Gamida Cell Ltd. Stock Price, News & Analysis

Gamida Cell Ltd. (Nasdaq: GMDA) announced the appointment of Anat Cohen-Dayag, Ph.D., and Naama Halevi-Davidov, Ph.D., to its Board of Directors as Class II Directors. This move aims to enhance the company's scientific and financial capabilities in advancing its cell therapy pipeline. Dr. Cohen-Dayag brings over 25 years of biotech experience, while Dr. Halevi-Davidov has extensive financial expertise, previously serving as CFO of Kaltura, Inc. These additions are expected to strengthen Gamida Cell's mission to develop innovative cures for serious diseases.

Gamida Cell (NASDAQ: GMDA) has announced the initiation of a rolling BLA submission for its cell therapy omidubicel, expected to be fully submitted by mid-2022. The company is also exploring commercialization partnerships for omidubicel while implementing a 10% workforce reduction to extend its cash runway into mid-2023. The company ended 2021 with approximately $96.1 million in cash, anticipating operational cash use between $60 million and $70 million in 2022. Gamida Cell plans to report its 2021 financial results on March 16, 2022.

Gamida Cell Ltd. (Nasdaq: GMDA) announced plans to initiate a rolling Biologics License Application (BLA) submission for omidubicel after receiving positive feedback from the FDA. The full BLA submission is expected in the first half of 2022. This follows the establishment of analytical comparability between its commercial manufacturing and prior clinical sites. Omidubicel, which has Breakthrough Therapy Designation, represents a potential advancement in stem cell transplantation for blood cancer patients.

Gamida Cell Ltd. (NASDAQ: GMDA) announced eight presentations at the 2022 TCT Meetings from February 2-6, 2022, in Salt Lake City, UT, showcasing new data on its cell therapy, omidubicel. Key highlights include one-year data from a phase 3 study emphasizing lower non-relapse mortality rates (73% vs. 60% vs. standard umbilical cord blood transplantation). Other studies detail omidubicel's potential to enhance health-related quality of life and reduce racial health disparities among patients. Omidubicel is FDA-designated as a breakthrough therapy for blood cancers.

Gamida Cell Ltd. (NASDAQ: GMDA) announced promising two-year follow-up data for GDA-201, a cell therapy for relapsed or refractory non-Hodgkin lymphoma (NHL), showing a median duration of response of 16 months and a two-year overall survival rate of 78%. Additionally, the company revealed that omidubicel treatment significantly reduces hospitalization and healthcare resource utilization compared to standard cord blood transplants. These findings will be presented at the 63rd American Society of Hematology Annual Meeting in Atlanta on December 13, 2021.

Gamida Cell Ltd. (NASDAQ: GMDA) presented significant clinical data on omidubicel at the ASH Annual Meeting in Atlanta (December 11-14, 2021). An oral presentation highlighted rapid recovery of T and B cells in patients, supporting reduced severe infections compared to standard treatments. A poster presentation showed encouraging long-term outcomes from a single-center study with a 10-year follow-up, indicating sustained safety and effectiveness, with an overall survival rate of 48.5%. These findings reinforce omidubicel's potential as a transformative therapy for blood cancer patients.

Gamida Cell Ltd. (Nasdaq: GMDA) announced its participation in several upcoming virtual investor conferences. They will present at the Evercore ISI HealthCONx Conference on November 30, 2021, followed by the Piper Sandler Virtual Healthcare Conference on December 2, 2021, and the JMP Securities Hematology and Oncology Summit on December 6, 2021. A webcast of these events will be accessible through the company’s website for 14 days post-event. Gamida Cell focuses on innovative cell therapies for blood cancers and serious blood diseases.

Gamida Cell Ltd. (Nasdaq: GMDA) reported a net loss of $19.6 million for Q3 2021, up from $14.8 million in Q3 2020. The company has $121 million in cash, and is revisiting financial guidance due to a delayed Biologics License Application (BLA) submission for omidubicel, now expected in the first half of 2022. Data presented at the ASH Annual Meeting demonstrated a 78% overall survival rate at two years for GDA-201 and showed long-term benefits of omidubicel.

Gamida Cell (NASDAQ: GMDA) has completed a Pre-Biologics License Application (BLA) meeting with the FDA for omidubicel, a treatment for blood cancers. The FDA has requested a revised analysis of manufacturing data from Gamida Cell’s facility to ensure comparability with clinical trial products. Despite this delay, the company is optimistic about the feedback and aims to submit the BLA in the first half of 2022, pushing back from the end of 2021. Omidubicel is a breakthrough therapy intended to improve outcomes for patients needing stem cell transplants.