Processa receives FDA IND clearance for VT‑7208 Phase 2 urticaria trial

Processa Pharmaceuticals announced that the U.S. Food and Drug Administration approved its investigational new drug application to begin a Phase 2 study of VT‑7208 in chronic spontaneous urticaria. The trial will enroll roughly 120 adult participants and will also be followed by additional Phase 2 programs in food allergy and relapsing multiple sclerosis. The company also disclosed a research partnership with Generian Pharmaceuticals on an oral macrocyclic peptide FcRn antagonist and named Dr. Sheila Gujrathi as Executive Chair. Processa raised about $200 million in a private placement, extending its cash runway into the second half of 2029.

The IND approval de‑risks the lead asset and enables the company to generate clinical data that could drive future valuation. The new cash resources and extended runway reduce near‑term financing pressure, according to the company’s statement.

  • 1The FDA cleared Processa’s IND to start a Phase 2 study of VT‑7208 in chronic spontaneous urticaria.
  • 2The multicenter, double‑blind study is planned to enroll approximately 120 adults with moderate‑to‑severe disease.
  • 3Processa entered a research partnership and exclusive option deal with Generian Pharmaceuticals to develop an oral macrocyclic peptide FcRn antagonist program.
  • 4Dr. Sheila Gujrathi was appointed Executive Chair of Processa’s Board of Directors.
  • 5The company raised about $200 million in a private placement from institutional healthcare investors.
  • 6Current cash resources are expected to fund operations into the second half of 2029.

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