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 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.
Celcuity Inc. (Nasdaq: CELC) will release its first quarter 2024 financial results on May 15, 2024, with a webcast/conference call hosted by management to discuss the results and provide a corporate update. The company is a clinical-stage biotechnology firm developing targeted oncology therapies.
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