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ZGNX

Zogenix

$48.19

8.76 (22.22%)

14:48
06/27/19
06/27
14:48
06/27/19
14:48

Zogenix upgraded to Buy Fintepla NDA news at Guggenheim

As previously reported, Guggenheim analyst Yatin Suneja upgraded Zogenix to Buy from Neutral after speaking with management following the news on Fintepla NDA resubmission in Dravet in Q3. The analyst believes the company has a clear understanding with the FDA on potential approval pathway and views the news as the best case scenario. The company also announced the loss of breakthrough designation, which is surprising but in line with FDA policy, he notes, adding however, that it does not change his view on the approvability of the drug and thinks priority review could help with a speedy approval. Suneja also raised his price target on the shares to $64 from $40.

ZGNX Zogenix
$48.19

8.76 (22.22%)

04/09/19
EAMC
04/09/19
NO CHANGE
Target $66
EAMC
Buy
Zogenix selloff on RTF letter a buying opportunity, says Empire
Empire Asset Management views the selloff in shares of Zogenix after the company received a Refusal to File Letter for Fintepla as a buying opportunity. The FDA did not seem to indicate that additional clinical efficacy or safety data was needed, Empire tells investors in a research note. Further, the firm points out that Fintepla has FDA Breakthrough Therapy Designation and Fast-Track status, which it believes should expedite Zogenix's timeline to an FDA Type A meeting. Empire keeps a Buy rating on the shares with a $66 price target.
06/27/19
STFL
06/27/19
NO CHANGE
STFL
Buy
Fintepla RTF resolution a win for Zogenix, says Stifel
Stifel analyst Paul Matteis says Fintepla RTF resolution is a win for Zogenix and in line with the best-case scenario in terms of time-to-resubmission of the NDA. The analyst adds that the outcome reinforces his longstanding view that the RTF did not imply the existence an actual unknown approvability issue within the Fintepla clinical dataset. While Matteis acknowledges that the loss of Breakthrough Designation is a surprise, he does not think this negatively impacts Fintepla approvability, and believes that rescinding BTD is more of an administrative outcome linked to the lack of head-to-head data versus Epidiolex and the fact that Zogenix did not include any CBD-treated patients in its Phase 3 studies. The analyst has a Buy rating on the shares.
06/27/19
PIPR
06/27/19
NO CHANGE
Target $64
PIPR
Overweight
Zogenix agreement with FDA 'best case scenario,' says Piper Jaffray
The FDA, in a "surprise turn of events," indicated that it agreed with Zogenix's plan to re-submit their Fintepla new drug application without generating new preclinical toxicity data, Piper Jaffray analyst Danielle Brill tells investors in a research note. Although breakthrough therapy status was rescinded due to the recent approvals of two other drugs for Dravet Syndrome, Brill still expects an expedited review and she estimates approval and launch by Q2 of 2020. The analyst views the news as the "best case scenario" for Zogenix. She does not expect the delay to have any meaningful impact on Fintepla's overall commercial potential and reiterates an Overweight rating on the shares with a $64 price target. The stock in afternoon trading is up 21%, or $8.24, to $47.65.
06/27/19
GUGG
06/27/19
UPGRADE
GUGG
Buy
Zogenix upgraded to Buy from Neutral at Guggenheim

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PSMT

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ADTN

Adtran

$15.84

0.09 (0.57%)

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BHC

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EFC

Ellington Financial

$18.30

0.045 (0.25%)

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  • 18

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EPRT

Essential Properties Realty Trust

$19.83

-0.27 (-1.34%)

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FTSV

Forty Seven

$8.77

-1.38 (-13.60%)

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SNDE

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NYMT

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IBKC

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IBKC

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EBAY

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NFLX

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MIRM

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GSBC

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NFLX

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NFLX

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NFLX

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NFLX

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IBM

IBM

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-0.47 (-0.33%)

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