SPARC Receives FDA's Rare Pediatric Disease Priority Review Voucher for Sezaby®

1 min read     Updated on 03 Feb 2026, 08:34 AM
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Overview

Sun Pharma Advanced Research Company has been granted the FDA's Rare Pediatric Disease Priority Review Voucher associated with Sezaby® approval. This tradable voucher can be used to accelerate future drug applications and represents recognition of Sezaby®'s therapeutic value in treating neonatal seizures with its specialized benzyl alcohol and propylene glycol free formulation.

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Sun Pharma Advanced Research Company Ltd. (SPARC) has received the United States Food and Drug Administration's (USFDA) Rare Pediatric Disease Priority Review Voucher (PRV) associated with the approval of Sezaby®. This milestone underscores the company's commitment to addressing high unmet medical needs and provides strategic flexibility for future pipeline acceleration.

Priority Review Voucher Details

The Priority Review Voucher represents a significant regulatory achievement for SPARC. The PRV is a tradable voucher granted by the FDA specifically to encourage the development of new treatments for rare pediatric diseases. This voucher can be redeemed to receive priority review for a subsequent, separate drug application, providing valuable strategic options for the pharmaceutical company.

Parameter: Details
Voucher Type: Rare Pediatric Disease Priority Review Voucher
Associated Product: Sezaby®
Granting Authority: United States Food and Drug Administration
Strategic Use: Pipeline acceleration for future applications

Management Commentary

Anil Raghavan, CEO of SPARC, emphasized the significance of this achievement. "Receiving this Priority Review Voucher is a significant milestone for SPARC and a testament to our commitment to addressing the urgent, unmet needs of patients," he stated. "This award not only recognizes the therapeutic value of Sezaby® but also provides SPARC with additional strategic flexibility to accelerate our pipeline development to bring more therapies to patients faster."

About Sezaby®

Sezaby® represents an important therapeutic advancement in neonatal care. The product is a benzyl alcohol and propylene glycol free formulation of phenobarbital sodium powder for injection, specifically approved by the FDA for the treatment of neonatal seizures. This specialized formulation addresses critical safety considerations for vulnerable neonatal patients.

Product Feature: Description
Active Ingredient: Phenobarbital sodium powder
Formulation: Benzyl alcohol and propylene glycol free
Administration: For injection
Indication: Treatment of neonatal seizures
Regulatory Status: FDA approved

Company Profile

Sun Pharma Advanced Research Company Ltd. operates as a pharmaceutical company focused on continuously improving standards of care for patients globally through innovation in therapeutics and delivery. The company consistently aims to lower costs and improve operational efficiencies to advance availability and affordability of cures for patients across the world.

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Sun Pharma Advanced Research Company Issues Corrigendum to EGM Notice Following NSE Observations

2 min read     Updated on 29 Jan 2026, 07:48 PM
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Overview

Sun Pharma Advanced Research Company Limited issued a corrigendum on January 29, 2026, to its EGM notice dated January 14, 2026, following observations from NSE. The corrigendum provides additional clarity on shareholding patterns, showing promoter holding at 65.67% pre-issue and 69.31% post-allotment. The EGM is scheduled for February 9, 2026 at 4:00 p.m. via video conferencing, with no changes to the proposed warrants issue structure.

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Sun pharma advanced research co has issued a corrigendum dated January 29, 2026, to its Extra-Ordinary General Meeting (EGM) notice, addressing observations from the National Stock Exchange of India Limited and providing additional clarity to shareholders ahead of the scheduled meeting.

EGM Details and Regulatory Compliance

The corrigendum pertains to the EGM notice originally dated January 14, 2026, which was dispatched on January 16, 2026. The company received observations from NSE through their letter dated January 27, 2026, pursuant to the In-Principle Approval Application filed by the company. The EGM is scheduled for Monday, February 9, 2026 at 4:00 p.m. (IST) through Video Conferencing and Other Audio-Visual Means.

The corrigendum forms an integral part of the original EGM notice and must be read in conjunction with it. All other contents of the EGM notice remain unchanged except for the modifications and supplements provided in the corrigendum.

Shareholding Pattern Clarification

The corrigendum provides detailed clarification on the company's equity share capital structure, specifically addressing Paragraph 5 of Item No. 1 of the Explanatory Statement. The shareholding pattern is presented with data as of January 14, 2026:

Category Pre-issue Shares Pre-issue % Post-Allotment Shares Post-Allotment %
Promoter & Promoter Group 21,31,15,095 65.67% 25,16,25,095 69.31%
Indian Individuals/HUF 6,54,40,885 20.17% 6,54,40,885 18.03%
Bodies Corporate 13,72,17,968 42.28% 17,57,27,968 48.40%
Person Acting in Concert 1,03,01,320 3.17% 1,03,01,320 2.84%
Public Shareholding 11,14,06,493 34.33% 11,14,06,493 30.69%
Total 32,45,21,588 100.00% 36,30,31,588 100.00%

Capital Structure Details

The company has provided comprehensive details about its share capital structure based on the Reconciliation of Share Capital Audit filed for the December 2025 quarter:

Parameter Number of Shares
Issued Capital 32,45,34,125
Listed Capital 32,44,99,774
Paid-up Capital 32,45,21,588

The differences between these figures are attributed to specific historical events, including shares kept under abeyance from the May 5, 2007 allotment and share forfeitures that occurred on July 24, 2015.

Publication and Dissemination

The corrigendum will be published in Financial Express (English) and Financial Express Ahmedabad Edition (Gujarati) on January 30, 2026. It will also be made available on the websites of BSE Limited and National Stock Exchange of India Limited, as well as on the company's website. The document will be circulated to members through electronic means to ensure adequate dissemination before e-voting commences.

The company has confirmed that there is no change to the proposed size, pricing, or structure of the Warrants Issue mentioned in the original EGM notice. The post-issue shareholding pattern assumes full conversion of all warrants into equivalent equity shares.

Historical Stock Returns for Sun Pharma Advanced Research Co

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+4.01%+11.13%+2.31%-7.33%-10.69%-26.32%
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