Welcome to our dedicated page for Amphastar Pharma news (Ticker: AMPH), a resource for investors and traders seeking the latest updates and insights on Amphastar Pharma stock.
Amphastar Pharmaceuticals, Inc. (NASDAQ: AMPH) is a biopharmaceutical company focused on technically challenging generic and proprietary injectable, inhalation, and intranasal products, as well as insulin API products. The AMPH news feed on Stock Titan brings together the company’s press releases and market-moving updates so readers can follow how its product portfolio, licensing deals, and financial performance evolve over time.
News about Amphastar often centers on regulatory milestones and pipeline progress. The company has reported U.S. Food and Drug Administration approval of its ANDA for Iron Sucrose Injection, USP, a generic iron sucrose injection indicated for iron deficiency anemia in chronic kidney disease. It also issues updates on its ANDAs, biosimilar insulin candidate, and proprietary peptide and protein products, including licensed peptide assets targeting oncology and ophthalmology.
Another recurring theme in AMPH news is strategic licensing and research agreements. Amphastar has announced exclusive license agreements with Nanjing Anji Biotechnology Co., Ltd. and Nanjing Hanxin Pharmaceutical Technology Co., Ltd. for proprietary peptide products and for AMP-110, a fully synthetic ACTH analog in early-phase human clinical development. The company also discloses contract research agreements for recombinant peptide research cell banks supporting its pipeline.
Investors can also track quarterly earnings releases, non-GAAP financial metrics, and share repurchase authorizations, as well as announcements about expanded manufacturing capacity and distribution partnerships, such as the exclusive distribution of BAQSIMI® in parts of the Greater China region. By following AMPH news, readers gain insight into Amphastar’s mix of complex generics, proprietary medicines, manufacturing footprint, and related-party agreements that shape its long-term business profile.
Amphastar Pharmaceuticals (NASDAQ:AMPH) reported Q4 2025 net revenues of $183.1M and fiscal 2025 net revenues of $719.9M. GAAP net income was $24.4M in Q4 and $98.1M for the year; GAAP diluted EPS was $0.51 and $2.03, respectively. Adjusted non-GAAP net income was $34.2M for Q4 and $156.6M for the year. BAQSIMI drove double-digit growth, iron sucrose and teriparatide received FDA approvals, R&D and G&A rose due to clinical programs, ERP and a $23.1M legal settlement. Cash flow from operations was $156.1M.
Amphastar (NASDAQ:AMPH) announced FDA approval of its Ipratropium Bromide HFA Inhalation Aerosol 17mcg/actuation, found bioequivalent and therapeutically equivalent to Atrovent HFA. The FDA confirmed 180 days of generic exclusivity as the first Paragraph IV ANDA filer.
The company plans a commercial launch early in Q2 2026. IQVIA U.S. sales for Atrovent HFA were about $112 million for the 12 months ended December 31, 2025. Amphastar also disclosed multiple ANDA and biosimilar filings and development programs targeting markets worth billions.
Amphastar Pharmaceuticals (NASDAQ:AMPH) will release fourth-quarter 2025 results after market close on Thursday, February 26, 2026 and will host a conference call the same day at 2:00 p.m. Pacific Time.
Investors can access the live call by dialing the provided toll-free or international numbers or via the company's Investors page at www.amphastar.com; a webcast replay will be posted within 24 hours.
Amphastar (NASDAQ:AMPH) entered an exclusive U.S. and Canada license with Nanjing Hanxin for AMP-110, a fully synthetic human ACTH analog targeting inflammatory and autoimmune conditions.
Key deal terms include a $2 million upfront payment, up to $14 million in development milestones, up to $75 million in sales milestones, and royalty payments to Hanxin not to exceed $7.5 million per year with a $60 million cumulative cap. Hanxin retains non-exclusive rights outside the U.S. and Canada. AMP-110 is in early-phase human studies with an early promising safety profile. The U.S. ACTH market exceeded $684 million in 2024.
Amphastar Pharmaceuticals (NASDAQ: AMPH) will present at the J.P. Morgan 2026 Healthcare Conference on Wednesday, January 14, 2026 at 2:15 PM PT. Jack Zhang, CEO and President, and Bill Peters, CFO, will deliver the presentation. A live webcast will be available at http://ir.amphastar.com and will remain accessible for 30 days after the presentation.
Amphastar focuses on developing, manufacturing, marketing, and selling technically challenging generic and proprietary injectable, inhalation, and intranasal products, and sells insulin active pharmaceutical ingredient products. Most finished products are used in hospital or urgent care settings and are distributed via group purchasing organizations and drug wholesalers.
Amphastar (NASDAQ: AMPH) announced FDA approval of its ANDA for teriparatide injection, USP 560 mcg/2.24 mL (250 mcg/mL) single‑patient‑use prefilled pen, judged bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO.
Company plans a commercial launch by end of 2025, notes U.S. teriparatide sales of ~$585 million for the 12 months ended September 30, 2025 (IQVIA), and says the product is manufactured entirely in‑house at its U.S. facility.
Amphastar Pharmaceuticals (NASDAQ:AMPH) said Bill Peters, CFO, and Tony Marrs, EVP of Regulatory Affairs and Clinical Operations, will take part in an analyst-moderated fireside chat at the 37th Annual Piper Sandler Healthcare Conference on Wednesday, December 3, 2025 at 2:00 PM ET.
The presentation will be available via webcast on Amphastar's investor website and will remain accessible for 30 days after the event.
Amphastar Pharmaceuticals (NASDAQ:AMPH) said its CFO Bill Peters and EVP of Corporate Administration Jacob Liawatidewi will participate in an analyst-moderated fireside chat at the Jefferies Global Healthcare Conference on Wednesday, November 19, 2025 at 3:30 PM GMT.
The event will be webcast and available for 30 days after the presentation. For access, visit the company investor website.
Amphastar Pharmaceuticals (NASDAQ: AMPH) reported Q3 2025 net revenues of $191.8M, GAAP net income of $17.4M or $0.37 per diluted share, and adjusted non-GAAP net income of $44.7M or $0.93 per diluted share for the three months ended September 30, 2025.
Key drivers included BAQSIMI sales of $53.6M (14% growth year‑over‑year) and the August 2025 launch of iron sucrose injection ($2.4M). GAAP results were affected by a $23.1M litigation provision included in general and administrative expenses and a $5.3M upfront R&D payment under an exclusive license with Nanjing Anji for three proprietary peptides. Operating cash flow for the nine months ended September 30, 2025 was $123.3M. The company will hold a conference call on November 6, 2025 at 2:00 p.m. PT.
Amphastar Pharmaceuticals (NASDAQ: AMPH) said it will release results for its third quarter of 2025, which ended September 30, 2025, after market close on Thursday, November 6, 2025. The company will hold a conference call that day at 2:00 p.m. Pacific Time to discuss results, accessible by toll-free dial-in and via webcast on the company Investors page, with a replay posted within 24 hours.
The release reiterates forward-looking statements about product sales, development, regulatory timing, manufacturing capacity expansion, and other future events, and points readers to Amphastar's SEC filings for risk factors and additional details.