Announced Fri, 26 Jun · 09:38 IST
Lupin gets U.S. FDA tentative approval for Enzalutamide Tablets
LUPIN · price
▲ positive · ▼ negative · ● neutral filings · teal = economic event · numbered = multiple that day (click to pick). Times IST.
Price reaction · full curve 14 horizons · vs prior close
+3.3%1-day move
₹2348.50
prior close
₹2350.00
base price
After-mkt
timing
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+0.4+0.5+0.7+1.2+3.3+2.0+2.2+5.6+6.0+4.6+5.9———
Up moveDown movePending
AI summary
Lupin has received tentative approval from the U.S. FDA for its generic Enzalutamide Tablets in strengths of 40 mg, 80 mg, 120 mg, and 160 mg. The drug is a generic version of Astellas' Xtandi, used to treat prostate cancer. The 120 mg and 160 mg strengths offer new dosing options. Tentative approval means the drug meets FDA standards but cannot be launched in the U.S. until existing patent or exclusivity barriers are resolved.
Likely market impact
Positive for U.S. pipeline. Revenue from this product is deferred until patent or exclusivity restrictions on Xtandi are cleared.