Plus Therapeutics, Inc. (NASDAQ: PSTV) completed a Type B meeting with the U.S. Food and Drug Administration on November 7, 2025, and announced the outcome on November 24, 2025. The meeting focused on the company’s lead radiotherapeutic candidate REYOBIQ and its planned clinical development strategy for leptomeningeal metastases (LM).
During the discussion, the company presented interim data from its ReSPECT‑LM trial, including early safety signals and preliminary efficacy observations. The FDA’s feedback centered on trial design, endpoint selection, and the timing of a potential pivotal or registrational study. The company indicated it will implement specific amendments to the LM trial to align with the FDA’s recommendations and will provide a detailed update on next steps in early 2026.
The regulatory engagement is a key milestone for a drug targeting a rare and difficult‑to‑treat CNS cancer indication. Successful navigation of the Type B meeting could accelerate the clinical timeline and influence the company’s future regulatory strategy. The company’s CEO, Dr. Marc H. Hedrick, described the meeting as “very constructive” and emphasized that the feedback will help streamline the development pathway for REYOBIQ in LM and other CNS indications.
Financially, Plus Therapeutics reported a negative free‑cash‑flow of $15.8 million for the twelve months ended June 30, 2025, while holding $6.9 million in cash and investments. The company has received a 180‑day Nasdaq compliance extension, giving it until May 2026 to meet the minimum bid‑price requirement. In addition, the LM program is supported by a $17.6 million grant from the Cancer Prevention & Research Institute of Texas, underscoring external validation of the program’s potential.
Management highlighted that the FDA’s constructive feedback will allow the company to refine its trial design and potentially shorten the path to regulatory approval. Dr. Hedrick noted that the company will “implement certain focused amendments to our LM trial that should help advance the overall clinical development timeline in alignment with the FDA recommendations.” The company’s strategy remains focused on advancing REYOBIQ across multiple CNS indications, including recurrent glioblastoma and pediatric brain cancer, while maintaining a disciplined approach to cash burn and regulatory milestones.
While no immediate market reaction data were available at the time of the announcement, analysts have noted the company’s historical volatility and the importance of regulatory milestones in shaping investor expectations. The FDA meeting is expected to be a positive signal for the company’s pipeline and may influence future analyst coverage and investor sentiment as the company progresses toward potential approval.
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