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FDA accepts Roche's giredestrant NDA for early-stage ER-positive breast cancer under priority review.

Market News
02 Jun 2026
Na
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Bullish
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The FDA has accepted Roche's New Drug Application for giredestrant, an oral selective estrogen receptor degrader (SERD), as an adjuvant treatment for early-stage ER-positive, HER2-negative breast cancer. The approval decision is expected by November 30, 2026. Phase III trial data showed giredestrant reduced the risk of invasive disease recurrence or death by 30% compared to standard endocrine therapy, marking the first major advance in adjuvant endocrine therapy in over 20 years. Giredestrant was well tolerated with fewer treatment discontinuations, potentially setting a new standard of care for over 90% of early-stage ER-positive breast cancer patients.

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dsm-firmenich repurchases 184,000 shares at €72.36 each to reduce capital and cover share plans

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CTNT stock jumps 71% after acquiring Hong Kong industrial equipment trader for $4.98M

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Virginia passes new zoning laws to expand placement of manufactured homes statewide from July 1, 2026.

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