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 (CELC) delivers innovative oncology solutions through its integrated approach combining advanced cellular diagnostics with targeted therapeutic development. This dedicated news hub provides investors and researchers with essential updates on clinical milestones, regulatory developments, and strategic partnerships.
Access authoritative information about Celcuity's Phase 3 trials for gedatolisib in advanced breast cancer, progress in prostate cancer research, and advancements in their CELsignia companion diagnostic platform. Our curated collection includes press releases about trial enrollments, partnership announcements with pharmaceutical leaders, and financial disclosures critical for market analysis.
Key updates cover therapeutic pipeline progress, diagnostic technology enhancements, and scientific presentations at major oncology conferences. The resource serves both expert analysts and general investors seeking to understand Celcuity's position in precision medicine.
Bookmark this page for real-time access to verified CELC developments. For comprehensive tracking of this clinical-stage biotech leader's progress in personalized cancer treatment, revisit regularly as new information becomes available.
Celcuity (NASDAQ:CELC), a clinical-stage biotechnology company, has announced the pricing of two concurrent public offerings. The company is offering $175 million of 2.750% convertible senior notes due 2031, along with 1,836,842 shares of common stock at $38.00 per share and pre-funded warrants for up to 400,000 shares.
The convertible notes will have an initial conversion rate of 19.4932 shares per $1,000 principal amount, equivalent to a conversion price of $51.30 per share. The company expects to raise approximately $248.7 million in net proceeds, which will be used for working capital and general corporate purposes, including clinical trials, commercial launch, and R&D expenditures.
The offerings are expected to close on July 31 and August 1, 2025, with Jefferies, TD Cowen, and Leerink Partners acting as joint book-running managers.Celcuity (Nasdaq: CELC), a clinical-stage biotechnology company, has announced two concurrent public offerings: $150 million in convertible senior notes due 2031 and $75 million in common stock shares. The company is also granting underwriters 30-day options to purchase additional amounts of up to $22.5 million in convertible notes and $11.25 million in common stock.
The convertible notes will be senior unsecured obligations maturing on August 1, 2031, with semi-annual interest payments. The company plans to implement capped call transactions to reduce potential dilution. The net proceeds will fund capped call transactions costs and general corporate purposes, including clinical trials, commercial launch preparations, and R&D expenditures.
Jefferies, TD Cowen, and Leerink Partners are serving as joint book-running managers for both offerings, with LifeSci Capital acting as lead manager for the notes offering and passive bookrunner for the stock offering.
Celcuity (NASDAQ:CELC) announced breakthrough topline results from the PIK3CA wild-type cohort of its Phase 3 VIKTORIA-1 trial evaluating gedatolisib combinations for HR+/HER2- advanced breast cancer. The gedatolisib triplet therapy showed a 76% reduction in disease progression risk (HR=0.24) with 9.3 months median PFS vs. 2.0 months for fulvestrant alone. The gedatolisib doublet demonstrated a 67% reduction (HR=0.33) with 7.4 months median PFS.
These results represent unprecedented efficacy in HR+/HER2- advanced breast cancer treatment, with both combinations showing better safety profiles than previous trials. Treatment discontinuation rates were lower than observed in Phase 1b and other Phase 3 trials. Celcuity plans to submit a New Drug Application to the FDA in Q4 2025, with full data presentation scheduled for later this year.
Celcuity (NASDAQ:CELC), a clinical-stage biotechnology company focused on targeted oncology therapies, has scheduled a conference call and webcast for July 28, 2025, at 8:00 AM ET to present topline results from the PIK3CA Wild-Type Cohort of their Phase 3 VIKTORIA-1 trial in HR+/HER2- advanced breast cancer.
The management team will host the presentation with a live webcast available, and participants can register for the teleconference in advance. A replay will be accessible on Celcuity's website after the event.
Celcuity (NASDAQ:CELC) has initiated patient dosing in its Phase 3 VIKTORIA-2 clinical trial, evaluating gedatolisib combination therapy as a first-line treatment for HR+/HER2- advanced breast cancer (ABC) patients with endocrine therapy resistance.
Gedatolisib, a novel multi-target PI3K/AKT/mTOR inhibitor, demonstrated promising results in a Phase 1b trial when combined with palbociclib and letrozole, achieving a median progression-free survival of 48.6 months, median overall survival of 77.3 months, and an objective response rate of 79%.
The VIKTORIA-2 study aims to evaluate gedatolisib's efficacy in combination with CDK4/6 inhibitor and fulvestrant, regardless of patients' PIK3CA status or metabolic profile.
Celcuity (Nasdaq: CELC) has secured a new U.S. patent (No. 12,350,276) for the clinical dosing regimen of gedatolisib, its lead drug candidate for ER+/HER2- breast cancer patients. This patent extends the company's exclusivity until 2042.
The company's gedatolisib patent portfolio now includes 13 U.S. patents and 290 foreign patents, covering composition, formulations, and methods of use. Celcuity expects to release topline data from the VIKTORIA-1 clinical trial for the PIK3CA wild-type cohort in Q3 2025 and the PIK3CA mutant cohort in Q4 2025.
Celcuity (NASDAQ:CELC) has reported promising clinical data from two early-phase studies of gedatolisib, their multi-target inhibitor drug. The first study, a Phase 1 trial in metastatic castration-resistant prostate cancer (mCRPC), showed a 66% six-month radiographic progression-free survival rate when gedatolisib was combined with darolutamide.
In the second study, a Phase 2 trial for HER2+ metastatic breast cancer, gedatolisib combined with trastuzumab-pkrb demonstrated an objective response rate of 43% in heavily pre-treated patients. The median progression-free survival was 6.0 months, with median overall survival reaching 24.7 months.
Both studies demonstrated favorable safety profiles, with no patients discontinuing gedatolisib due to treatment-related adverse events. The company is now exploring additional dosing options in the mCRPC trial, with plans to enroll more patients across multiple cohorts to determine the recommended Phase 2 dose.
Celcuity Inc. (NASDAQ: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has announced upcoming presentations at two major investor conferences. CEO and Co-founder Brian Sullivan will participate in:
- A fireside chat at the TD Cowen 6th Annual Oncology Innovation Summit on May 28, 2025, at 9:30 a.m. ET
- A fireside chat at the Jefferies Global Healthcare Conference on June 5, 2025, at 7:35 a.m. ET
Both presentations will be available via live webcast and can be accessed through the company's investor relations website, with recordings available shortly after the events.
Celcuity (Nasdaq: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has announced the timing for its Q1 2025 financial results release. The company will release its results after market close on Wednesday, May 14, 2025, followed by a management-hosted webcast and conference call at 4:30 p.m. Eastern Time. Domestic participants can dial 1-800-717-1738, while international callers should use 1-646-307-1865. A live webcast will be available, and a replay will be accessible on Celcuity's website after the event.
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