PLUS THERAPEUTICS, INC. 8-K

What Happened
Plus Therapeutics, Inc. (PSTV) announced on April 8, 2026 (via an 8-K and attached press release) that the U.S. Food and Drug Administration has granted Orphan Drug Designation to REYOBIQ™ (rhenium Re186 obisbemeda) for the treatment of pediatric malignant gliomas.

Key Details

• FDA granted Orphan Drug Designation for REYOBIQ for pediatric malignant gliomas (announcement dated April 8, 2026).
• The company published a press release attached as Exhibit 99.1 to the Form 8-K.
• The Form 8-K was signed by President & CEO Marc H. Hedrick, M.D., on April 8, 2026.

Why It Matters
Orphan Drug Designation is an official FDA status intended to encourage development of treatments for rare diseases. That designation can make REYOBIQ eligible for benefits commonly tied to orphan status — for example, potential U.S. market exclusivity if approved, tax credits for clinical testing, and certain fee waivers — which can improve the commercial and development outlook for a drug candidate. Investors should view this as a regulatory milestone for REYOBIQ; it does not indicate FDA approval or a guaranteed commercial outcome, but it is a recognized positive step in the drug-development pathway.