Alembic Pharmaceuticals Sees Stock Rise Following USFDA Approval for Darolutamide Tablets
Alembic Pharma gains after receiving USFDA nod for Darolutamide tablets
Business Standard
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Alembic Pharmaceuticals' stock increased by 1.57% to ₹780.50 after receiving tentative approval from the US Food and Drug Administration (USFDA) for Darolutamide Tablets. This drug targets prostate cancer and has a projected market size of $3.155 billion by March 2026.
- 01Alembic Pharmaceuticals' stock rose by 1.57% following USFDA approval.
- 02The approved drug, Darolutamide, is used for treating prostate cancer.
- 03The estimated market size for Darolutamide is $3.155 billion.
- 04Alembic now holds a total of 238 ANDA approvals from the USFDA.
- 05The company reported a decline in net profit despite an increase in sales.
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Alembic Pharmaceuticals experienced a 1.57% increase in its stock price, reaching ₹780.50, after the company announced it received tentative approval from the US Food and Drug Administration (USFDA) for its abbreviated new drug application (ANDA) for Darolutamide Tablets, 300 mg. This approval positions Darolutamide as therapeutically equivalent to Bayer HealthCare Pharmaceuticals' Nubeqa Tablets, 300 mg. Darolutamide is an androgen receptor inhibitor used for treating non-metastatic castration-resistant prostate cancer (nmCRPC) and metastatic castration-sensitive prostate cancer (mCSPC). According to IQVIA, the market for Darolutamide Tablets is estimated to reach $3.155 billion by March 2026. With this latest approval, Alembic has achieved a total of 238 ANDA approvals from the USFDA, including 219 final and 19 tentative approvals. Despite this positive development, Alembic reported a 3.9% decline in consolidated net profit to ₹132.97 crore for the third quarter of FY26, even as net sales increased by 10.8% to ₹1,876.31 crore compared to the same quarter last year.
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The approval of Darolutamide could enhance Alembic Pharmaceuticals' market position, potentially leading to increased revenue and job stability in the pharmaceutical sector.
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