FDA Orphan-Drug Designation for Rhenium Therapy in Breast Cancer Patients

Shares of Plus Therapeutics surged in premarket trading today after the clinical-stage pharmaceutical company obtained FDA orphan-drug designation for its revolutionary rhenium ((186) Re) obisbemeda radiotherapy. The treatment targets individuals suffering from breast cancer with leptomeningeal metastases, a rare complication where the cancer spreads to the cerebrospinal fluid and the surrounding brain and spinal cord tissues.

Currently, there are no FDA-approved therapies specifically designed for patients with leptomeningeal metastases. This revolutionary development brings hope to those affected by this devastating condition, as it addresses an unmet medical need.

It is estimated that 3% to 5% of breast cancer patients eventually develop leptomeningeal metastases, highlighting the urgency for targeted treatment options.

The FDA's orphan-drug program acknowledges the critical importance of innovative drugs and biologics for diseases and disorders that affect fewer than 200,000 people in the U.S. Moreover, it offers an extended marketing exclusivity timeframe that protects the drug from competition.

Shares of Plus Therapeutics, which closed at $1.36 on Thursday, experienced a 23% surge in premarket trading, reaching $1.67.