$GMDA News
Last published 11mo ago
- 11mo agoGMDAFDA Approves First Cellular Therapy to Treat Patients with Severe Aplastic AnemiaFDA Press ReleasesThe U.S. Food and Drug Administration today announced it has approved Omisirge (omidubicel-onlv), the first hematopoietic stem cell transplant (HSCT) therapy to treat patients with severe aplastic anemia (SAA). Omisirge is indicated for adults and pediatric patients 12 years and older with hematologic malignancies and now is approved for adults and pediatric patients six years and older with SAA f ...
- 1y agoGMDALPTXPPBTWSTPurple Biotech Appoints Shai Lankry as Chief Financial OfficerGlobeNewswireU.S.-based Lankry brings over 20 years of financial leadership in biotech and healthcare with a proven track record of driving strategic growth, operational excellence, and capital market execution, including leading a
- 2y agoARVNGMDAHOOKHOOKIPA Pharma Announces Leadership Changes to Intensify Focus on HB-200GlobeNewswireDirector Dr. Malte Peters named Chief Executive Officer and Director Terry Coelho named Executive Vice President and Chief Financial OfficerCompany is conducting a review of its business operations and strategy to
- 2y agoGMDAXRTXXORTX Welcomes New Member to the Board of DirectorsGlobeNewswireCALGARY, Alberta, April 08, 2024 (GLOBE NEWSWIRE) -- XORTX Therapeutics Inc. ("XORTX" or the "Company") (NASDAQ:XRTX, TSXV:XRTX, Frankfurt: ANUA WKN: A3UNZ)), a late-stage clinical pharmaceutical company
- 2y agoAQSTEBSGMDAAquestive Therapeutics Strengthens Board of Directors with Experienced Biotech ExecutiveGlobeNewswireWARREN, N.J., April 01, 2024 (GLOBE NEWSWIRE) -- Aquestive Therapeutics, Inc. (NASDAQ:AQST) ("Aquestive" or the "Company"), a pharmaceutical company advancing medicines to bring meaningful improvement to patients'
- 2y agoGMDAGamida Cell Ltd. (GMDA) Q4 2023 Earnings Call TranscriptEarnings Call Transcripts
- 2y agoGMDAGamida Cell Reports Fourth Quarter and Full-Year 2023 Financial Results and Provides Company UpdateGlobeNewswireCompany announces commencement of restructuring process supported by Highbridge Capital Management Continued progress of launch of Omisirge® (omidubicel-onlv), with the delivery of six units in 2023, as well as
- 2y agoGMDAGamida Cell Announces Commencement of Restructuring Process Supported by Highbridge Capital ManagementGlobeNewswireCompany expected to receive significant new capital from Highbridge to bolster the commercialization of allogeneic stem cell transplant Omisirge® (omidubicel-onlv) Gamida Cell to become a private company under
- 2y agoGMDAGamida Cell to Report Fourth Quarter and Full-Year 2023 Financial ResultsGlobeNewswireBOSTON, March 22, 2024 (GLOBE NEWSWIRE) -- 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
- 2y agoGMDAGamida Cell Data Presented at the 2024 Tandem Meetings of ASTCT® and CIBMTR®GlobeNewswireExpanded access program (EAP) data for omidubicel are consistent with Phase 3 trial results on rates of hematopoietic recovery and infections following stem cell transplant with Omisirge® (omidubicel-onlv)
- 2y agoGMDAGamida Cell Actively Pursuing Strategic AlternativesGlobeNewswireBOSTON, Jan. 29, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced it is actively pursuing strategic alternatives in order
- 2y agoGMDAGamida Cell to Present at the 2024 Tandem Meetings of ASTCT® and CIBMTR®GlobeNewswireBOSTON, Jan. 17, 2024 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced it will present new data on its FDA approved allogeneic
- 2y agoGMDAPNTPPBTSCNIPurple Biotech Appoints Dr. Yael Margolin to its Board of DirectorsGlobeNewswireDr. Margolin brings 35 years of expertise in biotechnology, pharma, and venture capital Purple Biotech also announces the resignation of Mr. Fabien Sebille, who served as the Company's Chief Business Officer REHOVOT,
- 2y agoGMDAGamida Cell to Host Virtual Thought Leader Fireside Chat on December 4, 2023GlobeNewswireBOSTON, Nov. 27, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, is hosting a virtual fireside chat with thought leader Gary Schiller,
- 2y agoGMDAGamida Cell Reports Third Quarter 2023 Financial Results and Provides Company UpdateGlobeNewswireCompany continues to advance launch, reports initial revenue from Omisirge® (omidubicel-onlv) Company to host conference call today at 8:30 a.m. ET BOSTON, Nov. 14, 2023 (GLOBE NEWSWIRE) --
- 3y agoGMDAGamida Cell Presents New Data on Allogeneic Stem Cell Therapy Omidubicel and Natural Killer (NK) Cell Therapy Candidate GDA-201 at Society for Immunotherapy of Cancer (SITC) Annual MeetingGlobeNewswireBOSTON, Nov. 04, 2023 (GLOBE NEWSWIRE) -- Gamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today shared new data on the impact of the company's proprietary
- 3y agoGMDAGamida Cell to Report Third Quarter 2023 Financial ResultsGlobeNewswireBOSTON, Nov. 01, 2023 (GLOBE NEWSWIRE) -- 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
- 3y agoGMDAGamida Cell Reports Preliminary Data from Phase 1 Study of Natural Killer (NK) Cell Therapy Candidate GDA-201Business WireData show promising early evidence of anti-tumor activity in patients with relapsed/refractory B cell non-Hodgkin lymphoma Full data readout of Phase 1 study expected in Q1 2024 Gamida Cell Ltd. (NASDAQ:GMDA), a
- 3y agoGMDAGamida Cell Issues Update on Israel OperationsBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today issued an update on its operations in Israel. "We remain profoundly saddened by the attacks in Israel this
- 3y agoGMDAGamida Cell to Present Corporate Highlights at 2023 Cell & Gene Meeting on the MesaBusiness WireAbbey Jenkins, President and Chief Executive Officer, to also participate in the panel "A record setting year for cell and gene therapies – how do we keep the momentum going?" Gamida Cell Ltd. (NASDAQ:GMDA), a cell
- 3y agoGMDAGamida Cell to Present at Society for Immunotherapy of Cancer's (SITC) 38th Annual MeetingBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that it will be presenting at the Society for Immunotherapy of Cancer's 38th Annual Meeting (SITC
- 3y agoGMDAFirst Patient Receives Gamida Cell's Omisirge™ (omidubicel-onlv)Business WireOmisirge is the only allogeneic stem cell therapy approved by the U.S. Food and Drug Administration (FDA) on the basis of a global randomized Phase 3 trial Rapid onboarding of transplant centers and significant payer
- 3y agoGMDAGamida Cell to Present Corporate Highlights at the H.C. Wainwright 25th Annual Global Investment ConferenceBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that its management team will present corporate highlights at the upcoming H.C. Wainwright 25th
- 3y agoADESGMDAGamida Cell Reports Second Quarter and First Half 2023 Financial Results and Provides Company UpdateBusiness WireStrong start for Omisirge® (omidubicel-onlv) launch with significant payer coverage and number of transplant centers onboarded exceeding expectations Company continues to pursue strategic partnership to further
- 3y agoGMDAGamida Cell to Report Second Quarter 2023 Financial ResultsBusiness WireConference Call and Webcast Scheduled for Monday, August 14th at 8:30 am Eastern Time Gamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the
- 3y agoGMDAData Published in Transplantation and Cellular Therapy Suggest Antiviral Protection After Transplantation with Gamida Cell's Omisirge® (omidubicel-onlv)Business WireFaster immune reconstitution and decreased rate of post-transplant viral infection in patients transplanted with Omisirge versus umbilical cord blood Gamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to
- 3y agoGMDASTAND UP TO CANCER NAMES JULIAN ADAMS, Ph.D., CHIEF SCIENCE OFFICERPR NewswireVeteran Oncology Researcher to Guide Investment in Breakthrough Cancer Treatments LOS ANGELES, July 10, 2023 /PRNewswire/ -- Stand Up To Cancer® (SU2C) today announced that Julian Adams, Ph.D., a longtime oncology
- 3y agoGMDAGamida Cell To Host Investor DayBusiness WireThought leaders Dr. Steven Devine and Dr. Usama Gergis to share perspectives on unmet needs and the clinical landscape in stem cell transplant Update on the progress of the commercial launch for Omisirge® to be
- 3y agoGMDAGamida Cell to Present Corporate Highlights at the Jefferies Healthcare ConferenceBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that Michele Korfin, Chief Operating and Chief Commercial Officer, will present corporate
- 3y agoGMDAData To Be Presented on Gamida Cell Natural Killer (NK) Cell Therapy Candidate GDA-201 at the International Society for Cell & Gene Therapy 2023 Annual MeetingBusiness WireNew data for batch-to-batch variability and cytotoxicity of GDA-201 show long term stability and unique phenotype of allogeneic NAM-NK cell therapy GDA-201 is in an ongoing Phase 1/2 clinical trial for non-Hodgkin
- 3y agoFWBIGMDAHOOKGamida Cell Appoints Terry Coelho as CFOBusiness WireIndustry veteran Coelho brings more than 35 years of experience at emerging growth and global companies to role; Shai Lankry to leave company June 2 Gamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to
- 3y agoGMDAGamida Cell Reports First Quarter 2023 Financial Results and Provides Company UpdateBusiness WireCompany reports positive feedback and continued progress on transplant center onboarding and payer coverage around launch of Omisirge® (omidubicel-onlv), a new cell therapy for allogeneic stem cell transplant
- 3y agoGMDAGamida Cell Announces the Date of Its First Quarter 2023 Financial Results and WebcastBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the company will host a conference call and live audio webcast on Monday, May 15, 2023, at
- 3y agoGMDAGamida Cell Announces Pricing of $23 Million Public Offering of SecuritiesBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced the pricing of an underwritten public offering of 17,500,000 ordinary shares and accompanying
- 3y agoGMDAGamida Cell Announces Launch of Public Offering of SecuritiesBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced the launch of a follow-on public offering of its ordinary shares and accompanying warrants to
- 3y agoGMDAGamida Cell's Allogeneic Cell Therapy Omisirge® (omidubicel-onlv) Receives FDA ApprovalBusiness WireOmisirge is approved by the FDA as a new donor source for allogeneic stem cell transplant Global, randomized Phase 3 clinical trial showed faster neutrophil recovery and reduced bacterial and fungal infections as
- 3y agoGMDAFDA Approves Cell Therapy for Patients with Blood Cancers to Reduce Risk of Infection Following Stem Cell TransplantationFDA Press ReleasesToday, the U.S. Food and Drug Administration approved Omisirge (omidubicel-onlv), a substantially modified allogeneic (donor) cord blood-based cell therapy to quicken the recovery of neutrophils (a subset of white blood cells) in the body and reduce the risk of infection. The product is intended for use in adults and pediatric patients 12 years and older with blood cancers planned for umbilical co ...
- 3y agoGMDAGamida Cell Reports Full Year 2022 Financial Results and Provides Company UpdateBusiness WireCompany reports on productive interactions with FDA and preparations for launch of omidubicel, if approved, in advance of May 1 PDUFA date Company outlines strategic restructuring, plans to prioritize omidubicel launch
- 3y agoGMDAGamida Cell Announces Changes to Board of DirectorsBusiness WireShawn Cline Tomasello to become Chairwoman, succeeding Chairman Robert I. Blum, who is resigning; Company focuses on upcoming regulatory milestone and commercialization Directors Dr. Naama Halevi-Davidov and Dr. Anat
- 3y agoGMDAGamida Cell Announces the Date of Its Fourth Quarter and Full Year 2022 Financial Results and WebcastBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), a cell therapy pioneer working to turn cells into powerful therapeutics, today announced that the company will host a conference call and live audio webcast on Monday, March 27, 2023, at
- 3y agoGMDAGamida Cell to Present Corporate Highlights at the Oppenheimer 33rd Annual Healthcare ConferenceBusiness WireGamida Cell Ltd. (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
- 3y agoGMDAData Presented on Gamida Cell's Omidubicel, GDA-201 at the 2023 Tandem Meetings of ASTCT and CIBMTRBusiness WireNew 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.S. Food and Drug Administration (FDA) of May 1, 2023 New data
- 3y agoGMDAGamida Cell Announces Closing of $25 Million Financing With HighbridgeBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), the global leader in the development of NAM-enabled cell therapies for patients with hematologic and solid cancers and other serious diseases, announced the closing of a senior secured
- 3y agoGMDAGamida Cell to Present Corporate Highlights at Multiple Upcoming Investor ConferencesBusiness WireGamida Cell Ltd. (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 that members of the management team
- 3y agoGMDAGamida Cell Provides Regulatory Update on OmidubicelBusiness WireRecent company submission in response to FDA request extends PDUFA date by three months Gamida Cell Ltd. (NASDAQ:GMDA), the leader in the development of NAM-enabled cell therapies for patients with hematological and
- 3y agoGMDAGamida Cell Reports Third Quarter 2022 Financial Results and Provides Company UpdateBusiness Wire– Commercial launch preparations underway ahead of January 30, 2023 PDUFA target action date – – New data presented across multiple medical meetings to support the potential of omidubicel as an advanced cell therapy,
- 4y agoGMDAGamida Cell to Present Corporate Highlights at the Jefferies London Healthcare ConferenceBusiness WireGamida Cell Ltd. (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 that Abbey Jenkins, President and
- 4y agoGMDAGamida Cell Announces the Date of Its Third Quarter 2022 Financial Results and WebcastBusiness WireGamida Cell Ltd. (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 that the company will host a
- 4y agoGMDAGDA-501, NAM enabled NK Cell Therapy, Demonstrates Promising Antitumor Activity Against HER2+ CancersBusiness WirePreclinical data presented at Society of Immunotherapy of Cancer's 37th Annual Meeting shows proprietary NAM technology expands NK cells, enhances functionality, increases antitumor activity, and improves homing to
- 4y agoGMDAGamida Cell Announces Omidubicel Data To Be Presented as an Oral Presentation at 64th ASH Annual MeetingBusiness WireGamida Cell Ltd. (NASDAQ:GMDA), the leader in the development of NAM-enabled cell therapy candidates for patients with hematological and solid cancers and other serious diseases, today announced an oral presentation of