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 Fast Track Designation from the FDA. Here’s what’s going on:

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PSTV Stock Gains On Fast Track Designation

In the press release, Plus Therapeutics said that the FDA has granted Fast Track Designation for its lead investigational drug, Rhenium NanoLiposomes. The Designation was provided for the potential treatment of patients with recurrent glioblastoma.

Importantly, PSTV has already received Orphan Drug Designation from the FDA for its treatment as a potential glioblastoma therapeutic.

The Fast Track Designation provided to the company comes with several benefits, including:

  • More frequent face to face and over the phone meetings with the FDA to discuss the development plan of the drug.
  • More frequement written communication from the FDA about the use of biomarkers, trial design, and more.
  • The potential for Accelerated Approval and Priority Review.
  • Finally, the company is subject to a Rolling Review. This means that it can submit completed sections of its NDA to the FDA for review, rather than waiting until every section of the NDA is completed before submission.

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

Fast Track designation validates the potential importance of this novel radiotherapeutic for patients with recurrent glioblastoma who currently have no good treatment options. With this designation in hand, we intend to move into Cohort 6 of the trial, one key step closer to bringing forth a novel therapy for these patients.

This News Is Huge

The news released by Plus Therapeutics this morning is overwhelmingly positive. Fast Track Designation was designed by the FDA to help companies working on drugs that address serious conditions with unmet medical need bring their treatments to market faster.

That’s exactly what this designation has the potential to do for PSTV.

Importantly, the company is in the midest of the ReSPECT Phase 1 clinical trial. Last week, the DSMB approved the Company to proceed with Cohort 6, suggesting that so far, the maximum tolerated dose has not yet been found and that the treatment has a favorable safety and tolerability profile.

Should things continue to go well with RNL, it may eventually make it to market. If this is the case, it will prove to be a huge opportunity. After all, PSTV stock currently trades with a market cap of around $10 million. Tapping into just a small percent of the glioblastoma market, which is expected to be worth $3.3 billion by 2024, would be a massive move for the company and its investors.

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