Vyome Holdings VT-1953 Clinical Trial Success
Vyome Holdings announced the final results from an investigator-initiated Phase 2 proof of concept study of VT-1953 topical gel in people with malignant fungating wounds. VT-1953, an immunomodulator for this indication, achieved both its primary and secondary endpoints. With this result, Vyome plans to advance to Phase III pivotal trial and seek FDA approval. On the primary endpoint of bad smell or malodor scored by the investigator, patients treated with VT-1953 achieved a statistically significant improvement from what was a very severe bad smell at baseline to a much milder smell within just 14 days of treatment. The improvement at the end of 14 days seen with VT-1953 was statistically significant compared with vehicle-treated patients. A statistically significant improvement was seen with VT-1953 as early as Day 7. VT-1953 was well-tolerated by patients. On the secondary endpoint of patient-reported impact of bad smell on the quality of life, VT-1953 resulted in a statistically significant improvement compared to vehicle-treatment by Day 14. Patients treated with VT-1953 also reported a clinically significant improvement in pain symptoms by Day 14. On a patient-reported Quality of life component score, treatment with VT-1953 resulted in a significant improvement by Day 14 compared to baseline and vs vehicle-treatment.
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- Annual Reinvested Distributions: Harvest Portfolios Group has announced the final annual reinvested distributions for its ETFs for the 2025 tax year, with all distributions being non-cash, ensuring that the number of units held and the net asset value of the ETFs remain unchanged, thereby maintaining asset stability for investors.
- Tax Implications Explained: The distributions will be reported as taxable, which will increase each unitholder's adjusted cost base, impacting future tax handling and ensuring investors are aware of their tax responsibilities.
- Distribution Details Update: All final reinvested capital gain and income distributions for Harvest ETFs are reported as zero, reflecting the company's cautious strategy in the current market environment aimed at protecting investor interests.
- Enhanced Information Transparency: Harvest commits to reporting the actual taxable amounts and nature of distributions to brokers through CDS in early 2026, enhancing transparency and aiding investors in making informed decisions.
- Reinvestment Distribution Announcement: Harvest Portfolios Group Inc. announces the final annual reinvested distributions for its ETFs for the 2025 tax year, with all distributions being non-cash, ensuring that the number of units held and the net asset value of the ETFs remain unchanged.
- Tax Implications Explained: The distributions will be reported as taxable, expected to be communicated to brokers through CDS in early 2026, which will increase each unitholder's adjusted cost base and impact future tax considerations.
- Distribution Details Update: All Harvest ETFs report zero reinvested capital gain and income distributions, indicating no distributable earnings for the year, which may affect investor return expectations.
- Record Date Set: December 31, 2025, is established as the ex-dividend date for all unitholders of record, ensuring investors are informed of distribution details to make timely investment decisions.
- Distribution Amount Revision: Harvest has announced a revision of the estimated reinvested distributions for 2025, which will be reported to brokers through CDS in early 2026, ensuring investors are informed about tax implications.
- Non-Cash Distribution Mechanism: The annual distributions for all Harvest ETFs will be reinvested in a non-cash format, ensuring that the number of units held and the net asset value remain unchanged, thereby maintaining asset stability for investors.
- Tax Implications Explained: The reinvested distributions will be treated as taxable distributions, increasing each unitholder's adjusted cost base, which will impact future tax planning.
- Final Distribution Announcement: Harvest expects to announce the final year-end reinvested distribution amounts around December 31, 2025, ensuring investors receive timely access to critical information.
- Clinical Trial Success: Vyome's VT-1953 treatment achieved statistically significant improvements in malodor associated with malignant wounds within 14 days (P=0.002), laying the groundwork for entering a $1 billion market opportunity.
- Quality of Life Enhancement: The significant improvement in the patient-reported impact of malodor on quality of life (P=0.0256) not only boosts patient mental health but also potentially enhances Vyome's competitive position in the market.
- Pain Relief Effectiveness: VT-1953 demonstrated significant pain reduction (P=0.002), indicating its potential in improving overall patient health outcomes and satisfaction.
- Future Development Plans: Vyome aims to initiate a Phase III clinical trial in 2026 to further advance VT-1953 towards FDA approval, reflecting the company's confidence in the product and its market prospects.
Monthly Distributions Announcement: Harvest Portfolios Group Inc. has announced monthly distributions for various Harvest ETFs for November 2025, with payments scheduled for December 5, 2025, to unitholders of record on November 28, 2025.
Distribution Details: The distributions vary by ETF, with amounts ranging from $0.0250 to $0.4300 per unit, depending on the specific ETF and its currency denomination.
Estimated Distribution for Canadian T-Bill ETF: An estimated distribution of $0.0935 per unit for the Harvest Canadian T-Bill ETF will also be paid on December 5, 2025, with the final amount to be confirmed on November 27, 2025.
Company Background: Harvest Portfolios Group Inc., founded in 2009, manages over $9.6 billion in assets and focuses on long-term wealth preservation through high-quality business investments, utilizing various covered call strategies across its ETFs.
Corporate Milestones: Vyome Holdings successfully completed a streamlined Nasdaq listing and reported encouraging interim Phase 2 results for its drug VT-1953, aimed at treating malignant fungating wounds, while maintaining a disciplined cash burn rate that extends its runway through 2026.
Leadership and Strategy: The company appointed a new CTO and SVP of Clinical Development with extensive Big Pharma experience and launched an AI strategy through the acquisition of MIT startup Oculo, enhancing its capabilities in drug development.
Clinical Progress: VT-1953 demonstrated significant reductions in malodor and pain in patients, with plans for FDA discussions on pivotal study design and orphan drug designation in 2026, targeting a $1 billion market opportunity with no existing FDA-approved treatments.
Financial Overview: As of September 30, 2025, Vyome reported total cash of $5.7 million, a clean capital structure with no preferred stock, and a net loss primarily due to one-time merger-related expenses, reflecting a strong position for future growth.








