Processa Pharmaceuticals is expanding its clinical and research pipeline following its June acquisition of Vidya Therapeutics. The company said the FDA has cleared its application to begin a Phase 2 study of VT-7208 in chronic spontaneous urticaria, and it has entered a research collaboration with Generian Pharmaceuticals to explore another immune-disease treatment program.
The announcements also bring a leadership change: Sheila Gujrathi, who joined Processa’s board through the Vidya transaction, is now its executive chair. Former chair Justin Yorke remains a director. Processa says cash from its recent financing is expected to fund operations into the second half of 2029.
Key details
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VT-7208 moves toward Phase 2 in chronic spontaneous urticaria (CSU). The FDA cleared the investigational application, allowing Processa to proceed with a planned study in adults with moderate-to-severe CSU whose symptoms are not adequately controlled by H1 antihistamines. FDA clearance permits the study to proceed; it is not a finding that the drug is safe or effective for treating CSU.
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The planned CSU trial will compare VT-7208 with placebo. Processa expects to enroll about 120 adults in a multicenter, randomized, double-blind study lasting 12 weeks. It will assess efficacy, safety, tolerability and pharmacologic activity.
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Processa is planning two other Phase 2 programs for VT-7208. The company intends to study the oral Bruton’s tyrosine kinase inhibitor in food allergy and relapsing multiple sclerosis, alongside CSU. It describes VT-7208 as a once-daily, central-nervous-system-penetrant treatment and says Phase 1 is complete. The three programs remain in development, with clinical results still to come.
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A research collaboration adds a separate immune-disease program. Processa and Generian will work on a potential oral macrocyclic peptide that blocks the neonatal Fc receptor, or FcRn, a mechanism used in treatments for certain IgG-mediated autoimmune diseases. The agreement includes an exclusive option, but the announcement did not provide financial terms or detail the conditions for exercising it. The companies say their goal is to develop an oral alternative to existing injectable FcRn therapies.
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Gujrathi takes on an expanded board role. Appointed executive chair effective immediately, she will support the management team on corporate strategy, capital allocation and organizational development. Gujrathi is a physician-scientist and biotech executive who founded Vidya and has held leadership roles at Gossamer Bio, Ventyx Biosciences, Turning Point Therapeutics, ADARx Pharmaceuticals and Receptos.
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Yorke remains on the board. He resigned as chair on October 27, and the board appointed Gujrathi the following day. The change shifts the chair role but does not, by itself, remove Yorke from the board.
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The company cited substantial financing and a multiyear runway. Processa said the Vidya acquisition was accompanied by an approximately $200 million private placement from institutional healthcare investors. It expects current cash resources to support operations into the second half of 2029.
What changes for investors: Processa now has three planned Phase 2 studies for VT-7208 and a separate early-stage research program aimed at FcRn. Gujrathi’s appointment gives her a more direct role in guiding strategy and capital allocation, while Yorke continues as a director. The stated runway provides a funding horizon for the company’s planned work, but the programs remain investigational and their clinical outcomes are not yet established.