Natco gets US FDA tentative nod for cancer drug Erdafitinib generic

Regulatory Product ApprovalBusiness Updates View source PDF Explain this filing

NATCOPHARM · price

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Price reactionminutes from the announcement price · days from the prior close

+4.0%Reaction day

₹823.00

prior close

₹850.60

announcement price

In-mkt

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Nifty Smallcap 250market · index membership as recorded later (tracked since Jun 2026)+2.9%+1.1% vs market

Pharmaceuticals peers, median of 157sector+2.6%+1.5% vs sector

On the reaction day the stock moved 1.1 pts more than Nifty Smallcap 250 and 1.5 pts more than its Pharmaceuticals peers, over the same two closes: a difference in percentage points, not a measure of what the filing did.

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UpDownMarket · Nifty Smallcap 250Sector · Pharmaceuticals peers, median of 157Pending

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AI summary

Natco Pharma has received tentative approval from the U.S. FDA for its generic version of Balversa (Erdafitinib tablets) in 3 mg, 4 mg, and 5 mg strengths, used to treat a type of advanced bladder cancer. The brand had estimated US sales of about USD 60 million for the 12 months ending September 2025. Tentative approval means the drug meets FDA standards but cannot be launched until patent or exclusivity barriers on the original product are resolved.

Likely market impact

Positive for the US generics pipeline. Tentative approval is not a final launch clearance; commercial contribution depends on when exclusivity expires.