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Why Is The Creative Medical (CELZ) Stock Falling By 16% In Pre-Market Trading?

As of the most recent check during premarket trading, Creative Medical Technology Holdings Inc. (NASD: CELZ) was down -12.60% to trade at $0.437 on the charts. The stock appears to be paring back its 24% session-high rise on the announcement that its application for a new medicine had been approved.

Which approval does CELZ possess?

The U.S. Food and Drug Administration (FDA) has approved Creative Medical’s (CELZ) application for an investigational new drug (IND), allowing the company to move forward with starting a clinical study for Type 1 Diabetes utilizing AlloStem.

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AlloStem uses a novel strategy to maximize the potential of perinatal tissue-derived cells (PRDCs), which include self-renewal capacity, minimal antigenicity, decreased toxicity, and broad clinical extension. Evaluation of AlloStem in individuals with newly diagnosed Type 1 Diabetes is the study’s main goal (CELZ-201). Patient recruitment is anticipated to start in Q1 2023, and updates on the start of the study will follow.

Dr. Camillo Ricordi is the study’s national primary investigator. At the University of Miami in Florida, where he holds the titles of Stacy Joy Goodman Professor of Surgery, Distinguished Professor of Medicine, Professor of Biomedical Engineering, and Professor of Microbiology and Immunology, Dr. Ricordi is also the Director of the Diabetes Research Institute and the Cell Transplant Program. Yesterday during the 8th Perinatal Stem Cell Society Congress/Workshop at 9:00 am EST, Dr. Ricordi provided an update on the work.

Since this is Creative Medical Technology’s first FDA-approved IND, it is a significant occasion. A famous research institute and one of the most reputable clinical diabetes researchers in the world will oversee CELZ’s start of the study.

What other future plans does CELZ have?

The usage of Creative Medical Technology’s (CELZ) exclusive AlloStem product in this research was also announced. This confirms CELZ’s efforts in building resources that support our method of producing immunotherapies. With the IND clearance, CELZ is stepping up its efforts to find new biologics and create treatments with the potential to successfully address patients’ unmet needs.