Impax announces FDA performs inspection on Taiwan facility Impax announced that the FDA performed a general GMP inspection and a Pre-Approval Inspection for RYTARYTM at the company's Taiwan manufacturing facility from July 21 to July 26. At the conclusion of the inspection, the FDA issued a Form 483 with ten inspectional observations. The Taiwan facility was approved for product manufacturing by the FDA in September 2009 and by Taiwan FDA in July 2010. The facility currently manufactures 12 products for distribution in the United States. The FDA did not provide any status or classification to these observations and will wait until they have received and reviewed the company's response to provide this information. The Ccmpany has also not been informed by the FDA of the impact this Form 483 may have on RYTARY's October 9 review date under the Prescription Drug User Fee Act.
Impax downgraded to Sell from Neutral at UBS UBS downgraded Impax Laboratories to Sell saying the risk/reward is biased to the downside following the recent rally in shares. UBS attributes the recent run-up in shares to expectations the company will do more deals or get acquired. The firm does not see either scenario driving the stock much above current levels "any time soon." It keeps a $36 price target for Impax shares.
Impax price target raised to $58 from $49 at Piper Jaffray Piper Jaffray raised its price target for Impax Laboratories to $58 saying retail prescription data shows the company's generics business is "quietly performing well." Piper believes revenue from the generics segment could outperform its expectations for 2015 and also drive "significant"growth longer-term. It reiterates an Overweight rating on Impax.