Plus Therapeutics Receives FDA Fast Track Designation for 186RNL Targeted Radiotherapeutic for Leptomeningeal Metastases
PLUS THERAPEUTICS, Inc. (PSTV)
Company Research
Source: GlobeNewswire
AUSTIN, Texas, Nov. 09, 2021 (GLOBE NEWSWIRE) -- Plus Therapeutics, Inc. (Nasdaq: PSTV) (the “Company”), a clinical-stage pharmaceutical company developing innovative, targeted radiotherapeutics for rare and difficult-to-treat cancers, today announced that the U.S. Food and Drug Administration (FDA) has granted the Company Fast Track designation for Rhenium-186 NanoLiposome (186RNL) for the treatment of leptomeningeal metastases (LM), a rare complication in which the disease spreads to the membranes (meninges) surrounding the brain and spinal cord, affecting nearly 5% of people living with cancer. The Company recently announced clearance of its Investigational New Drug (IND) application from the FDA, and expects to initiate patient accrual in the ReSPECT-LM Phase 1 dose escalation clinical trial of 186RNL in the fourth quarter of 2021. “The incidence of LM is rising and represents a rapidly progressing and fatal complication of several cancer types,” said Marc H. Hedrick M.D.,
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News
- Neuro-Oncologist Andrew Brenner, M.D., Ph.D. and Barbara Blouw, Ph.D. Join Plus’ Management TeamGlobeNewswire
- Plus Therapeutics to Present at the National Comprehensive Cancer Network Annual ConferenceGlobeNewswire
- Plus Therapeutics Announces Validation & Clinical Implementation of CSF-01 Leptomeningeal Cancer Cell Diagnostic [Yahoo! Finance]Yahoo! Finance
- Plus Therapeutics Announces Validation & Clinical Implementation of CSF-01 Leptomeningeal Cancer Cell DiagnosticGlobeNewswire
- Plus Therapeutics Completes Dosing in Cohort 5 of ReSPECT-LM Phase 1 Trial of Rhenium (186Re) Obisbemeda in Leptomeningeal Metastases [Yahoo! Finance]Yahoo! Finance
PSTV
Earnings
- 10/31/23 - Miss
PSTV
Sec Filings
- 3/14/24 - Form 8-K
- 3/13/24 - Form 8-K
- 3/8/24 - Form S-1/A
- PSTV's page on the SEC website