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 cutting-edge biotechnology company committed to developing targeted therapies for oncology. The company's proprietary functional cellular analysis platform offers a unique approach to personalized medicine by assessing the functionality of disease-related signaling pathways directly from a patient's diseased cells ex vivo. This innovative technology provides specific insights into how effectively a drug therapy impacts a patient's tumor cells, thereby transforming the treatment paradigm.
Celcuity's lead therapeutic candidate is gedatolisib, a potent, reversible dual inhibitor that targets all Class I PI3K isoforms and mTOR. Gedatolisib exhibits a highly differentiated mechanism of action and pharmacokinetic properties compared to other approved and investigational therapies that focus on PI3K or mTOR pathways individually or together. The company is actively pursuing multiple clinical trials to explore the efficacy of gedatolisib in various oncology indications.
Currently, Celcuity is enrolling patients for its Phase 3 VIKTORIA-1 clinical trial, which evaluates gedatolisib in combination with fulvestrant with or without palbociclib in patients with HR+/HER2- advanced breast cancer. The Phase 1b/2 clinical trial (CELC-G-201) is assessing gedatolisib in combination with darolutamide for treating metastatic castration-resistant prostate cancer (mCRPC).
In recent preclinical studies, gedatolisib has been shown to be more effective than single node PAM inhibitors in controlling crucial cellular functions necessary for cancer cell survival and proliferation. These promising results underline the potential of gedatolisib as a transformative treatment option for multiple solid tumor indications.
Celcuity has also announced the initiation of the Phase 3 VIKTORIA-2 clinical trial, which will evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as a first-line treatment for HR+/HER2- advanced breast cancer in patients who are endocrine therapy resistant. The trial is expected to start enrolling patients in the second quarter of 2025 and aims to add significant value to existing treatment protocols.
Celcuity's financial health is robust, supported by recent equity placements and a substantial debt facility agreement, which provides adequate capital to fund their operational activities into 2026. Further information about Celcuity, its pipeline, and ongoing clinical trials can be found on their official website.
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.
Celcuity announced a collaboration with Massachusetts General Hospital, UCLA, and others to conduct a Phase II trial for cancer treatments. Financial results for Q4 and the fiscal year 2020 showed a net loss of $2.55 million in Q4, up from $1.81 million in Q4 2019, with total expenses rising to $9.56 million for the year. The company expects interim results from its FACT-1 and FACT-2 trials in late 2021 or early 2022, while additional clinical trial collaborations are anticipated. Cash and equivalents dropped to $11.6 million from $18.7 million year-over-year.
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