Jul. 15 at 11:08 AM
Citizens⬆️
$CELC to
$177, reiterated Market Outperform and said -- Celcuity's REVTORPYK (gedatolisib) in combination with fulvestrant, with or without palbociclib, won early approval and may be priced at a premium.
$RLAY $NVS AZN PFE
Citizens added—The approval, which came several days ahead of schedule, currently applies to only ER+/HER2- BC patients without PIK3CA mutations, based on results from VIKTORIA-1 Study 1.
The sNDA for the PIK3CA-mutant population is expected in 3Q26.
The FDA approval sets the stage for Celcuity's transition to a commercial-stage company.
We remain optimistic, and view this as an additional buying opportunity ahead of a high potential launch; we look forward to further detail, including final price (at a premium).
We maintain our Market Outperform rating and raise our DCF-derived price target to
$177, from
$160, by raising the PoS of Revtorpyk (gedatolisib) in the PI3K WT population to 100% following approval.
