Plus Therapeutics Inc. (NASDAQ: PSTV) shares made a handy gain on Tuesday after the company announced an update from the U.S. Food and Drug Administration (FDA).
Specifically, the FDA has granted the company an orphan drug designation for its lead investigational drug, Rhenium NanoLiposomes (RNL), for the treatment of patients with recurrent glioblastoma.
RNL is currently being evaluated in the NIH/NCI-supported, multi-center ReSPECT Phase 1 dose-finding clinical trial.
Also, RNL is designed to safely, effectively and conveniently deliver a very high dose of radiation, which is up to 25 times greater concentration than currently used external beam radiation therapy. This can be beamed directly into the brain tumor for maximum effect.
Note that glioblastoma is the most common and most aggressive of the primary malignant brain tumors in adults. According to the most recent Central Brain Tumor Registry of the United States Statistical Report, annually there are about 11,833 cases of glioblastoma diagnosed within the United States, with historical one-year and five-year median survival rates of 40.8% and 6.8%, respectively.
One thing to note about orphan drug status is that the FDA’s Office of Orphan Drug Products grants this status to support the development of medicines for underserved patient populations, or rare disorders, that affect fewer than 200,000 people in the United States.
This designation provides the company with certain benefits, including market exclusivity upon regulatory approval, exemption of FDA application fees, and tax credits for qualified clinical trials.
Plus Therapeutics stock traded up about 8% to $2.65 on Tuesday, in a 52-week range of $0.93 to $16.00. The consensus price target is $5.00.