Amphastar Pharmaceuticals Gets Upgrade to Buy at Needham on AMP-002 Approval

Amphastar (AMPH) has been upgraded to Buy from Hold by Needham with a $36 price target. The upgrade is due to the FDA approval of AMP-002, an iron sucrose injection product with $515M annual sales. Needham believes AMP-002 sales will help Amphastar meet growth expectations for 2025 and 2026. However, the firm notes that an equivalent generic product by Viatris (VTRS) was also approved.

Amphastar Pharmaceuticals (NASDAQ:AMPH) has seen its stock price rise following a significant upgrade by Needham. The investment research firm upgraded the stock from Hold to Buy, setting a $36 price target. The catalyst for this upgrade is the FDA approval of Amphastar's iron sucrose injection product, previously known as AMP-002.

The approval of AMP-002 marks a significant milestone for Amphastar, as it is an equivalent to Venofer, which generated approximately $515 million in sales over the past 12 months [2]. The product is set to launch in the third quarter of 2025 and will be available in three dosage strengths: 50mg/2.5mL, 100mg/5mL, and 200mg/10mL, all packaged in single-dose vials.

Needham believes that the approval of AMP-002 will help Amphastar meet its growth expectations for 2025 and 2026. The firm estimates that the product could generate $80-100 million in sales, targeting approximately two-thirds of the Venofer market, specifically the dialysis setting not controlled by Fresenius [2]. However, Needham also notes that an equivalent generic product by Viatris (NASDAQ:VTRS) was also approved, which may impact market share.

The approval of AMP-002 comes after a long regulatory process, with the product having been in the Generic Drug User Fee Act (GDUFA) review since the second quarter of 2023. The approval ends what Needham described as a "2+yr regulatory purgatory" for the product [2].

Amphastar has a robust pipeline of products, with three ANDAs and one biosimilar insulin candidate currently under FDA review, targeting a market potential exceeding $2.5 billion. Additionally, the company is advancing three biosimilars targeting a market worth over $6 billion, as well as two generic products aimed at markets totaling more than $1 billion [1].

In other recent news, Amphastar Pharmaceuticals reported strong financial results for the second quarter of 2025, with earnings per share reaching 85 cents, surpassing analyst expectations of 74 cents. The company also reported revenues of $174.4 million, slightly above the forecast of $174.0 million [2].

References:
[1] https://investorshub.advfn.com/market-news/article/14485/amphastar-shares-rise-following-fda-approval-of-generic-iron-sucrose-injection
[2] https://ca.investing.com/news/analyst-ratings/needham-upgrades-amphastar-pharmaceuticals-stock-to-buy-on-iron-sucrose-approval-93CH-4151936