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), a clinical-stage biotechnology firm, will participate in the Canaccord Genuity 41st Annual Growth Conference from August 10-12, 2021. CEO Brian Sullivan will engage in a virtual fireside chat on August 12, 2021, at 8:30 a.m. ET. Interested parties can access the live webcast here or via the company’s Investors page. Celcuity focuses on enhancing cancer patient outcomes through its CELsignia diagnostic platform and related therapeutic strategies.
Celcuity Inc. (Nasdaq:CELC) will release its Q2 2021 financial results on August 9, 2021, after market close. A teleconference is scheduled for 4:30 p.m. Eastern Time on the same day to discuss the results. Celcuity focuses on cancer treatment through an integrated companion diagnostic and therapeutic strategy. Its CELsignia platform analyzes live tumor cells to identify cancer patients who may benefit from targeted therapies. For participation, dial 844-369-8770 (domestic) or 862-298-0840 (international).
Celcuity Inc. (Nasdaq:CELC), a clinical-stage biotechnology company focused on cancer treatment, will participate in the William Blair Biotech Focus Conference on July 14-15, 2021. CEO Brian Sullivan is scheduled for a fireside chat at 2 p.m. ET on July 15. A live webcast of the chat can be accessed at this link or through the Investors section of Celcuity's website, with a replay available shortly after the live event.
Celcuity utilizes its CELsignia companion diagnostic platform to analyze live cancer cells and identify patients who may benefit from targeted therapies.
Celcuity Inc. (NASDAQ:CELC) announced the pricing of its underwritten public offering, which includes 2,250,000 shares at $25.00 each, aiming for gross proceeds of about $56.25 million. The offering has a 30-day option for underwriters to buy an additional 337,500 shares. Closing is expected on July 1, 2021. Proceeds will support working capital, R&D, and business expansion efforts. The company emphasizes its focus on innovative cancer treatments through its CELsignia platform.
Celcuity Inc. (CELC) announced the launch of an underwritten public offering of its common stock. The offering includes a 30-day option for underwriters to purchase an additional 15% of shares. Proceeds from the offering will be used for working capital and general corporate purposes, including R&D and clinical trials. Jefferies and Cowen are acting as joint bookrunning managers, with additional participation from Canaccord Genuity and Needham & Company. The actual size and terms of the offering remain subject to market conditions.
Celcuity Inc. (NASDAQ:CELC) announced the hiring of two senior executives to strengthen its clinical team: Dr. Igor Gorbatchevsky as VP of Clinical Development and Jill Krause as VP of Clinical Operations. Both leaders bring extensive experience from previous roles in oncology and clinical operations. Celcuity is advancing gedatolisib, a dual inhibitor targeting PI3K/mTOR, with promising Phase 1b trial results. The company plans to initiate a Phase 3 trial for ER+/HER2- metastatic breast cancer, pending FDA feedback, aiming to enhance patient treatment options.
Celcuity (NASDAQ:CELC) announced a global licensing agreement with Pfizer for gedatolisib, aimed at treating ER+/HER2-negative metastatic breast cancer. Preliminary Phase 1b trial results show a 60% objective response rate. The company secured $43 million in financing and entered collaborations for clinical trials with leading research centers, including Novartis and Puma. Total operating expenses were $2.79 million, with a net loss of $2.79 million or $0.25 per share. Cash reserves reached $34.9 million at the end of Q1 2021, expected to grow with new funding.
Celcuity Inc. (NASDAQ:CELC) will release its financial results for the first quarter of 2021 on May 10, 2021, after market close. The management team will host a webcast/conference call at 4:30 p.m. ET to discuss these results. Celcuity focuses on extending cancer patients' lives through its CELsignia companion diagnostic platform, which analyzes live tumor cells to identify suitable targeted therapies. The company aims to align its diagnostics with therapeutic developments to enhance patient outcomes.
Celcuity Inc. (NASDAQ:CELC) presented new findings at the AACR Annual Meeting regarding gedatolisib, a pan-PI3K/mTOR inhibitor, which inhibited hyperactive RAS network signaling significantly more effectively than a PI3K-α inhibitor. Key data revealed that gedatolisib was nine times more effective in inhibiting such signaling. Additionally, it was noted that combining gedatolisib with a BCL inhibitor like navitoclax could enhance anti-tumor effects. The company aims to start a Phase 2/3 clinical trial in 2022 for advanced breast cancer.
Celcuity Inc. (Nasdaq:CELC) announced promising preliminary data from its Phase 1b trial of gedatolisib, a dual PI3K/mTOR inhibitor, in 103 patients with advanced ER+/HER2- breast cancer. As of January 11, 2021, 60% of evaluable patients achieved an objective response, with 75% showing clinical benefit. Gedatolisib was well tolerated, with most side effects being mild. The company plans to initiate a Phase 2/3 trial in H1 2022, subject to FDA feedback. Additionally, Celcuity secured a $25 million debt financing agreement for further development.