Vyome Files for VT-1953 Orphan Drug Status, Furthers Strategic Focus On VT-1953 Program Over the Next 6 Months

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Key Terms

orphan drug designation regulatory

Orphan drug designation is a special status given to medicines developed to treat rare diseases affecting only a small number of people. This status often provides benefits like faster approval processes and financial incentives, making it more attractive for companies to develop these drugs. For investors, it signals potential for exclusive market rights and reduced competition, which can impact the drug’s profitability.

pdufa regulatory

PDUFA, short for the Prescription Drug User Fee Act, is a law that allows drug companies to pay fees to the government to speed up the review process for new medicines. This helps bring important drugs to market more quickly, which can impact their availability and pricing. For investors, PDUFA timelines can influence the timing of a drug’s approval and potential market success.

rnpv financial

Risk‑adjusted net present value (rNPV) is a way to estimate how much a future stream of profits from a project or drug candidate is worth today after accounting for the chance it will fail. Think of it as multiplying the expected future cash by the probability of success and then discounting it back to today — like valuing a lottery ticket by both its payout and the odds of winning. Investors use rNPV to compare projects with different risk levels and to judge whether the potential reward justifies the investment.

total addressable market financial

Total addressable market is the total potential sales opportunity for a product or service if it were to reach every possible customer. It helps investors understand the maximum size of the market and the growth potential for a business. Think of it as the entire pie available to be shared, indicating how big the opportunity could be.

contract research organizations technical

Contract research organizations (CROs) are independent service providers that run research, testing and regulatory work for companies developing drugs, medical devices or other health products — think of them as the specialized contractors who manage experiments, patient trials and paperwork that companies outsource. Investors care because CROs play a direct role in how quickly and cheaply products move through testing and approval; delays, cost overruns or regulatory problems at a CRO can affect the timelines and value of the companies that hire them, and in turn the CRO’s own revenue and growth.

phase 3 medical

Phase 3 is the late-stage clinical testing step for a new drug or medical treatment, where the product is given to large groups of patients to confirm effectiveness, monitor side effects, and compare it to standard care. Successful Phase 3 results are often the final scientific hurdle before regulators decide on approval and market launch—like passing a final exam before graduation—and can sharply change a company's valuation and future revenue prospects.

02/11/2026 - 07:00 AM

Acceptance of Orphan Drug Status would confer certain anticipated US Market Exclusivity, R&D tax benefits, and PDUFA fee waiver of approximately $3M
Independent third-party assessment estimates a current VT-1953 valuation of approximately $455M today and ~$1B after a successful Phase 3 study
FDA interactions planned in Q2 2026 for the Phase 3 protocol based on earlier announced positive Phase 2 results

CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Vyome Holdings, Inc. (“Vyome”) (NASDAQ: HIND), a clinical-stage biopharmaceutical company focused on developing therapies for serious immuno-inflammatory and rare conditions, today announced that it has filed for Orphan Drug Status for VT-1953, its lead clinical program.

Key anticipated benefits of an orphan drug designation include 7 years of U.S. market exclusivity, up to 25% of tax credits on clinical trials conducted in the USA, exemption from FDA Prescription Drug User Fee Act (PDUFA) fees, which can save millions in submission costs, and specialized regulatory support.

VT-1953 is being developed for treating symptoms of MFW, a debilitating medical condition that afflicts approximately 10% of advanced cancer patients. Patients suffer from severe malodor, pain, and emotional distress. Currently, no FDA-approved therapies exist for treating this condition. Vyome recently announced positive Phase 2 clinical results, where VT-1953 met key primary and secondary clinical endpoints. Additionally, according to an independent, comprehensive assessment by Destum Partners, the total addressable pharmacologic market in the United States for malignant fungating wounds (“MFW”) is approximately $2.2 billion. Using a risk-adjusted net present value (rNPV) methodology, the estimated U.S. asset value as of now, with the positive Phase 2 data, is projected to be $455 million, and following successful Phase 3 completion, is projected to approach $1 billion, according to Destum Partners.

“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.”

Vyome believes that VT-1953 is central to its value proposition as follows:

Independent third-party assessment estimates a current VT-1953 valuation of approximately $455 million. The same analyst independently illustrated the VT-1953 value at $1 billion post-Phase 3, supported by an estimated $2.2 billion U.S. total addressable market.
Submission for orphan drug designation to the FDA is in line with improving cost and regulatory process efficiency.
FDA interaction on the Phase 3 protocol is planned in Q2 of 2026.
All contract research organizations (“CRO”) necessary to complete the Phase 3 are currently engaged with clear cost expectations.
The Company has required capital on hand to reach critical interim results from the Phase 3 efficacy study, expected 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. 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,” stated Venkat Nelabhotla, CEO of Vyome.

About Vyome Holdings, Inc.

Vyome is building the world’s premier platform spanning the US-India innovation corridor. Based in Cambridge, MA, Vyome’s immediate focus is on leveraging its clinical-stage assets to transform the lives of patients with immuno-inflammatory conditions. By applying groundbreaking science and its unique positioning, Vyome seeks to deliver lasting value to shareholders in a cost-efficient manner while upholding global standards of quality and safety. To learn more, please visit www.vyometx.com.

Forward-Looking Statements

Certain statements made in this press release are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be identified by the use of words such as “target,” “believe,” “expect,” “will,” “shall,” “may,” “anticipate,” “estimate,” “would,” “positioned,” “future,” “forecast,” “intend,” “plan,” “project,” “outlook,” and other similar expressions that predict or indicate future events or trends or that are not statements of historical matters. Such statements include, but are not limited to, statements contained in this press release relating to Vyome’s business strategy, Vyome’s future operating results and liquidity and capital resources outlook, the successful Phase 3 completion in connection with VT-1953, and anticipated FDA interactions, timing and expenses relating to the same. Forward-looking statements are based on Vyome’s current expectations and assumptions regarding Vyome’s business, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. Vyome’s actual results may differ materially from those contemplated by the forward-looking statements. They are neither statements of historical fact nor guarantees of assurance of future performance. Vyome cautions you, therefore against relying on any of these forward-looking statements. Important factors that could cause actual results to differ materially from those in the forward-looking statements include, without limitation, Vyome’s ability to protect Vyome’s intellectual property rights; the impact of any infringement actions or other litigation brought against Vyome; competition from other providers and products; Vyome’s ability to develop and commercialize products and services, including VT-1953; changes in government regulation; Vyome’s ability to complete capital raising transactions; and other factors relating to Vyome’s industry, operations and results of operations. Actual results may differ significantly from those anticipated, believed, estimated, expected, intended, or planned. Factors or events that could cause Vyome’s actual results to differ may emerge from time to time, and it is not possible for Vyome to predict all of them. Vyome cannot guarantee future results, levels of activity, performance, or achievements. Vyome assumes no obligation to update any forward-looking statements in order to reflect any event or circumstance that may arise after the date of this release, except as may be required under applicable securities law.

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