Welcome to our dedicated page for Amphastar Pharmaceuticals news (Ticker: AMPH), a resource for investors and traders seeking the latest updates and insights on Amphastar Pharmaceuticals stock.
Amphastar Pharmaceuticals develops, manufactures, and commercializes technically challenging generic and proprietary injectable, inhalation, and intranasal pharmaceutical products, and also sells active pharmaceutical ingredient products. Its finished products are distributed through group purchasing organizations, drug wholesalers, and drug retailers, with many used in hospital or urgent care settings.
Company news commonly covers quarterly financial results, product sales trends for therapies such as BAQSIMI®, Primatene MIST®, glucagon and epinephrine products, FDA approvals and launches, and spending on insulin, inhalation, and proprietary pipeline programs. Updates also include licensing activity, including AMP-110, a fully synthetic corticotropin compound for inflammatory and autoimmune conditions, as well as healthcare conference presentations and corporate communications.
Amphastar Pharmaceuticals (NASDAQ:AMPH) has received FDA approval for its generic Iron Sucrose Injection, USP (AMP-002), which is bioequivalent to Venofer® for treating iron deficiency anemia in chronic kidney disease patients. The approved product will be available in three dosage strengths: 50mg/2.5mL, 100mg/5mL, and 200mg/10mL in single-dose vials.
The company plans to launch the product in Q3 2025. The reference drug Venofer® generated U.S. sales of approximately $513 million for the 12 months ended June 30, 2025. Amphastar's robust pipeline includes three ANDAs and one biosimilar insulin candidate targeting a $2.5 billion market, three biosimilar products targeting a $6 billion market, and two generic products targeting a $1 billion market.
Amphastar Pharmaceuticals (NASDAQ:AMPH) reported Q2 2025 financial results with net revenues of $174.4 million and GAAP net income of $31.0 million ($0.64 per share). The company's adjusted non-GAAP net income was $40.9 million ($0.85 per share).
BAQSIMI® emerged as a key revenue driver with a 51% increase to $46.7 million, while the company faced challenges with decreased sales in epinephrine (-42%) and glucagon (-25%). The company announced a major strategic initiative to quadruple manufacturing capacity at its Rancho Cucamonga headquarters. Additionally, the Board authorized a $50 million increase to the share buyback program.
The company's pipeline includes 4 ANDAs and one biosimilar insulin candidate filed with FDA, targeting products with a combined market size exceeding $3 billion, plus three biosimilar products targeting a $6 billion market.
Amphastar Pharmaceuticals (NASDAQ:AMPH) has scheduled its second quarter 2025 earnings release and conference call for August 7, 2025. The financial results will be released after market close, followed by a conference call at 2:00 p.m. Pacific Time.
Amphastar is a bio-pharmaceutical company specializing in developing, manufacturing, and marketing technically challenging generic and proprietary injectable, inhalation, and intranasal products. The company also produces insulin API products, with most of its finished products being used in hospital or urgent care clinical settings.
Amphastar Pharmaceuticals (NASDAQ:AMPH) has announced a significant expansion of its U.S. manufacturing operations at its Rancho Cucamonga, California headquarters. The company plans to quadruple its production capacity over the next 3-5 years, marking its largest domestic infrastructure investment to date.
The expansion includes a new state-of-the-art production plant, enhanced automation, and advanced technologies integration to support critical medication production and pipeline candidates. The initiative will create new jobs across R&D, engineering, manufacturing, and quality operations. Notably, all of Amphastar's finished pharmaceutical products are manufactured in the U.S., reinforcing their commitment to domestic production and supply chain resilience.
Amphastar Pharmaceuticals (NASDAQ:AMPH) announced its participation in the upcoming Jefferies Global Healthcare Conference. The company's CFO Bill Peters and EVP of Corporate Administration Jacob Liawatidewi will engage in an analyst-moderated fireside chat on June 5th, 2025, at 2:00 pm ET. Investors can access the presentation through Amphastar's website at ir.amphastar.com, with the webcast remaining available for 30 days after the event.
Amphastar Pharmaceuticals (NASDAQ:AMPH) announced that its CFO Bill Peters and SVP of Corp. Communication Dan Dischner will participate in a fireside chat at the 2025 Bank of America Health Care Conference. The presentation is scheduled for Wednesday, May 14th, 2025, at 1:40 pm PT. Investors can access the webcast through Amphastar's website at http://ir.amphastar.com, and the recording will remain available for 30 days after the presentation.
Amphastar Pharmaceuticals has scheduled its Q1 2025 earnings release and conference call for May 7th, 2025. The company will disclose financial results after market close, followed by a conference call at 2:00 p.m. Pacific Time.
Amphastar, a bio-pharmaceutical company, specializes in developing and manufacturing complex injectable, inhalation, and intranasal products. Their product portfolio includes technically challenging generic and proprietary medications, primarily used in hospitals and urgent care settings. The company also produces insulin API products and distributes through group purchasing organizations and drug wholesalers.
Investors can join the conference call via toll-free number 877-407-0989 or international number 201-389-0921. A webcast will be available on the company's website, with a replay accessible within 24 hours after the live call.
Amphastar Pharmaceuticals (NASDAQ:AMPH) has announced its participation in the 24th Annual Needham Virtual Healthcare Conference. The company will be represented by CFO Bill Peters and SVP of Corp. Communication Dan Dischner in an analyst-moderated fireside chat scheduled for Wednesday, April 9th, 2025, at 1:30 pm ET.
The presentation will be accessible through Amphastar's investor relations website at http://ir.amphastar.com, with the webcast remaining available for 30 days following the event.
Amphastar Pharmaceuticals (NASDAQ:AMPH) subsidiary International Medication Systems (IMS) has received the FDA's Drug Shortage Assistance Award for addressing the shortage of epinephrine injection 0.1 mg/mL syringes. The recognition highlights IMS's efforts in submitting and obtaining approval of a new drug application for epinephrine injection.
The company's pipeline includes 4 ANDAs targeting products with >$2 billion market size, 4 biosimilar products targeting >$7 billion market size, and 2 generic products targeting >$1.3 billion market size, based on IQVIA data for 2024. Amphastar is developing multiple proprietary products with injectable and intranasal dosage forms.