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.
Overview of Celcuity Inc.
Celcuity Inc. (Nasdaq: CELC) is a clinical-stage biotechnology company specializing in the development of targeted therapies and companion diagnostics for oncology. Based in Minneapolis, Celcuity aims to transform cancer treatment by leveraging precision medicine to improve therapeutic outcomes for patients with advanced solid tumors. The company’s innovative approach focuses on addressing critical gaps in cancer care by combining its proprietary diagnostic platform with cutting-edge therapeutic candidates.
Therapeutic Innovations: Gedatolisib
Celcuity’s lead therapeutic candidate, gedatolisib, is a potent, reversible inhibitor targeting the PI3K/AKT/mTOR signaling pathway, a critical driver in many cancers. Unlike other therapies that selectively inhibit individual components of this pathway, gedatolisib uniquely targets all Class I PI3K isoforms as well as mTORC1 and mTORC2. This comprehensive mechanism of action minimizes the potential for drug resistance, making it a highly differentiated candidate among currently approved and investigational therapies. Gedatolisib has demonstrated robust clinical efficacy and a manageable safety profile in Phase 1b trials, particularly in patients with HR+/HER2- advanced breast cancer.
The drug is currently being evaluated in multiple clinical trials, including:
- VIKTORIA-1: A Phase 3 trial assessing gedatolisib in combination with fulvestrant, with or without palbociclib, for patients with HR+/HER2- advanced breast cancer.
- CELC-G-201: A Phase 1b/2 trial exploring gedatolisib in combination with darolutamide for metastatic castration-resistant prostate cancer.
- VIKTORIA-2: An upcoming Phase 3 trial investigating gedatolisib as a first-line treatment for HR+/HER2- advanced breast cancer in combination with a CDK4/6 inhibitor and fulvestrant.
Diagnostic Breakthrough: CELsignia Platform
Complementing its therapeutic efforts, Celcuity has developed the CELsignia companion diagnostic platform, a proprietary technology designed to analyze live tumor cells and identify patients most likely to benefit from specific targeted therapies. Unlike traditional genomic or proteomic diagnostics, CELsignia assesses the functional activity of signaling pathways in real-time, providing actionable insights for personalized treatment strategies. This platform has the potential to redefine patient selection and improve clinical trial outcomes by identifying previously unrecognized patient subgroups.
Strategic Positioning in Oncology
Celcuity operates at the forefront of precision oncology, a rapidly growing segment of the biotechnology industry. By combining innovative drug development with advanced diagnostics, the company addresses the increasing demand for personalized medicine. Its focus on solid tumor indications, particularly HR+/HER2- advanced breast cancer and metastatic prostate cancer, positions it within high-need therapeutic areas. The FDA’s Breakthrough Therapy designation for gedatolisib underscores its potential to deliver significant clinical benefits.
Challenges and Opportunities
As a clinical-stage biotechnology company, Celcuity faces challenges typical of its industry, including the high costs and risks associated with clinical trials and regulatory approvals. However, its differentiated approach and robust pipeline provide significant opportunities for growth. The company’s focus on combination therapies and its ability to address resistance mechanisms in cancer treatment set it apart from competitors.
Conclusion
Celcuity Inc. is a pioneering force in the biotechnology sector, combining innovative targeted therapies with advanced diagnostic solutions to address unmet needs in oncology. Its dual focus on gedatolisib and the CELsignia platform highlights its commitment to advancing precision medicine and improving patient outcomes. With multiple clinical trials underway and a strong foundation in personalized oncology, Celcuity is well-positioned to make a lasting impact on cancer treatment.
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.
Celcuity Inc. (Nasdaq: CELC) announced a collaboration for a Phase II clinical trial with MD Anderson Cancer Center, Novartis, and Puma Biotechnology. The study will evaluate the efficacy of TABRECTA® and NERLYNX® in metastatic HER2-negative breast cancer using Celcuity’s CELsignia Multi-Pathway Activity Test for patient selection. MD Anderson leads the trial, expecting interim results 12-15 months post-activation. Celcuity believes there's significant interest in new therapies for patients whose cancers have progressed, marking this as their fifth collaboration in cancer research.
Celcuity Inc. (NASDAQ:CELC) announced the closing of its public offering of 1,971,100 shares of common stock on February 26, 2021, raising gross proceeds of $27.6 million. This includes 257,100 shares from the underwriter's full exercise of their option for over-allotments. The shares were sold at $14.00 each, under an effective shelf registration statement filed with the SEC. The managing underwriter for this offering was Craig-Hallum Capital Group. The funds raised will support Celcuity's ongoing development of its 3rd generation diagnostic platform for cancer treatment.
Celcuity Inc. (NASDAQ:CELC) has priced an upsized underwritten public offering of 1,714,000 shares at $14.00 per share, aiming for gross proceeds of approximately $24 million. This offering, set to close on February 26, 2021, includes a 30-day option for the underwriter to purchase an additional 257,100 shares. Proceeds from the offering will be utilized for working capital and general corporate purposes, including R&D and clinical trials. The offering is conducted under an effective shelf registration statement previously filed with the SEC.
Celcuity Inc. (NASDAQ:CELC) announced a public offering of $20 million in common stock, with a potential additional 15% available for purchase by the underwriter within 30 days. The funds will be used for working capital, including research and development and clinical trials. The offering is pending market conditions and is being managed by Craig-Hallum Capital Group. The shares are being offered under an effective shelf registration statement previously filed with the SEC.
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