Creative Medical announces WHO's proposed INN for CELZ-101, advancing its regenerative medicine clinical pipeline.
Quiver AI Summary
Creative Medical Technology Holdings, Inc. has announced that it has achieved a significant milestone by obtaining its second International Nonproprietary Name (INN), "etaroleucel," for its CELZ-101 autologous T-cell immunotherapy program from the World Health Organization (WHO). This is a part of the company's progress in advancing its clinical pipeline of regenerative medicine therapies aimed at high-unmet-need indications. The CELZ-101 treatment is designed to induce immune tolerance in conditions such as Type 1 diabetes related to pancreatic islet transplantation. The achievement follows the previous INN designation of "olastrocel" for the CELZ-201 allogeneic cell therapy, further showcasing Creative Medical's ability to navigate the regulatory landscape effectively. CEO Timothy Warbington emphasized that these milestones are crucial for global clinical development and commercialization, reflecting the company's commitment to delivering innovative solutions for complex medical conditions.
Potential Positives
- Creative Medical has achieved its second International Nonproprietary Name (INN) milestone with the World Health Organization (WHO), enhancing its credibility and recognition in the global pharmaceutical landscape.
- The proposed INN “etaroleucel” for CELZ-101 demonstrates the company's regulatory progress and the potential for its autologous regulatory T-cell immunotherapy in treating complex autoimmune conditions.
- The dual INN recognition for both CELZ-101 and CELZ-201 underscores Creative Medical's capability to advance multiple cell therapy programs effectively through recognized regulatory frameworks.
- CEO Timothy Warbington emphasized that INN recognition is vital for global clinical development and commercialization, marking a significant step towards long-term value creation for the company.
Potential Negatives
- The press release mentions "risks and uncertainties" associated with clinical trial outcomes and regulatory decisions, indicating potential challenges ahead for the company's progress.
- The need for a formal objection period before final confirmation of the INN could delay the commercialization efforts of the Company's therapies.
- Forward-looking statements highlight the potential for significant variability in actual results compared to the Company's expectations, pointing to inherent instability in their projected success.
FAQ
What is the significance of the proposed INN for CELZ-101?
The proposed INN "etaroleucel" for CELZ-101 signifies regulatory progress and global recognition for the company's Treg immunotherapy program.
Who published the proposed INN for CELZ-101?
The proposed INN "etaroleucel" was published by the World Health Organization (WHO) after expert review.
What are CELZ-101 and CELZ-201 used for?
CELZ-101 (etaroleucel) targets autoimmune conditions like Type 1 diabetes, while CELZ-201 (olastrocel) focuses on chronic lower back pain and degenerative disc disease.
How does Creative Medical's pipeline address unmet medical needs?
Creative Medical's pipeline aims to deliver regenerative therapies for conditions in orthopedics, immunotherapy, endocrinology, urology, and gynecology, targeting underserved markets.
What was CEO Timothy Warbington's comment on the INN achievements?
Warbington stated that achieving proposed INNs for both CELZ-101 and CELZ-201 validates their science and supports regulatory execution for long-term value creation.
Disclaimer: This is an AI-generated summary of a press release distributed by GlobeNewswire. The model used to summarize this release may make mistakes. See the full release here.
$CELZ Hedge Fund Activity
We have seen 8 institutional investors add shares of $CELZ stock to their portfolio, and 6 decrease their positions in their most recent quarter.
Here are some of the largest recent moves:
- DRW SECURITIES, LLC added 15,101 shares (+inf%) to their portfolio in Q3 2025, for an estimated $50,286
- NORTHERN TRUST CORP removed 11,707 shares (-100.0%) from their portfolio in Q3 2025, for an estimated $38,984
- CITADEL ADVISORS LLC removed 11,145 shares (-100.0%) from their portfolio in Q3 2025, for an estimated $37,112
- GLOBAL RETIREMENT PARTNERS, LLC added 7,918 shares (+inf%) to their portfolio in Q4 2025, for an estimated $15,519
- GEODE CAPITAL MANAGEMENT, LLC added 5,211 shares (+22.4%) to their portfolio in Q4 2025, for an estimated $10,213
- ALLWORTH FINANCIAL LP removed 4,000 shares (-100.0%) from their portfolio in Q4 2025, for an estimated $7,840
- AMERITAS ADVISORY SERVICES, LLC removed 2,276 shares (-100.0%) from their portfolio in Q3 2025, for an estimated $7,579
To track hedge funds' stock portfolios, check out Quiver Quantitative's institutional holdings dashboard.
Full Release
PHOENIX, Feb. 10, 2026 (GLOBE NEWSWIRE) -- Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) (“Creative Medical” or the “Company”) , a regenerative medicine company advancing disruptive cell-based therapies for high-unmet-need indications, today announced the achievement of its second International Nonproprietary Name (INN) milestone with the World Health Organization (WHO), marking continued regulatory progress across its expanding clinical pipeline. INNs are assigned by the WHO to uniquely and universally identify pharmaceutical substances and biologics worldwide.
The WHO has published the proposed INN “etaroleucel” for CELZ-101, the Company’s autologous regulatory T-cell (Treg) immunotherapy program, in Proposed INN List 134, following expert review during the 80th WHO INN Consultation (March 18–21, 2025). As part of the standard WHO process, the name is now entering the formal objection period prior to final confirmation.
CELZ-101 (etaroleucel) is designed to induce immune tolerance in complex autoimmune settings, including Type 1 diabetes in the context of pancreatic islet transplantation. The CELZ-101 platform has also been validated in cardiovascular and hepatic clinical applications.
This achievement follows WHO approval of “olastrocel” as the INN for the active cellular substance in CELZ-201, the Company’s lead allogeneic cell therapy also known as AlloStem®. This name was reviewed during the 79th WHO INN Consultation (October 22–25, 2024) and published in Proposed INN List 133, underscoring Creative Medical’s ability to advance multiple, distinct cell therapy programs through internationally recognized regulatory frameworks.
CELZ-201 (olastrocel) is being developed for chronic lower back pain and degenerative disc disease.
CEO Commentary
“Achieving proposed INN status for a second independent clinical program is a powerful validation of both our science and our regulatory execution,” said Timothy Warbington, President and CEO of Creative Medical. “Very few emerging regenerative medicine companies successfully advance multiple platforms through the WHO INN process. The recognition of both olastrocel and etaroleucel highlights the differentiation of our technologies and reflects the growing maturity of our pipeline.”
Warbington continued: “These milestones are not symbolic — they are foundational. INN recognition is essential for global clinical development, regulatory alignment, and eventual commercialization. We believe Creative Medical is building a scalable, internationally credible platform positioned for long-term value creation.”
Momentum Across the Pipeline
With both programs advancing through internationally recognized regulatory pathways, Creative Medical continues to execute on its strategy to translate innovative cell technologies.
About Creative Medical Technology Holdings, Inc.
Creative Medical Technology Holdings, Inc. (NASDAQ: CELZ) is a clinical-stage biotechnology company pioneering regenerative medicine therapies derived from adult and perinatal stem cell technologies. The Company’s pipeline targets large, underserved markets across orthopedics, immunotherapy, endocrinology, urology, and gynecology, with a mission to deliver scalable, disease-modifying solutions for patients with high unmet medical needs.
For more information, visit www.creativemedicaltechnology.com
Forward-Looking Statements
This press release contains forward-looking statements regarding clinical development, regulatory strategy and positioning, commercialization potential, and market opportunity. These statements are based on current expectations and involve risks and uncertainties that could cause actual results to differ materially. Factors include clinical trial outcomes, regulatory decisions, manufacturing considerations, competitive dynamics, and market conditions. Please refer to the Company’s filings with the SEC for a discussion of these risks. The Company undertakes no obligation to update forward-looking statements except as required by law.
Investor & Media Contacts
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