July 11 (Reuters) - The U.S. Food and Drug

Administration has declined to approve Ultragenyx

Pharmaceutical's ( RARE ) experimental gene therapy to treat a

rare inherited disorder, citing manufacturing concerns, the

company said on Friday.

The therapy, UX111, was developed to treat Sanfilippo

syndrome type A - a rare, inherited disorder that begin in early

childhood causing severe brain damage and early death.

The company said the FDA's observations, related to

facilities and processes, are addressable and not directly

related to the therapy's quality.

Ultragenyx plans to address the concerns and resubmit the

application, anticipating a six-month review period following

the resubmission.