Education
About Us
Working with TipRanks
Follow Us
Celularity (CELU)
NASDAQ:CELU
Pembrolizumab, Trastuzumab, Cyclophosphamide, Fludarabine, Mesna, Cynk-101, Recombinant Human Interleukin-2
Metastatic Her2 Positive Gastroesophageal Junction Cancer
Phase I/II
Terminated
CYNK-101 in Combination with Trastuzumab and Pembrolizumab in Patients with Locally Advanced Unresectable or Metastatic HER2-Positive Gastric or Gastroesophageal Junction (G/GEJ) Adenocarcinoma
Jan 12, 2022
―
Cynk-001
Neoplasms, Leukemia, Myeloid, Acute, Neoplasms By Histologic Type, Leukemia, Hematologic Diseases, Relapsed Adult Aml, Physiological Effects Of Drugs, Refractory Aml, Leukemia, Myeloid, Immunosuppressive Agents, Immunologic Factors, Alkylating Agents, Antimetabolites, Antineoplastic, Antiviral Agents, Analgesics, Non-Narcotic, Anti-Infective Agents, Analgesics, Peripheral Nervous System Agents, Hematologic Neoplasms, Leukemia In Remission
Phase I
Terminated
Natural Killer Cell (CYNK-001) Infusions in Adults with AML
Mar 12, 2020
―
FAQ
What are the FDA phases for drug approval?
The FDA approval process for new drugs is divided into several phases:
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
a. Preclinical testing
b. Phase 1 – Safety and dosage
c. Phase 2 – Effectiveness and side effects
d. Phase 3 – Confirmation of effectiveness, monitoring of adverse reactions, and comparison with existing treatments
e. Phase 4 – Post-marketing studies to track long-term safety and effectiveness
What is a clinical trial?
A clinical trial is a carefully designed study in which researchers test a drug, treatment, or medical device in people to evaluate its safety, effectiveness, and potential side effects. These trials are essential for determining whether a new treatment should be approved for widespread use.
What drugs does Celularity (CELU) have in its pipeline
CELU is currently developing the following drugs: Pembrolizumab, Trastuzumab, Cyclophosphamide, Fludarabine, Mesna, Cynk-101, Recombinant Human Interleukin-2, Cynk-001. These drug candidates are in various stages of clinical development as the company works toward FDA approval.