Shares of Shilpa Medicare Ltd gained nearly 3% on Monday, hitting an intraday high of Rs 385.80 before settling at Rs 378.90, following the company’s announcement of successful Phase 3 clinical trial results for its once-weekly Ondansetron Extended-Release Injection (OERIS™), developed for the prevention of chemotherapy-induced nausea and vomiting (CINV).
The stock rose 2.81% from the previous close of Rs 368.55, with a market capitalization of Rs 7,426 crore and a P/E ratio of 148.45. The trading volume stood at 2.3 lakh shares on the NSE.
In a statement released from Raichur, the company confirmed that the pivotal Phase 3 study (SMLINJ011) met all primary and secondary endpoints. The trial, conducted across multiple oncology centers in India with 240 enrolled patients, showed that 89% of patients in the OERIS™ arm achieved a complete response (no emesis through 120 hours post-chemotherapy) versus 82% in the conventional ondansetron arm.
No serious adverse events were reported, and the once-weekly formulation demonstrated superior patient convenience and compliance compared to existing multi-dose treatments.
Managing Director Vishnukant Bhutada said, “OERIS™ exemplifies Shilpa’s commitment to scientific innovation and patient-centric design. This product enhances our oncology supportive care portfolio and strengthens our position as a leader in differentiated, specialty therapeutics.”
The company plans to submit the product to the DCGI for approval and later pursue global registration under the 505(b)(2) pathway in the U.S. and other key international markets.
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