Dermata Therapeutics Announces Strategic Pivot to Over-the-Counter Skin Care Treatments

About this update from Dermata Therapeutics, Inc.

[{"type":"text","content":"SAN DIEGO, CA / ACCESS Newswire / September 10, 2025 / Dermata Therapeutics, Inc. (Nasdaq:DRMA)(Nasdaq:DRMAW) ("Dermata" or the "Company"), a science-driven leader in dermatologic solutions, today announced a bold strategic pivot to prioritize the development and distribution of over-the-counter (OTC) pharmaceutical dermatology focused products that can be sold directly to consumers. This decision was informed by the knowledge gained while developing the Company's Spongilla technology as well as current market dynamics. The Company believes this transition represents a significant landmark in the Company's mission to deliver patients with safe, effective, and consumer-friendly dermatology products.","length":735,"tagName":"p"},{"type":"text","content":"For over a decade, Dermata has focused on researching and developing innovative treatments for patients worldwide, including XYNGARI™, a once-weekly topical product for the treatment of moderate-to-severe acne utilizing the Company's proprietary Spongilla technology. In March 2025, the Company announce that XYNGARI™ achieved statistically significant results in the Company's US Food and Drug Administration (FDA) Phase 3 Spongilla Treatment Acne Research clinical study (STAR-1) for the treatment of moderate-to-severe acne. Following the completion of the STAR-1 trial and in light of the growing capital requirements, extended regulatory timeline, and everchanging dermatology insurance landscape for prescription drug development, the Company's management, in agreement with its board of directors, has decided to shift the Company's strategic focus toward developing and distributing OTC pharmaceutical dermatology products.","length":947,"tagName":"p"},{"type":"text","content":"The Company believes this repositioning through leveraging FDA's OTC monograph pathway, may accelerate Dermata's path to commercialization, reduce its regulatory burden, and give it access to a broader customer base not limited by insurance coverage. This pivot is designed to address a growing demand for high-quality, scientifically proven OTC pharmaceutical products that empower consumers to manage their skin health independently. Dermata intends to leverage its knowledge in research, development, and regulatory compliance to deliver a robust portfolio of OTC p...

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