Washington, D.C., Jan. 23, 2025 (GLOBE NEWSWIRE) -- The New Civil Liberties Alliance has filed an amicus curiae brief in Burgess v. Whang, urging the U.S. Court of Appeals for the Fifth Circuit to uphold a preliminary injunction stopping the Federal Deposit Insurance Corporation’s (FDIC) unconstitutional administrative enforcement proceeding against Cornelius Campbell Burgess. FDIC is trying to heavily fine Mr. Burgess, a former executive for a small Texas bank, and ban him from the banking industry for lif ...

Amicus Therapeutics (FOLD) announced preliminary total revenues for the fourth quarter and full-year 2024. The company’s top line currently comprises sales of the lead product, Galafold (migalastat), which is approved for treating Fabry disease and Pombiliti + Opfolda.The FDA approved Pombiliti + Opfolda, a two-component therapy for treating late-onset Pompe disease, in September 2023.Along with the preliminary results, Amicus also outlined key strategic priorities and outlook for 2025.In the past year, sha ...

43rd Annual J.P. Morgan Healthcare Conference January 13, 2025 Forward-Looking Statements This presentation contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995 relating to the prospects requlatory and pricing and reimbursement approvals of our products, commercialization plans, manufacturing and supply plans, financing plans, a profitability and cash position for the Company. The inclusion of forward-looking statements should not be regarded as a ...

Company Overview - Amicus Therapeutics is a global biotechnology company focused on developing and commercializing novel medicines for rare diseases [1] - The company is dedicated to advancing a pipeline of first- or best-in-class medicines for rare diseases [1] - Amicus Therapeutics is committed to delivering high-quality medicines for patients with rare diseases [1] Financial Performance - Total revenue in 2024 reached $528.5 million, representing a year-over-year increase of 32% [7] - Fourth quarter total revenue was $149.9 million [7] - The company anticipates total revenue growth of 17-24% on a constant currency basis for 2025 [7] - Galafold net product sales in 2024 were $458.2 million, a year-over-year increase of 18% [7] - Pombiliti + Opfolda net product sales in 2024 were $70.3 million [7] - The company anticipates achieving positive GAAP Net Income during H2 2025 [7] Product Highlights - Galafold is an oral pharmacological chaperone for the treatment of Fabry disease in adults with amenable GLA variants [14] - Pombiliti + Opfolda is a two-component therapy for the treatment of late-onset Pompe disease [17] - As of the end of 2024, there were ~2,730 patients living with Fabry disease on Galafold [7] - There were ~220 patients treated or scheduled with Pombiliti + Opfolda as of the end of 2024 [7] Strategic Priorities - The company is focused on delivering significant long-term revenue growth and anticipates surpassing $1 billion in total sales by 2028 [7] - Amicus is advancing ongoing studies to broaden labels and scientific leadership in Fabry and Pompe diseases [7] - The company reached a settlement with Teva on the Galafold U.S. patent litigation, preventing Teva from commercializing generic migalastat in the U.S. until Jan 2037 [7] Market Expansion - Multiple Pombiliti + Opfolda pricing and reimbursement agreements were achieved in Italy, Sweden, Switzerland, and Czech Republic [7] - The company anticipates new regulatory decisions in Australia, Canada, and Japan in 2025 [7] - Additional reimbursement agreements are expected throughout 2025 [7] Corporate Updates - Bradley Campbell, President and CEO, highlighted the company's significant revenue growth and non-GAAP profitability in 2024 [5] - The company's strong intellectual property position and global rare disease organization are expected to enable sustainable revenue growth [5] - Mr. Campbell will present at the 43rd Annual J.P. Morgan Healthcare Conference on January 13, 2025 [21]

Live Chat on The Biotech Forum has been dominated by discussion of lucrative buy-write or covered call opportunities on selected biotech stocks over the past several months. To see what I and the other season biotech investors are targeting as trading ideas real-time, just join our community at The Biotech Forum by clicking HERE .Shares of rare disease concern Amicus Therapeutics, Inc. ( NASDAQ: FOLD ) are down 15% since producing a profitable 3Q24 on a non-GAAP basis that compelled management to raise its ...

Washington, D.C., Dec. 23, 2024 (GLOBE NEWSWIRE) -- Today, the New Civil Liberties Alliance filed an amicus curiae brief at the U.S. Supreme Court in support of the Respondents in Food and Drug Administration v. R.J. Reynolds Vapor Company. NCLA’s brief urges the Justices to reject FDA’s effort to insulate itself from accountability. Even though the law allows “any person adversely affected” by an FDA order to challenge the agency’s decision in court, FDA oddly claims vaping retailers are not adversely affe ...

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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. ...

Amicus Therapeutics (FOLD) reported third-quarter 2024 adjusted earnings of 10 cents per share, beating the Zacks Consensus Estimate of 8 cents. The company had incurred a loss of 1 cent 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 third quarter totaled $141.5 million, up 37% year over year on a reported basis a ...

It doesn't matter your age or experience: taking full advantage of the stock market and investing with confidence are common goals for all investors. Luckily, Zacks Premium offers several different ways to do both.The research service features daily updates of the Zacks Rank and Zacks Industry Rank, full access to the Zacks #1 Rank List, Equity Research reports, and Premium stock screens, all of which will help you become a smarter, more confident investor.It also includes access to the Zacks Style Scores.W ...