Shilpa Medicare soars over 11% to record high on positive phase 3 trial results for fatty liver drug NorUDCA

Shilpa Medicare shares surged over 11 percent to its record high after the company announced a successful outcome in Phase 3 studies for SMLNUD07, a drug known as NorUDCA. This medication is designed to treat patients with Nonalcoholic Fatty Liver Disease (NAFLD).

Shilpa Medicare shares skyrocketed over 11 percent to reach a record high following the company’s announcement of successful Phase 3 trial results for SMLNUD07, a drug known as NorUDCA. This medication is developed to treat Nonalcoholic Fatty Liver Disease (NAFLD), a condition affecting millions globally, including around 188 million people in India.

The company heralded NorUDCA as a potential game-changer for NAFLD treatment. In a regulatory filing, Shilpa Medicare stated that the tablets are expected to "revolutionize the treatment of patients suffering from NAFLD." The Phase 3 trial was a multicentric, placebo-controlled, double-blinded study involving 165 NAFLD patients across India.

The results of the trial were promising. "No serious adverse events were reported in this Phase 3 study, and the treatment was well tolerated at the dose of 1,500 mg per day for the duration of 24 weeks," Shilpa Medicare added. This success in the advanced clinical trials significantly bolstered investor confidence, leading to a notable surge in the company's stock price.

Stock price trend

The stock soared as much as 11.6 percent, reaching a new high of ₹778.20. Following this rally, Shilpa Medicare's shares are now up 162.5 percent from their 52-week low of ₹296.45, recorded on October 26, 2023.

Over the past year, the stock has jumped nearly 93 percent, and in 2024 alone, it has surged around 136 percent, delivering positive returns in 7 of the 8 months so far.

August has seen the stock gain over 9 percent, marking its third consecutive month of gains. In July, the stock advanced 19.5 percent, while in June, it rose by 15 percent. The only setback this year came in May, when the stock corrected by 10 percent. Prior to that, Shilpa Medicare was in the green for the first four months of the year, posting gains of 11.5 percent in January, 13 percent in February, 10.5 percent in March, and 19.5 percent in April.

NAFLD is the most common liver disease worldwide, estimated to affect about 25 percent of the global population, or approximately 1.2 billion people. In India alone, 188 million individuals are believed to suffer from NAFLD, noted Shilpa Medicare. If left untreated, NAFLD can progress to nonalcoholic steatohepatitis (NASH), a condition with potentially fatal implications.

The Phase 3 trial for NorUDCA resulted in significant clinical outcomes, including at least a one-stage decrease in liver fibrosis and a reduction in fat accumulation in the liver. "The results indicate that NorUDCA could become a new standard of care with significant improvements in restoring liver function in NAFLD patients," Shilpa Medicare stated.

The company plans to submit these Phase 3 clinical trial findings to the Central Drugs Standard Control Organisation (CDSCO) in India at the earliest, seeking marketing authorization to bring this promising treatment to market.

With this latest development, Shilpa Medicare is positioned as a key player in the treatment of liver diseases, and its stock performance reflects growing investor confidence in the company’s future prospects.