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Top FDA Drug Regulator Leaves, Agency Cites Personal Conduct
Insurance Journal· 2025-11-05 06:30
Core Points - The resignation of George Tidmarsh from the FDA occurred shortly after being placed on administrative leave due to personal conduct concerns [1][4] - Tidmarsh was sued for defamation by Aurinia Pharmaceuticals, which accused him of having a personal vendetta against the company's chairman [2][6] - Tidmarsh's LinkedIn post, which labeled Aurinia's lupus drug as toxic, led to a significant drop in the company's stock price [2][9] Group 1: Tidmarsh's Resignation and Legal Issues - Tidmarsh was placed on administrative leave after serious concerns about his personal conduct were raised [4] - He resigned two days later, with the HHS Secretary emphasizing the expectation of high ethical standards [4] - Aurinia Pharmaceuticals filed a lawsuit against Tidmarsh, claiming he harbored a vendetta against its chairman, Kevin Tang [2][6] Group 2: Impact on Aurinia Pharmaceuticals - Following Tidmarsh's LinkedIn post, Aurinia's shares fell approximately 20% before recovering slightly [5][9] - The company’s chairman, Kevin Tang, has a history with Tidmarsh, having previously asked him to resign from multiple positions due to management concerns [6][7] - Aurinia alleged that Tidmarsh sent harassing messages to Tang and targeted companies associated with him after joining the FDA [7][8] Group 3: Tidmarsh's Claims and Concerns - Tidmarsh claimed his leave was a result of raising concerns about the legality of a drug approval program, which he believed politicized the review process [3] - He later clarified that his LinkedIn post reflected his personal views and not those of the FDA [9]
Aurinia Pharmaceuticals: Lupkynis Growth And AUR200 Pipeline Justify Buy Rating
Seeking Alpha· 2025-10-23 03:20
Group 1 - Aurinia Pharmaceuticals (NASDAQ: AUPH) stock is experiencing a slow month with double-digit losses, potentially indicating profit-taking after stronger double-digit gains over the past six months [1] - The anticipated market movements in the coming month suggest a focus on the stock's performance and investor sentiment [1] Group 2 - The article highlights the author's background as a seasoned financial professional with experience in analyzing financial statements, capital markets, and macro-economy [1] - The author has contributed to reputable publications and holds advanced qualifications in investments and portfolio management [1] - There is an emphasis on the author's commitment to Responsible Investment and promoting Environmental, Social, and Governance (ESG) principles in investment decision-making [1]
Aurinia Pharma: The Easiest Money May Have Been Made (Rating Downgrade)
Seeking Alpha· 2025-08-06 22:02
Group 1 - Aurinia Pharmaceuticals Inc.'s Lupkynis sales appeared to have peaked in early to mid-2024, with stock prices falling below $5 [1] - Q1 2024 earnings report indicated a resumption of sales growth for Lupkynis in May [1]
Aurinia (AUPH) Surges 7.5%: Is This an Indication of Further Gains?
ZACKS· 2025-06-27 14:01
Company Overview - Aurinia Pharmaceuticals (AUPH) shares increased by 7.5% to $8.63 in the last trading session, with a notable trading volume that exceeded the average [1] - The stock has shown a modest gain of 0.6% over the past four weeks [1] Product Performance - The rise in stock price is linked to positive investor sentiment regarding Lupkynis, the company's only marketed drug for treating adults with active lupus nephritis (LN) [2] - Sales of Lupkynis grew by 25% year-over-year, reaching $60 million in the first quarter of 2025 [2] Earnings Expectations - Aurinia is projected to report quarterly earnings of $0.18 per share, reflecting an 800% increase year-over-year [3] - Expected revenues for the upcoming quarter are $64.23 million, which is a 12.3% increase from the same quarter last year [3] - The consensus EPS estimate has remained stable over the last 30 days, indicating no recent revisions in earnings estimates [4] Industry Context - Aurinia holds a Zacks Rank of 3 (Hold), indicating a neutral outlook [5] - In the same medical-drugs industry, Corcept Therapeutics (CORT) also holds a Zacks Rank of 3 (Hold) and has seen a 0.5% increase in its stock price, but has returned -4.7% over the past month [5][6]