Celcuity Inc. — News

CELC Investigation: Kessler Topaz Meltzer and Check, LLP Encourages Celcuity Inc. (NASDAQ: CELC) Investors to Contact the Firm PR N

gurufocus.com - 2026-07-31 12:00:00

RADNOR, Pa., July 31, 2026 /PRNewswire/ -- Kessler Topaz Meltzer & Check, LLP (www.ktmc.com), a nationally recognized securities litigation law firm, is investigating potential violations of the federal securities laws by Celcuity Inc. (NASDAQ: CELC) on behalf of investors who purchased or acquired Celcuity Inc. securities and experienced significant financial losses.

prnewswire.com - 2026-07-31 11:22:00

NEW YORK, July 30, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Celcuity Inc. ("Celcuity" or the "Company") (NASDAQ: CELC). Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext.

prnewswire.com - 2026-07-30 10:00:00

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 therapy 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 therapy

globenewswire.com - 2026-07-30 08:30:00

RADNOR, Pa., July 29, 2026 (GLOBE NEWSWIRE) -- Kessler Topaz Meltzer & Check, LLP (www.ktmc.com), a nationally recognized securities litigation law firm, is investigating potential violations of the federal securities laws by Celcuity Inc. (NASDAQ: CELC) on behalf of investors who purchased or acquired Celcuity Inc. securities and experienced significant financial losses.

globenewswire.com - 2026-07-29 10:55:00

RADNOR, Pa.--(BUSINESS WIRE)-- #classaction--Kessler Topaz Meltzer & Check, LLP (www.ktmc.com), a nationally recognized securities litigation law firm, is investigating potential violations of the federal securities laws by Celcuity Inc. (NASDAQ: CELC) on behalf of investors who purchased or acquired Celcuity Inc. securities and experienced significant financial losses. Celcuity Announces Unexpected Delayed Drug Launch On July 14, 2026, Celcuity Inc. issued a press release announcing that it had secured F.

businesswire.com - 2026-07-28 19:50:00

NEW YORK, July 28, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Celcuity Inc. (“Celcuity” or the “Company”) (NASDAQ: CELC).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.

globenewswire.com - 2026-07-28 17:31:00

NEW YORK, July 23, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Celcuity Inc. ("Celcuity" or the "Company") (NASDAQ: CELC).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext.

prnewswire.com - 2026-07-23 10:00:00

Bragar Eagel & Squire, P.C.  Litigation Partner  Brandon Walker  Encourages Investors Who Suffered Losses In Celcuity (CELC) To Contact Him Directly To Discuss Their Options

globenewswire.com - 2026-07-21 16:58:00

Celcuity slides 15% despite FDA approval of Revtorpyk as investors focus on a late Q3 2026 launch that delays commercial sales and near-term revenues.

zacks.com - 2026-07-21 14:31:07

NEW YORK, July 21, 2026 (GLOBE NEWSWIRE) -- Pomerantz LLP is investigating claims on behalf of investors of Celcuity Inc. (“Celcuity” or the “Company”) (NASDAQ: CELC).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext. 7980.

globenewswire.com - 2026-07-21 13:26:00

NEW YORK, July 20, 2026 (GLOBE NEWSWIRE) -- The law firm of Kirby McInerney LLP is investigating potential claims against Celcuity Inc. (“Celcuity” or the “Company”) (Nasdaq: CELC). The investigation concerns whether the Company and/or members of its senior management may have violated federal securities laws or engaged in other unlawful business practices.

globenewswire.com - 2026-07-20 20:00:00

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 executive officer, said on a conference call that REVTORPYK was approved in the United States

defenseworld.net - 2026-07-18 03:34:44

NEW YORK, July 16, 2026 /PRNewswire/ -- Pomerantz LLP is investigating claims on behalf of investors of Celcuity Inc. ("Celcuity" or the "Company") (NASDAQ: CELC).  Such investors are advised to contact Danielle Peyton at [email protected] or 646-581-9980, ext.

prnewswire.com - 2026-07-16 19:52:00

Celcuity Inc. (CELC) Discusses FDA Approval of REVTORPYK for Advanced HR+/HER2- Breast Cancer and Commercial Launch Plans Transcript

seekingalpha.com - 2026-07-15 16:17:57

Celcuity Inc. secured FDA approval for REVTORPYK, the first pan-PI3K, mTORC1/2 inhibitor for 2nd-line PIK3CA wild-type HR+/HER2- advanced breast cancer. I downgrade CELC from Strong Buy to Buy due to phase 3 mutant cohort data underperforming prior results and rising competitive threats from Relay Therapeutics. REVTORPYK demonstrated strong efficacy in both wild-type and mutant cohorts, but delayed commercial launch and potential for superior competitor data temper near-term enthusiasm.

seekingalpha.com - 2026-07-15 13:45:24

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