Calidi Biotherapeutics Granted FDA Fast Track Designation for CLD-201 (SuperNova), a First-in-Class Stem Cell-Delivered Oncolytic Virus Therapy for Soft Tissue Sarcoma

July 29, 2025

DENVER, Colo., Jul 29, 2025 (247marketnews.com)- Calidi Biotherapeutics (NYSE:CLDI) stated that the U.S. Food and Drug Administration (FDA) granted Fast Track designation for CLD-201 (SuperNova), the company’s novel allogeneic adipose-derived stem cell-delivered oncolytic virus therapy, for the treatment of patients with soft tissue sarcoma.

CLD-201 is a first-in-class therapeutic platform designed to deliver a potent oncolytic virus directly to tumors using proprietary SuperNova stem cell carriers, potentially transforming outcomes for patients with difficult-to-treat cancers.

The Fast Track designation is reserved for therapies that treat serious or life-threatening conditions and have the potential to address unmet medical needs. This designation enables Calidi to benefit from more frequent interactions with the FDA, as well as potential priority review and accelerated approval opportunities for CLD-201.

“We believe CLD-201 has the potential to provide durable and transformational treatment to patients with sarcoma as well as patients with other advanced tumor types. We want to thank the FDA for its support and partnership and look forward to continued collaboration with the agency,” said Guy Travis Clifton, M.D., Calidi’s Chief Medical Officer

Calidi previously announced FDA Investigational New Drug (IND) clearance for CLD-201 on April 17, 2025. The upcoming Phase 1 trial will be a first-in-human, open-label, multicenter study evaluating the safety, tolerability, and early efficacy of CLD-201 across three cancer types: soft tissue sarcoma, triple-negative breast cancer, and head and neck squamous cell carcinoma.

About 24/7 Market News
As a pioneer in digital financial market media, 24/7 Market News (24/7MN) is dedicated to the swift distribution of financial market news and information. 24/7 MN incorporates comprehensive corporate communications resources and tools to engage the investment community. Visit 24/7 Market News website here.

24/7 MARKET NEWS, INC Disclaimer
Please go to https://247marketnews.com/disclaimer/ for disclaimer information.

CONTACT:
24/7 Market News
Editor@247marketnews.com

Related news for (CLDI)

NASDAQ and NYSE quotes and data are delayed 15 minutes unless indicated otherwise. Market data and exchange information are provided for informational purposes only and is not intended for trading purposes. Neither 24/7 Market News Editors, 247 Market News, or data and content providers shall be liable for any errors or omissions, delays, misquotes or other market information relayed in any press materials. You should Use Realtime data to conduct due diligence before investing or trading, and trading in any stock is risky you could lose all your money.