Bajaj Healthcare Shares Surge 10% After SEC-CDSCO Approval for Anti-Seizure Drug Trials

Shares of Bajaj Healthcare surged nearly 10% to reach a new 52-week high of ₹740 per share on March 19, following the company’s announcement of receiving approval from the Central Drugs Standard Control Organisation (CDSCO) to conduct Phase III clinical trials for its anti-seizure medication, Cenobamate.

However, the Bajaj Healthcare share price later trimmed some of its gains, trading at ₹731 per share—8% higher than its previous closing price.

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Regulatory Approval and Clinical Trial Details

In an exchange filing, Bajaj Healthcare revealed that CDSCO’s Subject Expert Committee (Neurology & Psychiatry) has recommended proceeding with Phase III trials for Cenobamate tablets in varying strengths, including 12.5mg, 25mg, 50mg, 100mg, 150mg, and 200mg. Phase III trials serve as the final stage of drug development before regulatory approval and are crucial in determining the drug's safety and efficacy in a larger patient population.

Designed to treat partial-onset seizures in adults, Cenobamate works by regulating excessive neuronal activity, thereby significantly reducing seizure frequency and improving patient outcomes, the company stated. Bajaj Healthcare further emphasized its commitment to providing a safe and effective treatment for epilepsy patients in India.

The large-scale Phase III trials will assess the drug's efficacy, safety, and overall performance across a diverse population. Upon successful completion, Bajaj Healthcare will seek final regulatory approval for the tablet’s commercial launch in the Indian market. Additionally, the company will oversee the manufacturing of the drug's active pharmaceutical ingredient (API).

Market Impact and Industry Implications

The approval for Phase III trials is a significant milestone for Bajaj Healthcare, as it brings the company closer to launching a much-needed treatment for epilepsy patients in India. The development of Cenobamate aligns with the company’s broader strategy of expanding its portfolio in the neurology and psychiatry segments.

Analysts believe that the introduction of Cenobamate could position Bajaj Healthcare as a key player in the epilepsy treatment market, which has been witnessing increasing demand for innovative and effective therapies. With epilepsy affecting millions in India, the availability of a new, clinically validated treatment could make a substantial impact on patient care.

Company’s Vision and Future Prospects

Bajaj Healthcare has been actively investing in research and development, focusing on creating advanced pharmaceutical solutions that address unmet medical needs. The company’s expertise in manufacturing high-quality APIs and finished dosage formulations gives it a competitive edge in the Indian pharmaceutical sector.

Expressing optimism, Bajaj Healthcare Managing Director Anil Jain stated, “We are pleased with the SEC’s approval and look forward to advancing the necessary procedures. With our robust R&D capabilities and manufacturing infrastructure, we are confident in bringing Cenobamate to the Indian market. As demand for effective epilepsy treatments continues to rise, we remain committed to addressing this critical need with high-quality pharmaceutical solutions.”

With regulatory approvals underway and clinical trials set to begin, investors and industry stakeholders will closely watch the progress of Cenobamate. If the trials yield positive results, Bajaj Healthcare could see a strong boost in revenue and market position, further strengthening its role in India's growing pharmaceutical landscape.