FDA Grants Orphan Drug Designation to Dewpoint Therapeutics’ DPTX3186 for the Treatment of Gastric Cancer

• First orphan designation ever granted to a condensate-modulating therapeutic
• Builds on recent IND opening for DPTX3186, a first-in-class oral condensate modulator targeting the Wnt/β-catenin pathway
• Provides key regulatory and commercial advantages, including seven years of U.S. market exclusivity upon approval and eligibility for expedited FDA review
  

BOSTON, Oct. 29, 2025 (GLOBE NEWSWIRE) -- Dewpoint Therapeutics, the leader in condensate biology, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to DPTX3186, its first-in-class condensate modulator for the treatment of gastric cancer. The designation follows the recent opening of Dewpoint’s Investigational New Drug (IND) application for DPTX3186, marking the company’s transition to a clinical-stage biotech and the first human study of a condensate-modulating therapeutic.

“The FDA’s decision to grant Orphan Drug Designation to DPTX3186 is an extraordinary validation of both the promise of condensate biology and the importance of our work in gastric cancer,” said Isaac Klein, MD, PhD, Chief Scientific Officer and Head of R&D at Dewpoint Therapeutics. “This recognition reflects the agency’s confidence in our mechanism, our science, and our shared goal of bringing new hope to patients facing this devastating disease.”

The Orphan Drug Designation program is designed to encourage the development of medicines for rare diseases or conditions affecting fewer than 200,000 people in the U.S. The designation provides several important advantages, including seven years of market exclusivity upon approval, FDA fee waivers, tax credits for qualified clinical trials, and eligibility for enhanced regulatory support and expedited review.

DPTX3186 is an oral small-molecule condensate modulator designed to selectively target oncogenic Wnt/β-catenin signaling by redistributing β-catenin into an inactive condensate state within tumor cells – a mechanism that overcomes historical safety challenges associated with Wnt inhibition. The program is accompanied by a condensate-based biomarker strategy that directly measures pharmacodynamic effects in patient samples.

Dewpoint expects to dose the first patient with DPTX3186 before year-end 2025 at leading cancer centers in the United States.

About Dewpoint
Dewpoint is a clinical-stage biotech company, leading the application of biomolecular condensate biology towards the development of a new generation of therapeutics to address diseases of high unmet need. The realization that a vast range of conditions are regulated by or arise from the dysfunction of condensates has provided new possibilities for modulating the function of high-value targets previously deemed ‘undruggable’, opening unexplored avenues to identify hundreds of novel therapeutic targets. Dewpoint’s proprietary AI/ML-powered state-of-the-art integrated technology underlies a drug discovery pipeline that spans multiple therapeutic areas, including oncology, neurodegenerative, cardiopulmonary, and metabolic diseases. Through collaborations with Bayer, Novo Nordisk, and Mitsubishi Tanabe Pharma Corporation, Dewpoint pushes the boundaries to accelerate the translation of condensate biology into medicine for patients suffering from difficult-to-treat diseases. Learn more at Dewpointx.com and follow us on LinkedIn. 

About Condensates   
Condensates are membraneless organelles that form dynamically throughout the cell via a process called phase separation. These subcellular compartments organize and concentrate molecules within cells to enable a diversity of key biochemical processes. The dysregulation of biomolecular condensates has been observed in many diseases, including cancer, diabetes, cardiopulmonary and neurological disorders. Condensate-modulating drugs (c-mods) potentially provide novel therapeutic options for complex diseases and historically undruggable targets. Learn more about condensate science at Condensates.com.  

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