Welcome to our dedicated page for Celularity news (Ticker: CELUW), a resource for investors and traders seeking the latest updates and insights on Celularity stock.
Celularity Inc. (Nasdaq: CELU; warrants: CELUW) is frequently in the news as a regenerative and aging-related cellular medicine company focused on placenta-derived biomaterials and cell therapies. Its news flow covers developments across wound care, longevity-focused cell therapy, ophthalmic biologics, and corporate and capital markets activity. Readers following CELUW-related headlines can use this page to see how Celularity’s scientific, clinical, commercial, and financing updates intersect with the value of its listed warrants.
Company press releases highlight clinical milestones, such as publication of Phase 2 trial results for PDA-002, a placenta-derived mesenchymal stromal-like cell therapy evaluated in complex diabetic foot ulcers with peripheral artery disease. Other news items describe real-world evidence for Biovance human amniotic membrane allograft products in chronic wound healing, as well as the impact of Medicare coverage and payment policies on skin substitute products used in wound care.
Celularity also reports on strategic partnerships that extend its platform into new settings. Examples include a collaboration with Fountain Life to supply stem cell therapy products for use under a Florida statute governing stem cell therapies in orthopedics, wound care, and pain management, and an exclusive sublicense and manufacturing role for DefEYE, Inc. in ophthalmic biologics, including Biovance, Biovance 3L, Interfyl, and CentaFlex.
In addition, Celularity’s news includes financing transactions, balance sheet restructuring, and Nasdaq listing compliance updates, all of which can influence perceptions of risk and opportunity around CELU common stock and CELUW warrants. Investors and observers can use this news feed to monitor clinical data releases, reimbursement and regulatory developments, strategic alliances, and capital structure changes that the company discloses over time.
Celularity Inc. (Nasdaq: CELU) has received recommendation letters from the FDA Tissue Reference Group confirming that its Natalin and Acelagraft™ wound care products meet criteria to be regulated solely under section 361 of the PHS Act as human cell, tissue and cellular and tissue-based products (HCT/P).
Natalin is a decellularized dehydrated amnion derived tri-layer graft, while Acelagraft™ is a decellularized dehydrated amnion derived bi-layer graft. Both products are indicated for use in partial and full thickness acute and chronic wounds.
According to Nova One Advisor, the global Biological Skin Substitutes market was valued at $347.75 million in 2024 and is projected to grow at a CAGR of 8.83% through 2034, reaching $810.50 million. The chronic wounds segment is expected to grow fastest at 9.13% CAGR, with North America representing 42% of the global market.
Celularity (NASDAQ: CELU) has entered into a Master Services Collaboration Agreement with BlueSphere Bio (BSB) for manufacturing BSB's cell therapy products. This marks Celularity's second such collaboration, showcasing its ability to leverage its cGMP manufacturing infrastructure.
The collaboration will initially focus on producing BSB's novel T cell receptor (TCR) T cell therapies at Celularity's 37,000 square foot Florham Park, NJ facility. The agreement covers all aspects of cell therapy manufacturing, including Chemistry, Manufacturing and Controls (CMC), Quality Assurance, and Quality Control. BSB will maintain oversight of its second cell therapy product for treating Acute Myelogenous Leukemia (AML) in the U.S. and internationally.
The partnership aims to provide BSB with affordable clinical advancement opportunities while maintaining process control, utilizing Celularity's technical capabilities and manufacturing infrastructure.
The MASS Coalition has welcomed President Trump's order to freeze regulatory guidance not yet in effect, including Medicare Local Coverage Determinations (LCDs) for skin substitute products. The freeze extends until at least April 13, 2025, allowing for further evaluation and public comment.
This decision particularly benefits Medicare beneficiaries with diabetic foot ulcers and venous leg ulcers, ensuring continued access to treatments that help prevent sepsis and amputations. The Coalition criticized the previous administration's LCD implementation process, stating it was conducted without proper stakeholder consultation and could create a healthcare crisis for diabetics by causing treatment shortages.
Celularity (Nasdaq: CELU) has successfully regained compliance with Nasdaq Listing Rule 5250(c)(1) following the filing of its Q3 2024 10-Q report. The company had faced listing compliance issues due to delayed filings of Q1 and Q2 2024 reports. To address these challenges, Celularity has implemented significant improvements to its financial reporting infrastructure, including engaging EisnerAmper LLP as its independent audit firm and enhancing internal controls. The resolution ensures the company's continued listing on the Nasdaq Capital Market.
Celularity (NASDAQ: CELU) has filed its Q3 2024 Form 10-Q, becoming current with quarterly report filings. The company reported significant growth in financial performance:
- Total net revenues reached $36.1 million for the nine months ended September 30, 2024, up 238.6% from $10.7 million in the same period last year
- Q3 2024 total net revenues were $9.3 million, increasing 145.5% from $3.8 million in Q3 2023
- Product sales showed exceptional growth, reaching $26.2 million for the nine months ended September 30, 2024, a 621.1% increase from $3.6 million in the previous year
The company has addressed its Nasdaq listing compliance issues by filing the Q3 Form 10-Q and is implementing improvements to ensure timely financial disclosures.
Celularity (Nasdaq: CELU) received a notification from Nasdaq on November 21, 2024, stating non-compliance with listing requirements due to delayed filing of Q3 2024 Form 10-Q. The notice doesn't immediately affect the company's stock listing on Nasdaq Capital Market. Celularity must submit a compliance plan by January 20, 2025, and if accepted, has until May 13, 2025, to implement it. The filing delay stems from a backlog related to previous quarterly filings. The company expects to file Q3 Form 10-Q shortly and has implemented improvements to its financial reporting infrastructure.
Celularity (CELU) announced that its strategic partner, Genting Berhad, has broken ground on Fontaine Vitale, a state-of-the-art stem cell and regenerative medicine facility in Bali, Indonesia. The facility will use Celularity's placenta-derived stem cells manufactured in their US facility. Operations are expected to start by late 2026. The Asia Pacific stem cell market is valued at $3.0 billion (2024) with projected growth to $7.2 billion by 2030 at a 16.4% CAGR. Future plans include initiating onsite manufacturing operations under Celularity's technical supervision.
Celularity Inc. (CELU) has resolved its Nasdaq listing compliance matter after curing its filing delinquency. The company had previously received notification of non-compliance with Nasdaq Listing Rule 5250(c)(1) due to delayed quarterly reports for March and June 2024. Celularity successfully filed both outstanding Form 10-Q reports by November 7, 2024, achieving compliance and ensuring continued listing on Nasdaq. The filing delays were attributed to financial challenges in the biotech sector affecting access to capital and audit services. The company has implemented improvements including engaging EisnerAmper LLP as its independent auditor and enhancing internal controls.
Celularity (NASDAQ: CELU) has raised its full-year 2024 net sales guidance to $54-60 million, up from the previously announced $50-56 million. The company reported expected net sales of $44.4 million through October 2024, with October marking its highest single-month sales at $8.3-8.9 million. The guidance includes $49-54.5 million from advanced biomaterial products and $5.0-5.5 million from biobanking services. The company's new Rebound™ product contributed approximately $9 million to sales. Celularity has also filed its delayed Q2 2024 Form 10-Q, addressing Nasdaq compliance issues.
Celularity Inc. (Nasdaq: CELU) has provided a corporate update to shareholders. The company is working to regain full compliance with Nasdaq's listing requirements and has filed its annual report for 2023 and Q1 2024 report. The Q2 2024 report is expected to be filed soon. Celularity's commercial advanced biomaterials business has seen significant growth, with sales exceeding $24 million in the first half of 2024, surpassing full-year 2023 sales. The company recently acquired Rebound, a placental-derived allograft matrix product, which has already generated over $9 million in sales.
Celularity is developing several new products, including Celularity Tendon Wrap, FUSE Bone Void Filler, and Celularity Placental Matrix, with plans to submit 510(k) notifications to the FDA in 2025 and 2026. The company maintains its guidance of expected combined Net Sales for advanced biomaterial products and biobanking businesses to be between $50 million and $56 million.