News summary

Vivacta Bio and Grit Bio Announce FDA Orphan Drug Designation for In Vivo CAR-T Therapy GT801 in Autoimmune Hemolytic Anemia

Source: PR Newswire • Published: 17 Oct 2026, 12:00

Summarized by Masters of Longevity from PR Newswire.

An article previewing a biotech news story about regulatory progress and early clinical development of an in vivo CAR‑T therapy for autoimmune hemolytic anemia, inviting readers to learn about the therapy’s development pathway and clinical interest.

Vivacta Bio and Grit Bio Announce FDA Orphan Drug Designation for In Vivo CAR-T Therapy GT801 in Autoimmune Hemolytic Anemia
Key Takeaways
  • The FDA granted Orphan Drug Designation to GT801 for treating autoimmune hemolytic anemia.
  • Preliminary clinical data showed two AIHA patients achieved complete responses after GT801 treatment.
  • GT801 is an in vivo CAR-T using mRNA delivered by T-cell-targeted lipid nanoparticles to deplete CD19-positive B cells.
Read the full article at PR Newswire ↗

Continue exploring

Recommended MoL Picks

MoL PickSemaglutide Extended Lifespan in Mice. What Would Make It a Human Longevity Drug?A new animal study sharpens an important question: when do benefits in a particular disease become evidence for a longer, healthier life?MoL PickThe Next Obesity-Drug Race Is About What Weight You LoseRegeneron’s myostatin and activin A antibodies point to a sharper question for the GLP-1 era: not whether people can lose more weight, but whether medicine can preserve the tissue that makes weight loss healthier.MoL PickNucleotides and Longevity: Is the Evidence Ready?They help build DNA and keep cells working. Early human studies make nucleotide supplements interesting—but leave important questions about healthy ageing unanswered. Yet.