Amphastar Pharmaceuticals, Inc. (AMPH)

On Monday, the U.S. Food and Drug Administration (FDA) approved Amphastar Pharmaceuticals, Inc.'s AMPH Abbreviated New Drug Application (ANDA) for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002.

Agreement strengthens proprietary peptide pipeline targeting high-value oncology and ophthalmology indications RANCHO CUCAMONGA, CA / ACCESS Newswire / August 12, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar"), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, today announced that it has entered into an exclusive license agreement ("Agreement") with Nanjing Anji Biotechnology Co., Ltd. ("Anji") for the development, manufacturing, use, and commercialization of three proprietary peptides, ("Licensed Products"), in the United States and Canada ("Territory").

According to the FDA, Amphastar's iron sucrose injection meets the criteria for bioequivalence and therapeutic equivalence to Venofer ® for the treatment of iron deficiency anemia in patients with chronic kidney disease RANCHO CUCAMONGA, CA / ACCESS Newswire / August 11, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, today announced that the U.S. Food and Drug Administration ("FDA") has approved the Company's Abbreviated New Drug Application ("ANDA") for Iron Sucrose Injection, USP 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials, previously referred to as AMP-002. Iron sucrose injection is an iron replacement product indicated for the treatment of iron deficiency anemia (IDA) in patients with chronic kidney disease (CKD).

Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.

Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH ) Q2 2025 Earnings Conference Call August 7, 2025 5:00 PM ET Company Participants Dan Dischner - Senior Vice President of Human Resources & Corporate Communication Tony Marrs - Executive VP of Regulatory Affairs & Clinical Operations William J. Peters - CFO, Executive VP of Finance, Treasurer & Director Conference Call Participants David A.

Although the revenue and EPS for Amphastar (AMPH) give a sense of how its business performed in the quarter ended June 2025, it might be worth considering how some key metrics compare with Wall Street estimates and the year-ago numbers.

Amphastar Pharmaceuticals (AMPH) came out with quarterly earnings of $0.85 per share, beating the Zacks Consensus Estimate of $0.71 per share. This compares to earnings of $0.94 per share a year ago.

- Reports Net Revenues of $174.4 million for the Three Months Ended June 30, 2025 - GAAP net income of $31.0 million, or $0.64 per share, for the second quarter - Adjusted non-GAAP net income of $40.9 million, or $0.85 per share, for the second quarter - Company to hold a conference call today at 2:00 p.m. Pacific Time RANCHO CUCAMONGA, CA / ACCESS Newswire / August 7, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) ("Amphastar" or the "Company"), a biopharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, today reported results for the three months ended June 30, 2025.

Amphastar (AMPH) doesn't possess the right combination of the two key ingredients for a likely earnings beat in its upcoming report. Get prepared with the key expectations.

Amphastar is undervalued (~71% upside), but lacks an economic moat and faces modest growth, so I favor a cautious gradual strategy. The business is defensive, with a diversified product mix and pipeline, but faces headwinds from competition, tariffs, and patent expirations. My base-case DCF-based fair value is $38.23; even in a pessimistic scenario, the stock seems at least fairly valued, limiting downside risk.

RANCHO CUCAMONGA, CA / ACCESS Newswire / July 29, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced that the Company will release results for its second quarter of 2025 ended June 30, 2025, after the market closes on Thursday, August 7, 2025, and will hold a conference call to discuss its financial results at 2:00 p.m. Pacific Time.

Amphastar (AMPH) might move higher on growing optimism about its earnings prospects, which is reflected by its upgrade to a Zacks Rank #2 (Buy).

Here at Zacks, our focus is on the proven Zacks Rank system, which emphasizes earnings estimates and estimate revisions to find great stocks. Nevertheless, we are always paying attention to the latest value, growth, and momentum trends to underscore strong picks.

Amphastar (AMPH) is technically in oversold territory now, so the heavy selling pressure might have exhausted. This along with strong agreement among Wall Street analysts in raising earnings estimates could lead to a trend reversal for the stock.

RANCHO CUCAMONGA, CA / ACCESS Newswire / July 14, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH), a bio-pharmaceutical company focused on developing, manufacturing, and marketing complex generic and proprietary injectable, inhalation, and intranasal products, has announced a multi-year expansion of its U.S. manufacturing operations at its headquarters in Rancho Cucamonga, California. The company plans to quadruple its production capacity at this location over the next three to five years, reinforcing its commitment to domestic pharmaceutical manufacturing and strengthening supply chain resilience.

RANCHO CUCAMONGA, CA / ACCESS Newswire / May 22, 2025 / Amphastar Pharmaceuticals, Inc. (NASDAQ:AMPH) announced today that Bill Peters, CFO and Jacob Liawatidewi, EVP of Corporate Administration, will be participating in an Analyst-Moderated fireside chat at the Jefferies Global Healthcare Conference on Thursday, June 5th, 2025, at 2:00 pm ET. For access, visit Amphastar's Pharmaceuticals website at http://ir.amphastar.com.