Core Viewpoint - The case of FDA v. R.J. Reynolds Vapor Company addresses whether retailers can challenge FDA's decisions regarding the sale of vaping products, with implications for judicial review rights under the Family Smoking Prevention and Tobacco Control Act (TCA) [1][4][5]. Group 1: Legal Context - Under the TCA, manufacturers must obtain FDA approval to sell certain vaping products, and R.J. Reynolds Vapor Company's application for its "Vuse" e-cigarettes was denied, leading to a ban on sales by retailers [1]. - Retailers filed a petition for review in the U.S. Court of Appeals for the Fifth Circuit, claiming the FDA's decision adversely affected their sales [1]. - The Fifth Circuit ruled that retailers have standing to challenge the FDA's decision, rejecting the FDA's argument that only manufacturers could be adversely affected [1]. Group 2: Implications of the Case - The outcome of this case could set a precedent affecting the scope of judicial review provisions across various statutes, potentially limiting the ability of individuals and businesses to seek relief from agency actions [5]. - NCLA's amicus brief emphasizes the importance of maintaining broad judicial review rights for all parties adversely affected by FDA decisions, in line with Congressional intent [5]. Group 3: Advocacy and Perspectives - NCLA argues that restricting the right to sue FDA to only parties involved in agency proceedings undermines the controlling statute and Supreme Court precedent [4][5]. - The organization highlights the necessity for accountability from the FDA, given its significant regulatory power over individuals and businesses [6].

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Washington, D.C., Dec. 03, 2024 (GLOBE NEWSWIRE) -- Today, the New Civil Liberties Alliance filed an amicus curiae brief in Moats v. National Credit Union Administration Board urging the U.S. Court of Appeals for the Fifth Circuit to reverse an order depriving former Texas credit union CEO Jeffrey Moats of a jury trial. The National Credit Union Administration (NCUA) prosecuted and punished Mr. Moats for alleged misconduct in its in-house tribunal overseen by an Administrative Law Judge (ALJ) it appointed. ...

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For the quarter ended September 2024, Amicus Therapeutics (FOLD) reported revenue of $141.52 million, up 36.7% over the same period last year. EPS came in at $0.10, compared to -$0.07 in the year-ago quarter.The reported revenue compares to the Zacks Consensus Estimate of $133.91 million, representing a surprise of +5.68%. The company delivered an EPS surprise of +25.00%, with the consensus EPS estimate being $0.08.While investors scrutinize revenue and earnings changes year-over-year and how they compare w ...

Exhibit 99.1 Amicus Therapeutics Announces Third Quarter 2024 Financial Results and Corporate Updates Q3 2024 Total Revenue of $141.5M, a 37% Increase Year-over-Year GalafoldQ3 Revenue of $120.4M, up 20% Year-over-Year Pombiliti+ Opfolda Q3 Revenue of $21.1M, up 33% from Q2 2024 Raising 2024 Total Revenue Growth Guidance to 30%-32% at CER Reducing non-GAAP Operating Expense Guidance to $340M to $350M Conference Call and Webcast Today at 8:30 a.m. ET PRINCETON, NJ, November 6, 2024 – Amicus Therapeutics (Nas ...

Amicus Therapeutics (FOLD) closed the last trading session at $11.47, gaining 8.2% over the past four weeks, but there could be plenty of upside left in the stock if short-term price targets set by Wall Street analysts are any guide. The mean price target of $17.33 indicates a 51.1% upside potential.The average comprises 12 short-term price targets ranging from a low of $13 to a high of $20, with a standard deviation of $2.39. While the lowest estimate indicates an increase of 13.3% from the current price l ...

PRINCETON, N.J., Nov. 01, 2024 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that management will participate in upcoming presentations at the following investor conferences in November. Guggenheim Healthcare Innovation Conference in Boston, MA, on Tuesday, November 12, 2024, at 2:30 p.m. ETJefferies London Healthcare Conference in London, U.K. on Tuesday, November 19, 2024, at 8:00 a.m. GMT A live audio webcast of each presentation can also be accessed via the investors section of ...

PRINCETON, N.J., Oct. 28, 2024 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq: FOLD) today announced that the Company will host a conference call and live audio webcast on Wednesday, November 6, 2024, at 8:30 a.m. ET to discuss financial results for the third quarter ended September 30, 2024. Participants and investors interested in accessing the call by phone will need to register using the online registration form. After registering, all phone participants will receive a dial-in number along with a perso ...

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