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. develops targeted oncology therapies as a clinical-stage biotechnology company, with news centered on gedatolisib, an investigational pan-PI3K/mTORC1/2 inhibitor for solid tumors. Company updates frequently cover Phase 3 VIKTORIA-1 data in HR+/HER2- advanced breast cancer, including PIK3CA wild-type and mutant cohorts and combination regimens with fulvestrant and palbociclib.
Recurring announcements also address FDA regulatory submissions and review status for gedatolisib, publications and medical-meeting presentations, quarterly financial results, corporate updates, investor conference participation, and board governance changes.
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.
Celcuity Inc. (Nasdaq:CELC) has signed a global licensing agreement with Pfizer Inc. for exclusive rights to gedatolisib, a Phase 1b pan-PI3K/mTOR inhibitor aimed at treating ER+/HER2-negative advanced breast cancer. Celcuity paid $10 million, comprising cash and stock, to Pfizer. Pfizer is entitled to potential milestone payments of up to $330 million and tiered royalties on sales. Gedatolisib shows promise in overcoming endocrine resistance in breast cancer patients, and a Phase 2/3 clinical trial is set to initiate in 2022, pending FDA feedback.