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Sarepta Therapeutics (NASDAQ:SRPT) and BioMarin Pharmaceutical (NASDAQ:BMRN) are working to become the recipients of an FDA coupon for a fast review, that could be worth more than $350 million.
Sarepta Therapeutics (NASDAQ:SRPT) and BioMarin Pharmaceutical (NASDAQ:BMRN) are working to become the recipients of an FDA coupon for a fast review, that could be worth more than $350 million.
According to Fierce Biotech:
The two companies separately received the FDA’s rare pediatric disease designation for their in-development treatments for Duchenne muscular dystrophy. And if they can win approval for the drugs next year–by no means guaranteed–each will receive a voucher that promises its holder a 6-month FDA review for any drug, truncating the standard 10-month process. Such vouchers can be sold to the highest bidder, and their market value has skyrocketed over the past year.
Each company is developing a treatment for DMD, a muscle-wasting disease that primarily affects young boys and severely shortens life expectancy. And each has faced setbacks along the way, as critics have questioned whether positive results from tiny studies merit approval. But after months of delays, both treatments will likely be up for FDA decisions over the next 8 months. BioMarin, which acquired Prosensa Therapeutics for up to $840 million to get its DMD drug, filed first and expects final word by the end of this year. Sarepta is about two months behind.
Now, in addition to old fashioned revenue, the pair could be in for a sizable cash windfall if they can win approval.
Click here to read the entire article on Fierce Biotech.