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ZGNX

Zogenix

$47.48

8.05 (20.42%)

13:10
06/27/19
06/27
13:10
06/27/19
13:10

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 Although breakthrough therapy status was rescinded due to the recent approvals of two other drugs for Dravet Syndrome, Brill still expects an expedited review and she estimates approval and launch by Q2 of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.

ZGNX Zogenix
$47.48

8.05 (20.42%)

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.
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.
04/09/19
WBLR
04/09/19
NO CHANGE
WBLR
Outperform
Zogenix shares likely to remain weak in near term, says William Blair
William Blair analyst Tim Lugo lowered his fair value estimate for Zogenix to $57 and concedes the stock will likely remain weak in the near following Fintepla's refusal to file letter from the FDA. The analyst assumes Zogenix will need to conduct the preclinical studies cited in the letter and he pushed out the U.S. Fintepla launch from Q4 of 2019 to the first half of 2021. However, Lugo continues to believe Fintepla holds a best-in-class therapeutic profile from a safety, efficacy, and duration of effect standpoint that could achieve "near blockbuster status" in Dravet syndrome. He keeps an Outperform rating on Zogenix.
04/09/19
LEER
04/09/19
NO CHANGE
Target $48
LEER
Outperform
Zogenix price target lowered to $48 from $60 at SVB Leerink
SVB Leerink analyst Marc Goodman lowered his price target for Zogenix to $48 from $60 after the company received a Refusal to File letter from the FDA regarding the NDA filing for Fintepla in Dravet syndrome. The analyst notes that the FDA decision was based on two reasons, namely certain non-clinical studies that were not submitted, and an incorrect version of a clinical data set that was submitted. This is "clearly disappointing news," he contends, suggesting that management made a clear error in regard to what the FDA wanted in the filing. Goodman reiterates an Outperform rating on the shares.

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