Natco Pharma shares surged 4.25% to ₹951.50 following the company's announcement of receiving tentative approval from the United States Food and Drug Administration (USFDA) for its generic version of Olaparib Tablets. The stock's significant rally reflects strong investor confidence in the approval, which covers Olaparib Tablets in 100 mg and 150 mg strengths that are bioequivalent to AstraZeneca's drug Lynparza. The approved abbreviated new drug application (ANDA) is therapeutically equivalent to the reference listed drug for the indications specified in the approved labelling, with the company set to manufacture the product while its marketing partner, Alembic Pharmaceuticals Ltd., will distribute it in the U.S. market.
The approval addresses a significant $1.4-billion U.S. market opportunity for Olaparib tablets, as reported by industry sales data for the 12 months ended March 2026. Olaparib, marketed under the brand name Lynparza, is a targeted cancer therapy belonging to the class of PARP inhibitors that is indicated for the treatment of certain types of ovarian, breast, pancreatic and prostate cancers. The drug prevents cancer cells with specific genetic mutations, such as BRCA or HRR mutations, from repairing damaged DNA. The company noted that the Para IV patent litigation remains ongoing, which could impact the final approval process, with the commercial launch timeline remaining subject to the ongoing litigation.
On July 14, the company completed the acquisition of an additional 13.25% stake in Adcock Ingram Holdings Proprietary Limited, one of South Africa's leading pharmaceutical and healthcare companies. According to The Economic Times, the transaction, executed through its wholly-owned subsidiary Natco Pharma South Africa Proprietary Limited, increased Natco's stake in Adcock Ingram from 35.75% to 49%. The acquisition was completed for an aggregate consideration of around ZAR 1.81 billion (approximately ₹1,060 crore).
The company reported challenging financial results for Q4 FY26, with consolidated net profit declining 34.11% year-on-year to ₹267.9 crore compared with ₹406.6 crore in the corresponding quarter last year. Revenue from operations declined 39.46% YoY to ₹739.1 crore during the quarter ended March 31, 2026. Despite the quarterly decline, the tentative FDA approval provides a positive catalyst for future growth prospects in the specialty oncology segment.
