Processa gets FDA clearance for VT-7208 Phase 2 in chronic hives, names new board chair

Processa Pharmaceuticals announced on October 29, 2026 a series of updates following its acquisition of Vidya Therapeutics, including FDA clearance of an IND application for a Phase 2 study of its drug VT-7208 in chronic spontaneous urticaria (CSU). The FDA has cleared the IND application for VT-7208 in CSU, enabling Processa to advance the program into a Phase 2 study in adults with moderate-to-severe disease.¹

The planned trial is a multicenter, randomized, double-blind, placebo-controlled study expected to enroll approximately 120 adults whose disease is not adequately controlled with H1 antihistamines, comparing VT-7208 to placebo over 12 weeks while measuring efficacy, safety, tolerability and pharmacologic activity.¹ The company described CSU as a condition that affects an estimated 1.6 to 2 million U.S. adults¹, marked by hives and swelling with no identifiable trigger.

Processa is also moving VT-7208 toward two additional Phase 2 programs, in food allergy and relapsing multiple sclerosis, describing the drug as a next-generation, CNS-penetrant, once-daily oral BTK inhibitor¹ being tested across these three indications.

Separately, Processa said it entered into a research collaboration and exclusive option agreement with Generian Pharmaceuticals, which it described as a UPMC Enterprises portfolio company tied to the UPMC and University of Pittsburgh research ecosystem¹, to develop an oral macrocyclic peptide neonatal Fc receptor (FcRn) antagonist, expanding Processa's immunology pipeline.¹

The board also saw a leadership change. On October 27, 2026, Justin Yorke resigned as chair of the board, and on October 28, 2026, the board appointed Dr. Sheila Gujrathi as non-employee executive chair, effective immediately.¹ Yorke will remain a board member.¹ Gujrathi has served on the board since Processa's acquisition of Vidya in June 2026, where she had been founder and executive chair.¹

Processa said its current cash resources are expected to support operations into the second half of 2029¹, following an approximately $200 million private placement from institutional healthcare investors tied to the Vidya acquisition.¹