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News · 26 weeks330%
2025-10-262026-04-19
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25 items- PRVyome Presents Transformational VT-1953 Phase 2 Clinical Study Data at Prestigious AACR 2026VT-1953 topical gel significantly reduced MFW-associated severe malodor over a 14 Day period (P=0.0020) as scored by investigators. VT-1953 efficacy was significantly superior to the vehicle control (P= 0.0015). 70% of patients treated with VT-1953 vs 0% of patients treated with vehicle (control arm) reported an improvement in patient-reported outcome measure of impact of malodor on life by Day 14 (P= 0.0256). Patients treated with VT-1953 reported a clinically significant 2 point improvement in lesion pain by Day 14 (p= 0.0020) as scored using a 10-point VAS scale. No change seen in vehicle-treated arm. No treatment-emergent adverse effects were reported in this Phase 2 study.
- PRVyome to Present Compelling Phase 2 Clinical Data on VT-1953 for Treatment of MFW at AACR 2026Complete Phase 2 clinical data on the efficacy and safety of VT-1953 in MFW patients accepted for presentation at the annual meeting of the American Association for Cancer Research Vyome Holdings, Inc. ("Vyome") (NASDAQ:HIND) today announced that the company will present its full Phase 2 investigator initiated study results and preclinical data supporting the efficacy and safety of VT-1953 as a potential treatment for malodor and other symptoms of Malignant Fungating Wounds ("MFW") at the 2026 American Association for Cancer Research (AACR) Annual Meeting, taking place on April 17-22, 2026, in San Diego. Venkat Nelabhotla, CEO of Vyome, stated that, "There are currently no FDA approved
- SECSEC Form DEF 14A filed by Vyome Holdings Inc.DEF 14A - Vyome Holdings, Inc (0001427570) (Filer)
- PRVyome Reports Transformational 2025 Results: Company Well Positioned for Breakout PhaseCompleted a streamlined Nasdaq listing through a merger transaction, with a common stock capital structure and no preferred stock or debt Delivered positive final Phase 2 results for VT-1953 in treating symptoms of malignant fungating wounds, in line with expectations Independent valuation consulting firm, Destum Partners, valued VT-1953 at approximately $1 billion after a successful pivotal study Disciplined, cost-efficient operations as Vyome burned less cash than expected, giving the company a cash runway expected to extend through mid 2027, taking it up to pivotal trial interim readouts Added a new CTO, SVP of Clinical Development, and Senior Medical Advisor, bringing Big P
- SECSEC Form PRE 14A filed by Vyome Holdings Inc.PRE 14A - Vyome Holdings, Inc (0001427570) (Filer)
- SECSEC Form 10-K filed by Vyome Holdings Inc.10-K - Vyome Holdings, Inc (0001427570) (Filer)
- SECVyome Holdings Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Other Events, Financial Statements and Exhibits8-K - Vyome Holdings, Inc (0001427570) (Filer)
- PRLivechain Completes Acquisition of Senior, Secured Debt of Humanyze, An MIT Incubated, AI Enabled HR Analytics CompanyLivechain Creates Path to Seek Potential Uplisting to National Exchange in 2026 Livechain, Inc. ("Livechain") (OTCX: LICH), a subsidiary of Vyome Holdings, Inc. ("Vyome") (NASDAQ:HIND), announced today that it has executed a debt purchase agreement with Remus Capital, a leading AI-focused venture capital firm, in order to acquire Sociometric Solutions, Inc, d/b/a, Humanyze ("Humanyze"), a rapidly emerging human resources data and analytics company. The transaction was structured as an all-stock transaction in which LICH issued shares of its common stock, valued at approximately $325,000, in exchange for acquiring a senior, secured convertible note issued to Remus by Humanyze. Through th
- SECVyome Holdings Inc. filed SEC Form 8-K: Regulation FD Disclosure, Financial Statements and Exhibits8-K - Vyome Holdings, Inc (0001427570) (Filer)
- PRVyome Files for VT-1953 Orphan Drug Status, Furthers Strategic Focus On VT-1953 Program Over the Next 6 MonthsAcceptance 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 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 antici
- PRVyome Successfully Capitalizes All VT-1953 Funding Requirements For Initial Phase 3 ResultsCompany Chose Minimal Dilution Path with No Warrants and Has Sufficient Liquidity to Deliver Initial Phase 3 Results for MFW product Vyome Holdings, Inc. ("Vyome" or the "Company") (NASDAQ:HIND) announced it has successfully funded the budget for its VT-1953 Phase 3 study, which provides the Company sufficient capital to fund the estimated costs to release Phase 3 interim results on the efficacy of its drug focused on symptoms of Malignant Fungating Wounds ("MFW"). The Company accomplished this funding need using its existing At-The-Market ("ATM") facility. Additional details on this funding are as follows: All additional funds were raised on January 27, 2026. 1,089,045 common sha
- SECVyome Holdings Inc. filed SEC Form 8-K: Regulation FD Disclosure, Other Events, Financial Statements and Exhibits8-K - Vyome Holdings, Inc (0001427570) (Filer)
- PRIndependent Analyst Values Vyome's VT-1953 at USD 1 Billion Upon Successful Completion of Phase 3 StudyThird-party analysis estimates the total addressable U.S. market to be approximately USD 2.2 billion Modeled peak annual U.S. sales approaching USD 600 million for VT-1953 Independent valuation analysis estimates post-Phase 3 asset value approaching USD 1 billion, and the current valuation with a positive Phase 2 is estimated to be USD 455 million Vyome Holdings, Inc. ("Vyome") (NASDAQ:HIND), a clinical-stage biopharmaceutical company focused on developing therapies for serious immuno-inflammatory and rare conditions, today announced key findings from an independent U.S. market assessment, commercial forecast, and valuation analysis commissioned by Vyome and conducted by Destum Pa
- SECVyome Holdings Inc. filed SEC Form 8-K: Entry into a Material Definitive Agreement, Financial Statements and Exhibits8-K - Vyome Holdings, Inc (0001427570) (Filer)
- PRVyome Subsidiary LiveChain (LICH) to Acquire Senior Secured Note in Humanyze, An MIT Incubated CompanyVyome Board completes review of strategic alternatives for LICH, executes critical first step in building a scalable, standalone business Vyome Holdings, Inc. ("Vyome') (NASDAQ:HIND) announced its subsidiary, LiveChain, Inc. ("Livechain" or "LICH") (OTC Markets: LICH) has executed a binding letter of intent ("LOI") with Remus Capital, a leading AI-focused venture capital firm, that will put LiveChain in control of the Humanyze brand, intellectual property, and other know-how of Sociometric Solutions, Inc. DBA Humanyze ("Humanyze"), a rapidly emerging AI-enabled human resources data and analytics company. The LOI contemplates that, as consideration for the transaction, LICH shall issue s
- PRVyome Reports Positive Final Phase 2 Results for VT-1953; Plans to Advance Into Pivotal Study For FDA ApprovalVT-1953 treatment over 14 days resulted in highly statistically significant improvements in bad smell or malodor associated with malignant fungating wound (primary endpoint) (P = 0.002). Patient-reported impact of bad smell or malodor on quality of life (secondary endpoint) improved significantly (P = 0.0256), as did wound pain reduction (P = 0.002) VT-1953 was well-tolerated, with no new safety concerns observed. Based on these positive Phase 2 results, the company plans to advance VT-1953 into a pivotal study following discussions with the FDA to seek approval to enter $1B potential addressable market opportunity. Vyome Holdings, Inc. ("Vyome") (NASDAQ:HIND) announced the final r
- SECSEC Form 424B3 filed by Vyome Holdings Inc.424B3 - Vyome Holdings, Inc (0001427570) (Filer)
- PRVyome Appoints Renowned Medical Oncologist, Dr. Aditya Bardia, as Senior Medical Advisor to Guide the Development of MFW ProgramDr. Bardia has led the clinical development and FDA approvals of multiple blockbuster drugs Vyome Holdings, Inc. ("Vyome") (NASDAQ:HIND), a clinical-stage healthcare holding company, today announced Dr. Aditya Bardia as Senior Medical Advisor to Vyome. In this consulting role, Dr. Bardia will guide the clinical development of Vyome's lead asset, VT-1953, for the treatment of symptoms of malignant fungating wounds (MFW), a debilitating condition in cancer patients for which approval is being targeted in 2026. "I am excited to work with Vyome team and guide the clinical development of VT-1953 for the treatment of symptoms of malignant fungating wound, a debilitating condition that can signi
- SECVyome Holdings Inc. filed SEC Form 8-K: Results of Operations and Financial Condition, Financial Statements and Exhibits8-K - Vyome Holdings, Inc (0001427570) (Filer)
- INSIDERSEC Form 4 filed by Director Pomichter Stanley D Iii4 - Vyome Holdings, Inc (0001427570) (Issuer)
- INSIDERSEC Form 3 filed by new insider Pomichter Stanley D Iii3 - Vyome Holdings, Inc (0001427570) (Issuer)
- INSIDERDirector Jolly Mohanjit was granted 454,456 shares (SEC Form 4)4 - Vyome Holdings, Inc (0001427570) (Issuer)
- INSIDERSEC Form 3 filed by new insider Jolly Mohanjit3 - Vyome Holdings, Inc (0001427570) (Issuer)
- PRVyome Holdings Announces Transformational First Quarter Following Nasdaq Listing(Quarter Ended September 30, 2025) Completed a streamlined Nasdaq listing, with a 100% common stock capital structure Delivered encouraging interim Phase 2 results for VT-1953 in treating symptoms of malignant fungating wounds, in line with expectations. Disciplined, cost-efficient operations as Vyome burned less cash than expected, giving the company a cash runway expected to extend through 2026, inclusive of clinical trials. Added a new CTO and SVP of Clinical Development, bringing Big Pharma backgrounds, deep drug-development expertise, and experience across multiple FDA-approved therapies. Launched AI strategy with the acquisition of MIT startup Oculo Vyome Holdings, I
- INSIDERSEC Form 4 filed by Director Tincoff John M. Iii4 - Vyome Holdings, Inc (0001427570) (Issuer)