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Home Breaking News

Setback for PTC Therapeutics Translarna in Europe Potential Path Forward in the US

Elaine Mendonca by Elaine Mendonca
January 26, 2024
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On January 26, 2024, PTC Therapeutics was hit with a major setback in Europe. The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) issued a negative opinion on the conditional marketing authorization of PTC Therapeutics’ drug Translarna (ataluren) for the treatment of nonsense mutation Duchenne Muscular Dystrophy. This unfortunate decision will result in the removal of Translarna from the European market.

Matthew Klein, the CEO of PTC Therapeutics, expressed his disappointment with the CHMP’s ruling. He firmly believes that the data clearly demonstrate the safety and effectiveness of Translarna in patients suffering from this particular condition. Despite this setback, PTC Therapeutics is determined to fight the decision and plans to appeal to the CHMP.

It’s worth noting that in the United States, Translarna is still classified as an investigational new drug. PTC Therapeutics is currently engaged in discussions with the FDA to determine the regulatory pathway for a potential re-submission of a New Drug Application for Translarna in the US market.

PTCT Stock Plummets: Caution Advised for Investors Amidst Bearish Sentiment

On January 26, 2024, PTCT stock experienced a decline in price momentum, trading near the bottom of its 52-week range and below its 200-day simple moving average. The stock opened $0.95 lower than its previous close, indicating a bearish sentiment in the market. Investors should exercise caution and conduct thorough research before making any investment decisions.

PTCT Stock Performance on January 26, 2024: Mixed Results and Long-Term Sustainability Concerns

PTCT stock performances on January 26, 2024, showed mixed results for the company. According to data from CNN Money, PTCT reported a total revenue of $698.80 million for the past year, which represents a 29.75% increase compared to the previous year. However, the company experienced a decrease in revenue of 8.06% since the last quarter, with total revenue amounting to $196.58 million.

In terms of net income, PTCT reported a loss of -$559.02 million for the past year. This represents a decrease of 6.7% compared to the previous year. However, the company saw a significant improvement in net income since the last quarter, with a decrease of 33.14% to -$132.97 million.

The earnings per share (EPS) for PTCT also showed mixed results. The company reported an EPS of -$7.79 for the past year, reflecting a decrease of 4.82% compared to the previous year. However, there was a notable increase in EPS since the last quarter, with a growth of 33.72% to -$1.76.

Overall, PTCT’s stock performance on January 26, 2024, reflects a combination of positive and negative trends. While the company has shown growth in total revenue and improvement in net income and EPS since the last quarter, the decrease in revenue and net income compared to the previous year raises concerns about its long-term sustainability. Investors should closely monitor PTCT’s financial performance and future developments to make informed investment decisions.

Tags: PTCT
Elaine Mendonca

Elaine Mendonca

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