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 clinical-stage biotechnology company headquartered in Minneapolis and focused on targeted therapies for oncology. News about Celcuity primarily centers on the development of its lead investigational drug, gedatolisib, a multi-target PI3K/AKT/mTOR (PAM) pathway inhibitor being studied in multiple solid tumor indications, including HR+/HER2- advanced breast cancer and metastatic castration resistant prostate cancer.
On this page, readers can follow Celcuity’s clinical trial milestones, such as topline and detailed results from the Phase 3 VIKTORIA-1 trial in HR+/HER2-/PIK3CA wild-type and mutant advanced breast cancer, as well as updates on the Phase 3 VIKTORIA-2 first-line trial and the Phase 1/2 CELC-G-201 study of gedatolisib plus darolutamide in mCRPC. Company press releases frequently report progression-free survival data, objective response rates, safety outcomes, and subgroup analyses from these studies.
Celcuity’s news flow also includes regulatory and corporate developments, such as the submission of a New Drug Application to the U.S. FDA for gedatolisib in HR+/HER2-/PIK3CA wild-type advanced breast cancer under the Real-Time Oncology Review program, participation in major medical meetings like the ESMO Congress and the San Antonio Breast Cancer Symposium, and presentations at healthcare investment conferences. In addition, the company announces financing transactions, including equity offerings, convertible senior notes, and amendments to its term loan facilities that support ongoing clinical and potential commercial activities.
Investors and healthcare professionals can use this news feed to monitor Celcuity’s latest disclosures on gedatolisib’s clinical performance, safety profile, regulatory progress, and capital strategy. Regular updates provide context on how the company’s oncology pipeline is advancing through late-stage development and regulatory review.
Celcuity (NASDAQ: CELC) announced the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial is fully enrolled and that topline data are expected in late Q1 2026 or Q2 2026.
Celcuity also released updated analysis from a Phase 1b trial of gedatolisib plus fulvestrant and palbociclib: for PIK3CA-mutated advanced HR+/HER2- breast cancer (n=30) median PFS was 14.6 months with an ORR of 48%; in the subgroup receiving the intermittent dose (n=11) median PFS was 19.7 months with ORR 64%. For PIK3CA wild-type (n=60) median PFS was 9.0 months and ORR 41%.
Celcuity (NASDAQ:CELC), a clinical-stage biotech company, has announced that results from its pivotal Phase 3 VIKTORIA-1 trial will be presented at the 2025 ESMO Congress in October. The late-breaking presentation will focus on efficacy and safety data from the PIK3CA wild-type cohort, specifically examining gedatolisib plus fulvestrant with or without palbociclib versus fulvestrant in HR+/HER2- advanced breast cancer patients.
The presentation is scheduled for October 18, 2025, from 10:15 am to 11:45 am CEST, with the abstract number 3535. The late-breaking abstracts will be published on ESMO's website on the presentation day.
Celcuity (NASDAQ:CELC) has significantly expanded its senior secured credit facility with Innovatus Capital Partners and Oxford Finance to $500 million, up from its previous amount. The enhanced facility includes $350 million in committed capital and an additional $150 million at mutual discretion.
The amendment provides $170 million in new committed capital, including $100 million tied to FDA approval of gedatolisib for second-line wild-type advanced breast cancer, and $120 million linked to commercial revenue milestones. The initial funding was $30 million, bringing the total outstanding loan to $130 million. The deal extends the interest-only period by 14 months, with a potential 7-month extension upon FDA approval.
Celcuity (NASDAQ:CELC) announced that the FDA has agreed to review its New Drug Application (NDA) for gedatolisib in HR+/HER2- advanced breast cancer under the Real-Time Oncology Review program. The company plans to initiate a rolling submission in September 2025, with completion targeted for Q4 2025.
The submission is based on groundbreaking Phase 3 VIKTORIA-1 trial results where the gedatolisib-triplet therapy reduced disease progression risk by 76% compared to fulvestrant alone, with a median PFS of 9.3 vs 2.0 months. The gedatolisib-doublet showed a 67% risk reduction with median PFS of 7.4 vs 2.0 months. These results represent unprecedented improvements in HR+/HER2- advanced breast cancer treatment.
Celcuity (NASDAQ:CELC) reported significant Q2 2025 milestones for its cancer drug gedatolisib. The company announced breakthrough results from the PIK3CA wild-type cohort of Phase 3 VIKTORIA-1 trial in HR+/HER2- advanced breast cancer, showing a 76% reduction in disease progression risk with the gedatolisib triplet therapy and a 67% reduction with the doublet therapy.
The company plans to submit an NDA to FDA in Q4 2025. Additionally, Celcuity raised $286.5 million through offerings, bringing total cash position to $455 million on a proforma basis. Q2 operating expenses increased to $44.0 million from $24.3 million year-over-year, with a net loss of $45.3 million. The company's cash runway extends through 2027.
Celcuity (NASDAQ: CELC), a clinical-stage biotechnology company focused on developing targeted oncology therapies, has scheduled its second quarter 2025 financial results release for Thursday, August 14, 2025 after market close.
Management will host a webcast and conference call at 4:30 p.m. Eastern Time to discuss the results and provide a corporate update. Investors can access the call via phone (domestic: 1-800-717-1738, international: 1-646-307-1865) or through a live webcast. A replay will be available on Celcuity's website after the event.
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.
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