Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) announced significant corporate and pipeline updates on October 29, 2026, following its acquisition of Vidya Therapeutics. The company disclosed that the U.S. Food and Drug Administration (FDA) has cleared the Investigational New Drug (IND) application for VT-7208, a Bruton’s tyrosine kinase (BTK) inhibitor, to advance into a Phase 2 study in chronic spontaneous urticaria (CSU).
The planned Phase 2 study is a multicenter, randomized, double-blind, placebo-controlled trial designed to enroll approximately 120 adults with moderate-to-severe CSU who have not been adequately controlled with H1 antihistamines. The study will evaluate VT-7208 versus placebo over a 12-week period to assess efficacy, safety, tolerability, and pharmacologic activity. CSU is a chronic inflammatory disease affecting an estimated 1.6 to 2 million U.S. adults.
In addition to the IND clearance, Processa announced a research collaboration and exclusive option agreement with Generian Pharmaceuticals. This collaboration aims to advance a novel oral macrocyclic peptide-based neonatal Fc receptor (FcRn) antagonist program, expanding the company’s immunology pipeline.
On the corporate governance front, the company announced that Dr. Sheila Gujrathi has been appointed Executive Chair of the Board of Directors, effective immediately. Dr. Gujrathi succeeds Justin Yorke, who resigned as Chair on October 27, 2026, but will remain a member of the Board. The company stated that its current cash resources are expected to fund operations into the second half of 2029.
