Amphastar announces FDA approval for teriparatide injection.
FDA Approval: Amphastar Pharmaceuticals received FDA approval for its teriparatide injection, confirming it is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO.
Market Launch: The company plans to launch its teriparatide injection by the end of the year, with U.S. sales for teriparatide injection reaching approximately $585 million for the year ending September 30, 2025.
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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.
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.
ETFs on the Move This Monday: IHE, BLOK
ETF Performance: The Amplify Transformational Data Sharing ETF is underperforming, down approximately 3.3% in Monday afternoon trading.
Weakest Components: Notable declines among its components include Cleanspark, which fell by about 13.3%, and Hut 8, which decreased by about 10.1%.
Market Context: The article provides insights into the performance of specific ETFs and their components, reflecting broader market trends.
Author's Perspective: The views expressed in the article are those of the author and do not necessarily represent Nasdaq, Inc.
Amphastar Pharmaceuticals Receives FDA Approval for Teriparatide Injection Device
- 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.
Amphastar announces FDA approval for teriparatide injection.
FDA Approval: Amphastar Pharmaceuticals received FDA approval for its teriparatide injection, confirming it is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO.
Market Launch: The company plans to launch its teriparatide injection by the end of the year, with U.S. sales for teriparatide injection reaching approximately $585 million for the year ending September 30, 2025.
CRMD Surges Over 40% Year-to-Date: Should You Buy, Sell, or Hold?
CorMedix Stock Performance: CorMedix (CRMD) shares have surged 41.4% year-to-date, significantly outperforming the industry and S&P 500, driven by the strong market uptake of its FDA-approved therapy, DefenCath, which addresses catheter-related bloodstream infections in kidney failure patients.
DefenCath Market Position: DefenCath is the only FDA-approved antimicrobial catheter lock solution in the U.S., with strong sales of $167.6 million in the first nine months of 2025, and is expected to continue growing as CorMedix expands its marketing efforts and considers label expansions.
Acquisition of Melinta Therapeutics: CorMedix's $300 million acquisition of Melinta Therapeutics diversifies its revenue streams and adds seven approved therapies to its portfolio, enhancing its presence in hospital acute care and infectious disease markets, with potential for significant growth from products like Rezzayo.
Competitive Landscape and Outlook: Despite CorMedix's unique market position, it faces potential competition from major players like Pfizer and Amphastar, which could challenge its growth. However, improving earnings estimates and a strong sales performance suggest a positive outlook for the company.
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.
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.
ETFs on the Move This Monday: IHE, BLOK
ETF Performance: The Amplify Transformational Data Sharing ETF is underperforming, down approximately 3.3% in Monday afternoon trading.
Weakest Components: Notable declines among its components include Cleanspark, which fell by about 13.3%, and Hut 8, which decreased by about 10.1%.
Market Context: The article provides insights into the performance of specific ETFs and their components, reflecting broader market trends.
Author's Perspective: The views expressed in the article are those of the author and do not necessarily represent Nasdaq, Inc.
Amphastar Pharmaceuticals Receives FDA Approval for Teriparatide Injection Device
- 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.
Amphastar announces FDA approval for teriparatide injection.
FDA Approval: Amphastar Pharmaceuticals received FDA approval for its teriparatide injection, confirming it is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO.
Market Launch: The company plans to launch its teriparatide injection by the end of the year, with U.S. sales for teriparatide injection reaching approximately $585 million for the year ending September 30, 2025.
CRMD Surges Over 40% Year-to-Date: Should You Buy, Sell, or Hold?
CorMedix Stock Performance: CorMedix (CRMD) shares have surged 41.4% year-to-date, significantly outperforming the industry and S&P 500, driven by the strong market uptake of its FDA-approved therapy, DefenCath, which addresses catheter-related bloodstream infections in kidney failure patients.
DefenCath Market Position: DefenCath is the only FDA-approved antimicrobial catheter lock solution in the U.S., with strong sales of $167.6 million in the first nine months of 2025, and is expected to continue growing as CorMedix expands its marketing efforts and considers label expansions.
Acquisition of Melinta Therapeutics: CorMedix's $300 million acquisition of Melinta Therapeutics diversifies its revenue streams and adds seven approved therapies to its portfolio, enhancing its presence in hospital acute care and infectious disease markets, with potential for significant growth from products like Rezzayo.
Competitive Landscape and Outlook: Despite CorMedix's unique market position, it faces potential competition from major players like Pfizer and Amphastar, which could challenge its growth. However, improving earnings estimates and a strong sales performance suggest a positive outlook for the company.
