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LCI

Lannett

$23.00

0.35 (1.55%)

07:00
11/30/16
11/30
07:00
11/30/16
07:00

Lannett granted 90-day extension by FDA for Methylphenidate ER documentation

Lannett announced that the FDA granted the company a 90-day extension to submit documentation concerning its Methylphenidate Hydrochloride, or HCl, Extended-Release, or ER, Tablets. The new deadline for submitting the supporting documentation is March 20, 2017. It is hoped that the extension will allow the Agency sufficient time to provide the underlying documents on which its decision was based. Lannett filed a request under the Freedom of Information Act for those supporting documents. Based on the additional information Lannett will provide, FDA will decide whether to grant a hearing to evaluate the issue further. As announced on October 19, 2016, the company received a notice from the FDA that it will seek to withdraw approval of the company's Abbreviated New Drug Application for Methylphenidate HCl ER Tablets. That decision is reportedly based on a revised Agency methodology for evaluating bioequivalence of extended release formulations of the drug.

  • 14

    Dec

LCI Lannett
$23.00

0.35 (1.55%)

05/27/16
SUSQ
05/27/16
NO CHANGE
Target $35
SUSQ
Neutral
News of Valeant offer could put floor under 'beaten up' names, says Susquehanna
Susquehanna analyst Andrew Finkelstein commented on the media report that Valeant (VRX) was approached by TPG and Takeda (TKPYY) about a potential buyout, noting the timing mentioned means the approach came when Valeant shares were trading at or below the mid-$30 range. What is not known is whether a premium was offered, but the firm notes that private equity deals have generally been done at low multiples. However, this report and other recent news signaling private equity interest in the space could help put a a floor under "beaten up" pharma names like Endo (ENDP), Lannett (LCI) and Akorn (AKRX), Finkelstein tells investors. The report does not change Susquehanna's fundamental views on Valeant, added the analyst, who keeps a Neutral rating and $35 price target on Valeant shares.
06/29/16
DBAB
06/29/16
INITIATION
Target $26
DBAB
Hold
Lannett initiated with a Hold at Deutsche Bank
Deutsche Bank analyst Gregg Gilbert started Lannett with a Hold rating and $26 price target.
08/24/16
ROTH
08/24/16
NO CHANGE
Target $40
ROTH
Buy
Lannett price target raised to $40 from $27.50 at Roth Capital
Roth Capital analyst Scott Henry raised his price target for Lannett to $40 from $27.50 after the company reported "strong" quarterly results and "impressive" 2017 guidance. The analyst reiterates a Buy rating on the shares.
11/04/16
ROTH
11/04/16
NO CHANGE
Target $34
ROTH
Buy
Lannett price target lowered to $34 from $40 at Roth Capital
Roth Capital analyst Scott Henry lowered his price target for Lannett to $34 from $40 on valuation. The analyst recognizes that the Department of Justice investigation is a "black box," but notes that the market appears to be pricing in the worst. He reiterates a buy rating on the shares for those "willing to absorb this risk."

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, SEED

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CGEN

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WDC

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LW

Lamb Weston

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