Welcome to our dedicated page for Celcuity news (Ticker: CELC), a resource for investors and traders seeking the latest updates and insights on Celcuity stock.
Celcuity Inc. (NASDAQ: CELC) is a clinical-stage biotechnology company headquartered in Minneapolis and focused on targeted therapies for oncology. News about Celcuity primarily centers on the development of its lead investigational drug, gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) pathway inhibitor being studied in multiple solid tumor indications, including HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.
On this page, readers can follow Celcuity’s clinical trial milestones, such as topline and detailed results from the Phase 3 VIKTORIA-1 trial in HR+/HER2-/PIK3CA wild-type and mutant advanced breast cancer, as well as updates on the Phase 3 VIKTORIA-2 first-line trial and the Phase 1/2 CELC-G-201 study of gedatolisib plus darolutamide in mCRPC. Company press releases frequently report progression-free survival data, objective response rates, safety outcomes, and subgroup analyses from these studies.
Celcuity’s news flow also includes regulatory and corporate developments, such as the submission of a New Drug Application to the U.S. FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer under the Real-Time Oncology Review program, participation in major medical meetings like the ESMO Congress and the San Antonio Breast Cancer Symposium, and presentations at healthcare investment conferences. In addition, the company announces financing transactions, including equity offerings, convertible senior notes, and amendments to its term loan facilities that support ongoing clinical and potential commercial activities.
Investors and healthcare professionals can use this news feed to monitor Celcuity’s latest disclosures on gedatolisib’s clinical performance, safety profile, regulatory progress, and capital strategy. Regular updates provide context on how the company’s oncology pipeline is advancing through late-stage development and regulatory review.
Celcuity Inc. (NASDAQ:CELC) has successfully closed a private placement yielding approximately $100 million in gross proceeds. This event correlates with the initiation of the Phase 3 clinical trial, VIKTORIA-1, which tests its leading drug, gedatolisib. The funding will support operational needs through 2025 and enable a draw of $20 million from an existing debt facility. Led by Venrock Healthcare Capital Partners and other investors, the private placement includes shares sold at $5.75 each and warrants at a premium. Further details on securities registration are forthcoming.
Celcuity Inc. (Nasdaq: CELC) presented encouraging updates from its Phase 1b trial of gedatolisib for advanced breast cancer at the 2022 San Antonio Breast Cancer Symposium. High response rates were found, with a median progression-free survival (PFS) of 42.3 months for treatment-naïve patients. Efficacy was noted regardless of PIK3CA mutation status, with an overall response rate (ORR) of up to 85%. Celcuity plans further evaluation of gedatolisib combined with CDK4/6 inhibitors and endocrine therapy in future trials, highlighting its unique mechanism of action.
Celcuity Inc. (Nasdaq:CELC) has announced the dosing of its first patient in the Phase 3 clinical trial, VIKTORIA-1, which is testing gedatolisib for HR+/HER2- advanced breast cancer. This milestone enables the closing of a $100 million PIPE financing and draws down a $20 million term loan. Gedatolisib is designed to provide better treatment options for patients whose cancer progressed under previous therapies. The FDA has granted Breakthrough Therapy status to gedatolisib, signaling promising prospects for faster regulatory review.
Celcuity Inc. (NASDAQ:CELC) announced that an abstract for a Spotlight Poster presentation at the 2022 San Antonio Breast Cancer Symposium (SABCS) is now available on the SABCS website. The event occurs from December 6-10, 2022. The presentation will showcase updated efficacy and safety data from a Phase 1b study of gedatolisib and palbociclib in women with advanced breast cancer, highlighting promising results regardless of PIK3CA mutation status. Notably, treatment-naïve patients showed an objective response rate (ORR) of 85%.
Celcuity Inc. (NASDAQ:CELC) announced CEO Brian Sullivan's participation in one-on-one and small group meetings at the 13th Annual Craig-Hallum Alpha Select Conference on November 17, 2022, in New York. The clinical-stage biotechnology company focuses on developing targeted therapies for various cancers, with gedatolisib as its lead candidate. Gedatolisib is currently evaluated in the Phase 3 VIKTORIA-1 trial for HR+/HER2- advanced breast cancer. The company also utilizes its CELsignia companion diagnostic platform to identify potential patients for targeted therapies.
Celcuity Inc. (NASDAQ:CELC) has made significant strides in its Phase 3 VIKTORIA-1 clinical trial for gedatolisib, completing the selection of 200 clinical sites and activating the first site. The FDA granted Breakthrough Therapy designation for gedatolisib in July 2022, expediting the review process. Financially, the company reported a net loss of $10.9 million for Q3 2022, up from $6.0 million in Q3 2021, with total operating expenses at $10.6 million. Cash and cash equivalents stood at $57.5 million as of September 30, 2022.
Celcuity Inc. (NASDAQ:CELC) will release its financial results for Q3 2022 on November 10, 2022, after market close. Management will host a webcast and conference call at 4:30 p.m. ET the same day to discuss the results. Celcuity is focused on developing targeted therapies for various cancers, with its leading candidate, gedatolisib, targeting Class 1 PI3K isoforms and mTOR. A Phase 3 study for gedatolisib in patients with HR+/HER2- advanced breast cancer is expected to begin soon.
Celcuity Inc. (NASDAQ:CELC) has announced the appointment of Polly Murphy, D.V.M., Ph.D. to its Board of Directors on September 14, 2022. Dr. Murphy brings over 20 years of experience in pharmaceutical business development, including leadership roles at Pfizer. Her expertise includes overseeing global marketing and strategy in oncology. As Chief Business Officer at UroGen Pharma, she enhances Celcuity's strategic capabilities, especially as the company advances its lead candidate, gedatolisib, towards a Phase 3 clinical trial for HR+/HER2- advanced breast cancer.
On August 11, 2022, Celcuity announced key developments including the FDA granting Breakthrough Therapy designation for its drug gedatolisib in treating HR+/HER2- advanced breast cancer. The company entered into a $100 million private placement agreement and expanded its debt facility from $25 million to $75 million to finance operations through 2025. The Phase 3 VIKTORIA-1 clinical trial is on track to begin dosing patients soon. Despite a net loss of $10 million in Q2 2022, operating expenses were reduced significantly, indicating a focus on maintaining financial health.
Celcuity Inc. (NASDAQ:CELC), a biotechnology firm concentrating on targeted therapies for hormonally driven cancers, will release its Q2 2022 financial results on August 11, 2022, after market close. A webcast/teleconference will follow at 4:30 p.m. Eastern Time for discussion of the results and corporate updates. Celcuity's lead candidate, gedatolisib, is a dual inhibitor targeting Class I PI3K isoforms and mTOR, with a Phase 3 study expected to begin in 2022 for HR+/HER2- advanced breast cancer. The CELsignia platform identifies patients likely to benefit from targeted therapies.