Cenobamate SEC nod lifts Bajaj Healthcare stock 2026

Bajaj Healthcare Limited (NSE: BAJAJHCARE) moved sharply after it said a Subject Expert Committee (SEC) under the Central Drugs Standard Control Organisation (CDSCO) recommended permission to manufacture and market Cenobamate tablets. The company also said it is the first in India to receive an SEC recommendation for Cenobamate.

The market reaction was immediate. One cited move showed the stock up 12.98% to ₹345, while another report described a rise of more than 16% on June 29 after the development. The jump reflects how investors typically price in regulatory milestones, even though the SEC step is not the final clearance.

What the SEC recommendation covers

The SEC for Neurology and Psychiatry reviewed Bajaj Healthcare’s Phase 3 clinical-trial report and recommended that the company be granted permission to manufacture and market Cenobamate tablets. The recommendation covers six strengths, ranging from 12.5 milligrams to 200 milligrams.

Cenobamate is positioned as a next-generation anti-seizure medication, and the indication mentioned is partial-onset seizures in adults. Bajaj Healthcare has indicated it plans to manufacture both the finished tablets and the active pharmaceutical ingredient (API) at its facilities.

Strengths planned for the tablets

Bajaj Healthcare has said the product will be produced in six strengths. The SEC recommendation also lists these strengths as part of the permission it has recommended.

Prescription controls and labelling changes flagged by the SEC

Alongside the recommendation, the SEC asked for specific safeguards and documentation alignment. The committee recommended that Cenobamate should be sold on a neurologist’s prescription.

It also asked Bajaj Healthcare to align its prescribing information with the innovator product. These requirements matter because they can determine what the final product label looks like and what documentation must be filed before the regulator closes the review.

What is still pending at CDSCO

The SEC recommendation is a key regulatory step, but it is not the final approval. Bajaj Healthcare has said the last approval from CDSCO is still pending.

The company also needs to submit revised prescribing information reflecting the SEC’s comments before final regulatory documentation can be completed. Until CDSCO issues formal manufacturing and marketing permission, the product remains at the recommendation stage rather than a fully approved commercial medicine.

Launch window: Q2 FY27 target, not yet confirmed

Bajaj Healthcare had previously targeted a Q2 FY27 launch. That places the expected commercial window between July and September 2026.

The favourable SEC recommendation supports that timeline, but it does not remove the dependency on final CDSCO clearance. In the disclosures cited, the company had not provided a confirmed launch date, and the final approval was still awaited.

How the market reacted to the regulatory milestone

Reports around the event cited a sharp share-price move after the announcement. One cited move was up 12.98% to ₹345 following the company’s statement on the SEC recommendation.

Separately, the stock was also described as having surged more than 16% on June 29 after becoming the first company in India to secure a regulatory committee recommendation for Cenobamate tablets. The difference in percentages reflects different snapshots of the same broader reaction, but both point to heightened investor focus on regulatory progress.

Quick facts table

Background: prior milestones referenced by the company

The Cenobamate development is the latest in a sequence of regulatory updates associated with Bajaj Healthcare. A prior item noted that on April 2, 2025, the company received an SEC-CDSCO nod for Phase III clinical trials for Cenobamate tablets.

Another update referenced March 19, 2025, when Bajaj Healthcare received approval from DCGI to manufacture the API and drug formulation of Pimavanserin. These entries provide context for the company’s broader pipeline and regulatory engagement, but the price action described in the current reports was tied to Cenobamate and the SEC recommendation for manufacturing and marketing.

Other corporate action mentioned: Tarapur unit sale

Separately from the Cenobamate update, the company disclosed that it approved the sale of its operational business unit in Tarapur to M/s Orchem Products. The consideration mentioned was up to ₹4.05 Cr.

The transaction was approved by the Board on June 23, 2026, and was expected to close by October 31, 2026. While this corporate action is not directly linked to the Cenobamate recommendation, it was reported in the same broader set of company updates.

Why this step matters, and what to watch next

For investors, the SEC recommendation matters because it signals that the committee has reviewed the Phase 3 clinical-trial report and is supportive of permission for manufacturing and marketing, subject to the remaining process. But the reports also underline that this is not the final regulatory clearance.

The next milestones repeatedly referenced are: conversion of the recommendation into formal permission from CDSCO, submission of revised prescribing information as requested, and clarity on a commercial launch that was earlier targeted for Q2 FY27. Until the final CDSCO approval is issued, Cenobamate remains an upcoming product rather than an approved commercial launch.