Celularity Submits Request to U.S. FDA for Orphan Drug Designation for PDA-002 Asset Treating Facioscapulohumeral Muscular Dystrophy
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Mar 20 2024
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Should l Buy CELU?
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Analyst Views on CELU
About CELU
Celularity Inc. is a regenerative and cellular medicine company. The Company is developing and commercializing advanced biomaterial products and allogeneic, cryopreserved, placental-derived cell therapies, all derived from the postpartum placenta. Its therapeutic programs target aging-related diseases, including degenerative diseases, cancer, and immune disorders, using mesenchymal-like adherent stromal cells, T-cells engineered with CAR (CAR T-cells), and genetically modified and unmodified natural killer (NK) cells. It develops, manufactures and commercializes advanced biomaterial products derived from structural tissue components of the postpartum placental tissues, including the umbilical cord. Its advanced biomaterials include Celularity Tendon Wrap, FUSE Bone Void Filler and Celularity Placental Matrix. Its advanced biomaterial products include Biovance, Biovance 3L, CentaFlex, Interfyl and Rebound products.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Celularity Secures $12.2 Million from Sale of Tax Credits and NOLs
- Capital Injection: Celularity secured $12.2 million in net cash proceeds from the sale of approximately $126.3 million in unused New Jersey net operating losses (NOLs) and $1.9 million in R&D tax credits, significantly enhancing the company's liquidity and financial stability.
- Non-Dilutive Capital: This funding is viewed as non-dilutive and tax-free capital that supports Celularity's capital allocation towards commercial opportunities in stem cell and regenerative medicine programs, particularly targeting longevity.
- Policy Support: The transaction was facilitated through New Jersey's Technology Business Tax Certificate Transfer Program, which aims to assist technology and life sciences companies in converting NOLs and R&D tax credits into cash, demonstrating state support for innovative enterprises.
- Future Outlook: The CEO of Celularity stated that this funding will aid the company's ongoing development in regenerative medicine, especially in developing therapeutic solutions addressing aging mechanisms and related diseases.
See More
Celularity's Biovance Products to Maintain Medicare Coverage Post LCD Withdrawal
- Medicare Coverage Continuation: Celularity's Biovance and Biovance 3L products will continue to be eligible for Medicare coverage following the CMS withdrawal of skin substitute LCDs effective January 1, 2026, ensuring competitive positioning and product accessibility in the market.
- Stable Payment Structure: CMS will implement a flat payment rate of $127.28 per square centimeter for all skin substitute applications, providing Celularity with a sustainable revenue stream that enhances its financial stability.
- Manufacturing Capability Enhancement: Celularity's GMP/GTP-certified facility in New Jersey not only produces commercial biomaterials but also employs advanced digitized and AI-driven Industry 5.0 manufacturing systems, improving production efficiency and supply chain resilience.
- Market Performance Review: Over the past year, CELU's stock price fluctuated between $1.00 and $4.35, with the latest closing price at $1.34, reflecting a 1.52% increase from the previous trading day, indicating market confidence in the company's outlook.
See More
Celularity Withdraws Skin Substitute LCDs; Biovance® Remains Medicare Eligible
- Policy Impact: On December 24, 2025, CMS withdrew the Local Coverage Determinations (LCDs) for skin substitutes set to take effect on January 1, 2026, which, while allowing Celularity's Biovance® to remain Medicare eligible, eliminated coverage for 158 other products, potentially reshaping market competition.
- Medicare Payment Policy: Despite the withdrawal of the LCDs, CMS's new payment policy will reimburse skin substitutes at a flat rate of $127.28 per square centimeter, providing Celularity with a stable revenue foundation that ensures its ongoing competitiveness in the market.
- Clinical Evidence Support: Celularity has amassed substantial real-world evidence demonstrating Biovance®'s effectiveness in treating chronic wounds across diverse patient populations, particularly those with multiple health issues, highlighting its unique value proposition in the market.
- Manufacturing Capability Enhancement: Since its commercial launch in April 2014, Biovance® has leveraged a highly efficient, scalable manufacturing process, integrating an 'Industry 5.0' approach that incorporates digitization and AI, thereby enhancing the adaptability and resilience of its production systems, further solidifying its market position.
See More
Celularity Responds to CMS Withdrawal of Skin Substitute Policies
- Policy Impact: On December 24, 2025, CMS withdrew the Local Coverage Determinations (LCDs) for skin substitutes set to take effect on January 1, 2026, which while maintaining Medicare coverage for Celularity's Biovance®, eliminates coverage for 158 other products, potentially reshaping market dynamics.
- Stable Payment Policy: Despite the withdrawal of the LCDs, CMS's new payment policy will still take effect on January 1, 2026, establishing a reimbursement rate of $127.28 per square centimeter for all skin substitute applications, providing a stable revenue foundation for Celularity's offerings.
- Clinical Evidence Support: CEO Hariri emphasized that Biovance® has demonstrated effectiveness in treating chronic wounds across diverse patient populations, supported by substantial real-world evidence, which enhances its competitive positioning in the market.
- Manufacturing Capability Enhancement: Since its commercial launch in April 2014, Celularity has developed a highly efficient and scalable manufacturing process, integrating an 'Industry 5.0' approach to enhance flexibility and digitization in production systems, ensuring operational viability under the new Medicare reimbursement framework.
See More
Celularity Secures $10 Million Financing to Enhance Financial Flexibility
- Successful Financing: Celularity has closed a financing transaction with Philip A. Barach, co-founder of DoubleLine Capital, securing $10 million to strengthen its financial foundation to support ongoing operations and strategic initiatives.
- Loan Structure: The financing includes a $7 million senior secured term loan, which provides a first-priority lien on nearly all of Celularity's assets, thereby enhancing the company's asset security and financing capabilities.
- Convertible Notes: Celularity issued secured convertible notes with commitments of up to $5 million, convertible at $1.66 per share, which is expected to provide flexibility in the company's future capital structure and attract more investor interest.
- Strategic Direction: The company plans to articulate its corporate strategy in the new year, focusing on applications related to healthy aging and performance optimization, aiming to drive sustainable value through innovation.
See More
Celularity Secures $12 Million Financing to Support Strategic Priorities
- Financing Support: Celularity has entered into two financing agreements with Philip A. Barach, co-founder of DoubleLine Capital, expected to provide up to $12 million to support its strategic priorities around longevity and human performance preservation.
- Loan Structure: This includes a $7 million senior secured term loan, which secures a first-priority lien on substantially all of Celularity's assets, thereby enhancing the company's financial flexibility to advance its core technologies.
- Convertible Notes: Celularity plans to issue up to $5 million in secured convertible notes with a conversion price of $1.66 per share, which is anticipated to provide additional capital liquidity to support future R&D efforts.
- Strategic Partnership: Barach's investment not only reflects a recognition of Celularity's scientific foundation but also aims to provide financial support and constructive perspectives as the company navigates necessary changes for a more focused future.
See More
Celularity Secures $12.2 Million from Sale of Tax Credits and NOLs
- Capital Injection: Celularity secured $12.2 million in net cash proceeds from the sale of approximately $126.3 million in unused New Jersey net operating losses (NOLs) and $1.9 million in R&D tax credits, significantly enhancing the company's liquidity and financial stability.
- Non-Dilutive Capital: This funding is viewed as non-dilutive and tax-free capital that supports Celularity's capital allocation towards commercial opportunities in stem cell and regenerative medicine programs, particularly targeting longevity.
- Policy Support: The transaction was facilitated through New Jersey's Technology Business Tax Certificate Transfer Program, which aims to assist technology and life sciences companies in converting NOLs and R&D tax credits into cash, demonstrating state support for innovative enterprises.
- Future Outlook: The CEO of Celularity stated that this funding will aid the company's ongoing development in regenerative medicine, especially in developing therapeutic solutions addressing aging mechanisms and related diseases.
See More
Celularity's Biovance Products to Maintain Medicare Coverage Post LCD Withdrawal
- Medicare Coverage Continuation: Celularity's Biovance and Biovance 3L products will continue to be eligible for Medicare coverage following the CMS withdrawal of skin substitute LCDs effective January 1, 2026, ensuring competitive positioning and product accessibility in the market.
- Stable Payment Structure: CMS will implement a flat payment rate of $127.28 per square centimeter for all skin substitute applications, providing Celularity with a sustainable revenue stream that enhances its financial stability.
- Manufacturing Capability Enhancement: Celularity's GMP/GTP-certified facility in New Jersey not only produces commercial biomaterials but also employs advanced digitized and AI-driven Industry 5.0 manufacturing systems, improving production efficiency and supply chain resilience.
- Market Performance Review: Over the past year, CELU's stock price fluctuated between $1.00 and $4.35, with the latest closing price at $1.34, reflecting a 1.52% increase from the previous trading day, indicating market confidence in the company's outlook.
See More
Celularity Withdraws Skin Substitute LCDs; Biovance® Remains Medicare Eligible
- Policy Impact: On December 24, 2025, CMS withdrew the Local Coverage Determinations (LCDs) for skin substitutes set to take effect on January 1, 2026, which, while allowing Celularity's Biovance® to remain Medicare eligible, eliminated coverage for 158 other products, potentially reshaping market competition.
- Medicare Payment Policy: Despite the withdrawal of the LCDs, CMS's new payment policy will reimburse skin substitutes at a flat rate of $127.28 per square centimeter, providing Celularity with a stable revenue foundation that ensures its ongoing competitiveness in the market.
- Clinical Evidence Support: Celularity has amassed substantial real-world evidence demonstrating Biovance®'s effectiveness in treating chronic wounds across diverse patient populations, particularly those with multiple health issues, highlighting its unique value proposition in the market.
- Manufacturing Capability Enhancement: Since its commercial launch in April 2014, Biovance® has leveraged a highly efficient, scalable manufacturing process, integrating an 'Industry 5.0' approach that incorporates digitization and AI, thereby enhancing the adaptability and resilience of its production systems, further solidifying its market position.
See More
Celularity Responds to CMS Withdrawal of Skin Substitute Policies
- Policy Impact: On December 24, 2025, CMS withdrew the Local Coverage Determinations (LCDs) for skin substitutes set to take effect on January 1, 2026, which while maintaining Medicare coverage for Celularity's Biovance®, eliminates coverage for 158 other products, potentially reshaping market dynamics.
- Stable Payment Policy: Despite the withdrawal of the LCDs, CMS's new payment policy will still take effect on January 1, 2026, establishing a reimbursement rate of $127.28 per square centimeter for all skin substitute applications, providing a stable revenue foundation for Celularity's offerings.
- Clinical Evidence Support: CEO Hariri emphasized that Biovance® has demonstrated effectiveness in treating chronic wounds across diverse patient populations, supported by substantial real-world evidence, which enhances its competitive positioning in the market.
- Manufacturing Capability Enhancement: Since its commercial launch in April 2014, Celularity has developed a highly efficient and scalable manufacturing process, integrating an 'Industry 5.0' approach to enhance flexibility and digitization in production systems, ensuring operational viability under the new Medicare reimbursement framework.
See More
Celularity Secures $10 Million Financing to Enhance Financial Flexibility
- Successful Financing: Celularity has closed a financing transaction with Philip A. Barach, co-founder of DoubleLine Capital, securing $10 million to strengthen its financial foundation to support ongoing operations and strategic initiatives.
- Loan Structure: The financing includes a $7 million senior secured term loan, which provides a first-priority lien on nearly all of Celularity's assets, thereby enhancing the company's asset security and financing capabilities.
- Convertible Notes: Celularity issued secured convertible notes with commitments of up to $5 million, convertible at $1.66 per share, which is expected to provide flexibility in the company's future capital structure and attract more investor interest.
- Strategic Direction: The company plans to articulate its corporate strategy in the new year, focusing on applications related to healthy aging and performance optimization, aiming to drive sustainable value through innovation.
See More
Celularity Secures $12 Million Financing to Support Strategic Priorities
- Financing Support: Celularity has entered into two financing agreements with Philip A. Barach, co-founder of DoubleLine Capital, expected to provide up to $12 million to support its strategic priorities around longevity and human performance preservation.
- Loan Structure: This includes a $7 million senior secured term loan, which secures a first-priority lien on substantially all of Celularity's assets, thereby enhancing the company's financial flexibility to advance its core technologies.
- Convertible Notes: Celularity plans to issue up to $5 million in secured convertible notes with a conversion price of $1.66 per share, which is anticipated to provide additional capital liquidity to support future R&D efforts.
- Strategic Partnership: Barach's investment not only reflects a recognition of Celularity's scientific foundation but also aims to provide financial support and constructive perspectives as the company navigates necessary changes for a more focused future.
See More
