Plus Therapeutics Adds Second GMP Site for REYOBIQ to Strengthen Radiopharmaceutical Trial Supply Chain

Adding a second GMP manufacturing site for a clinical-stage radiopharmaceutical is a meaningful supply-chain decision, and Plus Therapeutics has done exactly that for REYOBIQ (rhenium Re186 obisbemeda), onboarding SpectronRx to support dual-site readiness ahead of the ReSPECT-LM and ReSPECT-GBM pivotal trials.

The move addresses a structural vulnerability common in radiopharmaceutical development: single-source manufacturing. Short half-lives and the handling requirements of radiolabeled compounds make site redundancy operationally complex, and the addition of SpectronRx signals that Plus is treating commercial manufacturing readiness as a parallel workstream to clinical execution, not a post-approval problem. For contract manufacturing organizations and clinical trial supply planners operating in this space, the qualification of a second site at this stage of development reflects a maturing approach to radiopharmaceutical GMP compliance and supply assurance.

On the regulatory side, the FDA granted Orphan Drug Designation for REYOBIQ on April 8, 2026, covering pediatric malignant gliomas and, notably, progressive pediatric ependymoma, a scope broader than the company's original request. A Type B meeting with the FDA also returned constructive feedback on the leptomeningeal metastases development plan, providing clearer parameters for the pivotal trial framework. Separately, an American Medical Association Category III CPT reimbursement code was secured for convection-enhanced delivery with REYOBIQ, a procedural coding milestone that carries downstream implications for site reimbursement and trial feasibility assessments.

The CNSide cerebrospinal fluid assay platform, a companion commercial program, reached approximately 81 million covered lives following a new payer agreement with Blue Shield of California effective April 2026, adding to existing coverage through United Healthcare, Humana, and Highmark. Medicare enrollment and a unique PLA billing code were also secured during the quarter, advancing the reimbursement infrastructure for CNS cancer diagnostics.

Financially, Plus reported $1.0 million in Q1 2026 revenue, comprising CPRIT grant funding for REYOBIQ and CNSide diagnostic billings, against a cash and investments balance of $15.1 million as of March 31, 2026, up from $8.6 million at year-end 2025 following a $15 million gross-proceeds public offering in January. Three senior appointments were also completed: Eric J. Daniels, M.D., MBA as Chief Development Officer; Randy H. Goodman, Ph.D., M.H.A. as Vice President, Value Strategy and Health Economics and Outcomes Research; and Colby Squire as Vice President of Research and Development.

The qualification timeline for SpectronRx as a second GMP site, and its alignment with the ReSPECT-LM trial initiation schedule, will be a measurable indicator of whether Plus Therapeutics' dual-site supply strategy holds under the operational demands of a pivotal radiopharmaceutical program.

Source: Plus Therapeutics, Inc. via GlobeNewswire, May 15, 2026.