24/7 Market News Snapshot 13 August, 2025 – Creative Medical Technology Holdings, Inc. Common Stock (NASDAQ:CELZ)

August 13, 2025

DENVER, Colo., 13 August, 2025 (www.247marketnews.com) – (NASDAQ:CELZ) are discussed in this article.
Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ), a leading clinical-stage biotechnology firm focused on regenerative and immune cellular therapies, is witnessing a significant surge in market interest, as evidenced by a pre-market stock price of $3.288, marking an increase of approximately 6.58% from the previous closing price. This movement is driven by strong buying activity, with a trading volume of 806.44K shares, reflecting heightened investor confidence likely stemming from positive developments within the company.

The recent announcement of Fast Track designation from the U.S. Food and Drug Administration (FDA) for CELZ’s lead investigational therapy, CELZ-201-DDT, which targets degenerative disc disease (DDD), has significantly contributed to this momentum. This prestigious designation is reserved for therapies addressing critical medical needs, facilitating accelerated drug development processes, including rolling Biologics License Application (BLA) submissions and the possibility of priority review. These measures not only aim to improve timelines for market access but also promise enhanced patient care choices.

CELZ-201-DDT is based on the Company’s AlloStem® platform and uses an allogeneic perinatal cell therapy approach, administered through minimally invasive, ultrasound-guided intramuscular injections. Clinical evidence thus far indicates a favorable safety profile and early signs of efficacy, positioning this therapy as a promising solution for chronic back pain associated with DDD.

Timothy Warbington, President and CEO, emphasized that the FDA’s Fast Track designation substantiates the company’s innovative scientific endeavors and acts as a catalyst for value creation, particularly in light of the ongoing opioid crisis and the urgent need for non-addictive pain management alternatives. As DDD significantly limits treatment options for millions, Creative Medical Technology is committed to transforming treatment paradigms and improving patient outcomes. The Company plans to release an expanded access policy for CELZ-201-DDT within 15 days, further underscoring its commitment to patient access and safety in groundbreaking biotherapeutic initiatives.

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