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SAGE

Sage Therapeutics

$126.62

-10.64 (-7.75%)

07:55
11/06/18
11/06
07:55
11/06/18
07:55

Sage Therapeutics to hold a conference call on FDA meeting

Management discusses the FDA's joint advisory committees favorable decision in support of the Company's New Drug Application for ZULPRESSO (Brexanolone) for treatment of Postpartum Depression, as well as 3Q earnings results, on a conference call to be held on November 6 at 8 am. Webcast Link

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    Dec

SAGE Sage Therapeutics
$126.62

-10.64 (-7.75%)

11/01/18
ADAM
11/01/18
NO CHANGE
Target $220
ADAM
Buy
Sage Therapeutics FDA briefing documents read 'ok,' says Canaccord
Canaccord analyst Sumant Kulkarni noted the FDA posted its briefing documents related to Sage Therapeutics' brexanolone ahead of the advisory committee meeting on the product scheduled for November 2. The analyst said they appear "ok" and said the drug could be the first approved for the treatment of post-partum depression. The analyst said with the stock down roughly 10% since the FDA confirmed the date of the AdCom meeting, he is telling investors to buy the shares. Kulkarni reiterated his Buy rating and $220 price target on Sage Therapeutics shares.
10/31/18
10/31/18
NO CHANGE
Target $206

Overweight
Sage briefing docs 'clearly supportive of approval,' says Piper Jaffray
In a midday research note partially titled "Nothing Too Spooky in Brex Briefing Docs," Piper Jaffray analyst Danielle Brill says this morning's FDA's briefing documents for Sage Therapeutics' brexanolone were overall supportive of approval for postpartum depression. The agency appears comfortable with brexanolone's efficacy, and focused on recommended dosing as a key topic of discussion, Brill writes in a note to investors. The major safety concern, loss of consciousness during infusion which occurred in 4% of women treated, does not appear to be barring of approval, says the analyst. However, Brill adds that while she views the tone of the docs as "clearly supportive of approval," prohibiting administration "at-home" has "obvious negative implications for commercial potential." She has an Overweight rating on Sage Therapeutics with a $206 price target. The stock in midday trading is up 6%, or $7.77, to $129.00.
10/31/18
BMOC
10/31/18
NO CHANGE
Target $203
BMOC
Outperform
BMO sees approval for Sage after Zulresso briefing docs
The FDA this morning released briefing documents for Friday's panel meeting to discuss Sage Therapeutics' Zulresso to treat postpartum depression. It appears the FDA is satisfied with the drug's efficacy and overall tolerability and recognizes a significant unmet need for postpartum depression, BMO Capital analyst Gary Nachman tells investors in a research note. He believes Zulresso will likely be approved on the December 19 FDA action date. Nachman adds, however, that there are some questions on the recommended dosing, since initially the lower dose appears more effective but the doses start to separate during titration when going out beyond 24 hours. He has an Outperform rating on Sage Therapeutics with a $203 price target. The stock in early trading is up 1% to $122.47.
10/17/18
STFL
10/17/18
NO CHANGE
Target $239
STFL
Buy
Stifel confident in approval of Sage Therapeutics' brexanolone ahead of AdComm
Ahead of an FDA advisory committee meeting on Nov 2 to review brexanolone, Stifel analyst Paul Matteis said he is confident in FDA approval and expects the debate on the drug to be centered on labeling, REMS and necessary monitoring requirements. While noting that brexanolone comprises a minority of his Sage valuation, Matteis said the most important thing for the stock is that the panel is both positive and doesn't raise any sort of issue that would read negatively onto SAGE-217, which comprises the majority of his Sage valuation. He maintains a Buy rating and $239 price target on Sage Therapeutics shares.

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