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.S. approval.

reuters.com - 2026-07-15 08:43:57

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.

marketbeat.com - 2026-07-15 04:02:07

MINNEAPOLIS, July 14, 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 the U.S. Food and Drug Administration (“FDA”) approved REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-”), locally advanced or metastatic breast cancer without a PIK3CA mutation detected following progression on or after treatment with at least one line of endocrine therapy in the metastatic setting. REVTORPYK is the only inhibitor of class I PI3K isoforms (α, β, δ, γ) and mTOR complexes mTORC1 and mTORC2 to receive FDA approval.

globenewswire.com - 2026-07-14 16:53:00

Celcuity Inc. (CELC) Presents at Goldman Sachs 47th Annual Global Healthcare Conference 2026 Transcript

seekingalpha.com - 2026-06-10 15:32:13

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) ("Celcuity" or the "Company"), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced the pricing of its upsized underwritten public offering of $500,000,000 aggregate principal amount of its 0.

globenewswire.com - 2026-06-03 22:13:20

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (“Celcuity” or the “Company”), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced the pricing of its upsized underwritten public offering of $500,000,000 aggregate principal amount of its 0.250% convertible senior notes due 2032 (the “Convertible Notes”). The aggregate principal amount of the offering was increased from the previously announced offering size of $400,000,000.

globenewswire.com - 2026-06-03 22:13:00

Celcuity (CELC) shares dropped over 25% despite Phase 3 VIKTORIA-1 data confirming gedatolisib's best-in-class efficacy in advanced breast cancer. Gedatolisib demonstrated superior progression-free survival and objective response rates versus current standards, supporting blockbuster potential in a $6bn market. FDA approval for HR+/HER2- PIK3CA wild-type breast cancer is expected by July 2026, with a supplementary NDA for the mutant cohort planned.

seekingalpha.com - 2026-06-03 09:33:26

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) ("Celcuity" or the "Company"), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced a proposed underwritten public offering of $400,000,000 aggregate principal amount of its convertible senior notes due 2032 (the "Convertible Notes").

globenewswire.com - 2026-06-03 07:19:12

MINNEAPOLIS, June 03, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC) (“Celcuity” or the “Company”), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced a proposed underwritten public offering of $400,000,000 aggregate principal amount of its convertible senior notes due 2032 (the “Convertible Notes”).

globenewswire.com - 2026-06-03 07:19:00

Celcuity Inc. (CELC) Discusses VIKTORIA-1 Trial Results for PIK3CA Mutant Advanced Breast Cancer and Gedatolisib Efficacy Transcript

seekingalpha.com - 2026-06-02 16:11:55

Celcuity Inc. (NASDAQ:CELC) on Tuesday reported detailed efficacy and safety findings from the PIK3CA-mutated cohort of its Phase 3 VIKTORIA-1 trial.

benzinga.com - 2026-06-02 13:37:26

Celcuity shares slumped 25% , set for their biggest one-day decline, on Tuesday after its experimental breast cancer treatment extended ​the period of time a patient lives without the disease ‌worsening but underperformed a previous trial.

reuters.com - 2026-06-02 13:20:26

MINNEAPOLIS, June 02, 2026 (GLOBE NEWSWIRE) --  Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced detailed efficacy and safety results from the PIK3CA mutant (“MT”) cohort of the Phase 3 VIKTORIA-1 clinical trial of gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor, in adults with hormone receptor positive (“HR+”), human epidermal growth factor receptor 2 negative (“HER2-“), PIK3CA mutated, locally advanced or metastatic breast cancer (“ABC”), following progression on, or after, treatment with a CDK4/6 inhibitor and an aromatase inhibitor. VIKTORIA-1 is the first Phase 3 clinical trial to compare the efficacy of two PI3K/AKT/mTOR (“PAM”) inhibitors in this patient population.

globenewswire.com - 2026-06-02 08:25:00

MINNEAPOLIS, June 01, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced it will host a conference call and live webcast to review results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial on Tuesday, June 2, 2026 at 8:00 a.m. EDT / 7:00 a.m.

globenewswire.com - 2026-06-01 08:30:00

MINNEAPOLIS, May 28, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of 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:

globenewswire.com - 2026-05-28 08:30:00

On Thursday, Celcuity Inc. (NASDAQ:CELC) announced amendments to its Phase 3 VIKTORIA-2 clinical trial evaluating gedatolisib as a first-line treatment for patients with hormone receptor-positive, HER2-negative advanced or metastatic breast cancer.

benzinga.com - 2026-05-15 13:13:15

Celcuity Inc. (CELC) Q1 2026 Earnings Call Transcript

seekingalpha.com - 2026-05-14 20:20:42

Celcuity NASDAQ: CELC reported a wider first-quarter loss as the biotechnology company increased spending tied to commercial launch preparations and continued development of gedatolisib, its investigational therapy for hormone receptor-positive, HER2-negative advanced breast cancer.

marketbeat.com - 2026-05-14 19:11:03

MINNEAPOLIS, May 14, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on the development of targeted therapies for the treatment of multiple solid tumor indications, today announced financial results for the first quarter ended March 31, 2026 and other recent business developments.

globenewswire.com - 2026-05-14 16:01:00

Development of a gedatolisib formulation for subcutaneous injection is underway; first patent application submitted to the U.S. Patent and Trademark Office Development of a gedatolisib formulation for subcutaneous injection is underway; first patent application submitted to the U.S. Patent and Trademark Office

globenewswire.com - 2026-05-14 07:30:00

MINNEAPOLIS, May 07, 2026 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will release its financial results for the first quarter 2026 after the market closes on Thursday, May 14, 2026. Management will host a webcast/teleconference the same day at 4:30 p.m.

globenewswire.com - 2026-05-07 08:00:00

Celcuity Inc. (NASDAQ:CELC) shares are up during Monday's premarket session following positive news about its Phase 3 VIKTORIA-1 trial results.

benzinga.com - 2026-05-04 07:05:45

Detailed data for the gedatolisib triplet and doublet regimens will be presented at a late-breaking abstract oral session at the 2026 ASCO Annual Meeting Detailed data for the gedatolisib triplet and doublet regimens will be presented at a late-breaking abstract oral session at the 2026 ASCO Annual Meeting

globenewswire.com - 2026-05-01 17:03:00

Celcuity (CELC) is rated a cautious Buy, with upside contingent on positive mutant cohort data for gedatolisib in 2L HR+/HER2- advanced breast cancer. Current $6B valuation already prices in significant success, assuming $1–1.5B peak sales; management's $2.5B target requires broad label and strong market adoption. VIKTORIA-1 phase 3 data show gedatolisib offers best-in-class efficacy and manageable safety in wild-type patients, but mutant cohort results in Q2 2026 are the key catalyst.

seekingalpha.com - 2026-04-29 10:21:12

An analyst initiated coverage of the biotech.

fool.com - 2026-04-27 18:18:13