Celcuity Inc. — Form 8-K
Filed September 30, 2026 · analyzed by the 8-K Agent
8-K
▲ Likely positive
significance 72/100
What the filing says
Celcuity announced on September 30, 2026, that REVTORPYK (gedatolisib) is now commercially available in the U.S. for HR+/HER2- advanced breast cancer without PIK3CA mutation following progression after endocrine therapy. FDA approved the drug on July 14, 2026, for use in combination with fulvestrant alone (doublet) or with palbociclib plus fulvestrant (triplet). In the Phase 3 VIKTORIA-1 trial's PIK3CA wild-type cohort, REVTORPYK triplet and doublet reduced risk of disease progression or death by 76% and 67% respectively versus fulvestrant. The company has launched REVTORPYK Support Services for patient access and reimbursement assistance.
Why this rating
First FDA-approved product launch; addresses substantial breast cancer market (~70% of all breast cancers); clinical efficacy data strong (67-76% risk reduction); near-term revenue inflection material to $457.5M company. Commercialization risk remains.
Price action (we called it positive)
before filing · preread $81.00 | at our read pending | +10 min pending | +30 min pending | +1 hr pending | +4 hrs pending |
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