aibioProcessa clears VT-7208 CSU IND and names a new executive chair
Tickers PCSA
Processa said the FDA cleared an IND for a study of VT-7208 in chronic spontaneous urticaria, expected to enroll approximately 120 adults, and that its cash should fund operations into the second half of 2029.
Key facts
- Company
- Processa Pharmaceuticals, Inc. (NASDAQ: PCSA)
- News type
- Company Updates
- Primary source
- Processa Pharmaceuticals, Inc. 8-K (2026-10-29)
Processa Pharmaceuticals, Inc. (Nasdaq: PCSA) reported progress on October 29, 2026, following its acquisition of Vidya Therapeutics, in a release from Vero Beach, Florida. The company said the U.S. Food and Drug Administration cleared an investigational new drug application for a Phase 2 study of VT-7208 in chronic spontaneous urticaria, that it added a research collaboration to its pipeline and that its board has a new Executive Chair. It expects its cash resources to support operations into the second half of 2029.
IND clearance and collaboration
The FDA cleared the IND application for VT-7208 in chronic spontaneous urticaria (CSU), which allows Processa to advance the program into a Phase 2 study in adults with moderate-to-severe disease. The planned multicenter, randomized, double-blind, placebo-controlled study is expected to enroll approximately 120 adults whose disease is not adequately controlled with H1 antihistamines. It will compare VT-7208 with placebo over 12 weeks and assess efficacy, safety, tolerability and pharmacologic activity. The release says CSU affects an estimated 1.6 to 2 million U.S. adults.
Processa also entered a research collaboration and exclusive option agreement with Generian Pharmaceuticals, a UPMC Enterprises portfolio company, to advance a novel oral macrocyclic peptide-based neonatal Fc receptor (FcRn) antagonist program. The release says the program targets a clinically validated mechanism for IgG-mediated autoimmune diseases and aims at oral alternatives to currently available injectable FcRn therapies.
Board leadership
Sheila Gujrathi, M.D., was appointed Executive Chair of the Processa board. She has served on the board since the company acquired Vidya in June 2026, when she was Vidya's founder and executive chair. In the expanded role she will support management on corporate strategy, capital allocation and organizational development. The release lists her prior roles as executive chair of Ventyx Biosciences, chair of Turning Point Therapeutics, chair of ADARx Pharmaceuticals, co-founder and chief executive officer of Gossamer Bio, and chief medical officer of Receptos.
Justin Yorke, the former board chair, said: "We are pleased to have her step into the Executive Chair role as Processa advances its clinical strategy and broader pipeline." Gujrathi said the CSU IND is "an exciting step toward advancing VT-7208 across three planned Phase 2 programs." The company describes VT-7208 as a next-generation, CNS-penetrant, once-daily oral BTK inhibitor that it is developing in three Phase 2 proof-of-concept programs: food allergy, chronic spontaneous urticaria and relapsing multiple sclerosis. The release calls it a potentially best-in-class BTK inhibitor designed to improve on early-generation programs, and says the company intends to advance all three programs toward Phase 2 proof-of-concept studies.
Funding and the earlier pipeline
The release refers to an approximately $200 million private placement from leading institutional healthcare investors that accompanied the Vidya acquisition. It does not name the placement agents, underwriters or other advisers for that placement. The company expects its current cash resources to support operations into the second half of 2029. That is a forecast, and the release gives no cash balance.
The science is early. An IND clearance only lets the study begin, and the release gives no efficacy data for VT-7208 in any condition. It reports Phase 1 as complete without numbers. The company calls the drug potentially best-in-class, and the release shows no head-to-head data. Dr. Gujrathi was Vidya's founder, so the new Executive Chair comes from the company Processa just bought. The release does not say what happened to the cancer programs described in the 2025 annual report. Processa's annual report for 2025, filed March 18, 2026, reported a net loss of $13.6 million, compared with $11.9 million for 2024, and cash from operations of negative $11.4 million, compared with negative $11.2 million. Before the Vidya transaction, that report described a pipeline of next generation cancer therapies. NGC-Cap, a combination of PCS6422 and a lower dose of capecitabine, was in a Phase 2 trial in advanced or metastatic breast cancer, and the company said it had enrolled and dosed the 20 patients required for a planned first formal interim analysis.