Plus Therapeutics FDA Meeting on REYOBIQ: Incremental Progress Amid Persistent Financial and Regulatory Risks

What happened

Plus Therapeutics announced a Type B FDA meeting to discuss pivotal trial design for REYOBIQ in leptomeningeal metastases, framing it as a step toward accelerated approval. This regulatory engagement aligns with the company's strategy to advance its CNS radiotherapeutics, supported by non-dilutive grants like the $17.6M CPRIT award for LM development. However, the master report underscores that PSTV operates in a precarious state with a history of extreme dilution, going-concern warnings, and Nasdaq compliance issues, including a May 2026 deadline to regain a $1 bid price. Financial volatility, including a 2025 balance-sheet whiplash and share count explosion, highlights persistent capital-structure risks that overshadow clinical milestones. Thus, while the FDA discussion is a positive operational note, it does not address the core challenges of funding, dilution, or broader pipeline validation needed to shift the investment thesis.

Implication

The constructive FDA feedback on REYOBIQ's pivotal trial design for LM could potentially streamline regulatory pathways and enhance the asset's value in a high-unmet-need area. However, this news does not alter the company's structural loss-making profile, with ongoing cash burn and reliance on dilutive financings that have historically eroded per-share value. Nasdaq compliance remains a critical near-term risk, with a May 2026 deadline to lift the bid price above $1, and failure could trigger delisting and punitive financing terms. The diagnostics arm, CNSide, while promising with NCCN guidelines and a UnitedHealthcare agreement, has yet to generate significant revenue to offset R&D expenses, leaving the business dependent on external capital. Therefore, the implication is that investors should maintain a cautious stance, as this regulatory step alone is insufficient to de-risk the investment without clearer progress in financing, clinical data, or commercial traction.

Thesis delta

The FDA meeting on REYOBIQ for leptomeningeal metastases represents a procedural advance that slightly improves the outlook for the LM program but does not materially shift the overall investment thesis. The core thesis of a 'WAIT' rating remains unchanged, as persistent risks—including extreme dilution, going-concern warnings, and Nasdaq compliance—continue to dominate the equity story, requiring more substantive de-risking in financing or data before reconsideration.