Celularity and Fountain Life Announce Availability of Cenplacel-L for Investigational Use Under New Florida Law, Establishing Scalable Pathway for Advancement of Placental-Derived Cell Therapies
Rhea-AI Summary
Celularity (Nasdaq: CELU) and Fountain Life announced that cenplacel-L, a placental-derived allogeneic investigational cell therapy, will be available for physician-directed investigational use in Florida under new regenerative medicine statutes effective July 1, 2025.
The partnership leverages Celularity’s FDA-registered, GMP-compliant facility and Fountain Life’s preventive, longevity-focused care model.
Positive
- Florida law enables investigational use of cenplacel-L by licensed physicians starting July 1, 2025
- Celularity has FDA-registered, GMP-compliant manufacturing and clinical-grade cenplacel-L inventory
- Partnership with Fountain Life creates an initial clinical channel and patient selection framework
- State-level pathway may support broader market expansion for placental-derived cell therapies
Negative
- Cenplacel-L remains an investigational therapy without FDA approval
- Current access is limited to qualified physicians and patients within Florida
News Market Reaction – CELU
In the Jun 4 session, CELU declined 2.45%, reflecting a moderate negative market reaction.
Data tracked by StockTitan Argus on the day of publication.
Key Figures
Historical Context
| Date | Event | Sentiment | 24h Move | Catalyst |
|---|---|---|---|---|
| Jun 03 | Commercial leadership hire | Positive | -3.8% | Appointed Rick Gonzalez as Chief Commercial Officer to drive cenplacel-L rollout. |
| May 29 | Nasdaq 10-Q notice | Negative | +5.9% | Received Nasdaq notice for late Form 10-Q filing and outlined compliance timeline. |
| May 01 | Regained compliance | Positive | +2.8% | Filed 2025 Form 10-K, regained Nasdaq compliance and reduced liabilities by $13M. |
| Apr 21 | Asset sale, de-levering | Positive | -1.6% | Closed NexGel transaction, monetizing biomaterials assets and retiring nearly $13M debt. |
| Apr 17 | Nasdaq 10-K notice | Negative | +0.8% | Announced Nasdaq notice for late 2025 Form 10-K and potential cure period. |
24h Move is the share-price change in the day after each event; other market factors may also have contributed.
Recent news often saw price moves diverge from headline tone, with only one of five events showing price action aligned to the apparent sentiment.
Over the last few months, Celularity navigated listing compliance issues and strategic repositioning. Notices on late Form 10-K and Form 10-Q filings triggered mixed but mostly positive price reactions, while regaining Nasdaq compliance on May 1, 2026 and a $13 million liability reduction drew a modest gain. The April $13.3M biomaterials divestiture and a recent commercial leadership hire around cenplacel-L show a shift toward core cell therapy and longevity, into which today’s Florida-focused access news fits.
Key Terms
allogeneic medical
investigational cell therapy medical
gmp-compliant technical
immunomodulatory medical
regenerative medicine medical
stem-cell medicine medical
fda-registered regulatory
cellular therapies medical
AI-generated analysis. How Rhea-AI works. Not financial advice.
FLORHAM PARK, N.J. and ORLANDO, Fla., June 04, 2026 (GLOBE NEWSWIRE) -- Celularity Inc. (Nasdaq: CELU) (“Celularity”), a longevity-focused regenerative and cellular medicine company pioneering placental-derived cellular therapies, and Fountain Life Management, LLC (“Fountain Life”), a leading healthy longevity company delivering a next-generation preventive health model through advanced diagnostics, restorative therapeutics, and AI-driven health intelligence, today announced the availability of cenplacel-L, a placental-derived allogeneic investigational cell therapy, for investigational use by licensed physicians in the State of Florida under recently enacted legislation supporting responsible use of regenerative medicine.
This milestone marks the establishment of one of the first state-level frameworks in the United States enabling the physician-directed use of allogeneic cellular therapies outside of traditional federal approval pathways, creating a potential model for broader market expansion. Celularity is uniquely positioned to support this opportunity through its FDA-registered, GMP-compliant manufacturing infrastructure and existing inventory of clinical-grade product, enabling near-term clinical deployment.
Cenplacel-L, also known as PDA-001 or PDA-002 in clinical research settings, is a proprietary formulation of placental-derived investigational cell therapy in the broader category of stem-cell medicine developed by Celularity in the United States with demonstrated immunomodulatory and regenerative potential in clinical studies. Cenplacel-L represents a lead asset within Celularity’s broader platform of off-the-shelf, allogeneic cellular therapies targeting inflammation, degeneration, and age-related disease. Celularity maintains a robust inventory of cenplacel-L at its FDA-registered, GMP-compliant manufacturing facility and is prepared to support physician-directed investigational use consistent with the requirements of Florida law.
“We are proud to partner with Fountain Life and to support Florida’s forward-looking regulatory framework that empowers physicians to responsibly explore investigational regenerative therapies,” said Robert J. Hariri, MD, PhD, Chairman and Chief Executive Officer of Celularity. “Regenerative medicine is transitioning from theoretical promise to clinical reality, driven by advances in cell biology, manufacturing, and regulatory evolution. The human placenta is one of nature’s most powerful sources of cells capable of orchestrating repair and restoring balance in the body. By making cenplacel-L available to qualified physicians in Florida, we aim to advance access to innovations that may address unmet needs in wound care, orthopedics and other therapeutic areas permitted under state law while maintaining the highest ethical and quality standards. Florida’s framework represents an important step in enabling that transition: creating a responsible, physician-governed pathway that may serve as a model for broader adoption.”
Effective July 1, 2025, Florida Statutes § 458.3245 and § 459.0127 authorize licensed physicians to perform certain cell therapies that have not yet received approval from the United States Food and Drug Administration (“FDA”), provided such therapies are within the scope of the physician’s practice and comply with strict sourcing, manufacturing, accreditation and patient consent requirements. This regulatory clarity enables qualified physicians to incorporate investigational regenerative therapies into patient care while maintaining structured safeguards.
Celularity’s collaboration with Fountain Life provides an initial clinical channel for implementation, integrating advanced diagnostics, patient selection, and physician oversight within a preventive and longevity-focused care model. This partnership is expected to support early clinical experience, inform future development strategies, and contribute to the establishment of best practices for responsible deployment.
“Fountain Life is committed to expanding physician-led access to scientifically grounded, regenerative solutions that align with both innovation and patient safety,” said William Kapp, MD, Co-Founder and Chief Executive Officer of Fountain Life. “Aligning with Celularity’s expertise in placental stem cell biology, this availability in Florida represents an important step toward responsibly broadening investigational use under an established legal and compliant framework.”
Physicians interested in learning more about cenplacel-L and its investigational availability in Florida are encouraged to contact Celularity’s medical affairs team and the Fountain Life contact listed below.
About Celularity
Celularity Inc. (Nasdaq: CELU) is a longevity-focused regenerative and cellular medicine company developing and manufacturing allogeneic and autologous cell therapies derived from the postpartum placenta. Celularity leverages the placenta’s unique biology, immunologic properties and scalable availability to develop therapeutic solutions targeting fundamental mechanisms of aging and age-related disease.
For more information, please visit www.celularity.com.
About Fountain Life
Fountain Life is a leading longevity brand committed to helping people not only live longer but live better. By combining cutting-edge science, advanced AI-guided diagnostics, and restorative therapeutics, Fountain Life delivers a next-generation preventive health model. This approach integrates regenerative medicine and AI-driven health intelligence to detect disease early, optimize performance, and extend healthspan.
Founded in 2020 by pioneering leaders in business, medicine, and innovation Dr. Peter Diamandis, Tony Robbins, Dr. Robert Hariri and Dr. William Kapp Fountain Life was established to fill a critical void in healthcare: the absence of proactive, data-driven care that emphasizes prevention, optimization, and the extension of both healthspan and lifespan.
In 2025, Fountain Life was named Longevity Brand of the Year, underscoring its leadership in premium preventive healthcare and healthspan optimization. That same year, Zori AI. Fountain Life’s proprietary intelligence engine was recognized with a Global Tech Award, celebrating its breakthrough role in AI-powered health intelligence and personalized longevity guidance.
Through its tiered membership programs CORE, APEX, and APEX FAMILY, Fountain Life delivers scalable access to this groundbreaking model. At the heart of the experience is Zori AI, which synthesizes each member’s comprehensive health data to uncover hidden risks and provide highly personalized recommendations.
These insights are implemented through a dedicated care team and on-demand virtual care, ensuring ongoing support and precision delivery. Fountain Life is redefining the future of medicine, available now. To learn more or to take control of your health, visit www.fountainlife.com.
Forward Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements other than statements of historical fact and include, without limitation, statements regarding the expected availability, deployment and use of cenplacel-L by licensed physicians in Florida; the potential for Florida’s regulatory framework to serve as a model for broader market expansion or adoption; Celularity’s ability to support physician-directed investigational use through its manufacturing infrastructure and existing inventory; the potential therapeutic applications, immunomodulatory or regenerative properties, and clinical utility of cenplacel-L; the potential for early clinical experience to inform future development strategies or best practices; and Celularity’s plans, expectations, opportunities and objectives relating to regenerative medicine, longevity, cellular therapies, and physician-directed investigational use. Forward-looking statements are based on Celularity’s current expectations, estimates, assumptions and beliefs and are subject to substantial risks and uncertainties that could cause actual results, performance or achievements to differ materially from those expressed or implied by such statements. These risks and uncertainties include, among others, risks related to Celularity’s ability to establish, maintain or expand collaborations with Fountain Life or other clinical partners; Celularity’s ability to manufacture, release, store, distribute and support the use of cenplacel-L in compliance with applicable requirements; the interpretation, implementation or potential modification of Florida Statutes § 458.3245, § 459.0127 or other applicable laws and regulations; the role and requirements of the United States Food and Drug Administration (FDA) and other federal or state regulatory authorities with respect to investigational cellular therapies; the willingness and ability of licensed physicians to use cenplacel-L under applicable legal frameworks; patient demand, patient eligibility and physician adoption; the availability of clinical-grade inventory; the ability to generate meaningful clinical experience or data; safety, efficacy, quality, sourcing, manufacturing, accreditation, informed consent, commercial and operational risks; and other risks and uncertainties described in Celularity’s filings with the Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and other subsequent filings. Cenplacel-L has not been approved by the FDA for any indication or use, and its availability under Florida law does not constitute FDA approval or a determination of safety or effectiveness by the FDA. Except as required by law, Celularity undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Media/Investor Contact
Carlos Ramirez
Senior Vice President, Celularity Inc.
Carlos.ramirez@celularity.com
Medical Affairs Contact
Sharmila Koppisetti
Senior Vice President, Celularity Inc.
Clinical Development, Medical Affairs and Drug Safety
Sharmila.koppisetti@celularity.com
Media Contacts for Fountain Life:
Isabel Coscia
isabel.coscia@fountainlife.com
