Welcome to our dedicated page for Celcuity news (Ticker: CELC), a resource for investors and traders seeking the latest updates and insights on Celcuity stock.
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 (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.
Celcuity (Nasdaq: CELC) reported detailed Phase 3 VIKTORIA-1 results in PIK3CA-mutant HR+/HER2- advanced breast cancer. Gedatolisib plus fulvestrant and palbociclib cut risk of progression or death by 50% vs alpelisib/fulvestrant (HR=0.50) with median PFS 11.1 vs 5.6 months and ORR 48.9% vs 26.0%.
The gedatolisib doublet showed HR=0.51 and median PFS 11.3 months. Safety was generally manageable with low discontinuation rates. Celcuity plans an sNDA for PIK3CA-mutant disease and already has Priority Review for PIK3CA wild-type, with a PDUFA date of July 17, 2026.
Celcuity (Nasdaq: CELC) will host a conference call and live webcast on June 2, 2026 to discuss results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial in HR+/HER2- advanced breast cancer.
The event begins at 8:00 a.m. EDT / 7:00 a.m. CDT, with a replay available on Celcuity's website.
Celcuity (Nasdaq: CELC) announced CEO Brian Sullivan will present and hold one-on-one investor meetings at two upcoming healthcare investor conferences in June 2026.
Both fireside chats at Jefferies and Goldman Sachs will be available via live webcast and replay through dedicated links and the company’s investor relations website.
Celcuity (Nasdaq: CELC) reported Q1 2026 results and key updates for gedatolisib in HR+/HER2- advanced breast cancer.
The Phase 3 VIKTORIA-1 trial met its primary endpoint with statistically significant, clinically meaningful PFS benefit in PIK3CA mutant patients; an NDA has Priority Review with a July 17, 2026 PDUFA date. Cash was $387.1 million, expected to fund operations through 2027.