Retail chatter around Creative Medical Technology Holdings picked up on Wednesday after the company said the U.S. Food and Drug Administration (FDA) had granted Fast Track status to its lead experimental treatment, CELZ-201-DDT, for degenerative disc disease (DDD), which is a leading cause of chronic lower back pain and disability.

Creative Medical’s stock rose 4.70% to $3.23 on Wednesday before slipping 2.8% in after-hours trading.

The Fast Track designation is reserved for treatments that have the potential to address serious health conditions with limited existing treatment options. 

It allows for more frequent contact with the FDA, rolling submissions of the company’s Biologics License Application, and the possibility of priority review, potentially speeding the path to market.

CELZ-201-DDT is part of Creative Medical’s AlloStem platform and uses allogeneic perinatal cells, delivered through minimally invasive, ultrasound-guided intramuscular injections.  

The FDA's decision was based on clinical data that demonstrated the treatment's safety and evidence that the therapy may help patients. 

CEO Timothy Warbington said the designation was not only a scientific validation, but also a milestone that could accelerate development and address the unmet need for novel, non-addictive therapies for back pain at a time when the U.S. is in the midst of an opioid crisis.

DDD affects millions worldwide, with current care often limited to pain management or surgery. Creative Medical is aiming to treat the root causes, which are degeneration and inflammation, rather than just the symptoms. 

The company stated that the potential market for innovative therapies for spinal disorders could reach over $20 billion by 2030.

Within 15 days, Creative Medical will post its expanded access policy for CELZ-201-DDT.

On Stocktwits, retail sentiment for Creative Medical was ‘extremely bullish’ amid a 3,600% surge in 24-hour message volume.

One user said they were adding to their Creative Medical position on every dip, expecting the stock to move above 4. 

Another user said that if there is little to no new dilution, the shares should be trading at 32 rather than 3.20.

Creative Medical’s stock has risen nearly 40% so far in 2025.

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