By Shares of PTC Therapeutics took a hit in premarket trading after the company revealed that European approval for its key Duchenne muscular dystrophy drug Translarna may be in jeopardy. PTC’s stock dropped 21% as a result.
Conditional Approval under Scrutiny
Requesting a Re-examination
In response to this setback, PTC is planning to request a re-examination. This move will keep Translarna on the market until the re-examination process is completed.
Significant Revenue Impact
During the second quarter, Translarna generated net product revenue of $96.5 million, accounting for approximately 45% of PTC’s total revenue. The potential loss of European approval could have a significant impact on the company’s financial performance.
Analysts’ Perspective
Analysts at Truist previously expressed optimism about the likelihood of full EU marketing approval for Translarna. They highlighted the robust evidence supporting the drug’s benefits and historical support from the EU for real-world data. Despite the current setback, Truist maintains a buy rating on PTC shares and believes any negative impact on share price will be limited due to the strength of PTC’s portfolio.
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