Celcuity Inc
NASDAQ:CELC
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Celcuity Inc
Celcuity, Inc. is cellular analysis company. The company is headquartered in Minneapolis, Minnesota and currently employs 39 full-time employees. The company went IPO on 2017-09-20. The firm is focused on discovering cancer sub-types molecular-based approaches through developing companion diagnostic tests (CDx) and therapeutic (Rx). The firm's product pipeline includes CELsignia platform and Gedatolisib. The CELsignia diagnostic platform is used to analyze live patient tumor cells to identify the specific abnormal cellular process driving a patients cancer and the targeted therapy. The CELsignia platform provides traditional molecular diagnostics, which includes snapshot of the genetic mutations present in a patients tumor because they analyze cell fragments and molecular diagnostics can estimate the patients potential drug response based on a statistical analysis of the drugs clinical trial result. Its other product candidate includes Gedatolisib, is a small molecule dual inhibitor, administered intravenously, that targets all Class I isoforms of PI3K and mammalian target of rapamycin (mTOR).
Celcuity, Inc. is cellular analysis company. The company is headquartered in Minneapolis, Minnesota and currently employs 39 full-time employees. The company went IPO on 2017-09-20. The firm is focused on discovering cancer sub-types molecular-based approaches through developing companion diagnostic tests (CDx) and therapeutic (Rx). The firm's product pipeline includes CELsignia platform and Gedatolisib. The CELsignia diagnostic platform is used to analyze live patient tumor cells to identify the specific abnormal cellular process driving a patients cancer and the targeted therapy. The CELsignia platform provides traditional molecular diagnostics, which includes snapshot of the genetic mutations present in a patients tumor because they analyze cell fragments and molecular diagnostics can estimate the patients potential drug response based on a statistical analysis of the drugs clinical trial result. Its other product candidate includes Gedatolisib, is a small molecule dual inhibitor, administered intravenously, that targets all Class I isoforms of PI3K and mammalian target of rapamycin (mTOR).
Pivotal Data Milestone: Celcuity reported strong Phase III results for gedatolisib in HR-positive, HER2-negative advanced breast cancer, showing a significant improvement in median progression-free survival over existing treatment.
Regulatory Progress: The FDA accepted Celcuity's request to submit a New Drug Application for gedatolisib under the real-time oncology review program, with submission expected to complete this quarter.
Balance Sheet Strengthened: The company raised $287 million through concurrent offerings and increased its term loan facility to $500 million, providing resources for launch preparations.
Commercial Launch Preparation: Celcuity has accelerated hiring and infrastructure build-out for a potential 2026 US launch of gedatolisib, aiming for majority market share in the second-line setting.
Financial Results: The company reported a larger net loss for Q3 2025, reflecting increased R&D and G&A spending to support clinical trials and commercialization.
Market Opportunity: Management estimates a $5–6 billion US addressable market for gedatolisib in second-line breast cancer, with potential peak revenues of $2.5–3 billion.
International Plans: Celcuity intends to partner for ex-US commercialization, with regulatory submissions in Europe and Japan planned after additional data is available.
