CELUFDA Updates
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
Celularity Inc. and Fountain Life Management have announced the availability of cenplacel-L, a placental-derived cell therapy, for investigational use in Florida. This follows new legislation that allows licensed physicians to utilize certain unapproved therapies. The initiative aims to create a scalable pathway for regenerative medicine, leveraging Celularity's manufacturing capabilities and clinical-grade products.
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Celularity Releases CEO Letter to Shareholders
Celularity Inc. has released a letter from CEO Robert J. Hariri detailing the company's strategic focus on placental-derived cellular therapies, particularly cenplacel-L. The company has streamlined operations and out-licensed its biomaterials business to strengthen its financial position. Despite challenges in the capital markets, there is strong physician interest in cenplacel-L, positioning Celularity for potential growth in the regenerative medicine sector.
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Celularity Appoints Rick Gonzalez as Chief Commercial Officer
Celularity Inc. has appointed Rick Gonzalez as Chief Commercial Officer to enhance its global commercial strategy. His experience in biotechnology and medical technology is expected to drive growth for the company's cenplacel-L and Lifebank offerings. The appointment comes as Celularity aims to expand access to its regenerative therapies amid increasing physician interest.
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Celularity Receives Nasdaq Notice Regarding Form 10-Q
Celularity Inc. received a notice from Nasdaq regarding its delayed filing of the Form 10-Q for Q1 2026, indicating non-compliance with Nasdaq Listing Rule 5250(c)(1). The company has until July 28, 2026, to submit a compliance plan, with a potential extension until November 16, 2026. Despite the notice, trading of CELU stock remains unaffected.
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Celularity Announces Filing of Form 10-K, Regains Nasdaq Compliance and Highlights Continued Strategic Transformation
Celularity Inc. has filed its Form 10-K for the fiscal year ending December 31, 2025, regaining compliance with Nasdaq's listing requirements. The company has undertaken strategic initiatives, including the out-licensing of its biomaterials portfolio and a reduction in liabilities by about $13 million. Leadership emphasizes a focused approach towards advancing regenerative medicine and creating long-term value.
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Celularity Announces Closing of Transaction with NexGel
Celularity Inc. has completed a transaction with NexGel, where NexGel acquired assets related to Celularity's biomaterials portfolio. The deal, valued at $13.3 million, allows Celularity to focus on its therapeutic pipeline while potentially earning additional milestone payments. This transaction also helps Celularity retire significant debt, enhancing its financial position.
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Celularity Announces Receipt of Nasdaq Notice Regarding Late Form 10-K Filing
Celularity Inc. received a notice from Nasdaq for not filing its Form 10-K for the fiscal year ending December 31, 2025. The company has 60 days to submit a compliance plan and may receive an extension of up to 180 days to regain compliance. Despite the notice, trading of its stock continues without immediate effect.
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Celularity Receives $12.2 Million from Sale of New Jersey Net Operating Losses
Celularity Inc. announced it has received $12.2 million from the sale of its unused New Jersey net operating losses and research tax credits. This transaction, facilitated by the New Jersey Economic Development Authority, provides the company with non-dilutive capital to enhance liquidity and support its regenerative medicine initiatives. The funds will aid in advancing their cell therapies targeting aging mechanisms.
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Celularity CEO Comments on Centers for Medicare & Medicaid Services’ Withdrawal of Skin Substitute Local Coverage Determinations
Celularity's CEO, Dr. Robert J. Hariri, expressed support for the CMS's withdrawal of skin substitute Local Coverage Determinations (LCDs), which would have affected other companies' products. Despite the withdrawal, Celularity's Biovance® and Biovance 3L remain eligible for Medicare coverage. The new Medicare payment policy for skin substitutes will still apply, ensuring reimbursement at a flat rate.
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