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 (CELC) announced overall survival (OS) data from a Phase 1b trial evaluating gedatolisib in combination with palbociclib and endocrine therapy for HR+, HER2- advanced breast cancer. The study showed promising results with a median OS of 77.3 months in treatment-naïve patients and 33.9 months in patients previously treated with CDK4/6 inhibitors.
The data was presented at the San Antonio Breast Cancer Symposium (SABCS) in December 2024. The trial results support Celcuity's clinical development strategy of simultaneously blocking ER, CDK4/6, and PAM signaling pathways, which forms the basis for their ongoing VIKTORIA-1 and planned VIKTORIA-2 Phase 3 trials.
Celcuity Inc. (CELC) announced its Q3 2024 financial results and corporate updates. The company reported 100% enrollment completion for the PIK3CA wild-type cohort in the Phase 3 VIKTORIA-1 trial, with topline data expected in late Q1 2025 or Q2 2025. The PIK3CA mutant cohort data is anticipated in H2 2025. Financial highlights include $264.1 million in cash and investments, expected to fund operations through 2026. Q3 operating expenses were $30.1 million, with a net loss of $29.8 million ($0.70 per share). R&D expenses increased to $27.6 million, primarily due to clinical trial activities and increased personnel costs.
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on oncology targeted therapies, has announced upcoming presentations at two major investor conferences. CEO and Co-founder Brian Sullivan will participate in fireside chats at the Stifel 2024 Healthcare Conference on November 19 at 1:15 p.m. ET and the Jefferies London Healthcare Conference on November 21 at 11:30 a.m. GMT/6:30 a.m. ET. Both events will feature live webcasts and one-on-one investor meetings.
Celcuity (Nasdaq: CELC), a clinical-stage biotechnology company focused on targeted oncology therapies, has announced it will release its third quarter 2024 financial results after market close on Thursday, November 14, 2024. The company will host a webcast and conference call at 4:30 p.m. Eastern Time on the same day to discuss results and provide a corporate update. Domestic callers can dial 1-800-717-1738, while international callers should use 1-646-307-1865 to participate.
Celcuity Inc. (Nasdaq: CELC) reported its Q2 2024 financial results and provided a corporate update. Key highlights include:
1. Plan to initiate Phase 3 VIKTORIA-2 trial for gedatolisib in HR+, HER2- advanced breast cancer, with first patient enrollment expected in Q2 2025.
2. VIKTORIA-1 PIK3CA WT cohort enrollment target expected in Q4 2024, with topline data anticipated in late Q4 2024 or Q1 2025.
3. Raised $129 million in gross proceeds from equity and debt financings, extending operational runway through 2026.
4. Q2 2024 financial results: Total operating expenses of $24.3 million, net loss of $23.7 million ($0.62 per share), and cash position of $283.1 million as of June 30, 2024.
Celcuity Inc. (Nasdaq: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has announced the schedule for its second quarter 2024 financial results release. The company will disclose its financial performance after the market closes on Wednesday, August 14, 2024. Following the release, management will host a webcast and teleconference at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update.
Investors and interested parties can participate in the teleconference by dialing 1-800-717-1738 (domestic) or 1-646-307-1865 (international). Additionally, a live webcast presentation will be accessible via the provided weblink. For those unable to attend the live event, a replay of the webcast will be made available on the Celcuity website.
Celcuity (Nasdaq: CELC), a clinical-stage biotechnology firm focused on oncology therapies, announced its participation in the Jefferies Global Healthcare Conference from June 4-6, 2024, in New York.
Brian Sullivan, CEO and Co-founder, will engage in a fireside chat at 10:00 a.m. ET on June 6, 2024.
The event will be webcast live at this link: https://wsw.com/webcast/jeff302/celc/1809904, and accessible via the Investors section on Celcuity's website, with a replay available soon after.
Celcuity (NASDAQ: CELC), a clinical-stage biotechnology company, announced the pricing of an underwritten offering of 3,871,000 shares of common stock at $15.50 per share, aiming to raise $60 million. Notable investors include BVF Partners L.P., Vivo Capital, and Eventide Asset Management. The offering is expected to close by May 31, 2024, pending customary conditions.
Proceeds are earmarked for working capital, corporate purposes, and a Phase 3 trial for advanced breast cancer treatment. Combined with existing cash and investments, these funds should cover expenses through late 2026. Leerink Partners, TD Cowen, and Stifel are joint bookrunning managers. The offering is registered under a previous SEC filing.
Celcuity announced plans to initiate a Phase 3 trial for gedatolisib as first-line treatment for HR+/HER2- advanced breast cancer. The trial will assess gedatolisib combined with a CDK4/6 inhibitor and fulvestrant, targeting patients resistant to endocrine therapy. Initial trial results show promising efficacy, with a median progression-free survival of 48.6 months and an overall response rate of 79% in Phase 1b. Additionally, Celcuity secured $62 million in debt financing to support this initiative, amending its agreement with Innovatus Capital Partners and adding Oxford Finance as a new lender, increasing the total debt facility to $180 million. The Phase 3 trial, named VIKTORIA-2, will involve approximately 638 subjects across 200 global sites, with enrollment beginning in Q2 2025.
Celcuity Inc. (Nasdaq: CELC) reported its first-quarter financial results and provided a corporate update. The Phase 3 VIKTORIA-1 trial remains on track, with topline data expected in the second half of 2024. The company also initiated a Phase 1b/2 trial for gedatolisib in prostate cancer, and dosed its first patient in February 2024. Financial highlights include a net loss of $21.6 million ($0.64 per share) for Q1 2024, compared to $11.9 million ($0.55 per share) in Q1 2023. Operating expenses rose to $22.5 million from $12.6 million year-over-year. Cash reserves stand at $177.7 million, expected to fund operations into early 2026.
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