Natco Pharma shares surge 5% after US FDA's tentative nod Olaparib tablets

Natco Pharma shares rose sharply on Monday after the U.S. FDA granted tentative approval for its generic Olaparib tablets, a bioequivalent version of AstraZeneca’s Lynparza. The drug addresses a $1.4-billion U.S. market opportunity. The company wi...

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Natco Pharma shares climbed as much as 4.5% on Monday, touching an intraday high of Rs 987.55 on the NSE, after the company announced that it has received tentative approval from the United States Food and Drug Administration (U.S. FDA) for its generic version of Olaparib Tablets.

The pharmaceutical company informed exchanges that the U.S. FDA has granted tentative approval for Olaparib Tablets in 100 mg and 150 mg strengths, which are bioequivalent to AstraZeneca's drug Lynparza. The approval covers the indications specified in the reference-listed drug's approved labelling.

Natco Pharma will manufacture the Olaparib tablets, while its marketing partner Alembic Pharmaceuticals Ltd. will commercialise and distribute the product in the U.S. market. The company also noted that the Para IV patent litigation remains ongoing.


According to industry sales data, Olaparib tablets generated estimated U.S. sales of approximately $1.4 billion for the 12 months ended March 2026, highlighting the significant market opportunity once the product receives final approval and litigation hurdles are resolved.


Recent corporate development

The FDA update comes just a few days after Natco Pharma strengthened its international footprint through a strategic acquisition.

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.

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 Rs 1,060 crore).


Stock Performance

Natco Pharma shares touched an intraday high of Rs 987.55 on Monday. Despite the gains, the stock continues to trade well below its 52-week high of Rs 1,226.80, while its 52-week low stands at Rs 789.
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The company currently commands a market capitalisation of approximately Rs 16,925 crore.


Valuation Snapshot

Natco Pharma is trading at a price-to-earnings (P/E) ratio of 11.93 and a price-to-book (P/B) ratio of 1.83, indicating relatively modest valuations compared with many pharmaceutical peers.


Technical Outlook

On the technical charts, the stock's 14-day Relative Strength Index (RSI) stands at 47.6, suggesting neutral momentum. Typically, an RSI reading below 30 is considered oversold, while a reading above 70 indicates overbought conditions.

In terms of moving averages, the stock is trading below four of its eight key simple moving averages (SMAs) but continues to remain above its long-term 150-day and 200-day SMAs, reflecting resilience in the broader trend despite near-term weakness.


Shareholding Trend

Institutional shareholding data for the June 2026 quarter showed mixed trends. Foreign Institutional Investors (FIIs) reduced their stake to 16.99% from 17.37% in the previous quarter, while Mutual Funds increased their holdings to 1.92% from 1.72%, signalling selective domestic institutional buying.

(Disclaimer: Recommendations, suggestions, views and opinions given by the experts are their own. These do not represent the views of The Economic Times)
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