Processa gets FDA clearance for Phase 2 urticaria study

Processa Pharmaceuticals (PCSA) received FDA clearance for a Phase 2 study of VT-7208 in chronic spontaneous urticaria. The company plans additional Phase 2 studies for food allergy and relapsing multiple sclerosis. Processa also announced a collaboration with Generian and the appointment of Sheila Gujrathi as Executive Chair. The company expects cash resources to last until mid-2029 after a $200 million private placement.

Processa Pharmaceuticals, Inc. (PCSA) filed an SEC Form 8-K — Other Events. Exhibit 99.1 Processa Pharmaceuticals Announces Corporate and Pipeline Progress Following Acquisition of Vidya Therapeutics • U.S. FDA clears IND for Phase 2 study of VT-7208 in chronic spontaneous urticaria ; additional Phase 2 studies planned in food allergy and relapsing multi

Processa Pharmaceuticals (PCSA) received FDA clearance for a Phase 2 study of VT-7208 in chronic spontaneous urticaria. The company also expanded its pipeline through a research collaboration with Generian Pharmaceuticals and appointed Sheila Gujrathi, M.D., as Executive Chair. Processa raised $200M and expects its cash runway to extend into the second half of 2029.

Processa Pharmaceuticals (Nasdaq: PCSA) completed a July 2026 acquisition of Vidya Therapeutics, adding CNS-penetrant BTK inhibitor VT-7208 and shifting focus to immune-mediated diseases. Vidya holders received about 46% and private placement investors about 52.6%, leaving prior Processa holders about 0.9%. A $200M private placement funds operations into 2H 2029; Phase II starts planned in 2H 2026 (food allergy, CSU) and 1H 2027 (RMS).

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Processa Pharmaceuticals, Inc. (PCSA), a clinical-stage biotechnology company, has acquired privately held Vidya Therapeutics, Inc. and simultaneously raise approximately $200 million through a private financing. Vidya's lead candidate, VT-7208, is a next-generation CNS-penetrant Bruton's tyrosine kinase inhibitor (BTKi) being developed for immune-mediated diseases like food allergy, chronic spontaneous urticaria (CSU), and relapsing multiple sclerosis (RMS).