Celcuity Inc. develops targeted oncology therapies as a clinical-stage biotechnology company, with news centered on gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor for solid tumors. Company updates frequently cover Phase 3 VIKTORIA-1 data in HR+/HER2- advanced breast cancer, including PIK3CA wild-type and mutant cohorts and combination regimens with fulvestrant and palbociclib.
Recurring announcements also address FDA regulatory submissions and review status for gedatolisib, publications and medical-meeting presentations, quarterly financial results, corporate updates, investor conference participation, and board governance changes.
Celcuity (CELC) appointed David W. Gryska to its Board of Directors as the biotechnology company transitions into a commercial-stage business. Gryska brings over 35 years of financial and strategic leadership experience in life sciences, including former chief financial officer roles at Incyte and Celgene.
The appointment follows Celcuity’s first FDA approval for REVTORPYK. The company expects Gryska to support the product launch and continued clinical development. He has served on the boards of eight public biotechnology companies over the past 25 years and currently serves on Definium Therapeutics’ board.
Celcuity (CELC) has made REVTORPYK (gedatolisib) commercially available in the United States for eligible patients with advanced breast cancer. The FDA approved it on July 14, 2026, with fulvestrant, with or without palbociclib. Eligibility covers adults with hormone receptor-positive, HER2-negative locally advanced or metastatic breast cancer without a detected PIK3CA mutation, following progression on or after at least one endocrine therapy in the metastatic setting.
In the Phase 3 VIKTORIA-1 cohort without PIK3CA mutations, the three-drug and two-drug combinations reduced the risk of progression or death by 76% and 67%, respectively, versus fulvestrant. Celcuity submitted an additional FDA application in August for patients with PIK3CA-mutated advanced breast cancer; that use remains conditional on approval. The company also launched REVTORPYK Support Services for insurance coverage, financial assistance and treatment enrollment.
Celcuity (Nasdaq: CELC) announced that CEO and co-founder Brian Sullivan will participate in two upcoming investor conferences. He will join a fireside chat at the Wells Fargo 21st Annual Healthcare Conference/b) at 10:15 a.m. EDT on Tuesday, September 8, 2026, and a fireside chat at at 8:00 a.m. EDT on Wednesday, September 9, 2026. Live webcasts for both events will be accessible via conference weblinks and through the Investors section of Celcuity's website, with replays available shortly after the live events.
Celcuity (Nasdaq: CELC) submitted a supplemental New Drug Application (sNDA) to the U.S. FDA seeking to expand REVTORPYK™ (gedatolisib) to adults with HR+/HER2-, PIK3CA mutant locally advanced or metastatic breast cancer after at least one prior endocrine therapy. If approved, REVTORPYK would be the first therapy for this setting that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2.
The application is supported by the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial. REVTORPYK plus fulvestrant and palbociclib reduced risk of disease progression or death by 50% versus alpelisib plus fulvestrant (HR=0.50), with median PFS of 11.1 vs 5.6 months. The doublet regimen reduced risk by 49% (HR=0.51) with median PFS of 11.3 vs 5.6 months and showed ORRs of 49% (triplet) and 36% (doublet) with durable responses. REVTORPYK was FDA‑approved on July 14, 2026 for HR+/HER2- disease without PIK3CA mutation.
Celcuity (Nasdaq: CELC) reported second quarter 2026 results and major milestones for REVTORPYK (gedatolisib). On July 14, 2026, the FDA approved REVTORPYK for HR+/HER2-, PIK3CA wild-type locally advanced or metastatic breast cancer after at least one prior endocrine therapy in the metastatic setting. The NCCN Guidelines® now recommend REVTORPYK plus fulvestrant, with or without palbociclib, as a preferred Category 1 second-line and subsequent-line option.
The PIK3CA-mutant cohort of Phase 3 VIKTORIA-1 met its primary endpoint: gedatolisib triplet and doublet reduced risk of progression or death by ~50% vs alpelisib plus fulvestrant, with median PFS around 11 months vs 5.6 months. Celcuity plans an sNDA filing in Q3 2026 and has opened an Expanded Access Program ahead of a planned late Q3 2026 commercial launch.
Celcuity completed a $575.0 million 0.250% convertible senior note offering, generating net proceeds of $557.2 million, using $137.0 million to prepay term debt. Q2 2026 net loss was $78.9 million (vs $45.3 million), with operating expenses of $66.1 million. Cash, cash equivalents and short-term investments totaled $754.0 million, which Celcuity expects to fund operations at least into 2029.
Celcuity (Nasdaq: CELC) will release its second quarter 2026 financial results after the market closes on Thursday, August 13, 2026. Management will host a webcast/teleconference at 4:30 p.m. Eastern Daylight Time the same day to discuss results and provide a corporate update.
Celcuity (Nasdaq: CELC) announced that newly FDA‑approved REVTORPYK (gedatolisib), in combination with fulvestrant with or without palbociclib, has been added as a preferred Category 1 regimen in the NCCN Clinical Practice Guidelines for second‑line or later treatment of HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation after at least one line of endocrine therapy.
FDA approval on July 14, 2026 was supported by Phase 3 VIKTORIA‑1 results, where the triplet showed median PFS of 9.3 vs 2.0 months (HR=0.24) versus fulvestrant, and the doublet 7.4 vs 2.0 months (HR=0.33). REVTORPYK is described as the only approved inhibitor targeting all class I PI3K isoforms and mTORC1/2. Celcuity expects U.S. commercial availability in late Q3 2026, has established a patient support program, and is offering an expanded access program before launch.
Celcuity (Nasdaq: CELC) announced U.S. FDA approval of REVTORPYK™ (gedatolisib) for adults with HR+/HER2-, PIK3CA wild-type, locally advanced or metastatic breast cancer whose disease progressed after at least one line of endocrine therapy in the metastatic setting.
According to Celcuity, REVTORPYK is the first and only FDA‑approved therapy that simultaneously inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2. Approval is based on the Phase 3 VIKTORIA-1 trial in the PIK3CA wild-type cohort, where REVTORPYK plus palbociclib and fulvestrant achieved median progression‑free survival of 9.3 months versus 2.0 months with fulvestrant alone (HR=0.24), and REVTORPYK plus fulvestrant achieved 7.4 versus 2.0 months (HR=0.33). Celcuity anticipates commercial launch in late Q3 2026, will offer an expanded access program, and plans an sNDA in Q3 2026 for the PIK3CA‑mutated population.
Celcuity (Nasdaq: CELC) priced an upsized underwritten public offering of $500 million 0.250% convertible senior notes due 2032, increased from $400 million. The notes carry a 0.250% annual coupon, mature August 1, 2032, and are senior unsecured obligations.
The initial conversion rate is 8.0302 CELC shares per $1,000 principal (conversion price about $124.53, a 40% premium). Net proceeds are estimated at $484.3 million (or $557.0 million with full over-allotment), to repay Celcuity’s Oxford Finance loan and fund working capital, clinical and commercialization activities, and general corporate purposes.
Celcuity (Nasdaq: CELC) announced a proposed underwritten public offering of $400 million convertible senior notes due 2032, with a $60 million over-allotment option.
According to Celcuity, net proceeds will repay its Oxford Finance loan in full, with the balance for working capital and general corporate purposes.