24/7 Market News Snapshot 29 July, 2025 – Calidi Biotherapeutics, Inc. (NYSE:CLDI)
DENVER, Colo., 29 July, 2025 (www.247marketnews.com) – (NYSE:CLDI) are discussed in this article.
Calidi Biotherapeutics, Inc. is making headlines with its recent pre-market trading surge, witnessing a remarkable increase of 49.75% to $0.823, up from the previous session’s $0.550. The surge is accompanied by a robust trading volume, exceeding 25.78 million shares, reflecting growing investor enthusiasm and optimism surrounding the company’s innovative biotherapeutic advancements. As market participants remain focused on this upward momentum, expectations rise for further developments from Calidi Biotherapeutics.
In conjunction with this favorable trading response, Calidi Biotherapeutics has received Fast Track designation from the U.S. Food and Drug Administration (FDA) for CLD-201, an allogeneic adipose stem-cell loaded oncolytic virus. This designation is a significant achievement on the company’s path to developing targeted therapies for soft tissue sarcoma, a cancer indication marked by demanding therapeutic needs.
The Fast Track designation facilitates a prioritized development and review approach for promising treatments addressing severe conditions. With this milestone, Calidi anticipates improved communication channels with the FDA, potentially paving the way for a priority review and expedited approval trajectory for CLD-201.
Dr. Guy Travis Clifton, Calidi’s Chief Medical Officer, expressed optimism regarding this development, highlighting the importance of the FDA’s designation as affirmation of the urgent need for innovative therapies in sarcoma treatment. The forthcoming Phase 1 trial will be a pivotal first-in-human study assessing the safety, tolerability, and effectiveness of CLD-201 across various indications, including soft tissue sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.
Utilizing adipose-derived mesenchymal stem cells to enhance the delivery of oncolytic vaccinia virus, CLD-201 aims to improve therapeutic efficacy while overcoming immune system barriers. With its advanced Redtail platform, Calidi Biotherapeutics is committed to transforming oncology treatment approaches, striving to address significant health challenges presented by advanced solid tumors.
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