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KMPH

KemPharm

$4.40

0.01 (0.23%)

07:37
10/11/16
10/11
07:37
10/11/16
07:37

KemPharm receives FDA clearance to initiate KP415 clinical program

KemPharm announced that its Investigational New Drug, or IND, application for KP415 has been accepted by the FDA. KP415, KemPharm's co-lead product candidate, is an extended release d-threo-methylphenidate prodrug for the treatment of attention deficit hyperactivity disorder. KemPharm expects to commence and complete proof of concept human trials prior to the end of 2016, with additional human clinical trials initiating during the first half of 2017.

KMPH KemPharm
$4.40

0.01 (0.23%)

02/10/16
COWN
02/10/16
NO CHANGE
COWN
KemPharm's KP201 NDA accepted, says Cowen
Cowen said KemPharm's KP201 NDA has been accepted by the FDA and believes it will likely be the first hydrocodone/APAP product with abuse-deterrent claims. If approved, the firm's analyst expects clinicians will likely prescribe KP201 over other significantly more abusable options, driving significant share value from these levels.
05/06/16
OPCO
05/06/16
NO CHANGE
Target $11
OPCO
Outperform
KemPharm price target lowered to $11 from $28 at Oppenheimer
Oppenheimer analyst Rohit Vanjani lowered his price target for KemPharm to $11 from $28 given the higher risk of a non-approval or approval without AD labeling for the company's Apadaz after a negative FDA Advisory Committee meeting. Though panel members voted that Apadaz should get approved based on the bioequivalence data to the reference drug, the members voted against labeling it as an abuse-deterrent product, the analyst tells investors in a research note. However, Vanjani believes this will not be the "end of the story," reiterating an Outperform rating on the shares while he awaits further commentary from the FDA.
05/06/16
RBCM
05/06/16
NO CHANGE
RBCM
KemPharm price target lowered to $14 from $22 at RBC Capital
RBC Capital cut its price target on KemPharm after an FDA panel voted 16-4 to recommend approval of the company's Apadaz drug but voted 18-2 against inclusion of an abuse deterrent claim in the label. The firm says that the abuse deterrent label was the key to the drug's success. Nonetheless, the firm remains upbeat on the company's technology, and it keeps an Outperform rating on the shares.

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