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 granted Fast Track Designation for its CYNK-001, a non-genetically modified NK cell therapy aimed at treating acute myeloid leukemia (AML). The designation aims to expedite the development of treatments for serious conditions with unmet medical needs. CYNK-001 also holds orphan drug designation for malignant gliomas. The therapy utilizes placental-derived NK cells and aims to improve responses and durability in patients suffering from AML.
Celularity (NASDAQ: CELU) presented preclinical data on its placental-derived NK cell therapies (CYNK-101 and CAR19-CYNK) at the 63rd American Society of Hematology Meeting in Atlanta from December 11-14, 2021. Both therapies showed promise in treating hematological malignancies. CYNK-101 demonstrated effective synergy with daratumumab, avoiding fratricide and off-tumor effects. CAR19-CYNK displayed enhanced tumor cell killing against resistant lymphoma. These findings highlight Celularity's innovative approach to cellular therapies drawn from placental cells.
Celularity Inc. (Nasdaq: CELU) has received FDA clearance for its Investigational New Drug (IND) application to evaluate CYNK-101, a genetically engineered NK cell therapy, in combination with chemotherapy, trastuzumab, and pembrolizumab for advanced HER2/neu positive gastric cancer. The Phase 1/2a trial aims to assess the safety and preliminary efficacy of this combination. Notably, gastric cancer ranks fifth in global incidence, with poor survival rates in advanced stages. Celularity seeks to enhance treatment outcomes by leveraging placental-derived NK cell therapy.
Celularity Inc. (Nasdaq: CELU) presented preclinical data on its allogeneic NK cell therapy, CYNK-101, at the Society for Immunotherapy of Cancer Annual Meeting from November 10-14, 2021. CYNK-101, derived from genetically modified human placental CD34+ cells, demonstrated enhanced antibody-dependent cellular cytotoxicity against EGFR+ tumors when combined with Cetuximab. This research suggests potential applications in treating non-small cell lung cancer and head and neck cancers. Celularity aims to develop innovative therapies targeting unmet medical needs.
Celularity Inc. (Nasdaq: CELU) reported third-quarter financial results on Nov. 12, 2021, with revenues of $7.3 million, notably driven by the termination of the Sanuwave license agreement. However, research and development expenses surged by $12.5 million, largely due to increased clinical trial costs and stock-based compensation. The net income for Q3 2021 reached $49.9 million, translating to $0.47 per share (basic). Year to date, the company recorded a net loss of $96.1 million. The firm is advancing its placental-derived cell therapies, highlighting collaborations and innovative approaches targeting cancer.
Celularity Inc. (Nasdaq: CELU) and Oncternal Therapeutics, Inc. (Nasdaq: ONCT) have announced a research collaboration to develop placental-derived cellular therapies targeting the ROR1 receptor. This partnership aims to combine Oncternal's ROR1-targeted monoclonal antibody, cirmtuzumab, with Celularity’s natural killer (NK) cells and investigate ROR1-targeted CAR gene modifications. ROR1 is associated with aggressive tumor behavior in various cancers. Both companies believe that this collaboration may enhance therapeutic options for patients with solid tumors and hematological malignancies.
Celularity Inc. has appointed Dr. Andrew L. Pecora as President, effective immediately. With over 25 years in biotechnology, Dr. Pecora will advance Celularity’s clinical pipeline toward FDA approval, reporting to CEO Dr. Robert J. Hariri. His experience includes leadership roles in cellular medicine and drug development, enhancing the company’s strategic vision. Celularity specializes in placental-derived therapies for cancer and infectious diseases, conducting innovative work in allogeneic cell therapies.
Celularity Inc. (Nasdaq:CELU) secured approximately $138 million in funding through a merger with GX Acquisition Corp. and a PIPE investment. The company expanded its Phase 1 trial for CYNK-001 to include difficult-to-treat patients with acute myeloid leukemia. Additionally, the FDA granted Orphan Drug Designation for CYNK-001. Celularity formed strategic partnerships with Imugene Ltd and Palantir to enhance its therapeutic developments and data analysis capabilities. However, second quarter revenues decreased by $0.3 million, with a net loss of $64.5 million.
Imugene Ltd and Celularity Inc have entered a research collaboration to explore the combination of Imugene’s CF33-CD19 oncolytic virus with Celularity’s CD19-targeting CAR T-cell therapy, CyCART-19, aimed at treating solid tumors. The partnership plans to initiate nonclinical studies in 2021, leveraging Celularity’s advanced T-cell therapy, which demonstrates sustained efficacy against tumors. The collaboration could potentially expand CAR T-cell therapy's application beyond hematological malignancies, enhancing treatment options for solid tumors. The first clinical trial is anticipated to start in 2022.
Celularity, Inc. announced the successful closing of its merger with GX Acquisition Corp., with gross proceeds of approximately $138 million. Common stock will trade on Nasdaq as CELU starting July 19, 2021. The company aims to innovate cancer treatment through placental-derived cell therapies, having multiple clinical programs for acute myeloid leukemia and glioblastoma. Notable partnerships with Palantir and Arthrex are also anticipated to enhance growth and revenue.
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