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AAAP

Advanced Accelerator

$33.91

-1.125 (-3.21%)

07:21
11/28/16
11/28
07:21
11/28/16
07:21

Advanced Accelerator reports FDA feedback for Lutathera

Last week, the FDA issued feedback to the NDA for Lutathera for the treatment of gastroenteropancreatic neuroendocrine tumors, or GEP-NETs, in adults. The FDA feedback identified issues with the format, traceability, uniformity, and completeness relating to the NETTER-1 and Erasmus clinical datasets, which are precluding FDA reviewers from performing the required independent analysis of these clinical studies. AAA will work closely with the FDA and the company's Contract Research Organizations to resolve these issues and revise the data format to permit FDA review. AAA has concluded at this time that approval of Lutathera is unlikely to occur by the PDUFA date of December 28, 2016. The FDA comments were provided via a Discipline Review Letter, which is a letter sent to an applicant to convey early thoughts on possible deficiencies of an application. The letter refers to reviews of the Clinical, Statistical, and Clinical Pharmacology sections of the submission. The FDA noted that their feedback does not reflect a final decision, is preliminary and subject to change.

  • 28

    Nov

  • 28

    Dec

AAAP Advanced Accelerator
$33.91

-1.125 (-3.21%)

12/07/15
ADAM
12/07/15
INITIATION
Target $35
ADAM
Buy
Advanced Accelerator initiated with a Buy at Canaccord
Target $35.
12/07/15
12/07/15
INITIATION

On the Fly: Analyst Initiation Summary
Today's noteworthy initiations include: Advanced Accelerator (AAAP) initiated with an Outperform at JMP Securities...Akebia (AKBA) initiated with a Buy at H.C. Wainwright...CalAmp (CAMP) initiated with a Buy at Chardan...Emerge Energy (EMES) initiated with a Buy at DA Davidson...Energous (WATT) initiated with a Buy at Ladenburg...Enviva (EVA) coverage resumed with an Outperform at RBC Capital...Equity Bancshares (EQBK) initiated with an Overweight at Stephens...Fairmount Santrol (FMSA) initiated with a Buy at DA Davidson...Ferrari (RACE) initiated with an Overweight at Morgan Stanley...Match Group (MTCH) initiated with an Outperform at Wells Fargo...Motorola Solutions (MSI) initiated with a Hold at Jefferies...Potash (POT) reinstated with an Underperform at BofA/Merrill...Rose Rock Midstream (RRMS) initiated with a Market Perform at Wells Fargo...STORE Capital (STOR) initiated with an Overweight at Capital One...SemGroup (SEMG) initiated with an Outperform at Wells Fargo...Sorrento Therapeutics (SRNE) assumed with a Buy at H.C. Wainwright...Teva (TEVA) initiated with a Buy at Mizuho...U.S. Silica (SLCA) initiated with a Buy at DA Davidson...Voyager Therapeutics (VYGR) initiated with an Outperform at Cowen...Voyager Therapeutics initiated with an Overweight at Piper Jaffray...Wave Life Sciences (WVE) initiated with a Buy at Jefferies.
09/22/16
ADAM
09/22/16
NO CHANGE
Target $47
ADAM
Buy
Advanced Accelerator price target raised to $47 from $35 at Canaccord
Canaccord analyst John Newman raised his price target on Advanced Accelerator to $47 from $35 due to increasing confidence in the approval of Lutathera and Advanced Accelerator's ability to effectively commercialize the drug should it be approved. Newman reiterated his Buy rating on Advanced Accelerator shares.
10/18/16
WELS
10/18/16
INITIATION
WELS
Outperform
Advanced Accelerator initiated with an Outperform at Wells Fargo
Wells Fargo analyst Jim Birchenough started Advanced Accelerator Applications with an Outperform rating and $52-$58 price target range. The analyst expects near-term approval of the company's lead radionuclide therapeutic Lutathera for neuroendocrine tumors. He sees potential blockbuster opportunity.

TODAY'S FREE FLY STORIES

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MNRO

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CHFS

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MKC

McCormick

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0.42 (0.43%)

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Earnings
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  • 29

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MKC

McCormick

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0.42 (0.43%)

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PIR

Pier 1 Imports

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WB

Weibo

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WB

Weibo

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CNP

CenterPoint Energy

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ALSN

Allison Transmission

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NOAH

Noah Holdings

$27.69

1.13 (4.25%)

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GBX

Greenbrier

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PDS

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GBX

Greenbrier

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SPX

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IMGN

ImmunoGen

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GDX

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GLD

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NUGT

Direxion Gold Miners Bull

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JNUG

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DUST

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JDST

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