High-ranking FDA official Tidmarsh steps down following remarks on kidney medication and HHS investigation.
Tidmarsh's Dismissal: George Tidmarsh was removed from his position as director of the FDA's Center for Drug Evaluation and Research following accusations of making false statements about Aurinia Pharmaceuticals' drug, Lupkynis, and disparaging its efficacy.
Legal Action and Investigation: Aurinia filed a lawsuit against Tidmarsh for his comments, which negatively impacted the company's stock, and a federal investigation was initiated by the HHS Inspector General based on a complaint from Aurinia's chair, Kevin Tang.
Tidmarsh's Claims: Tidmarsh described the FDA as a "toxic environment" and criticized the agency's new National Priority Review Voucher program, expressing concerns over its legal foundations and implications for drug approvals.
Conflicting Reports on Resignation: While Tidmarsh was placed on administrative leave amid the investigation, he claimed he had not resigned and was still on leave, highlighting discrepancies in reports about his employment status.
Trade with 70% Backtested Accuracy
Analyst Views on AUPH
About AUPH
About the author
Reasons to Consider Aurinia Pharmaceuticals (AUPH) as a Strong Momentum Stock: Is It Time to Buy?
Momentum Investing Overview: Momentum investing involves buying stocks that are trending upwards, with the expectation that they will continue to rise. The Zacks Momentum Style Score helps investors identify stocks with strong momentum indicators.
Aurinia Pharmaceuticals Performance: Aurinia Pharmaceuticals (AUPH) has a Momentum Style Score of B and a Zacks Rank of #2 (Buy), with significant price increases of 19.8% over the past quarter and 72.41% over the last year, outperforming the S&P 500.
Earnings Estimate Revisions: AUPH has seen positive earnings estimate revisions, with four estimates moving higher in the past two months, boosting the consensus estimate from $0.62 to $0.78, indicating strong future potential.
Investment Opportunities in Technology: The convergence of artificial intelligence and quantum computing presents significant investment opportunities, with recommendations for stocks poised to benefit from this technological advancement available in a special report.
Examining Aurinia Pharmaceuticals (NasdaqGM:AUPH) Valuation Following Recent Increase in Share Price
Recent Stock Performance: Aurinia Pharmaceuticals (AUPH) has seen a significant stock surge, with shares up 22% in the last month and 84% year-to-date, driven by positive sentiment around its LUPKYNIS treatment and autoimmune drug pipeline.
Valuation Insights: The current share price of $16.12 is close to the fair value estimate of $16.50, indicating that analyst forecasts are influencing price dynamics, but the high price-to-earnings ratio of 27.3x suggests a valuation premium that could pose risks if growth slows.
Investor Confidence: Share repurchases exceeding $138 million and strong operating cash flow reflect confidence in future earnings, creating potential catalysts for improved earnings per share.
Risks and Considerations: Despite the optimistic outlook, reliance on LUPKYNIS and uncertainties in the drug pipeline development could challenge future growth, warranting caution among investors.
Inaugural Week of AUPH Options Trading for July 2026
Put Contract Overview: The $15.00 put contract for AUPH has a bid of $1.35, allowing investors to buy shares at a cost basis of $13.65, which is attractive compared to the current price of $15.89. There is a 66% chance the contract may expire worthless, offering a potential 9.00% return on cash commitment.
Call Contract Overview: The $18.00 call contract has a bid of $1.40, and if shares are purchased at $15.89 and the call is sold, it could yield a total return of 22.09% if exercised by July 2026. There is a 47% chance this contract may also expire worthless, providing an 8.81% additional return.
Volatility Insights: The implied volatility for the put contract is 70%, while for the call contract it is 66%. In contrast, the actual trailing twelve-month volatility is calculated at 48%.
YieldBoost Concept: Both the put and call contracts offer potential YieldBoosts, with the put providing a 13.98% annualized return if it expires worthless, and the call offering a 13.69% annualized return under similar conditions.
Aurinia Pharmaceuticals Stock Increases Following Jefferies Upgrade
- Stock Performance: Aurinia Pharmaceuticals (AUPH) shares increased by 4.4% during recent Friday trading.
- Analyst Upgrade: The rise in stock price followed an upgrade from Jefferies, indicating positive market sentiment.
Editorial | The FDA's Crisis Intensifies
FDA's Performance: The FDA is currently in the news for negative reasons, indicating a failure in its responsibilities that could have serious implications for patient health.
UniQure's Gene Therapy: Biotech firm UniQure has reported that the FDA has altered the criteria for approving its gene therapy for Huntington’s disease, a condition with no current approved treatments to slow its progression.
Breakthrough Therapy Designation: The FDA had previously designated UniQure’s treatment as a “breakthrough therapy” in April, highlighting its potential significance in addressing a critical health issue.
Impact on Patients: The ongoing dysfunction within the FDA raises concerns about the timely approval of therapies that could benefit patients suffering from debilitating diseases like Huntington’s.
Analysis | Democrats Shine in the Evening
Overview of D.C. Dynamics: The analysis provides insights into the political landscape of Washington D.C., highlighting both significant and lesser-known events of the week.
Subscription Invitation: Readers are encouraged to subscribe for more in-depth coverage and analysis of ongoing political developments.
Reasons to Consider Aurinia Pharmaceuticals (AUPH) as a Strong Momentum Stock: Is It Time to Buy?
Momentum Investing Overview: Momentum investing involves buying stocks that are trending upwards, with the expectation that they will continue to rise. The Zacks Momentum Style Score helps investors identify stocks with strong momentum indicators.
Aurinia Pharmaceuticals Performance: Aurinia Pharmaceuticals (AUPH) has a Momentum Style Score of B and a Zacks Rank of #2 (Buy), with significant price increases of 19.8% over the past quarter and 72.41% over the last year, outperforming the S&P 500.
Earnings Estimate Revisions: AUPH has seen positive earnings estimate revisions, with four estimates moving higher in the past two months, boosting the consensus estimate from $0.62 to $0.78, indicating strong future potential.
Investment Opportunities in Technology: The convergence of artificial intelligence and quantum computing presents significant investment opportunities, with recommendations for stocks poised to benefit from this technological advancement available in a special report.
Examining Aurinia Pharmaceuticals (NasdaqGM:AUPH) Valuation Following Recent Increase in Share Price
Recent Stock Performance: Aurinia Pharmaceuticals (AUPH) has seen a significant stock surge, with shares up 22% in the last month and 84% year-to-date, driven by positive sentiment around its LUPKYNIS treatment and autoimmune drug pipeline.
Valuation Insights: The current share price of $16.12 is close to the fair value estimate of $16.50, indicating that analyst forecasts are influencing price dynamics, but the high price-to-earnings ratio of 27.3x suggests a valuation premium that could pose risks if growth slows.
Investor Confidence: Share repurchases exceeding $138 million and strong operating cash flow reflect confidence in future earnings, creating potential catalysts for improved earnings per share.
Risks and Considerations: Despite the optimistic outlook, reliance on LUPKYNIS and uncertainties in the drug pipeline development could challenge future growth, warranting caution among investors.
Inaugural Week of AUPH Options Trading for July 2026
Put Contract Overview: The $15.00 put contract for AUPH has a bid of $1.35, allowing investors to buy shares at a cost basis of $13.65, which is attractive compared to the current price of $15.89. There is a 66% chance the contract may expire worthless, offering a potential 9.00% return on cash commitment.
Call Contract Overview: The $18.00 call contract has a bid of $1.40, and if shares are purchased at $15.89 and the call is sold, it could yield a total return of 22.09% if exercised by July 2026. There is a 47% chance this contract may also expire worthless, providing an 8.81% additional return.
Volatility Insights: The implied volatility for the put contract is 70%, while for the call contract it is 66%. In contrast, the actual trailing twelve-month volatility is calculated at 48%.
YieldBoost Concept: Both the put and call contracts offer potential YieldBoosts, with the put providing a 13.98% annualized return if it expires worthless, and the call offering a 13.69% annualized return under similar conditions.
Aurinia Pharmaceuticals Stock Increases Following Jefferies Upgrade
- Stock Performance: Aurinia Pharmaceuticals (AUPH) shares increased by 4.4% during recent Friday trading.
- Analyst Upgrade: The rise in stock price followed an upgrade from Jefferies, indicating positive market sentiment.
Editorial | The FDA's Crisis Intensifies
FDA's Performance: The FDA is currently in the news for negative reasons, indicating a failure in its responsibilities that could have serious implications for patient health.
UniQure's Gene Therapy: Biotech firm UniQure has reported that the FDA has altered the criteria for approving its gene therapy for Huntington’s disease, a condition with no current approved treatments to slow its progression.
Breakthrough Therapy Designation: The FDA had previously designated UniQure’s treatment as a “breakthrough therapy” in April, highlighting its potential significance in addressing a critical health issue.
Impact on Patients: The ongoing dysfunction within the FDA raises concerns about the timely approval of therapies that could benefit patients suffering from debilitating diseases like Huntington’s.
Analysis | Democrats Shine in the Evening
Overview of D.C. Dynamics: The analysis provides insights into the political landscape of Washington D.C., highlighting both significant and lesser-known events of the week.
Subscription Invitation: Readers are encouraged to subscribe for more in-depth coverage and analysis of ongoing political developments.
