Our proprietary nicotinamide (NAM) technology expands the number of cells while maintaining their intrinsic HealthcareProfessionals. Simantov brings to the company extensive medical experience in late stage development and commercialization of cancer treatments. May 10, 2022 · Net loss for the first quarter of 2022 was $20. Gamida Cell collects, processes and transfers personal data to and from its investigational clinical sites in accordance with applicable state, federal and international law governing investigational drugs and the use and disclosure of protected health information. Apr 17, 2023 · About Gamida Cell. Nov 4, 2021 · BOSTON--(BUSINESS WIRE)--Nov. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematologic and solid cancers and other serious diseases, today announced the activation of the initial clinical sites to screen and enroll patients in the company-sponsored Phase 1/2 study evaluating a cryopreserved formulation of GDA Apr 25, 2022 · Gamida Cell is pioneering a proprietary NAM-enabled immunotherapy pipeline of diverse potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. 2023. GAMIDA CELL Q3 2023 FINANCIAL RESULTS CALL. Feb 9, 2021 · 2 Gamida Cell press release, “Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies,” issued May 12, 2020 Apr 17, 2023 · On April 17, 2023, the Food and Drug Administration approved omidubicel-onlv (Omisirge, Gamida Cell Ltd. 0 million. gamida Gamida Cell issued a statement on Oct. Aug 14, 2023 · About Gamida Cell. Naama Halevi-Davidov and Dr. BOSTON -- (BUSINESS WIRE)--Mar. PDF Version. Filing year. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has SEC Filings. Filing date. Food and Drug Administration said on Monday it had approved the use of Gamida Cell Ltd's cell therapy for cutting the risk of infection in patients undergoing treatment for blood cancer Mar 27, 2023 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. ) for use in adult and pediatric patients (12 years and older) with hematologic malignancies Recent company submission in response to FDA request extends PDUFA date by three months. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic Full BLA submission on track for first half of 2022. Confirm patient-specific identifiers on the RFI Certificate and Certificates of Analysis (CoAs) match the patient’s identity. (Address and telephone number, including area code of Registrant’s principal executive offices) Gamida Cell Inc. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated Apr 18, 2023 · FDA approves Omisirge (omidubicel-onlv), a nicotinamide modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery time of neutrophils (a subset of white blood cells) in the Mar 27, 2024 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. 42. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic Feb 18, 2023 · New data add to the body of evidence supporting efficacy of omidubicel, Gamida Cell’s lead product candidate, which has a target PDUFA action date with U. dollars in thousands (except share and per share data) September 30, December 31, 2023 : 2022 Apr 18, 2023 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. engages in the development of cell therapies to cure blood cancer and rare serious hematologic diseases. H. • Confirm receipt of the Release for Shipping Certificate. Cash burn has been a major overhang for the stock in 2023 and higher-than-expected Mar 22, 2024 · BOSTON, March 22, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and Dec 5, 2020 · Gamida Cell’s proprietary NAM-based cell expansion platform is designed to enhance the number and functionality of donor cells in culture, enabling the creation of potentially transformative therapies that move beyond what is possible with existing approaches. All of the shares in the offering are May 22, 2023 · About Gamida Cell. For additional information, please visit www. 29, 2022-- Gamida Cell Ltd. Anat Cohen-Dayag also stepping down. BOSTON, Nov. 20, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. will join the Company as its new Chief Medical . (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematological and solid cancers and other serious diseases, today provided an update on recent interactions with the U. Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapies for patients with solid tumor and blood cancers and other serious blood diseases. GDA-201, the lead candidate in the NAM-enabled NK cell pipeline, has demonstrated promising Feb 9, 2021 · Gamida Cell previously reported in May 2020 that the study achieved its primary endpoint, showing that omidubicel demonstrated a statistically significant reduction in time to neutrophil engraftment, a measure of how quickly the stem cells a patient receives in a transplant are established and begin to make healthy new cells, and a key Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. They can also provide support with a wide range of reimbursement, financial and logistical services for Aug 1, 2022 · Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. BOSTON -- (BUSINESS WIRE)--Oct. Gamida Cell KOL Fireside Chat. Nov 22, 2022 · With commercial preparations already underway, Gamida Cell was keenly eyeing the late January deadline for U. (Nasdaq: GMDA), a cell therapy pioneer working to turn Nov 14, 2023 · During the quarter, Gamida Cell delivered two units of Omisirge, and for the full year, the company expects to recognize revenue from another 2-4 units. My name is Daryl, and I'll be your operator for today's call. Description. 7, 2023-- Gamida Cell Ltd. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the company will release its financial results for the fourth quarter and full year ended December 31, 2023 and provide an update on the company on Wednesday, March 27, 2024. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM Apr 26, 2022 · Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy for the treatment of hematologic and solid tumors in combination with standard of care antibody therapies. 's business for stockholders, potential investors, and financial analysts. Award-winning, battle-tested pharmaceutical executive with 25+ years of experience…. Nov 14, 2023 · BOSTON, Nov. , a leading cellular and immune therapeutics company, today announced the pricing of its initial public offering of 6,250,000 ordinary shares at a public offering price of $8. Jerusalem, Israel and New York, New York, July 10, 2017 — Gamida Cell, a leader in cellular and immune therapies for the treatment of cancer and orphan genetic diseases, announced today that Ronit Simantov, M. 03 Bankruptcy or Receivership. 11. This cash runway guidance is based on the company’s current operational plans Liked by Abigail Jenkins. AND ITS SUBSIDIARY: CONDENSED CONSOLIDATED BALANCE SHEETS: U. com or visit www. · Experience: Aquestive Therapeutics · Education: Northwestern University Dec 10, 2020 · Gamida Cell's second program to enter clinical stage testing, GDA-201, is responsible for the stock's recent surge. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, announced that following receipt of positive Type B meeting correspondence from the U. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM The study will enroll patients from 12 years of age in clinical centers across the U. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and May 31, 2023 · GDA-201 is an investigational cell therapy candidate, and its safety and efficacy have not been established by the FDA or any other health authority. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood May 16, 2023 · Gamida Cell’s Omisirge (omidubicel) is an allogeneic source of hematopoietic stem cells for transplant, particularly in cases where patients have no matched adult bone marrow donors nor Jan 29, 2024 · Gamida lays off 17%, ditches NK cell therapy work to keep blood cancer drug on track Omisirge works by speeding the recovery of neutrophils, a type of white blood cells that combat infection. Listen to Webcast. We are committed to supporting healthcare professionals who care for patients and share our goal of improving clinical outcomes. The Board of Directors has elected Shawn Cline Tomasello About Gamida Cell Gamida Cell is an advanced cell therapy company committed to finding cures for patients with blood cancers and serious blood diseases. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today reported financial results for the quarter intended patient and the information on the documents from the Gamida Cell Assist Hospital Portal. 21, 2022-- Gamida Cell Ltd. Gamida Cell is developing allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. (the “Company”) filed a Current Report on Form 8-K (the “Form 8-K”) reporting, among other things, (i) the entry into a Restructuring Support Agreement with Gamida Cell Inc. Wainwright 25th Annual Global Investment Conference. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic Nov 14, 2023 · GAMIDA CELL LTD. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and Feb 16, 2021 · The proceeds from this sale of notes, together with the net proceeds of Gamida Cell’s sale of $75 million of ordinary shares in December 2020, are expected to provide Gamida Cell with sufficient liquidity to fund the company’s operations into the second half of 2022. We are a global company united by our passion for science, our spirit of relentless innovation, and — above all else — our commitment to changing the lives of patients, families and caregivers. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that Abbey Jenkins, President and Chief Executive Officer, will present its corporate highlights at the upcoming Oppenheimer 33 rd Annual Healthcare Conference on March 14 th, 2023 at 9:20 a. It onboarded 17 transplant centers during Mar 27, 2024 · Gamida Cell press release ( NASDAQ: GMDA ): Q4 GAAP EPS of -$0. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic Jan 29, 2024 · About Gamida Cell . The Israeli cell Mar 26, 2024 · On March 27, 2024, Gamida Cell Ltd. Gamida Cell is a clinical-stage biopharmaceutical company committed to developing advanced cell therapies with the potential to cure blood cancers and rare, serious hematologic diseases. Blum. 00 per share for aggregate gross proceeds of $50. 78M beats by $0. and certain funds managed by Highbridge Capital Management LLC (the “Support Agreement”) and (ii) the Company’s filing of a voluntary proceeding for restructuring (the Jun 1, 2022 · BOSTON--(BUSINESS WIRE)--Jun. 14, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. Nov. regulators to decide on the approval application of its stem cell transplant therapy Jun 19, 2019 · About Gamida Cell. as part of its previously announced restructuring, just a year after the company got its first drug approval in the U. Nov 4, 2023 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. S. 6 Apr 23, 2024 · Gamida Cell Ltd. Items per page 10 25 50. Revenue of $1. 116 Huntington Avenue. The company’s proprietary nicotinamide (NAM) technology 6 hours ago · Gamida Cell has gathered new capital as it emerges from bankruptcy, and InduPro raised a Series A. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM Oct 2, 2023 · About Gamida Cell. 19, 2022-- Gamida Cell Ltd. Mar 27, 2024 · Gamida Cell, a cell therapy company, enters into a restructuring agreement with Highbridge, its principal lender, to receive new capital and support Omisirge commercialization. Mar 27, 2024 · “In March 2023, Gamida Cell embarked on an extensive strategic process to address its capital structure and liquidity constraints by partnering Omisirge with a third party,” Gamida’s CEO MarketWatch: Stock Market News - Financial News - MarketWatch Feb 23, 2024 · Preliminary data presented on GDA-201, Gamida Cell’s natural killer (NK) cell therapy candidate in ongoing Phase 1 study for non-Hodgkin lymphoma, show promising early evidence of anti-tumor Gamida Cell Ltd. BOSTON--(BUSINESS WIRE)--Nov. 9, 2021-- Gamida Cell Ltd. As of December 31, 2023, Gamida Cell had total cash and equivalents of $46. Mar 28, 2024 · Welcome to Gamida Cell's conference call for a business update and fourth quarter and full year 2023 financial results. SEC Filings. A high-level overview of Gamida Cell Ltd. This treatment is essentially an off-the-shelf infusion of natural killer (NK Apr 28, 2023 · Gamida Cell ended FY2022 with just under $65 million of cash and marketable securities on the balance sheet. , Jerusalem, Israel. Boston, MA 02116. Gamida Cell expects that its current cash and cash equivalents will support the company’s ongoing operating activities into the second half of 2022. Nov 14, 2023 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. Apr 17, 2023 · The U. (GMDAQ) stock. 2 million in the first quarter of 2021. Filing Group. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic Gamida Cell Assist (GCA) provides personalized support through every step of the Omisirge journey. Stay up to date on the latest stock price, chart, news, analysis, fundamentals, trading and investment tools. We harness our cell expansion platform to create therapies with the potential to redefine standards of care in areas of serious medical need. (Name, address, including zip code, and telephone number, of agent for service) Copies to: Divakar Gupta. Gamida Cell will become a private company owned by Highbridge and issue contingent value rights to shareholders. At Gamida Cell, we’re working to turn cells into powerful therapeutics. Gamida Cell is a biotech company that develops and commercializes cell therapies for various diseases. Learn about its mission, values, team, leadership and board of directors. The Gamida Cell Studies Coordinating Center Oct 6, 2020 · 4 Gamida Cell press release, “Gamida Cell Announces Positive Topline Data from Phase 3 Clinical Study of Omidubicel in Patients with High-Risk Hematologic Malignancies,” issued May 12, 2020. (the “Debtor”) filed a petition for recognition for relief under Chapter 15 of Title 11 (“Chapter 15”) of the United States Bankruptcy Code in the United States Bankruptcy Court for the Mar 27, 2024 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. We are leveraging our proprietary nicotinamide-based, or NAM-based, cell expansion technology to develop product candidates designed to Gamida Cell Ltd. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and NK Nov 20, 2023 · The Gamida Cell management team will be available for one-on-one meetings dur. Food and Drug Administration (FDA Tel: (617) 892-9080. Nov 4, 2023 · Both omidubicel and GDA-201 are powered by Gamida Cell’s proprietary NAM technology, which enhances and expands cells to create potentially curative cell therapies for patients with cancer. Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. 1, 2022-- Gamida Cell Ltd. Gamida Cell is a biopharmaceutical company developing advanced cell therapies for patients with blood cancers and hematologic diseases. ET. Oct 16, 2023 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. As of March 31, 2022, Gamida Cell had total cash and cash Oct 16, 2023 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. Its product includes NiCord, a cell therapy based on NAM-expanded cord blood developed to improve and extend the life-saving benefits of hematopoietic stem cell transplant. Please be Nov 14, 2022 · Gamida Cell applied the capabilities of its nicotinamide (NAM)-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the potential treatment of hematologic and solid tumors in combination with standard of care antibody therapies. Tel: (617) 892-9080. The firm offers Omidubicel, an investigational product with potential as a Item 1. (Nasdaq: GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, today announced the presentation of new long term follow-up data and health-related quality of life scores of patients treated with Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. These capital infusions will be used to support manufacturing, regulatory Jun 2, 2022 · About Gamida Cell. has filed for bankruptcy in the U. If you are a patient, caregiver or physician who is interested in learning more about the study, please contact Gamida Cell at medicalinformation@gamida-cell. The company’s research and development efforts have produced potentially curative cell therapy candidates for patients with blood cancers. (Nasdaq: GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced the resignation of Chairman Robert I. Working to turn cells into powerful therapeutics for patients with cancer. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and expand cells, creating allogeneic cell therapy products and candidates that are potentially curative for patients with hematologic malignancies. 72M. Food and Drug Administration (FDA Mar 27, 2024 · The newly reorganized Gamida Cell will issue contingent value rights with a potential aggregate maximum value of $27. Apr 17, 2023 · The FDA on Monday approved Israel-based Gamida Cell's Omisirge (omidubicel-onlv), an allogeneic cord blood-based cell therapy used to quicken the recovery of white blood cells for cancer patients BOSTON--(BUSINESS WIRE)--Mar. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced that Aviad Pato, Ph. Our proprietary nicotinamide (NAM) technology expands the number of cells while maintaining their intrinsic properties to create potentially curative cell therapy products and candidates for patients with cancer. Food and Drug Administration (FDA) of May 1, 2023 New data for GDA-201, Gamida Cell’s natural killer (NK) cell therapy candidate in ongoing May 24, 2024 · Gamida Cell Ltd. 2 million, compared to a net loss of $19. How Gamida Cell Uses and Maintains Information Collected from its Clinical Trials. Form. 7 condemning the attacks on Israel and declaring its solidarity with its employees in Israel and the State of Israel, which can be found here. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced data evaluating the mechanism of action of nicotinamide (NAM)-enabled NK cells, demonstrating enhanced homing, cytotoxicity and tumor reduction by GDA-201, the lead candidate in its NAM-enabled NK cell therapy pipeline. Sep 19, 2022 · Gamida Cell is pioneering a diverse immunotherapy pipeline of potentially curative cell therapy candidates for patients with solid tumor and blood cancers and other serious blood diseases. clinicaltrials. 57 misses by $0. Several Boston-area biotechs shared the common goal of bringing in funding this week, even if the Oct 26, 2021 · About Gamida Cell. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells At Gamida Cell, we are maximizing the power of our proprietary NAM technology to create potentially curative therapies in areas of serious medical need. The Investor Relations website contains information about Gamida Cell Ltd. Nov 9, 2021 · BOSTON--(BUSINESS WIRE)--Nov. C. , Head of Immunology Research, presented data on two nicotinamide (NAM)-enabled NK cell therapies, GDA-501 and GDA-301, at the Protein & Antibody Engineering Summit (PEGS) Europe taking place in Jan 17, 2024 · About Gamida Cell Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. D. Mar 22, 2024 · About Gamida Cell. (Nasdaq: GMDA), an advanced cell therapy company committed to cures for cancer and other serious diseases, today announced four presentations at the 63 rd American Society of Hematology (ASH) Annual Meeting, which is being held in Atlanta, Georgia or virtually from December 11-14, 2021. Last accessed August 31, 2020 . Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. About Gamida Cell. Professionals. BOSTON--(BUSINESS WIRE)--Sep. On April 22, 2024, Abigail Jenkins, solely in her capacity as a duly authorized foreign representative (the “Foreign Representative”) of Gamida Cell Ltd. Healthcare. Hear from members of our team and explore opportunities to join us. 20, 2023-- Gamida Cell Ltd. gov (NCT04260698). We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood Mar 9, 2021 · Gamida Cell expects cash used for ongoing operating activities in 2021 to range from $100 million to $120 million. m. We apply a proprietary platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood-derived cells and Dr. GCA case managers can assist with patient enrollment, placing a cell order and tracking that order through manufacturing and delivery. BOSTON -- (BUSINESS WIRE)--Jan. The company’s research and development efforts have produced potentially curative cell therapy candidates Sep 12, 2022 · About Gamida Cell. We Gamida Cell applied the capabilities of its NAM-enabled cell expansion technology to develop GDA-201, an innate NK cell immunotherapy candidate for the treatment of hematologic and solid tumors in combination with standard-of-care antibody therapies. Filing Group 3,4,5 Annual Filings Current Reports Mergers & Acquisitions Other Proxy Filings Quarterly Filings Registration Statements. 14. 275 likes. We apply a proprietary expansion platform leveraging the properties of NAM to allogeneic cell sources including umbilical cord blood Mar 20, 2023 · Directors Dr. Our commitment to the patient community encompasses not just our efforts to develop potentially curative therapies, but to understand the needs and experiences of those we serve. 5 million to holders of Gamida Cell’s ordinary shares, subject to the Aug 1, 2023 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. The company’s proprietary nicotinamide (NAM) technology leverages the properties of NAM to enhance and Jan 29, 2024 · Gamida Cell is a cell therapy pioneer working to turn cells into powerful therapeutics. Sep. 26, 2018-- Gamida Cell Ltd. 4, 2021-- Gamida Cell Ltd. jp ti ug wm yl pv pd wu zk wn