PTC faces a delay in Europe for controversial Duchenne drug
PTC Therapeutics won’t be getting a decision soon from European regulators on its effort to get an extension of its conditional approval for Translarna (ataluren) as a treatment for Duchenne muscular dystrophy. The biotech announced this morning that the regulatory assessment won’t be completed mid-year, adding that execs expect “that Translarna’s current marketing authorization status will remain valid until a decision is adopted by the European Commission.”
Unlock this article instantly by becoming a free subscriber.
You’ll get access to free articles each month, plus you can customize what newsletters get delivered to your inbox each week, including breaking news.