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ADHD

Alcobra

$2.60

-0.11 (-4.06%)

08:51
10/07/16
10/07
08:51
10/07/16
08:51

Alcobra receives full clinical hold notice from FDA

Alcobra announced that it has received the written full clinical hold notice from the Division of Psychiatry Products of the FDA in follow up to their verbal communication on the matter. As stated in Alcobra's public communications last week, the clinical hold affects Alcobra's Phase III clinical study of Metadoxine Extended Release, or MDX, in adult patients with ADHD, known as the "MEASURE" study. The FDA indicated in the letter that the clinical hold was placed due to electrophysiological neurologic findings in previously submitted long-term animal studies with Metadoxine. The FDA letter did not reference any clinical safety data observed in the MEASURE study or in previous human studies with MDX. The Division recommended that Alcobra schedule a meeting to discuss a plan to collect additional human safety data in its development program. Alcobra will continue to work rapidly and diligently with the FDA to seek the removal of the clinical hold and will provide an update following its meeting with the Agency.

ADHD Alcobra
$2.60

-0.11 (-4.06%)

09/30/16
09/30/16
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Alcobra (ADHD) downgraded to Neutral from Overweight at Piper Jaffray analyst Charles Duncan citing the near-term increase in clinical risk and timeline uncertainty after the company's Metadoxine program was placed on full clinical hold by the FDA. 2. CNO Financial (CNO) downgraded to Neutral from Buy at Goldman and to Neutral from Buy at BTIG. 3. CalAmp (CAMP) downgraded to Equal-Weight from Overweight at First Analysis with analyst Howard Smith saying the shares are likely range-bound until the company can build investor confidence in its growth profile. 4. Knoll (KNL) downgraded to Market Perform from Outperform at Raymond James with analyst Budd Bugatch citing the reports from office furniture manufacturers and residential furniture retailers that indicate business activity slowed in July and only modestly recovered in August and September. 5. Core-Mark (CORE) downgraded to Hold from Buy at Jefferies saying he sees earnings risk in 2017 following the loss of Circle K's Southeast. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/30/16
PIPR
09/30/16
DOWNGRADE
Target $3
PIPR
Neutral
Alcobra downgraded to Neutral from Overweight at Piper Jaffray
Piper Jaffray analyst Charles Duncan yesterday after the close downgraded Alcobra to Neutral and cut his price target for the shares to $3 from $10. The analyst cites the near-term increase in clinical risk and timeline uncertainty after the company's Metadoxine program was placed on full clinical hold by the FDA.
09/29/16
PIPR
09/29/16
DOWNGRADE
PIPR
Neutral
Alcobra downgraded to Neutral from Overweight at Piper Jaffray
09/29/16
ROTH
09/29/16
NO CHANGE
Target $7.5
ROTH
Buy
Alcobra price target lowered to $7.50 from $12 at Roth Capital
Roth Capital analyst Michael Higgins lowered his price target for Alcobra to $7.50 from $12 after the company announced that the FDA would be placing a full clinical hold on its primary asset, MDX, which had been expected to report pivotal trial results in Q1 from a trial of 750 patients with ADHD. However, the analyst reiterates a Buy rating on the shares as he continues to believe MDX will reach the primary endpoint in the MEASURE trial.

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