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FLML

Ticker changed to AVDL

$12.86

-0.13 (-1.00%)

07:33
10/06/16
10/06
07:33
10/06/16
07:33

Flamel reaches agreement with FDA on FT218 Phase III pivotal trial protocol

Flamel Technologies announced that its Irish subsidiary, Flamel Ireland Holdings, has reached agreement with the FDA for the design and planned analysis of a Phase III clinical trial of FT218, a once nightly formulation of sodium oxybate utilizing the Company's proprietary drug delivery platform, Micropump. The agreement was reached through the Special Protocol Assessment, or SPA, process. A SPA is an acknowledgement by FDA that the design and planned analysis of the company's pivotal clinical trial of FT218 adequately addresses the objectives necessary to support a regulatory submission. The Phase III trial, titled "A Double-blind, Randomized, Placebo Controlled, Two Arm Multi-center Study to Assess the Efficacy and Safety of a Once Nightly Formulation of Sodium Oxybate for Extended-Release Oral Suspension, or FT218, for the Treatment of Excessive Daytime Sleepiness and Cataplexy in Subjects with Narcolepsy," recently commenced patient enrollment in Canada, with sites in Europe and the U.S. to be initiated near-term.

FLML Ticker changed to AVDL
$12.86

-0.13 (-1.00%)

03/02/16
RHCO
03/02/16
NO CHANGE
RHCO
Flamel weakness creates buying opportunity, says SunTrust
After speaking with Flamel's CEO regarding the company's decision to delay filing its 2015 Annual Report on its 10-K, SunTrust notes that this is the first year the company has filed as a U.S.-based company, meaning that it has an earlier deadline than in past years. The firm also says that the company uses "very conservative accounting methods." SunTrust believes there is a low chance that the company will "experience accounting irregularities," and it expects the company to file its 10-K by March 15. SunTrust keeps a Buy rating on the shares.
03/23/16
LEER
03/23/16
NO CHANGE
Target $16
LEER
Outperform
Akorn PDUFA removes Flamel's 'uber-bull case,' says Leerink
Leerink analyst Jason Gerberry says the "uber-bull case" for Flamel Technologies (FLML) has been removed after Akorn (AKRX) announced it has an FDA action date for its injectable ephedrine sulfate "sometime in 2016." Flamel's Eclat #3, believed to injectable ephedrine sulfate, also has a PDUFA in 2016 on April 30, Gerberry tells investors in a research note. The "uber-bull case" had Flamel possibly gaining five-year New Chemical Entity exclusivity as the sole approved version of ephedrine, the analyst points out. He notes, however, that Akorn's update is not a major surprise and that a duopoly in the ephedrine market for a couple of years can bring $100M in peak Flamel sales. Gerberry keeps an Outperform rating on the shares with a $16 price target.
05/02/16
LEER
05/02/16
NO CHANGE
Target $16
LEER
Outperform
Flamel Akovaz approval as expected, says Leerink
Leerink analyst Jason Gerberry says this morning's announcement that FDA has approved Flamel's Akovaz does not present a major surprise, with the company having already included Akovaz sales in its 2016 guidance. Flamel will launch the injectable pressor agent for treatment of hypotension in Q3, the analyst tells investors in a research note, adding that he forecasts about $100M in Akovaz sales in 2017. Gerberry notes that the FDA will make a decision on Akovaz NCE, or new chemical entity, status later this month and, in theory, it could confer 5 years of regulatory exclusivity. The analyst reiterates an Outperform rating and $16 price target on the shares.
07/19/16
RHCO
07/19/16
NO CHANGE
RHCO
Flamel has positive read through from delay of Akorn drug, says SunTrust
SunTrust says that the delay of Akorn's (AKRX) ephedrine injectable could make Flamel (FLML) the sole supplier of about 5M ephedrine vials. The firm estimates that the delay will boost the value of Flamel's stock by up to $3 per share if it does not raise the price of its injectable and by up to $8 per share if it does raise the price. The firm keeps a $31 price target and Buy rating on Flamel.

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