanding VIKTORIA-2 into first-line settings.

  • FDA approves REVTORPYK for HR+/HER2- ABC; launch likely late Q3 2026.
  • NCCN names REVTORPYK + fulvestrant (± palbociclib) as Category 1 second-line option.
  • VIKTORIA-1 MT: PIK3CA WT cohort shows strong PFS benefits; sNDA planned for Q3 2026.
  • VIKTORIA-2 expanded to first-line settings; broader addressable patient population.
  • Convertible notes raise $575M; net $557.2M; cash runway into 2029.

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