Plus Therapeutics, Inc. (PSTV) said on Wednesday that the U.S. Food and Drug Administration has granted Orphan Drug Designation to REYOBIQ for the treatment of pediatric malignant gliomas, a group of rare and aggressive brain tumors.
The company's shares rose more than 7% in pre-market trading after closing at $2.92 on Tuesday.
The designation provides incentives such as seven years of market exclusivity upon approval, tax credits for eligible clinical trial costs, and waivers of certain regulatory fees.
The latest designation builds on recent regulatory and clinical progress for REYOBIQ. The company has completed a Type B meeting with the FDA supporting development plans in leptomeningeal metastases, reported encouraging data from the ReSPECT-LM trial, and is advancing Phase 1 and Phase 2 studies. It has also received FDA clearance of its Investigational New Drug application to study REYOBIQ in pediatric patients with high-grade glioma and ependymoma.
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