Amphastar Pharmaceuticals Receives FDA Approval for Teriparatide Injection Device
Written by Emily J. Thompson, Senior Investment Analyst
Updated: Dec 15 2025
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Source: Newsfilter
- FDA Approval: Amphastar Pharmaceuticals' teriparatide injection has received FDA approval, marking the company's first pen device combination product and demonstrating its ongoing commitment to innovative drug delivery mechanisms, which is expected to enhance market competitiveness.
- Market Potential: According to IQVIA, U.S. sales for teriparatide injection were approximately $585 million for the 12 months ending September 30, 2025, indicating significant potential in the osteoporosis treatment market.
- Supply Chain Advantage: The drug is manufactured entirely in-house in the U.S., ensuring a reliable supply chain that sets Amphastar apart from many competitors reliant on overseas production, thereby strengthening its market position and operational agility.
- Future Development: Amphastar plans to launch the product by the end of the year and is developing multiple drugs targeting a combined market size exceeding $1.8 billion, further solidifying its strategic positioning in the biopharmaceutical sector.
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Analyst Views on AMPH
Wall Street analysts forecast AMPH stock price to rise over the next 12 months. According to Wall Street analysts, the average 1-year price target for AMPH is 30.60 USD with a low forecast of 25.00 USD and a high forecast of 34.00 USD. However, analyst price targets are subjective and often lag stock prices, so investors should focus on the objective reasons behind analyst rating changes, which better reflect the company's fundamentals.
5 Analyst Rating
2 Buy
3 Hold
0 Sell
Moderate Buy
Current: 26.150
Low
25.00
Averages
30.60
High
34.00
Current: 26.150
Low
25.00
Averages
30.60
High
34.00
About AMPH
Amphastar Pharmaceuticals, Inc. is a biopharmaceutical company that focuses primarily on developing, manufacturing, marketing, and selling generic and proprietary injectable, inhalation, and intranasal products. Additionally, it sells insulin API products. Most of its finished products are used in hospital or urgent care clinical settings and are primarily contracted and distributed through group purchasing organizations and drug wholesalers. The Company manufactures and sells over 25 products, such as BAQSIMI (glucagon) nasal powder 3mg, Primatene MIST, Glucagon for Injection Emergency Kit, Enoxaparin, Naloxone and Other Marketed Products, including Cortrosyn (cosyntropin for injection), Amphadase, Epinephrine injection, Lidocaine jelly, Lidocaine topical solution, Phytonadione injection, and others. The Company manufactures and sells two API products, Recombinant Human Insulin (RHI API) and porcine insulin API, for the injectable insulin market.
About the author
Emily J. Thompson
Emily J. Thompson, a Chartered Financial Analyst (CFA) with 12 years in investment research, graduated with honors from the Wharton School. Specializing in industrial and technology stocks, she provides in-depth analysis for Intellectia’s earnings and market brief reports.
Amphastar's Floyd Petersen Sells 16,679 Shares for $441,836
- Executive Transaction: Floyd Petersen of Amphastar Pharmaceuticals exercised 16,679 stock options and immediately sold all shares for approximately $441,836, indicating a potential lack of confidence in the stock's future performance.
- Ownership Change: Following the sale, Petersen retains 75,531 shares valued at around $2 million, reflecting a 4% reduction in his holdings since May 2024, which may suggest a cautious outlook on market conditions.
- Market Performance: On the transaction date, Amphastar's stock had declined by 42% over the year, contrasting sharply with the S&P 500's 14% total return, highlighting the company's relative underperformance in the market.
- Share Buyback Program: Since 2016, Amphastar has repurchased over 14.1 million shares for approximately $369.1 million, demonstrating a proactive capital management strategy aimed at enhancing shareholder value amidst market challenges.
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Weekly Update: CYTK Receives Initial FDA Approval, INSM Concludes Rhinosinusitis Research, XOMA Purchases GBIO
FDA Approvals: Several biotech companies received FDA approvals for new therapies, including GSK's Exdensur for severe asthma, Johnson & Johnson's RYBREVANT FASPRO for non-small cell lung cancer, and Amphastar's Teriparatide Injection for osteoporosis, among others.
Acquisitions: XOMA Royalty and Swedish Orphan Biovitrum AB made significant acquisitions to enhance their portfolios, with XOMA acquiring Generation Bio and SOBI set to acquire Arthrosi Therapeutics for up to $1.5 billion.
Clinical Trial Outcomes: Insmed and Argenx faced setbacks as they discontinued clinical trials due to disappointing results, while other companies like Processa and DBV Technologies reported positive outcomes in their respective trials.
New Drug Developments: Athira secured exclusive rights to the breast cancer drug Lasofoxifene, and Takeda's Zasocitinib met primary endpoints in a Phase 3 study for plaque psoriasis, showcasing ongoing advancements in drug development within the biotech sector.
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