Plus, Therapeutics, Inc. (NASDAQ:PSTV) shares are trading higher during the premarket session on Friday.

The company reported the publication of Phase 1 clinical trial results for Rhenium (186Re) Obisbemeda in the medical journal Nature Communications.

The treatment demonstrated safety and promising efficacy for glioblastoma patients, a condition affecting around 15,000 individuals annually in the U.S. and being the most common and lethal form of brain cancer, the company said.

According to Benzinga Pro, PSTV stock has gained over 100% in the past 5 days.

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Yesterday, the company’s stock jumped over 311% after the U.S. FDA granted Orphan Drug Designation to Rhenium (186Re) Obisbemeda for treating leptomeningeal metastases in lung cancer patients.

This designation marks a significant step in the company’s mission to develop a “much-needed” therapy for patients with “limited treatment options,” said Mike Rosol, Plus Therapeutics Chief Development Officer.

Rosol emphasized the urgent need for new therapies, given the rising incidence of LM in lung cancer.

The ODD status provides several benefits, including potential market exclusivity, tax credits, and exemptions from regulatory fees, supporting the company’s efforts to bring innovative solutions to underserved patients.

This milestone follows the completion of the ReSPECT-LM Phase 1 trial, and Plus Therapeutics is advancing Phase 2 and Phase 1 trials while working closely with the FDA on pivotal trial strategies.

Price Action: PSTV shares are trading higher by 37.5% to $1.98 premarket at last check Friday.

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