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PHOENIX - Creative Medical Technology Holdings, Inc. (NASDAQ:CELZ), a small-cap biotech company currently valued at around $8 million, announced Wednesday that the U.S. Food and Drug Administration has granted Fast Track designation to its investigational therapy for degenerative disc disease. The stock, which has seen a 33% gain year-to-date despite a recent 12% weekly decline according to InvestingPro data, appears fairly valued based on current metrics.
The company’s lead therapy, CELZ-201-DDT, is being developed to treat degenerative disc disease (DDD), a condition that causes chronic lower back pain and disability. The Fast Track status allows for accelerated FDA interactions, rolling Biologics License Application submissions, and potential priority review.
CELZ-201-DDT is an allogeneic perinatal cell therapy administered through minimally invasive, ultrasound-guided intramuscular injections. According to the press release, the designation was awarded based on clinical data showing a favorable safety profile and early efficacy signals.
"Lower back pain from degenerative disc disease remains a leading cause of disability worldwide, and the opioid crisis underscores the urgent need for new, non-addictive solutions," said Timothy Warbington, President and CEO of Creative Medical Technology Holdings. InvestingPro analysis shows the company maintains a strong financial position with more cash than debt and a healthy current ratio of 23.89, though it remains pre-profit with negative earnings of $3.01 per share over the last twelve months.
The company is nearing final enrollment in its FDA-cleared clinical trial for the therapy, which aims to target underlying cellular degeneration and inflammation rather than just managing symptoms.
Creative Medical Technology also announced it will post its expanded access policy for CELZ-201-DDT within 15 days, in accordance with Section 561A(f)(2) of the Federal Food, Drug, and Cosmetic Act.
Degenerative disc disease affects millions globally, with current treatment options often limited to symptom management or surgery. The global spinal disorders treatment market is projected to exceed $20 billion by 2030, according to information provided in the company’s statement. Analysts maintain a positive outlook with a $20 price target, though InvestingPro data indicates sales may decline in the current year. Subscribers can access 9 additional ProTips and comprehensive financial metrics for deeper analysis.
In other recent news, Creative Medical Technology Holdings, Inc. announced it has received a Notice of Allowance from the United States Patent and Trademark Office for a patent application. This patent focuses on treating Type 1 diabetes through cell-based immunotherapy. The patent, titled "Prevention and/or Treatment of Type 1 Diabetes by Augmentation of Myeloid Suppressor Cell Activity," will remain in effect until at least 2040 once granted. It covers the company’s ImmCelz product, which utilizes supercharged T regulatory cells. These developments highlight Creative Medical Technology’s ongoing efforts to innovate in the field of diabetes treatment.
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