Venus Remedies jumps as investigational drug secures QIDP tag from USFDA

Venus Remedies surges 5% after the company said its investigational drug candidate VRP-034 has received Qualified Infectious Disease Product (QIDP) designation from the US drug regulator.

The drug is intended for the treatment of bloodstream infections caused by polymyxin B (PMB)-susceptible strains in adults.

Developed by the Venus Medicine Research Centre (VMRC)the R&D arm of Venus RemediesVRP-034 is a novel supramolecular cationic (SMC) formulation of polymyxin B sulphate. It has been designed specifically to mitigate the nephrotoxic effects often associated with conventional polymyxin B therapy, a critical concern in treating drug-resistant infections.

The QIDP status has been granted under the Generating Antibiotic Incentives Now (GAIN) Act, a U.S. initiative aimed at encouraging the development of new antibiotics to combat serious or life-threatening infections. With this designation, VRP-034 now qualifies for several key regulatory benefits, including priority review, eligibility for fast track designation, and an additional five years of market exclusivity upon receiving FDA approval.

Polymyxins like PMB and colistin are critical last-resort antibiotics for treating multidrug-resistant (MDR) infections but are often limited by high rates of nephrotoxicity, affecting up to 60% of patients. Venus Remedies' investigational product, VRP-034, aims to overcome this limitation by maintaining the therapeutic profile of PMB while significantly reducing kidney toxicityby up to 70%as shown in preclinical studies. It has demonstrated strong efficacy against resistant pathogens and a favorable safety profile using advanced testing models. The recent QIDP designation by the US FDA highlights the drugs potential and reinforces the companys focus on tackling antimicrobial resistance.

Venus Remedies is a pharmaceutical company specializing in critical care injectables. It reported a consolidated net profit surged 186.13% to Rs 19.60 crore on a 23.31% increase in revenue from operations to Rs 176.85 crore in Q3 FY25 over Q3 FY24.

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