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SAGE

Sage Therapeutics

$156.08

-0.89 (-0.57%)

18:04
03/19/19
03/19
18:04
03/19/19
18:04

FDA approves Sage Therapeutics' Zulresso in PPD treatment

The FDA approved Zulresso or brexanolone injection for intravenous use for the treatment of postpartum depression (PPD) in adult women. This is the first drug approved by the FDA specifically for PPD. Zulresso will be available only through a restricted program called the Zulresso REMS Program that requires the drug be administered by a health care provider in a certified health care facility. The REMS requires that patients be enrolled in the program prior to administration of the drug. Zulresso is administered as a continuous IV infusion over a total of 60 hours. Because of the risk of serious harm due to the sudden loss of consciousness, patients must be monitored for excessive sedation and sudden loss of consciousness and have continuous pulse oximetry monitoring (monitors oxygen levels in the blood). While receiving the infusion, patients must be accompanied during interactions with their child(ren). The need for these steps is addressed in a Boxed Warning in the drug's prescribing information. Patients will be counseled on the risks of Zulresso treatment and instructed that they must be monitored for these effects at a health care facility for the entire 60 hours of infusion. Patients should not drive, operate machinery, or do other dangerous activities until feelings of sleepiness from the treatment have completely gone away. The efficacy of Zulresso was shown in two clinical studies in participants who received a 60-hour continuous intravenous infusion of Zulresso or placebo and were then followed for four weeks. One study included patients with severe PPD and the other included patients with moderate PPD. The primary measure in the study was the mean change from baseline in depressive symptoms as measured by a depression rating scale. In both placebo controlled studies, Zulresso demonstrated superiority to placebo in improvement of depressive symptoms at the end of the first infusion. The improvement in depression was also observed at the end of the 30-day follow-up period. The most common adverse reactions reported by patients treated with Zulresso in clinical trials include sleepiness, dry mouth, loss of consciousness and flushing. Health care providers should consider changing the therapeutic regimen, including discontinuing Zulresso in patients whose PPD becomes worse or who experience emergent suicidal thoughts and behaviors. Reference Link

  • 19

    Mar

SAGE Sage Therapeutics
$156.08

-0.89 (-0.57%)

12/27/18
PIPR
12/27/18
NO CHANGE
Target $206
PIPR
Overweight
Sage's 217 PPD data to be 'important' inflection point in Q1, says Piper Jaffray
Piper Jaffray analyst Danielle Brill told investors in a research note that data from Sage Therapeutics' ongoing trial with 217 in postpartum depression will be an important inflection point for the company in 1Q19 and says she remains bullish ahead of the data. The analyst, who has an Overweight rating and $206 price target on Sage shares, says she is "comfortable" that 217's MOA and PK profiles are very closely related to brex and it should achieve similar anti-depressant effects in the ongoing pivotal PPD trial.
01/07/19
PIPR
01/07/19
NO CHANGE
Target $206
PIPR
Overweight
Sage could be up over 50% folllowing 'clear win' in PPD, says Piper Jaffray
After Sage Therapeutics reported top-line results from the Phase 3 ROBIN study in women with postpartum depression, or PPD, Piper Jaffray analyst Danielle Brill said the data were "impressive and looked clean across the board" in a note titled "Clear Win as SAGE-217 Knocks It Out of the PPD Park." The analyst, who expects over 50% upside for Sage shares today, keeps an Overweight rating on the stock with a $206 price target. In pre-market trading, Sage Therapeutics shares are up $34.49, or 35%, to $132.
02/19/19
PIPR
02/19/19
NO CHANGE
Target $206
PIPR
Overweight
Piper sees 'significant unrealized value' in shares of Sage Therapeutics
Piper Jaffray analyst Danielle Brill keeps an Overweight rating on Sage Therapeutics with a $206 price target after the company reported fiscal 2018 results and an update on its pipeline. Enrollment in the SAGE-217 pivotal Phase 3 major depressive disorder trial is reportedly going well and top-line data are now expected by Q4 of 2019 or Q1 of 2020, Brill tells investors in a post-earnings research note. The analyst sees "significant unrealized value" for SAGE-217 and expects "various upcoming catalysts" to drive Sage shares higher.
02/22/19
GUGG
02/22/19
INITIATION
Target $205
GUGG
Buy
Sage Therapeutics initiated with a Buy at Guggenheim
Guggenheim analyst Yatin Suneja initiated Sage Therapeutics with a Buy rating and $205 price target, as he believes Zulresso and SAGE-217 have generated impressive data in PPD and MDD. The analysts, who thinks those drugs "have the potential to change the treatment paradigm for treating mood disorders," projects Zulresso and SAGE-217 could generate sales in the $3B-$5B range.

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