FDA Events for Celcuity (CELC)
This section highlights FDA-related milestones and regulatory updates for drugs developed by Celcuity (CELC).
Over the past two years, Celcuity has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
Gedatolisib. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Gedatolisib - FDA Regulatory Timeline and Events
Gedatolisib is a drug developed by Celcuity for the following indication: HR+ / HER2- Metastatic Breast Cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- Gedatolisib
- Announced Date:
- June 30, 2025
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced preliminary clinical data for gedatolisib in two early phase clinical trials. Gedatolisib is a multi-target inhibitor that addresses all four class I PI3K isoforms and the mTOR complexes mTORC1 and mTORC2 to induce comprehensive blockade of the PI3K/AKT/mTOR ("PAM") pathway.
AI Summary
Celcuity Inc. announced preliminary clinical data for gedatolisib in two early phase clinical trials. Gedatolisib is a multi-target inhibitor that blocks all four class I PI3K isoforms and both mTOR complexes, mTORC1 and mTORC2, to stop the PI3K/AKT/mTOR pathway. This comprehensive blockade is aimed at stopping cancer growth. In a Phase 1 trial for men with metastatic castration-resistant prostate cancer, combining gedatolisib with darolutamide, researchers observed a 66% six-month radiographic progression free survival rate. In a Phase 2 trial involving patients with HER2-positive metastatic breast cancer, the combination of gedatolisib with trastuzumab-pkrb led to a 43% objective response rate. Importantly, no patients stopped treatment due to side effects from gedatolisib, highlighting its good tolerability so far.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- December 11, 2024
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced overall survival (OS) data from two patient cohorts evaluated in a Phase 1b trial with gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either letrozole or fulvestrant, in patients with HR+, HER2-advanced or metastatic breast cancer.
AI Summary
Celcuity Inc. recently announced overall survival data from a Phase 1b trial evaluating gedatolisib, a pan-PI3K/mTORC1/2 inhibitor, in combination with palbociclib and either letrozole or fulvestrant for treating HR+, HER2– advanced or metastatic breast cancer. The study focused on two patient groups. One group, consisting of patients who were treatment-naïve in the advanced setting, achieved a median overall survival of 77.3 months. In contrast, patients who had previously been treated with a CDK4/6 inhibitor showed a median overall survival of 33.9 months.
According to Celcuity’s Chief Medical Officer, these findings are encouraging and compare favorably to published data for current first- and second-line treatments. The results will be presented in a poster session at the upcoming San Antonio Breast Cancer Symposium, highlighting a strategy that blocks the ER, CDK4/6, and PI3K/AKT/mTOR pathways simultaneously.
Read Announcement- Drug:
- Gedatolisib
- Announced Date:
- May 30, 2024
- Indication:
- HR+ / HER2- Metastatic Breast Cancer
Announcement
Celcuity Inc. announced that it plans to initiate a Phase 3 clinical trial to evaluate gedatolisib plus a CDK4/6 inhibitor and fulvestrant as first-line treatment for patients with HR+/HER2- advanced breast cancer ("ABC") who are endocrine therapy resistant. In conjunction with its plan to conduct this study, Celcuity today entered into an amendment to an existing debt facility agreement and received an additional term loan of approximately $62 million.
AI Summary
Celcuity Inc. announced plans to launch a Phase 3 clinical trial to investigate a new first‐line treatment for patients with HR+/HER2- advanced breast cancer who are resistant to endocrine therapy. The study will test a combination of gedatolisib with fulvestrant and a CDK4/6 inhibitor, with investigators having the choice between ribociclib or palbociclib. The trial aims to compare this new treatment approach against the current standard of care, addressing a pressing need for better therapies in resistant breast cancer cases.
Alongside the trial announcement, Celcuity amended an existing debt facility agreement and secured an additional term loan of approximately $62 million. The extra financing is expected to accelerate the trial’s initiation and support the company’s continued development of targeted therapies against advanced breast cancer.
Read Announcement
Celcuity FDA Events - Frequently Asked Questions
As of now, Celcuity (CELC) has not received any FDA approvals for its therapy in the last two years.
In the past two years, Celcuity (CELC) has reported FDA regulatory activity for Gedatolisib.
The most recent FDA-related event for Celcuity occurred on June 30, 2025, involving Gedatolisib. The update was categorized as "Clinical Data," with the company reporting: "Celcuity Inc. announced preliminary clinical data for gedatolisib in two early phase clinical trials. Gedatolisib is a multi-target inhibitor that addresses all four class I PI3K isoforms and the mTOR complexes mTORC1 and mTORC2 to induce comprehensive blockade of the PI3K/AKT/mTOR ("PAM") pathway."
Currently, Celcuity has one therapy (Gedatolisib) targeting the following condition: HR+ / HER2- Metastatic Breast Cancer.
More FDA Event Resources from MarketBeat
FDA Event Stage Terminology & Abbreviation Guide
- NDA: New Drug Application
- ANDA: Abbreviated New Drug Application
- sNDA: Supplemental New Drug Application
- BLA: Biologics License Application
- sBLA: Supplemental Biologics License Application
- FDA Approved: Approved by the FDA
- EMA: European Medicines Agency
- CE Mark: European Union Certification
- NMPA: China National Medical Products Administration
- MHLW: Japanese Ministry of Health
- FDA Meeting: Consultation with FDA
- Pre-IND: Pre-Investigational New Drug Meeting
- Breakthrough Therapy: Special FDA designation for promising therapies
- Fast Track: Accelerated FDA approval pathway
- Orphan Drug: Designation for rare disease treatments
- RPD: Rare Pediatric Disease Designation
- RMAT: Regenerative Medicine Advanced Therapy
- DSMB Review: Data Safety Monitoring Board Review
- IDMC Review: Independent Data Monitoring Committee
- MAA: MHRA Marketing Authorization Application
- RTF: Refusal to File (Rejected Application)
- 510(k): FDA Clearance for Medical Devices
- Rolling Submission: Staggered regulatory review process
This page (NASDAQ:CELC) was last updated on 7/9/2025 by MarketBeat.com Staff
