CELCCelcuity Inc.
Celcuity Inc., a clinical-stage biotechnology company, focuses on the development of targeted therapies for the treatment of various solid tumors in the United States. The company's lead drug candidate includes Gedatolis…
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![]() Celcuity (CELC) Q2 2026 Earnings Call Transcript Revtopik launch underway with 80 oncology specialists supporting expansion into first-line treatment. | ||
![]() Is Celcuity (CELC) A Bargain As Losses Widen Ahead Of Its First Launch? 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... | ||
![]() How Investors May Respond To Celcuity (CELC) Winning FDA Nod For Revtopik Amid Wider Quarterly Loss 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... | ||
![]() Celcuity Inc. Q2 2026 Earnings Call Summary Moby summary of Celcuity Inc.'s Q2 2026 earnings call | ||
Celcuity Inc (CELC) (Q2 2026) Earnings Call Highlights: FDA Approval and Commercial Launch ... Celcuity Inc (CELC) posts wider Q2 net loss amid REVTORPYK launch preparations, but strong cash position and positive Phase 3 data underscore growth potential. | ||
![]() Celcuity Q2 Earnings Call Highlights Celcuity (NASDAQ:CELC) said it remains on track to begin commercial shipments of REVTORPYK, its gedatolisib therapy for certain patients with advanced breast cancer, late in the third quarter of 2026 following its recent FDA approval. The FDA approved REVTORPYK in July in combination with fulvestra | ||
Why This Biotech Stock, With Its First FDA Approval, Just Crashed By Double Digits Celcuity stock crashed Wednesday after the biotech delayed the launch of its just-approved breast cancer treatment until the third quarter. | ||
Celcuity shares fall as delayed breast cancer drug launch eclipses first US FDA approval July 15 () - Shares of Celcuity fell about 8% in premarket trading on Wednesday, as the delayed commercial launch of its newly approved breast cancer drug and treatment-tolerability concerns overshadowed the company's first U. Food and Drug Administration on Tuesday approved gedatolisib, branded as Revtorpyk, for certain patients with advanced breast cancer whose tumors do not carry a PIK3CA mutation. | ||
Celcuity gains FDA approval for closely watched breast cancer drug Still, shares fell by nearly 20% after the company revealed a delay in the coming launch of Revtorpyk. Details in the drug’s prescribing information surprised some analysts, too. | ||
Celcuity Enters Commercial Stage as FDA Approves REVTORPYK for Advanced Breast Cancer Celcuity (NASDAQ:CELC) said the U.S. Food and Drug Administration has granted full approval to gedatolisib, now branded as REVTORPYK, for certain patients with advanced breast cancer, marking the company’s transition to a commercial-stage business. Brian Sullivan, Celcuity’s co-founder and chief ex | ||
CELC Stock Clocks Best Day In About 2 Months On First FDA Approval For Cancer Drug Gedatolisib, in-licensed from Pfizer in 2021, is Celcuity’s sole late-stage asset. | ||
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