Plus Therapeutics, Inc. (NASDAQ: PSTV) stock is seeing a sharp increase today, building on the previous session’s enthusiasm. According to the most recent premarket check, PSTV shares were trading at $2.25 rising 56.25%. This comes after a significant regulatory change caused an incredible 300% spike in the prior trading day.
Rhenium Classified as an Orphan Drug
Plus Therapeutics has reached a significant milestone with the U.S. Food and Drug Administration’s (FDA) designation of Rhenium (186Re) Obisbemeda as an Orphan Drug Designation (ODD). The drug is intended to treat patients with leptomeningeal metastases (LM) from lung cancer. This difference highlights the pressing need for novel therapies for this rare and aggressive disease.
A Brain Cancer Therapy
Rhenium (186Re) Obisbemeda is a cutting-edge injectable radiotherapy designed to specifically target cancers in the central nervous system (CNS) with high radiation dosages. In comparison to current medicines, its novel formulation seeks to provide a safer and more efficient treatment choice. Because of the shortcomings of existing therapies, the drug’s potential to lower risks and improve outcomes for patients with CNS cancer is very noteworthy.
Enhanced Innovation Pathway
Together with Plus Therapeutics’ previously awarded Fast Track status, the Orphan Drug Designation greatly enhances the company’s approach to creating novel radiotherapeutic solutions for this underprivileged patient population. Given the rising frequency of LM in lung cancer and the pressing need for additional potent treatments, the designation comes at a particularly good time.
The FDA offers significant advantages to drug companies in addition to its ODD, including prolonged market exclusivity, clinical trial tax incentives, and exemptions from high regulatory costs. This development follows the successful completion of the ReSPECT-LM Phase 1 study, which set the stage for more clinical research. Plus Therapeutics is now conducting Phase 2 and Phase 1 investigations while collaborating with the FDA to decide on the best course of action.