CELCUITY


Associated tags: Cancer, Patient, CELC, Pharmaceutical industry, Webcast

Locations: UNITED STATES, ASIA, SOUTH AMERICA, EUROPE, MINNEAPOLIS, MN, US, TD, USA, SAN FRANCISCO, NEW YORK

Celcuity Announces First Patient Dosed in Phase 1b/2 CELC-G-201 Clinical Trial of Gedatolisib for the Treatment of Metastatic Castration Resistant Prostate Cancer

Retrieved on: 
Thursday, February 22, 2024

MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).

Key Points: 
  • MINNEAPOLIS, Feb. 22, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company developing targeted therapies for oncology, today announced that the first patient has been dosed in its Phase 1b/2 study (CELC-G-201) evaluating gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC).
  • Gedatolisib, the company’s lead therapeutic candidate, is a potent, reversible dual inhibitor that selectively targets all Class 1 PI3K isoforms and mTORC1/2.
  • “We are excited to begin enrolling patients in our 201 trial and advancing towards our ultimate goal of providing a transformative therapeutic option for patients with prostate cancer,” said Igor Gorbatchevsky, M.D.
  • “As it stands, there are limited options for patients with mCRPC whose disease progressed on or after treatment with an androgen receptor inhibitor.

Celcuity Appoints Eldon Mayer as Chief Commercial Officer

Retrieved on: 
Tuesday, February 20, 2024

MINNEAPOLIS, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Eldon Mayer as Chief Commercial Officer.

Key Points: 
  • MINNEAPOLIS, Feb. 20, 2024 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced the appointment of Eldon Mayer as Chief Commercial Officer.
  • Mr. Mayer joins Celcuity with over 30 years of biopharmaceutical commercial experience in companies ranging from early-stage biotechs to full scale pharmaceutical companies across many therapeutic areas, including oncology.
  • Prior to Eiger, he was Executive Vice President and Chief Commercial Officer of Rigel Pharmaceuticals where he built and led the commercial organization and launched Tavalisse® (fostamatinib disodium hexahydrate) for chronic immune thrombocytopenia.
  • “I am excited to join Celcuity and work alongside driven, collaborative colleagues during this pivotal time for the company,” said Eldon Mayer.

Celcuity Presents Preclinical Data on Therapeutic Effects of Gedatolisib in Breast Cancer Models at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Wednesday, December 6, 2023

MINNEAPOLIS, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today presented data from preclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR (PAM) inhibitors in breast cancer cell lines during a poster session at the 2023 San Antonio Breast Cancer Symposium (SABCS).

Key Points: 
  • MINNEAPOLIS, Dec. 06, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today presented data from preclinical studies evaluating gedatolisib and other PI3K/AKT/mTOR (PAM) inhibitors in breast cancer cell lines during a poster session at the 2023 San Antonio Breast Cancer Symposium (SABCS).
  • The preclinical studies evaluated gedatolisib, a pan-PI3K/mTOR inhibitor, and PAM inhibitors that selectively target single PAM nodes (PI3Kα, AKT, and mTORC1) to compare the functional effect of inhibiting multiple vs. single PAM pathway nodes in a panel of breast cancer cell lines.
  • In cell viability and proliferation analyses, gedatolisib was found to be more cytotoxic and at least 300-fold more potent, on average, compared to the single node PAM inhibitors.
  • Mechanistically, gedatolisib decreased cell survival, DNA replication, protein synthesis, glucose consumption, lactate production and oxygen consumption more effectively than the other PAM inhibitors.

Celcuity to Present Preclinical Data for Gedatolisib at the 2023 San Antonio Breast Cancer Symposium

Retrieved on: 
Friday, December 1, 2023

MINNEAPOLIS, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an abstract accepted for a poster presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website.

Key Points: 
  • MINNEAPOLIS, Dec. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that an abstract accepted for a poster presentation at the 2023 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website.
  • The 2023 San Antonio Breast Cancer Symposium (SABCS) is being held virtually and in-person from December 5-9, 2023.
  • The presentation will include potency and efficacy data evaluating the effects of gedatolisib, a pan-PI3K/mTOR (PAM) inhibitor, and approved PAM inhibitors (PAMi) on breast cancer cell lines with mutated or non-mutated PAM pathway genes.
  • A Phase 3 VIKTORIA-1 trial evaluating gedatolisib plus fulvestrant with and without palbociclib is underway in in adults with HR+, HER2- advanced breast cancer.

Celcuity to Participate in the 6th Annual Evercore ISI HealthCONx Conference

Retrieved on: 
Wednesday, November 22, 2023

MINNEAPOLIS, Nov. 22, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the 6th Annual Evercore ISI HealthCONx Conference held in Miami.

Key Points: 
  • MINNEAPOLIS, Nov. 22, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced its participation in the 6th Annual Evercore ISI HealthCONx Conference held in Miami.
  • Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, is scheduled for a fireside chat at 12:30 p.m.
  • A live webcast of the event will be available using this weblink: https://wsw.com/webcast/evercore39/celc/2327201 .
  • Alternatively, the live webcast will be accessible from the Investors section of the company's website at https://ir.celcuity.com/events-presentations/ with a replay available shortly after.

Celcuity Inc. Reports Third Quarter 2023 Financial Results and Provides Corporate Updates

Retrieved on: 
Monday, November 13, 2023

ET

Key Points: 
  • ET
    MINNEAPOLIS, Nov. 13, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today reported financial results for the third quarter ended September 30, 2023 and provided other recent corporate updates.
  • Total operating expenses were $18.9 million for the third quarter of 2023, compared to $10.6 million for the third quarter of 2022.
  • General and administrative expenses were $1.4 million for the third quarter of 2023, compared to $1.0 million for the third quarter of 2022.
  • ET today to discuss the third quarter financial results and provide a corporate update.

Celcuity Inc. Schedules Release of Third Quarter 2023 Financial Results and Webcast/Conference Call

Retrieved on: 
Monday, November 6, 2023

MINNEAPOLIS, Nov. 06, 2023 (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 third quarter 2023 before the market opens on Monday, November 13, 2023.

Key Points: 
  • MINNEAPOLIS, Nov. 06, 2023 (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 third quarter 2023 before the market opens on Monday, November 13, 2023.
  • Management will host a webcast/teleconference the same day at 8:00 a.m. Eastern Time to discuss the results and provide a corporate update.
  • A live webcast presentation can also be accessed using this weblink: https://viavid.webcasts.com/starthere.jsp?ei=1639042&tp_key=7d2827005c .
  • A replay of the webcast will be available on the Celcuity website following the live event.

Celcuity To Present at Upcoming Stifel and Jefferies Investor Conferences

Retrieved on: 
Wednesday, November 1, 2023

MINNEAPOLIS, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chairman, Chief Executive Officer, and Co-founder of Celcuity, will present and be available for one-on-one investor meetings at the following investor conferences:

Key Points: 
  • MINNEAPOLIS, Nov. 01, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that Brian Sullivan, Chairman, 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 formal presentation at the Stifel 2023 Healthcare Conference in New York at 4:10 p.m.
  • ET on Tuesday, November 14, 2023.
  • A live webcast will be available using this weblink: https://wsw.com/webcast/stifel83/celc/2056478 ; and
    A fireside chat at the Jefferies London Healthcare Conference at 8:00 a.m. GMT / 4:00 a.m.
  • A live webcast will be available using this weblink: https://wsw.com/webcast/jeff287/celc/1825156 .

Celcuity to Host Virtual Science Day for Investors

Retrieved on: 
Thursday, September 7, 2023

ET on September 21, 2023

Key Points: 
  • ET on September 21, 2023
    MINNEAPOLIS, Sept. 07, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, today announced that it will host a Virtual Science Day for analysts and investors from 10:00 a.m. – 12:00 p.m.
  • In early 2024, Celcuity expects to initiate the Phase 1b/2 CELC-G-201 trial of gedatolisib in combination with the androgen receptor inhibitor Nubeqa® (darolutamide) in metastatic castration resistant prostate cancer.
  • Celcuity’s Virtual Science Day for analysts and investors will take place on Thursday, September 21, 2023, from 10:00 a.m. to 12:00 p.m.
  • A replay of the webcast will be available on the “Events & Presentations” section of Celcuity’s website following the event.

Celcuity Announces Plan to Conduct Phase 1b/2 Clinical Trial in Metastatic Castration Resistant Prostate Cancer

Retrieved on: 
Tuesday, August 22, 2023

MINNEAPOLIS, Aug. 22, 2023 (GLOBE NEWSWIRE) -- Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company pursuing development of targeted therapies for oncology, has been notified by the U.S. Food and Drug Administration (FDA) that its Investigational New Drug (IND) submission has been reviewed, and Celcuity can proceed with the clinical development of gedatolisib in combination with Nubeqa® (darolutamide), an approved androgen receptor inhibitor, for the treatment of patients with metastatic castration resistant prostate cancer (mCRPC). Celcuity’s Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor as first-line treatment for mCRPC. The Company anticipates initiating this Phase 1b/2 clinical trial in the first quarter of 2024.

Key Points: 
  • Celcuity’s Phase 1b/2 study (CELC-G-201) will enroll up to 54 participants with mCRPC who progressed after treatment with an androgen receptor inhibitor as first-line treatment for mCRPC.
  • The Company anticipates initiating this Phase 1b/2 clinical trial in the first quarter of 2024.
  • “We are excited to initiate the clinical development of gedatolisib in prostate cancer,” said Brian Sullivan, Chief Executive Officer and co-founder of Celcuity.
  • A replay of the webcast will be available on the “Events & Presentations” section of Celcuity’s website for a limited time following the event.