Impax Labs Shares Down Sharply After FDA CRL for RYTARY NDA; Canaccord Says Buy the Dip
Impax Pharmaceuticals, a division of Impax Laboratories, Inc. (NASDAQ: IPXL), announced early Sunday the U.S. Food and Drug Administration (FDA) issued a complete response letter regarding the New Drug Application (NDA) for RYTARY™ (IPX066), an extended-release capsule formulation of carbidopa-levodopa, a potential treatment for the symptomatic treatment of Parkinson's disease currently under review in the United States.
The complete response letter indicates that the FDA requires a satisfactory re-inspection of the company's Hayward facility as a result of the warning letter issued in May 2011 before the company's NDA may be approved due to the facility's involvement in the development of RYTARY, and supportive manufacturing and distribution activities. During the assessment of the NDA, the company withdrew the Hayward site as an alternative site of commercial production at launch.
“We will work with the FDA on the appropriate next steps for the RYTARY application,” said Larry Hsu, Ph.D., president and CEO, Impax Laboratories, Inc. “We remain committed to resolving the warning letter and bringing this new treatment option to patients who are suffering from Parkinson's disease.”
A complete response letter is issued by the FDA's Center for Drug Evaluation and Research when the review cycle for a drug is complete and the application is not yet ready for approval.
Following the move lower, Canaccord Genuity's Randall Stanicky is advising clients to buy the weakness in shares of Impax. Stanicky believes Impax will soon directly address the FDA's concerns, potentially pushing shares closer to $25.
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