Plus Therapeutics (PSTV) Stock Rockets On Orphan Drug Designation

Plus Therapeutics PSTV Stock News

Plus Therapeutics Inc (NASDAQ: PSTV) is running for the top in the market this morning, and for good reason. The company announced that it has received Orphan Drug Designation from the FDA. Here’s what’s going on:

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PSTV Stock Rockets On Orphan Drug Designation

As mentioned above, Plus Therapeutics is flying in the market today after the FDA granted Orphan Drug Designation. The Designation was granted to the company’s lead investigational drug known as Rhenium NanoLiposomes. Rhenium NanoLiposomes, or RNL, are currently being developed as a potential option for patients with recurrent glioblastoma.

In the release, PSTV said that RNL is designed to safely, effectively, and conveniently deliver a very high dose of radiation directly into the brain tumor. In fact, the concentration of radiation is up to 25 tijmes greater than what we see with current external beam radiation therapy.

At the moment, the company is evaluating the drug in the multi-center ReSPECT Phase 1 clinical trial. In the trial, the company is working to find the maximum tolerated dose.

In a statement, Dr. Marc Hedrick, President and CEO at PSTV, had the following to offer:

Receiving FDA orphan drug designation and approval to advance the trial into Cohort 6 are key milestones in our development of this treatment for recurrent glioblastoma. We believe RNL has the potential to prolong survival for patients with malignant brain tumors and that of other difficult to treat radiosensitive tumors.

This News Is Huge

The news released by Plus Therapeutics today is overwhelmingly positive. After all, Orphan Drug Designation isn’t just provided to any comapny that asks for it. The designation was designed to support the development of medicines that serve underserved patient populations.

This designation is great news. It provides the company with more contact with the FDA, a faster road to potential approval and exemption of the FDAs application fees. Moreover, Orphan Drug Designation provides the company with tax credits for certain qualified clinical trials.

The market is a massive one too. There are about 12,000 cases a year in the United States with one and five year median survival rates of 40.8% and 6.8% respectively. By 2024 it is expected that the Glioblastoma market will climb to be worth more than $3 billion annually. Should the company tap into a small percentage of that market, the revenue would be meaningful. All in all, PSTV is a stock that’s well worth watching.

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