FDA conditionally accepts new name for Plus Therapeutics drug

HOUSTON - Plus Therapeutics Inc. (NASDAQ:PSTV), a clinical-stage pharmaceutical company with a current market capitalization of $17.3 million, announced Thursday that the U.S. Food and Drug Administration (FDA) has conditionally accepted the proprietary name REYOBIQ™ for its lead radiotherapeutic candidate, rhenium Re186 obisbemeda, which is under clinical investigation for central nervous system (CNS) cancers, specifically Leptomeningeal Metastases (LM) and Recurrent Glioblastoma (GBM). According to InvestingPro data, the company has shown impressive revenue growth of 52.6% over the last twelve months, though it remains in development stage.

The acceptance of the proprietary name is a step forward for Plus Therapeutics as it prepares to submit a marketing application (NDA) to the FDA. The company’s VP of Corporate Strategy and New Product Planning, Russ Havranek, commented on the significance of branding for commercialization, emphasizing that the establishment of the REYOBIQ™ brand is expected to enhance recognition and engagement among stakeholders, including investigators, investors, and potential patients. The stock has experienced significant volatility, with InvestingPro analysis showing a 72.5% decline over the past year, though current valuations suggest the stock may be undervalued. Get access to 14 additional ProTips and comprehensive analysis with an InvestingPro subscription.

REYOBIQ™ is designed as an injectable radiotherapy to deliver targeted high dose radiation to CNS tumors, with the aim of improving patient outcomes by reducing risks associated with off-target effects of current therapies. The radioisotope rhenium-186 is chosen for its properties suitable for CNS therapeutic applications, including a short half-life and beta energy for cancer tissue destruction, coupled with gamma energy that allows for real-time imaging.

The drug is currently being evaluated in two clinical trials: ReSPECT-GBM, supported by the National Cancer Institute (NCI), and ReSPECT-LM, funded by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas (CPRIT).

Based in Houston, Texas, Plus Therapeutics is focused on developing targeted radiotherapeutics for challenging CNS cancers, aiming to improve clinical outcomes through image-guided local beta radiation and targeted drug delivery. The company has established strategic partnerships to facilitate the development, manufacturing, and potential future commercialization of its product candidates. Financial metrics from InvestingPro indicate the company operates with a moderate debt level and currently maintains a current ratio of 0.44, highlighting the importance of monitoring its financial health as it progresses through clinical development. Discover detailed financial analysis and expert insights in the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers.

The information in this article is based on a press release statement from Plus Therapeutics Inc.

In other recent news, Plus Therapeutics has made significant strides in its clinical and regulatory efforts. The company announced that the U.S. Food and Drug Administration (FDA) granted Orphan Drug Designation to its investigational treatment, Rhenium (186Re) Obisbemeda, for leptomeningeal metastases in lung cancer patients. This designation offers benefits such as potential market exclusivity and tax credits, enhancing the company’s development prospects. Plus Therapeutics has completed a Phase 1 trial for this treatment, setting a recommended Phase 2 dose and moving forward with further trials. Additionally, the company regained compliance with Nasdaq’s minimum stockholders’ equity requirement, ensuring its continued listing on The Nasdaq Capital Market.

Boral Capital recently initiated coverage of Plus Therapeutics with a Buy rating, citing the potential of its radionuclide Rhenium-186 in treating central nervous system cancers. The firm’s analysis reflects confidence in the company’s innovative approach to cancer treatment. Plus Therapeutics also set the recommended dose for its Phase 2 trial of ReSPECT-LM, focusing on treating leptomeningeal metastases, a challenging cancer complication. These developments indicate the company’s progress in advancing its proprietary cancer treatment technologies.

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