Celcuity Inc. CELC

REVTORPYK (gedatolisib) REVTORPYK (gedatolisib) vial and box REVTORPYK is indicated for patients with HR+/HER2- advanced breast cancer without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic settingREVTORPYK is the first and only FDA-approved therapy that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to comprehensively blockade the PI3K/AKT/mTOR (“PAM”) pathwayIn the PIK3CA wild-type coho

While early-stage biopharmaceutical firms typically lack historic multi-year revenue growth (0% 3-year CAGR at $0.00 TTM revenue), positive operating cash flow generation (-$153.3M TTM), or positive free cash flow conversion (-$192.3M TTM), Celcuity Inc. (NASDAQ:CELC) enters its commercial rollout backed by a balance sheet holding $754 million in cash and equivalents. Although historic return on […]

MINNEAPOLIS, Sept. 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that Brian Sullivan, Chief Executive Officer and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences: A fireside chat at the Wells Fargo 21st Annual Healthcare Conference at 10:15 a.m. EDT on T

On August 13, Celcuity (NASDAQ:CELC) walked investors through a quarter unlike any in the company’s history. The clinical-stage biotech is no longer just clinical: its breast cancer drug Revtopik won FDA approval on July 14, and the call was built around how the company plans to turn that approval into an actual business. The tone […]

If approved, REVTORPYK would be the first and only therapy for advanced breast cancer with a PIK3CA mutation that inhibits all class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 MINNEAPOLIS, Aug. 26, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced the submission of its supplemental New Drug Application (“sNDA”) to the U.S. Food and

Celcuity (CELC) drew fresh attention after reporting second quarter 2026 results that showed a wider net loss as the company ramps up spending ahead of its first commercial oncology launch. See our latest analysis for Celcuity. Celcuity’s latest earnings report and recent FDA approval news have come after a sharp pullback, with the 90 day share price return down 30.4%, even as the 1 year total shareholder return sits at 77.6%. This suggests earlier strong gains are now cooling as investors...

In the second quarter of 2026, Celcuity Inc. reported a wider net loss of US$78.86 million and basic loss per share of US$1.44, even as it prepared for the commercial launch of its newly FDA‑approved breast cancer therapy Revtopik (also referred to as REVTORPYK). The FDA approval of Revtopik for HR‑positive, HER2‑negative advanced breast cancer, combined with its upgrade to Category 1 preferred status in NCCN guidelines and strong VICTORIA‑1 efficacy data, marks a key turning point as...

Moby summary of Celcuity Inc.'s Q2 2026 earnings call

Celcuity Inc (CELC) posts wider Q2 net loss amid REVTORPYK launch preparations, but strong cash position and positive Phase 3 data underscore growth potential.

REVTORPYK™ (gedatolisib) approved by the U.S. FDA for the treatment of HR+/HER2- PIK3CA Wild-Type locally advanced or metastatic breast cancer on July 14, 2026; on track for commercial launch late third quarter 2026NCCN® Clinical Practice Guidelines recommended REVTORPYK in combination with fulvestrant, with or without palbociclib, as a preferred Category 1 option for second-line therapy in HR+/HER2- advanced breast cancerThe Phase 3 PIK3CA mutant cohort of the VIKTORIA-1 trial achieved its prim

MINNEAPOLIS, Aug. 06, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a commercial-stage biotechnology company focused on developing and commercializing targeted therapies for the treatment of multiple solid tumor indications, today announced that it will release its financial results for the second quarter 2026 after the market closes on Thursday, August 13, 2026. Management will host a webcast/teleconference the same day at 4:30 p.m. Eastern Daylight Time to discuss the results and prov

REVTORPYK (gedatolisib) in combination with fulvestrant, with or without palbociclib, listed as a preferred Category 1 regimen for second-line or subsequent treatment for tumors without a PIK3CA mutation following progression on or after at least one line of endocrine therapyMINNEAPOLIS, July 30, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a biotechnology company focused on developing and commercializing targeted therapies for multiple solid tumor indications, today announced that REV

Celcuity stock crashed Wednesday after the biotech delayed the launch of its just-approved breast cancer treatment until the third quarter.