Diffusion Pharmaceuticals Inc (NASDAQ:DFFN)
Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) shares are up over 20% after the clinical-stage biotechnology company reported the completion of a major production run of its lead drug candidate trans sodium crocetinate (TSC). DFFN shares had ended Tuesday at $1.94 and, after the news hit the market, gapped up to open at $2.51 before hitting the inter-day high of $3.04. Volumes for DFFN shares have been heavy, 5 million shares had traded hands by noon EST. The 30-day, daily volume average for DFFN is only 70,000 shares.
Trans sodium crocetinate (TSC) will be used in Diffusion Pharmaceuticals Inc (NASDAQ:DFFN)’s planned Phase 3 trial which will test TSC in the treatment of newly diagnosed inoperable glioblastoma (GBM) brain cancer patients. After this production run, TSC quantities are of sufficient quantity to support the entire trial. Diffusion Pharmaceuticals Inc (NASDAQ:DFFN) plans to initiate this clinical trial by the end of the year.
David Kalergis, Diffusion’s Chairman and CEO, stated “Diffusion has reached an important milestone for initiating the Phase 3 trial with this successful manufacture of Phase 3-ready TSC. In its End-of-Phase-2-Meeting response, the FDA required that any TSC used in upcoming Phase 3 studies must be made using commercially-ready processes, both for the active pharmaceutical ingredient (API) and formulated drug product. The necessary advanced production and formulation processes were implemented over the last eighteen months and were cleared with the FDA in June, immediately prior to the successful clinical trial supply production run earlier this month.”
Diffusion Pharmaceuticals Inc. (DFFN) is a clinical-stage biotechnology company developing novel small molecule therapeutics for cancer and other hypoxia-related diseases. Diffusion’s shares have had a rough time of it in the market. YTD, DFFN shares are down over 14% and are down over 80% for the year. DFFN shares are over 85% off their 52-week high of $15.50 and had been trading barely above the 52-week low of $1.80.
I have no positions in any of the stocks mentioned, and have no plans to initiate any positions within the next 72 hours. All information, including any data, is provided without any guarantees of accuracy.
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About the author: Marc has a degree in economics and a MSc. in Finance. Over his 20-year career, Marc has worked for global investment firms in Europe and the United States as an analyst, fund manager, and consultant.