The Board of Governors of the Federal Reserve System (the Fed) adopted Regulation II in 2011, establishing fees for debit-card transactions. Corner Post began operating in 2018 and filed its lawsuit challenging Regulation II in 2021, claiming it had incurred excessive interchange fees under the rule. The U.S. Court of Appeals for the Eighth Circuit ruled that Corner Post's opportunity to file suit had expired in 2017, six years after the rule first issued. "Because an APA plaintiff may not file suit and obt ...

Core Viewpoint - The U.S. Court of Appeals for the Tenth Circuit has reversed a district court decision regarding warrantless searches of dog training businesses, indicating potential violations of the Fourth Amendment rights of the appellants [1]. Group 1: Legal Context - The New Civil Liberties Alliance (NCLA) filed an amicus curiae brief arguing that the Kansas state law allowing warrantless searches infringes on the Fourth Amendment rights of individuals [1]. - The Tenth Circuit affirmed the dismissal of the claim regarding the right to travel but remanded the case to determine the applicability of the Fourth Amendment to warrantless searches of dog training businesses [1][4]. Group 2: Case Background - Scott Johnson and Harlene Hoyt operate Covey Find Kennel, a licensed dog training business, which is subject to unannounced inspections under the Kansas Pet Animal Act [2]. - The law requires one of the owners to be present for inspections with only 30 minutes' notice, allowing the Kansas Department of Agriculture to conduct searches without probable cause [2]. Group 3: Court's Reasoning - The Tenth Circuit found insufficient information to determine if Covey Find Kennel is a "closely regulated" business exempt from Fourth Amendment protections, criticizing the district court's broad application of this exception [4]. - The court's decision prevents the potential for widespread intrusions across various regulated industries in Kansas [4]. Group 4: NCLA's Position - NCLA argues that applying the Fourth Amendment exception for closely regulated businesses to dog training facilities is unreasonable and should be rejected by the district court [5]. - NCLA emphasizes the need to protect constitutional rights from being overridden by state licensing requirements [3].

Washington, D.C., June 05, 2024 (GLOBE NEWSWIRE) -- Today, the U.S. Court of Appeals for the Fifth Circuit issued a decision in National Association of Private Fund Managers v. Securities and Exchange Commission vacating SEC's recent final rule restricting—and in some cases prohibiting—certain common contractual agreements between private investment funds and investment advisers. Following the New Civil Liberties Alliance amicus curiae brief's advice, the Court declared that SEC exceeded its statutory autho ...

PRINCETON, N.J., June 04, 2024 (GLOBE NEWSWIRE) -- Amicus Therapeutics (NASDAQ:FOLD), a patient-dedicated global biotechnology company focused on developing and commercializing novel medicines for rare diseases, today announced that the Galien Foundation has awarded the 2024 Prix Galien U.K. Award for Best Pharmaceutical Product to Pombiliti® (cipaglucosidase alfa) + Opfolda® (miglustat). The prestigious Prix Galien is awarded to companies recognized for their outstanding advances in the discovery and devel ...

The company also markets Pombiliti + Opfolda, which was recently approved (October 2023) to treat adults with late-onset Pompe disease (LOPD). Management believes these two products have north of $1.5 billion peak sales potential combined. The stock trades for around $9.50 a share and has a market cap of just north of $2.8 billion. avdeev007 Today, we put rare disease concern Amicus Therapeutics (NASDAQ:FOLD) under the spotlight. The shares have recently slid under the $10 a share level, which seems too che ...

Amicus Therapeutics (FOLD) reported first-quarter 2024 adjusted loss of 2 cents per share, narrower than the Zacks Consensus Estimate of a loss of 6 cents. The company had incurred a loss of 6 cents per share in the year-ago quarter.The year-over-year improvement can be attributed to higher revenues from Galafold (migalastat) sales and incremental revenues from the sale of the newly approved combo drug, Pombiliti + Opfolda.Revenues in the reported quarter totaled $110.4 million, up 28% year over year on a r ...

For the quarter ended March 2024, Amicus Therapeutics (FOLD) reported revenue of $110.4 million, up 28% over the same period last year. EPS came in at -$0.02, compared to -$0.18 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $111.62 million, representing a surprise of -1.09%. The company delivered an EPS surprise of +66.67%, with the consensus EPS estimate being -$0.06.While investors closely watch year-over-year changes in headline numbers -- revenue and earnings - ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission file number 001-33497 Amicus Therapeutics, Inc. (Exact Name of Registrant as Specified in Its Charter) Delaware 71-0869350 (State or Other Juris ...

Financial Data and Key Metrics Changes - Total revenue for Q1 2024 reached $110 million, representing a 28% increase year-over-year [17][72] - Galafold revenue was $99 million globally, reflecting a 16% growth year-over-year on a constant currency basis [57][58] - Pombiliti and Opfolda reported revenue of $11 million for Q1 2024, a 30% increase compared to Q4 2023 [22] Business Line Data and Key Metrics Changes - Galafold continues to capture over 60% of the global amenable market, with potential to reach 85%-90% in mature markets [18][78] - The number of patients on Pombiliti and Opfolda treatment reached 155, with a significant increase in new commercial patients [5][75] - Non-GAAP operating expenses increased to $86 million in Q1 2024, compared to $81 million in the same period last year [27] Market Data and Key Metrics Changes - 66% of total revenue in Q1 2024 was generated outside the U.S., with 34% from within the U.S. [33] - The overall time from prescription to infusion has decreased to around 70 days, with improvements expected [8][134] - Pombiliti and Opfolda launched in Spain, with a fast reimbursement process enhancing access [25] Company Strategy and Development Direction - The company aims to maximize the number of patients on therapy by year-end 2024, with a focus on expanding patient access through reimbursement discussions [10][93] - The strategy includes sustaining double-digit growth for Galafold and executing multiple commercial launches for Pombiliti and Opfolda [96] - The company is committed to achieving non-GAAP profitability in 2024 while managing expenses carefully [38][62] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the successful launch of Pombiliti and Opfolda, anticipating it to become the standard-of-care for Pompe disease [11][49] - Positive trends in patient demand and physician feedback were highlighted, indicating strong momentum for the therapies [60][134] - The company expects to achieve full-year revenue growth of 25% to 30% in 2024, driven by Galafold and Pombiliti/Opfolda sales [37][38] Other Important Information - The company has submitted over 10 reimbursement dossiers and is in discussions for broader patient access across the EU [9][12] - Cash, cash equivalents, and marketable securities totaled $240 million as of March 31, 2024, down from $286 million at the end of December 2023 [36] Q&A Session Summary Question: What is the biggest disconnect between guidance for Pombiliti and Opfolda and Street models? - Management noted that understanding the timing for new patients through the insurance process was crucial, which led to a divergence in revenue expectations [44][46] Question: What are the expectations for patient switching from previous therapies? - Management indicated that trends show patients are switching from both Nexviazyme and Lumizyme, with a significant proportion of new patients coming from the naive population [23][126] Question: What are the goals for the Amicus Pompe registry? - The registry aims to collect real-world evidence and fulfill post-marketing commitments, with hundreds of patients expected to be enrolled [116][145] Question: How is the company addressing supply chain challenges? - Management expressed confidence in navigating supply challenges and highlighted progress in moving product out of China to central depots in Europe [85][106] Question: What proportion of revenue is expected from U.S. versus ex-U.S. markets? - The majority of revenue is expected to come from Europe initially, with a shift towards a more balanced distribution as more countries launch [109][110]

Exhibit 99.1 Amicus Therapeutics Announces First Quarter 2024 Financial Results and Corporate Updates 1Q 2024 Total Revenue of $110.4M, a 28% Increase Year-over-Year Guiding to Full-Year 2024 Total Revenue Growth of 25%-30% at CER Raising Full-Year 2024 Galafold Guidance on Continued Strong Demand Strong Pombiliti+ Opfolda Launch with Increasing Rate of Commercial Patient Starts Reiterating Full-Year Non-GAAP Profitability Projected in 2024 Conference Call and Webcast Today at 8:30 a.m. ET PRINCETON, NJ, Ma ...