CAMBRIDGE, Mass. — Vyome Holdings said it has filed an application with the U.S. Food and Drug Administration seeking orphan drug designation for VT-1953, its lead clinical program, as the company sharpens its strategic focus on advancing the therapy over the next six months.
If granted, orphan drug status would provide several regulatory and financial benefits, including seven years of U.S. market exclusivity, eligibility for tax credits on qualifying clinical trial expenses, and a waiver of Prescription Drug User Fee Act fees that can total several million dollars per application.
VT-1953 is being developed to treat malignant fungating wounds, a severe and debilitating condition affecting an estimated 10 percent of patients with advanced cancer. The condition is associated with chronic pain, malodor, and significant emotional distress, and there are currently no FDA-approved therapies available.
Vyome recently reported positive Phase 2 clinical results for VT-1953, with the therapy meeting its primary and secondary endpoints. Based on those data, an independent assessment by Destum Partners estimated the U.S. total addressable pharmacologic market for malignant fungating wounds at approximately $2.2 billion. Using a risk-adjusted net present value methodology, Destum Partners estimated the current U.S. asset value of VT-1953 at about $455 million, with the potential to approach $1 billion following a successful Phase 3 trial.
“Our responsibility is to maximize shareholder value, which includes advancing the Company’s most important assets and also ensuring the potential profits are treated correctly,” said Krishna Gupta, chairman of the board. “VT-1953 targets a serious condition with no approved therapies, and the roadmap outlined today reflects a deliberate and responsible approach.”
The company said it plans to engage with the FDA in the second quarter of 2026 to discuss the Phase 3 trial protocol, building on the earlier Phase 2 results. Vyome also said it has engaged the necessary contract research organizations for the Phase 3 study and has defined cost expectations for execution.
According to the company, existing capital is expected to be sufficient to reach key interim efficacy results from the Phase 3 trial, which are anticipated in mid-2027.
“As we have repeatedly stated since going public in August, we have been hyper-focused on capital discipline and dilution, well-planned key executional milestones, maintaining a clean capital structure while aligning long-term clinical execution with shareholder interests,” said Venkat Nelabhotla, chief executive officer of Vyome. “We have put an experienced and dedicated team in place in order to deliver the interim results of the Phase 3 study in mid-2027 with the required capital in place.”
