Bullish indicating open at $55-$60, IPO prices at $37
RANCHO CUCAMONGA - Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH), a pharmaceutical company currently valued at $1.1 billion with a "GREAT" financial health rating according to InvestingPro, announced Monday that the U.S. Food and Drug Administration has approved its generic iron sucrose injection for treating iron deficiency anemia in patients with chronic kidney disease.
The approved Abbreviated New Drug Application covers iron sucrose injection in three dosage forms: 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials. According to the FDA, the product meets bioequivalence and therapeutic equivalence criteria to Venofer.
"We look forward to launching our iron sucrose injection in the third quarter of 2025," said Dr. Jack Zhang, Amphastar’s President and Chief Executive Officer, in a press release statement.
The company plans to enter a market with significant potential, as U.S. sales for Venofer were approximately $513 million for the 12 months ended June 30, 2025, according to IQVIA data cited in the announcement.
Amphastar specializes in developing, manufacturing, and marketing technically challenging generic and proprietary injectable, inhalation, and intranasal products. The company’s product portfolio includes both generic and proprietary medications primarily used in hospital or urgent care settings.
The approval adds to Amphastar’s pipeline, which includes three other abbreviated new drug applications and one biosimilar insulin candidate currently under FDA review. The company also has three biosimilar products and two generic products in various stages of development.
In other recent news, Amphastar Pharmaceuticals reported its second-quarter 2025 earnings, revealing a diluted non-GAAP EPS of $0.85, which surpassed analysts’ expectations of $0.74. The company also posted revenues of $174.4 million, slightly above the anticipated $174.0 million. Despite this positive earnings report, Piper Sandler adjusted its price target for Amphastar Pharmaceuticals, lowering it from $30.00 to $25.00, citing competitive headwinds. The firm maintained a Neutral rating on the stock. These developments highlight the mixed reactions from the market and analysts regarding Amphastar’s financial performance and future outlook.
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