Natco Pharma Limited has informed the Exchange regarding a press release dated February 03, 2026, titled "NATCO receives Tentative Approval for Erdafitinib Tablets (generic of Balversa®)".
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Awaiting price reaction for this filing.
Natco Pharma has received a tentative approval from the US health regulator for its generic version of Erdafitinib Tablets, which is the generic of Balversa® — a drug used to treat a type of bladder cancer. A tentative approval means the product meets all safety and quality standards but cannot be launched commercially until existing patent or exclusivity rights on the branded drug expire or are resolved. Balversa® is an FGFR inhibitor marketed by Janssen (Johnson & Johnson) and has strong commercial potential in the oncology segment. This adds to Natco's growing portfolio of complex generic filings in the US market.
Positive for long-term prospects as it strengthens Natco's US oncology pipeline, but near-term revenue impact will be limited until the company gets full approval and a clear launch date. Existing Natco shareholders may see this as a pipeline positive without an immediate boost to earnings.