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AMRX 資訊
AMRX 事件
Amneal Pharmaceuticals Receives FDA Approval for Lanreotide Injection
Amneal Pharmaceuticals "announced that the U.S. Food and Drug Administration has approved its lanreotide injection, 120 mg/0.5 mL, in a sterile, single-dose prefilled syringe. The product references SOMATULINE(R) Depot and will launch immediately. The product received Competitive Generic Therapy designation from the FDA.U.S. annual sales for SOMATULINE(R) Depot for the 12 months ended July 2026 were $983 million, per IQVIA(R). Lanreotide Injection is indicated for: the treatment of acromegaly, advanced gastro-enteropancreatic neuroendocrine tumors, and carcinoid syndrome. It helps control hormone levels in acromegaly, improves progression-free survival in eligible GEP-NET patients, and reduces the need for rescue therapy in patients with carcinoid syndrome."
Selling Stockholders Plan to Sell 28.94M Shares of Class A Common Stock
This filing relates to the offer and sale from time to time by the selling stockholders of up to 28.94M shares of Class A common stock. The company is not selling any shares under this prospectus and will not receive any of the proceeds from the sale of shares by the selling stockholders.
Raises 2026 Revenue Outlook to $3.10B-$3.20B
2026 EPS consensus 98c. Raises 2026 revenue view to $3.10B-$3.20B from $3.05B-$3.15B, consensus $3.12B. Raises 2026 CapEx view to $150M from $110M.
Amneal Reports Q2 Revenue of $796M, Raises Full-Year Guidance
Reports Q2 revenue $796M, consensus $770.91M. "Amneal delivered strong, broad-based performance in the second quarter and first half of 2026, reflecting the strength of our diversified portfolio and the contributions from multiple growth drivers. This robust first-half performance gives us confidence to raise our full-year 2026 guidance for the second time this year. We are excited about the pending Kashiv transaction, which will establish biosimilars as an important new, durable growth vertical for Amneal, further diversifying our portfolio and expanding our long-term growth opportunities. As we look ahead to the remainder of 2026, 2027 and beyond, we remain highly confident in Amneal's outlook and the breadth and durability of the opportunities across our portfolio," said Chirag and Chintu Patel, Co-CEOs.
Amneal Receives FDA Approval for New iohexol Injection Strengths
Amneal Pharmaceuticals announced that it has received FDA approval for additional strengths and vial presentations of iohexol injection, 350 mg iodine/mL in 50 mL, 75 mL and 100 mL vials, as well as 300 mg iodine/mL in 50 mL vial. Amneal plans to launch these products in the third quarter of 2026. Iohexol is a radiographic contrast agent indicated for intrathecal, intra-arterial, intravenous, oral, rectal, intraarticular, and body cavity imaging procedures in adults and pediatric patients two weeks of age and older. The newly approved presentations complement Amneal's previously approved and launched iohexol injection 300 mg iodine/mL in 100 mL vials.
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