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CORAL GABLES, Fla. - Catalyst Pharmaceuticals (CPRX), a commercial-stage biopharmaceutical company with an "EXCELLENT" financial health rating according to InvestingPro, announced today that its sub-licensee Kye Pharmaceuticals has received acceptance from Health Canada for the New Drug Submission (NDS) of AGAMREE®, a novel treatment for Duchenne muscular dystrophy (DMD). The submission has been granted Priority Review, a status that accelerates the regulatory approval process, potentially leading to marketing authorization in Canada before the end of 2025.
AGAMREE, which is already approved and available in the United States, could become the first authorized DMD treatment in Canada if approved. The drug, a corticosteroid designed to maintain efficacy with a potentially better-tolerated side effect profile, represents a significant development for those affected by DMD, a genetic disorder characterized by progressive muscle degeneration and weakness.
Richard J. Daly, President and CEO of Catalyst, expressed the company's commitment to addressing the unmet needs of DMD patients in Canada, particularly in underserved communities. The company's focus remains on ensuring access to this innovative therapy.
The drug, AGAMREE (40 mg/mL oral suspension), received U.S. Food and Drug Administration (FDA) approval on October 26, 2023, and became commercially available in the U.S. on March 13, 2024. This expansion adds to Catalyst's impressive revenue growth of 23.49% over the last twelve months, supported by an industry-leading gross profit margin of 85.64%. In the pivotal VISION-DMD study, AGAMREE met the primary endpoint and demonstrated a good safety and tolerability profile. Common adverse events were of mild to moderate severity, including cushingoid features and psychiatric disorders.
Kye Pharmaceuticals, a Canadian specialty pharmaceutical company, is responsible for marketing AGAMREE in Canada. They currently market FIRDAPSE®, another Catalyst product for Lambert-Eaton myasthenic syndrome (LEMS), a rare neuromuscular disorder.
Catalyst Pharmaceuticals, a commercial-stage biopharmaceutical company, has been recognized for its success and growth. The company continues to seek expansion of its global commercial footprint through strategic partnerships. Currently trading below its InvestingPro Fair Value, with strong fundamentals including more cash than debt on its balance sheet, the company appears well-positioned for future growth. For detailed analysis and additional insights, investors can access the comprehensive Pro Research Report available on InvestingPro, which covers what really matters about Catalyst Pharmaceuticals through intuitive visuals and expert analysis. This information is based on a press release statement from Catalyst Pharmaceuticals and InvestingPro data.
In other recent news, Catalyst Pharmaceuticals reported strong financial results for the fourth quarter of 2024, with earnings per share (EPS) of $0.70, significantly surpassing the expected $0.32. The company's revenue for the quarter reached $141.8 million, exceeding the forecasted $133.68 million. For the full fiscal year 2024, Catalyst's total revenue was $491.7 million, marking a 23.5% increase from the previous year. Looking ahead, the company provided a revenue guidance for fiscal year 2025, projecting between $545 million and $565 million, driven by strong sales of products like AGAMREE. Stephens analyst Sudan Loganathan raised the price target for Catalyst Pharmaceuticals from $33.00 to $40.00, maintaining an Overweight rating on the stock. This adjustment follows Catalyst's financial earnings call and reflects confidence in the company's growth trajectory. Catalyst's cash and cash equivalents at year-end were reported at $517.6 million, indicating a robust financial position. The company also noted that FIRDAPSE and AGAMREE significantly contributed to its revenue growth during the year.
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