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Form 4 Celcuity Inc. For: Oct 07 Filed by: Furcht Leo

Fri, 09 Oct 2026 16:13:00 -0400

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Form 4 Celcuity Inc. For: Oct 01 Filed by: GRYSKA DAVID W

Mon, 05 Oct 2026 17:09:00 -0400

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Form 3 Celcuity Inc. For: Oct 01 Filed by: GRYSKA DAVID W

Mon, 05 Oct 2026 17:07:00 -0400

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Celcuity to present gedatolisib trial data at ESMO 2026

Mon, 05 Oct 2026 08:02:03 -0400

Celcuity Inc. (Nasdaq: CELC) announced it will present clinical trial data for its drug gedatolisib at the European Society for Medical Oncology Congress 2026, scheduled for October 23-27 in Madrid, Spain.

The company will feature one late-breaking rapid oral presentation and three poster presentations covering data from trials in hormone receptor positive, HER2-negative advanced breast cancer and metastatic castration-resistant prostate cancer.

The rapid oral presentation, assigned presentation number LBA 16, will cover updated results from VIKTORIA-1, a randomized, open-label Phase 3 study evaluating gedatolisib combined with fulvestrant, with or without palbociclib, versus standard of care in patients with HR+/HER2- advanced breast cancer.

Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026

Mon, 05 Oct 2026 08:00:00 -0400

Rapid oral presentation of additional sub-group analyses from the VIKTORIA-1 PIK3CA mutant-type cohort

Poster presentation of a comparative analysis of data for the gedatolisib triplet from the PIK3CA wild-type cohort of VIKTORIA-1 and other regimens evaluated in patients with HR+/HER2- advanced breast cancer

Poster presentation of sub-group analyses from the Phase 1b trial of gedatolisib plus darolutamide in patients with mCRPC

MINNEAPOLIS, Oct. 05, 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

Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026

Mon, 05 Oct 2026 08:00:00 -0400

Rapid oral presentation of additional sub-group analyses from the VIKTORIA-1 PIK3CA mutant-type cohort

Poster presentation of sub-group analyses from the Phase 1b trial of gedatolisib plus darolutamide in patients with mCRPC

Form 8-K Celcuity Inc. For: Oct 01

Fri, 02 Oct 2026 08:05:00 -0400

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Celcuity adds former Incyte CFO David Gryska to its board

Fri, 02 Oct 2026 08:01:07 -0400

Celcuity Inc. (Nasdaq: CELC) has appointed David W. Gryska to its Board of Directors, the Minneapolis-based biotechnology company announced Oct. 2, 2026.

Gryska previously served as Executive Vice President and Chief Financial Officer of Incyte Corporation, and as Senior Vice President and Chief Financial Officer of Celgene Corporation. Earlier in his career, he held CFO roles at Scios, Inc. and was a partner at Ernst & Young LLP in California.

Over the past 25 years, Gryska has served on the boards of eight public biotechnology companies. He currently serves on the Board of Directors of Definium Therapeutics and previously served on the

Celcuity Appoints David Gryska To Its Board Of Directors

Fri, 02 Oct 2026 08:00:00 -0400

MINNEAPOLIS, Oct. 02, 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 the appointment of David W. Gryska to its Board of Directors. Mr. Gryska is a seasoned executive who brings over 35 years of strategic and financial leadership experience in the life sciences industry to Celcuity, including advising early-stage biotechnology companies.

“On the heels of our first FDA approval for REVTORPYK™, we are pleased to welcome David to our Board of Directors as we transition into a

Celcuity Appoints David Gryska To Its Board Of Directors

Fri, 02 Oct 2026 08:00:00 -0400

“On the heels of our first FDA approval for REVTORPYK™, we are pleased to welcome David to our Board of Directors as we transition into a

Form 8-K Celcuity Inc. For: Sep 30

Wed, 30 Sep 2026 08:05:00 -0400

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Celcuity's Revtorpyk breast cancer drug now available in the US

Wed, 30 Sep 2026 08:04:53 -0400

Celcuity Inc. (Nasdaq: CELC) announced Sept. 30, 2026 that Revtorpyk (gedatolisib) is now commercially available in the United States for certain patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2-) locally advanced or metastatic breast cancer.

The drug is indicated for patients without a PIK3CA mutation detected following progression on or after at least one line of endocrine therapy in the metastatic setting. The U.S. Food and Drug Administration approved Revtorpyk on July 14, 2026, in combination with palbociclib and fulvestrant, and separately in combination with fulvestrant alone.

In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial,

Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States

Wed, 30 Sep 2026 08:00:00 -0400

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 setting
REVTORPYK 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”) pathway
In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, the REVTORPYK triplet and REVTORPYK doublet reduced the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant
Healthcare providers can visit

Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States

Wed, 30 Sep 2026 08:00:00 -0400

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 setting

REVTORPYK 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”) pathway

In the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial, the REVTORPYK triplet and REVTORPYK doublet reduced the risk of disease progression or death by 76% and 67%, respectively, compared to fulvestrant

Healthcare providers can visit

JPMorgan Starts Celcuity Inc (CELC) at Overweight

Thu, 17 Sep 2026 02:56:07 -0400

JPMorgan analyst Anupam Rama initiates coverage on Celcuity Inc (NASDAQ: CELC) with a Overweight rating and a price target of $157.00.
The analyst comments: “We are initiating coverage of Celcuity (CELC) with an Overweight rating and a December 2027 price target of $157, reflecting the long-term potential of Revtorpyk (gedatolisib) in breast cancer. Following the approval of Revtorpyk in 2L HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation (wild-type), the near-term focus will be on launch metrics, with product launch expected in late 3Q26. Accounting for near-term launch considerations, we expect 2026 / 2027 consensus estimates to moderate

JPMorgan Starts Celcuity Inc (CELC) at Overweight

Thu, 17 Sep 2026 02:56:07 -0400

JPMorgan analyst Anupam Rama initiates coverage on Celcuity Inc (NASDAQ: CELC) with a Overweight rating and a price target of $157.00.
The analyst comments: “We are initiating coverage of Celcuity (CELC) with an Overweight rating and a December 2027 price target of $157, reflecting the long-term potential of Revtorpyk (gedatolisib) in breast cancer. Following the approval of Revtorpyk in 2L HR+/HER2- locally advanced or metastatic breast cancer without a PIK3CA mutation (wild-type), the near-term focus will be on launch metrics, with product launch expected in late 3Q26. Accounting for near-term launch considerations, we expect 2026 / 2027 consensus estimates to moderate

Form 8-K Celcuity Inc. For: Aug 26

Wed, 26 Aug 2026 08:35:00 -0400
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Form 8-K Celcuity Inc. For: Aug 26

Wed, 26 Aug 2026 08:35:00 -0400
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Celcuity files sNDA for gedatolisib in PIK3CA mutant breast cancer

Wed, 26 Aug 2026 08:32:16 -0400

Celcuity Inc. (Nasdaq: CELC) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Revtorpyk (gedatolisib) to treat patients with hormone receptor positive, HER2-negative locally advanced or metastatic breast cancer with a PIK3CA mutation, following progression on at least one line of endocrine therapy.
The application is supported by results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial. In that cohort, the Revtorpyk-triplet regimen — gedatolisib combined with fulvestrant and palbociclib — reduced the risk of disease progression or death by 50% compared with alpelisib plus fulvestrant (HR=0.50; 95%

Celcuity files sNDA for gedatolisib in PIK3CA mutant breast cancer

Wed, 26 Aug 2026 08:32:16 -0400

Celcuity Inc. (Nasdaq: CELC) announced the submission of a supplemental New Drug Application (sNDA) to the U.S. Food and Drug Administration for Revtorpyk (gedatolisib) to treat patients with hormone receptor positive, HER2-negative locally advanced or metastatic breast cancer with a PIK3CA mutation, following progression on at least one line of endocrine therapy.
The application is supported by results from the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 clinical trial. In that cohort, the Revtorpyk-triplet regimen — gedatolisib combined with fulvestrant and palbociclib — reduced the risk of disease progression or death by 50% compared with alpelisib plus fulvestrant (HR=0.50; 95%

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Wed, 26 Aug 2026 08:30:00 -0400

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 Drug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Wed, 26 Aug 2026 08:30:00 -0400

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 Drug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Wed, 26 Aug 2026 08:30:00 -0400

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 Drug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Wed, 26 Aug 2026 08:30:00 -0400

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 Drug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Wed, 26 Aug 2026 08:30:00 -0400

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 Drug Administration (“FDA”) for REVTORPYK™ (gedatolisib) for the treatment of patients with hormone receptor positive (“HR+”), human epidermal growth

StreetInsider.com News Articles

Form 4 Celcuity Inc. For: Oct 07 Filed by: Furcht Leo

Form 4 Celcuity Inc. For: Oct 01 Filed by: GRYSKA DAVID W

Form 3 Celcuity Inc. For: Oct 01 Filed by: GRYSKA DAVID W

Celcuity to present gedatolisib trial data at ESMO 2026

Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026

Celcuity Announces Multiple Presentations At The European Society For Medical Oncology (ESMO) Congress 2026

Form 8-K Celcuity Inc. For: Oct 01

Celcuity adds former Incyte CFO David Gryska to its board

Celcuity Appoints David Gryska To Its Board Of Directors

Celcuity Appoints David Gryska To Its Board Of Directors

Form 8-K Celcuity Inc. For: Sep 30

Celcuity's Revtorpyk breast cancer drug now available in the US

Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States

Celcuity Announces That REVTORPYK™ (gedatolisib) Is Now Commercially Available In The United States

JPMorgan Starts Celcuity Inc (CELC) at Overweight

JPMorgan Starts Celcuity Inc (CELC) at Overweight

Form 8-K Celcuity Inc. For: Aug 26

Form 8-K Celcuity Inc. For: Aug 26

Celcuity files sNDA for gedatolisib in PIK3CA mutant breast cancer

Celcuity files sNDA for gedatolisib in PIK3CA mutant breast cancer

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer

Celcuity Submits sNDA to FDA for REVTORPYK™ (gedatolisib) for HR+/HER2-, PIK3CA Mutant Locally Advanced or Metastatic Breast Cancer