Venus Remedies shares climb 14% after US FDA grants QIDP status to VRP-034

The company's investigational product, VRP-034, has been granted QIDP designation by the US FDA for the treatment of bloodstream infections caused by polymyxin B (PMB)-susceptible strains in adults

Shares of pharmaceutical company, Venus Remedies were in strong demand on the bourses on Thursday, April 17, 2025. The pharma share climbed 14.07 per cent to ₹ 356.65 per share on the NSE, during the intra-day trade on Thursday.

 

The northward move in the Venus Remedies shares price came following the news that the company's investigational product, VRP-034, has been granted Qualified Infectious Disease Product (QIDP) designation by the US Food and Drug Administration (FDA) for the treatment of bloodstream infections caused by polymyxin B (PMB)-susceptible strains in adults.

 

"Developed by Venus Medicure Research Centre (VMRC), the R&D division of Venus Remedies, VRP-034 is a novel supramolecular cationic (SMC) formulation of polymyxin B sulfate, uniquely developed to mitigate the nephrotoxic effects associated with conventional polymyxin B therapy," said Venus Remedies in a release. 

 

 

Key preclinical findings for VRP-034, according the release, include, up to 70 per cent reduction in nephrotoxicity compared to marketed PMB, robust efficacy against resistant pathogens in both in vitro and animal models, and favorable safety profiles across multiple toxicity studies using advanced renal biomarkers and human organ-on-a-chip models. 

 

"The QIDP designation under the Generating Antibiotic Incentives Now (GAIN) Act provides VRP-034 with significant regulatory benefits, including priority review, eligibility for fast track designation, and an additional two years of market exclusivity upon approval in the United States."

 

Venus Remedies has developed the novel polymyxin-B formulation, VRP-034, using its proprietary Renal Guard technology. The company utilised kidney-on-a-chip technology (based on Organ-on-a-Chip model) to study established kidney injury biomarkers, including KIM-1, cystatin C, NAG, and NGAL, in response to polymyxin B, an antibiotic used against multidrug-resistant Gram-negative bacteria. These insights directly contributed to the earning of its Renal Guard technology, forming the foundation of the novel formulation.

 

"Polymyxins, particularly PMB and colistin, are among the last-resort antibiotics used against multidrug-resistant (MDR) infections. However, their clinical use is severely limited by nephrotoxicity, which affects up to 60 per cent of patients. VRP-034 offers a novel solution by preserving the pharmacokinetics and pharmacodynamics of PMB while significantly reducing oxidative stress and renal cell injury as demonstrated in multiple in vitro and in vivo studies," reads the release. 

 

Venus Remedies is an Indian pharmaceutical company. The company focuses on therapeutic areas like anti-infectives, oncology, neurology, and pain management. Venus Remedies has research and development capabilities and has a global presence, with over 800 marketing authorizations worldwide. 

 

As of April 17, 2025, the pharmaceutical company's market capitalisation stands at ₹ 450.94 crore on the NSE.

 

The company shares have yielded a return of around 6 per cent year-to-date. In contrast, the Nifty50 has declined nearly a percent during the same period.

 

The company’s shares, however, have taken a retreat. At around 12:01 PM on Thursday, Venus Remedies shares were quoted trading at ₹ 337.35 per share, up 7.90 per cent from their previous close of ₹ 312.65 on the NSE.