AMPH Overview

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.

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.

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.

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.