Panacea Biotec Limited has achieved a significant milestone in its dengue vaccine development program by completing the enrollment of study participants for the Phase III clinical trial of DengiAll. The pharmaceutical company announced that it has successfully enrolled 10,335 participants in this critical phase of clinical testing for its tetravalent dengue candidate vaccine.

Stock Performance and Market Response

Panacea Biotec shares demonstrated strong market response to the announcement, gaining 7% following the completion of enrollment news. The positive stock performance reflects investor confidence in the company's vaccine development capabilities and the potential market opportunity for DengiAll in addressing India's dengue challenge.

Clinical Trial Progress and Participant Details

The Phase III clinical trial represents a major advancement from the company's earlier announcement when the trial was initially launched in collaboration with the Indian Council of Medical Research (ICMR). The completion of enrollment marks a crucial step in the vaccine development process, transitioning from participant recruitment to the active monitoring phase across India.

Two-Year Monitoring Phase and Vaccine Design

Following the completion of enrollment, Panacea Biotec will now commence a comprehensive two-year monitoring period for each participant. During this phase, the company will track participants who have received either the investigational medicinal product (the vaccine) or a placebo. The primary objectives include examining the vaccine's efficacy in preventing dengue infection and assessing its immunogenicity profile.

DengiAll uses live, weakened strains of all four dengue virus serotypes DEN1, DEN2, DEN3 and DEN4 in a single dose formulation. This comprehensive approach targets all dengue virus variants, which is crucial for effective protection against the disease.

Market Entry and Global Context

DengiAll is positioned to become India's first indigenous single-shot dengue vaccine, representing a significant breakthrough in the country's public health infrastructure. The company expects the vaccine to enter the Indian market by 2027, subject to successful completion of the clinical trial and regulatory approvals.

Industry Challenges and Competitive Landscape

Dengue vaccine development has historically been challenging across the global pharmaceutical industry. Sanofi had withdrawn its dengue vaccine Dengvaxia from the Philippines following safety concerns and later discontinued its manufacture due to low demand. Studies had shown that Dengvaxia increased the risk of severe dengue in individuals who had not been previously infected.

Other global efforts are also underway in the dengue vaccine space. Japanese drugmaker Takeda introduced its dengue vaccine Qdenga in 2022, while the Butantan Institute in Brazil has developed the Butantan DV vaccine, which is yet to enter commercial production.

Health authorities continue to stress that preventing mosquito bites remains the primary line of defence against dengue, even as vaccine research progresses. The successful completion of enrollment demonstrates Panacea Biotec's execution capabilities in conducting large-scale clinical trials and positions the company for the next critical phase of vaccine development.

Panacea Biotec has disclosed receiving income tax demand orders aggregating ₹9.38 crores from the tax authorities on December 26, 2025. The pharmaceutical company made this disclosure under Regulation 30 of the SEBI Listing Obligations and Disclosure Requirements Regulations, 2015.

Details of Tax Demand Orders

The company received three separate demand orders dated December 24, 2025, from the Office of the Assistant Commissioner of Income Tax, Central Circle 29, Delhi. These orders were issued under Section 156 of the Income Tax Act, 1961, imposing penalties for alleged under-reporting of income.

Nature of Allegations

The Income Tax Department has alleged under-reporting of income in the assessment orders passed earlier for the respective assessment years. Based on these allegations, penalties have been imposed under Section 270A of the Income Tax Act, 1961. The demand orders specifically target discrepancies identified during the assessment process for the three financial years.

Company's Response and Impact Assessment

Panacea Biotec has stated that based on its assessment, the demand is not maintainable. The company is taking all necessary steps, including filing an appeal with the appellate authority against the said demand orders.

Regarding the financial impact, the company has indicated that it does not envisage any relevant impact on its financial, operational, or other activities. This suggests that the management believes the demands can be successfully contested through the appellate process.

Regulatory Compliance

The disclosure was made in compliance with regulatory requirements under Regulation 30 of the SEBI LODR Regulations, read with Para B of Part A of Schedule III. The company also followed the guidelines specified in SEBI Master Circular No. SEBI/HO/CFD/CFD/PoD2/CIR/P/0155 dated November 11, 2024, providing comprehensive details about the tax authority's action and its potential impact.

The disclosure was signed by Ankit Jain, General Manager – Legal & Company Secretary, indicating the matter's significance and the company's commitment to transparent communication with stakeholders regarding regulatory developments.