Amphastar Pharmaceuticals Receives FDA Approval for Teriparatide Injection
Amphastar Pharmaceuticals announced that the U.S. Food and Drug Administration has approved the Company's Abbreviated New Drug Application for teriparatide injection, USP 560 mcg/2.24mL single-patient-use prefilled pen. The FDA determined that Amphastar's teriparatide is bioequivalent and therapeutically equivalent to Eli Lilly's FORTEO.
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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.
