Welcome to our dedicated page for Celularity news (Ticker: CELU), a resource for investors and traders seeking the latest updates and insights on Celularity stock.
Celularity Inc. (NASDAQ: CELU) is a regenerative and aging-related cellular medicine company whose news flow reflects developments across placental-derived biomaterial products, cell therapies, financing, and regulatory milestones. As a Nasdaq-listed issuer, Celularity regularly reports corporate updates, clinical data, partnerships, and capital markets transactions that are relevant to investors and observers of the regenerative medicine and longevity sectors.
News about Celularity often covers its advanced biomaterial products and wound care franchise, including updates on Biovance and Biovance 3L human amniotic membrane allografts and related reimbursement and coverage policies. The company has commented on Centers for Medicare & Medicaid Services decisions affecting skin substitute products and has highlighted real-world evidence from clinical use of its wound care products. These items can influence perceptions of the company’s commercial trajectory in chronic wound management.
Another key category of Celularity news involves its placenta-derived cell therapy programs, such as PDA-002. The company has announced peer-reviewed Phase 2 clinical trial results in diabetic foot ulcers complicated by peripheral artery disease and has discussed how state-level laws, particularly in Florida, may enable physician-directed use of certain stem cell therapies in orthopedics, wound care, and pain management. Such updates provide insight into the clinical and regulatory landscape for its investigational products.
Celularity’s press releases also address strategic partnerships and corporate structure. Examples include collaborations with Fountain Life in longevity-focused centers and with DefEYE, Inc. in ophthalmic biologics, as well as internal restructuring into distinct operating subsidiaries. In addition, the company reports on financings, debt restructuring, Nasdaq listing rule matters, and preferred stock or warrant issuances. For readers tracking CELU, this news page aggregates these developments so they can follow how Celularity’s placental-derived platform, commercial units, and capital structure evolve over time.
Celularity Inc. (Nasdaq: CELU) announced that the FDA has conducted a preliminary classification of its investigational FUSE Bone Void Filler, recommending that it be classified as a device under its Center for Devices and Radiological Health (CDRH). This follows Celularity's Pre-Request for Designation (Pre-RFD) from October 2022. The company plans to submit its 510(k) pre-market notification to the FDA in early 2024. The global bone void filler market is expected to grow from $3.2 billion in 2021 to $7.3 billion by 2031, driven by factors such as an increase in orthopedic diseases and an aging population.
Celularity Inc. has entered into an exclusive distribution agreement with AD Ports Logistics to distribute Halal-Certified regenerative medicines and wellness products across the Middle East, including UAE, Qatar, Bahrain, Oman, Kuwait, and Egypt. This partnership follows a prior agreement for Saudi Arabia and aims to enhance access to innovative healthcare solutions in the region. Celularity's commercial biomaterial products include various types derived from human placental tissue. The regenerative medicine market is expected to grow significantly, reaching $37.10 billion by 2030, highlighting the importance of this distribution deal for both companies.
Celularity Inc. (NASDAQ: CELU) has entered an exclusive distribution agreement with AD Ports Logistics for the distribution of its Halal-Certified regenerative medicine products across the United Arab Emirates, Qatar, Bahrain, Oman, Kuwait, and Egypt. This follows a similar agreement for Saudi Arabia. The global regenerative medicine market, valued at approximately $9.80 billion in 2021, is projected to grow at a CAGR of 15.9%, reaching $37.10 billion by 2030. Celularity aims to expand its presence in the Middle East and North Africa, leveraging AD Ports’ logistics capabilities to enhance healthcare access in the region.
Celularity Inc. (Nasdaq: CELU) has announced intentions to submit a 510(k) pre-market notification to the FDA for its investigational Celularity Tendon Wrap (CTW). The FDA has agreed to regulate CTW as a device, based on the company's recommendation. The CTW is designed for tendon injuries without substantial tissue loss, serving as a surgical mesh. The global tendon repair market was valued at $2.1 billion in 2021, with a projected CAGR of 7.5% through 2030. Celularity also has exclusive agreements for distributing its biomaterial products in over 100 countries. The submission is expected by year-end with planned product launch in 2024.
Celularity Inc. (Nasdaq: CELU) announced progress in its strategic review, focusing on its commercial biomaterials and cell therapy programs. Key highlights include a new distribution agreement covering over 100 countries for Halal-certified products and ongoing advancements in its osteoarthritis programs. Promising preclinical results show significant improvements in cartilage formation and reduced inflammation using its placental-derived products. The company aims to align its operating priorities through targeted expense reductions while preparing for a biomaterials production ramp-up in 2023. Additionally, workforce notifications were made as part of its strategic realignment.
Celularity Inc. has partnered with Tamer Group as the exclusive distributor of its Halal-Certified regenerative biomaterial products in Saudi Arabia. This strategic collaboration aims to enhance public health and support Saudi Arabia's Vision 2030 healthcare objectives. With the global regenerative medicine market projected to reach $37.10 billion by 2030, this distribution agreement is positioned to capitalize on significant market growth. Products are expected to be available in Saudi Arabia in 2023, pending regulatory approval.
Celularity Inc. (NASDAQ: CELU) has partnered with CH Trading Group to distribute its Halal-Certified regenerative biomaterial products in over 100 countries. The agreement includes a minimum purchase commitment of
Celularity Inc. (Nasdaq: CELU) announced positive findings from its legacy studies on placental-derived mesenchymal-like adherent stromal cell (MLASC) therapy for Crohn’s disease. The re-analysis revealed a clinical remission rate of 50% at two years and an overall response rate of 83% among a limited patient group. The optimal treatment schedule involved two infusions a week apart. The safety profile was favorable with no dose-limiting toxicities. Celularity is moving forward with its genetically modified allogeneic therapy, APPL-001, in hopes of addressing unmet medical needs in Crohn's disease.
Celularity Inc. (Nasdaq: CELU) has appointed Paul Graves as Senior Vice President and Chief Communications Officer, effective January 2, 2023. Bringing over 30 years of experience in biopharmaceutical public relations, Graves will lead strategic communications as the company progresses towards FDA submissions for its clinical pipeline. Graves previously held senior communication roles at Janssen and Takeda Pharmaceuticals, focusing on R&D communication across various therapeutic areas. His role aims to enhance the visibility of Celularity's placental-derived therapies, which target cancer and other diseases.
Celularity Inc. (Nasdaq: CELU) has achieved Halal Certification for its cellular therapy candidates and biomaterial products, allowing access to Islamic markets globally. This certification, issued by Circle H International, validates compliance with Islamic law, facilitating Celularity's expansion strategy, particularly in the Middle East North Africa (MENA) region, focusing on Saudi Arabia. The MENA healthcare market is projected to reach
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