BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) Announced Today the Stock is Halted
November 24 2015 - 7:05AM
BioMarin Pharmaceutical Inc. (NASDAQ:BMRN) announced today that
NASDAQ has halted trading of the company’s stock. The
Peripheral and Central Nervous System Drugs Advisory Committee
(PCNS) of the U.S. Food and Drug Administration (FDA) is
meeting today to review BioMarin’s New Drug Application (NDA) for
Kyndrisa, an investigational antisense oligonucleotide drug
candidate for the treatment of patients with Duchenne muscular
dystrophy amenable to exon 51 skipping.
The PCNS advisory meeting is scheduled for November 24 at 8:00
a.m. to 5:30 p.m. EST. The briefing materials and webcast
information can be found on the FDA website at:
http://www.fda.gov/AdvisoryCommittees/Calendar/ucm467180.htm
The Prescription Drug User Fee Act (PDUFA) action date for
completion of FDA review of the Kyndrisa NDA is December 27,
2015.
About Duchenne Muscular Dystrophy
Changes in the dystrophin gene (mutations) that lead to the near
absence of dystrophin protein result in the most severe form of
dystrophin deficient muscular dystrophy, Duchenne muscular
dystrophy, also known as just Duchenne. Boys living with
Duchenne experience progressive muscle weakness, causing serious
medical complications including serious heart or
respiratory-related complications, resulting in death in early
adulthood.
Primarily affecting boys, Duchenne affects
approximately 1 in every 3,500-5,000 male children, making it the
most common fatal genetic disorder diagnosed in childhood.
There is currently no FDA approved therapy designed specifically to
treat Duchenne.
About BioMarin
BioMarin is a global biotechnology company that
develops and commercializes innovative therapies for patients with
serious and life-threatening rare and ultra-rare genetic diseases.
The company's portfolio consists of five commercialized products
and multiple clinical and pre-clinical product candidates. For
additional information, please visit www.BMRN.com.
Investors
Traci McCarty
BioMarin Pharmaceutical Inc.
(415) 455-7558
Media
Debra Charlesworth
BioMarin Pharmaceutical Inc.
(415) 455-7451
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