Breaking News Instant updates and real-time market news.

AMAG

Amag Pharmaceuticals

$11.39

0.23 (2.06%)

08:06
10/11/19
10/11
08:06
10/11/19
08:06

Amag Pharmaceuticals announces publication of Phase 3 Vyleesi data

AMAG Pharmaceuticals announced that the data from its two pivotal, double-blind placebo-controlled Phase 3 trials and its voluntary open-label one year extension studies were published in Obstetrics & Gynecology. These publications are currently available online and will appear in the November print issue. In both randomized placebo-controlled clinical trials, Vyleesi met the pre-specified co-primary efficacy endpoints of improvement in desire and reduction in associated distress as measured by validated patient-reported outcome instruments. These endpoints are the hallmark symptoms of hypoactive sexual desire disorder. The RECONNECT data from approximately 1,200 women was the basis for the June 2019 U.S. Food and Drug Administration approval of Vyleesi, the first and only as-needed treatment for premenopausal women with acquired, generalized HSDD. While patients were still blinded to their treatment assignment, they were asked via a validated, questionnaire, "Compared to the start of the study to what degree do you think you have benefited from treatment?" Nearly 60 percent of patients taking Vyleesi reported feeling "better" to "very much better" compared to 36 percent of patients in the placebo group. Among those who completed the placebo-controlled, double blind portion of the study, approximately 80 percent of those women chose to continue to the voluntary open-label extension phase where all patients received study drug. Data from this 52-week open-label extension showed sustained efficacy for patients who had received study drug in the initial study and no new safety signals were observed. Additionally, patients who began taking study drug during the extension phase for the first time showed similar improvements in desire and reductions in associated distress to those seen during the randomized portion of the study in patients treated with study drug. In the pivotal trials, the most common adverse events were nausea, flushing, injection site reactions, headache and vomiting. The majority of events were reported to be transient and mild-to-moderate in intensity. In the clinical trials, Vyleesi caused small, transient increases in blood pressure, and is contraindicated in women with uncontrolled high blood pressure or known cardiovascular disease.

  • 29

    Oct

AMAG Amag Pharmaceuticals
$11.39

0.23 (2.06%)

08/01/19
HCWC
08/01/19
INITIATION
Target $16
HCWC
Buy
Amag Pharmaceuticals initiated with a Buy at H.C. Wainwright
H.C. Wainwright analyst Douglas Tsao started Amag Pharmaceuticals with a Buy rating and $16 price target. The company's valuation is "now compelling with new opportunities approaching," Tsao tells investors in a research note. With FDA approval for Vyleesi now in hand and ciraparantag entering Phase 3, Amag has two assets that the company can build upon the base provided by the Makena autoinjector and Feraheme, says the analyst.
08/01/19
08/01/19
INITIATION

Fly Intel: Top analyst initiations
Catch up on today's top analyst initiations with this list compiled by The Fly: 1. AMD (AMD) and Maxim Integrated (MXIM) initiated with a Hold at Benchmark. 2. Amag Pharmaceuticals (AMAG) and Cassava Sciences (SAVA) initiated with a Buy at H.C. Wainwright. 3. Crispr Therapeutics (CRSP) initiated with a Buy at Jefferies. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
08/07/19
NEED
08/07/19
NO CHANGE
NEED
Hold
Amag 'story took some significant hits' in second quarter, says Needham
After Amag Pharmaceuticals reported lower than expected revenue in Q2 and cut its FY19 revenue guidance, Needham analyst Serge Belanger said the "story took some significant hits," pointing to Makena IM supply issues, partner Prasco discontinuing the authorized generic product, the company's development partner for ciraparantag terminating its collaboration agreement and news that the FDA is convening an Advisory Committee in Q4 to discuss the PROLONG trial. The analyst, who thinks concerns about Makena's future have worsened since the Q1 update, keeps a Hold rating on Amag shares.
08/07/19
PIPR
08/07/19
NO CHANGE
PIPR
Piper Jaffray lowers price target, remains Neutral on Amag Pharmaceuticals
Piper Jaffray analyst Christopher Raymond maintained a Neutral rating on Amag Pharmaceuticals and lowered his price target on shares to $9 from $13 after the company's Q2 earnings miss and lowered FY19 guidance. Raymond said he prefers to stay on the sidelines considering his skepticism about the Vyleesi launch. While the drug was recently approved, the analyst noted that its inconvenient dosing, which requires an injection 45 mintutes before sex, and ~40% nausea rate make it difficult to anticipate "substantial commercial uptake."

TODAY'S FREE FLY STORIES

VZ

Verizon

$60.11

-0.44 (-0.73%)

, CMCSA

Comcast

$45.42

-0.25 (-0.55%)

10:21
10/16/19
10/16
10:21
10/16/19
10:21
Initiation
Fly Intel: Top five analyst initiations »

Catch up on today's…

VZ

Verizon

$60.11

-0.44 (-0.73%)

CMCSA

Comcast

$45.42

-0.25 (-0.55%)

T

AT&T

$37.95

0.045 (0.12%)

INOV

Inovalon

$15.19

0.145 (0.96%)

ASMB

Assembly Biosciences

$10.95

1.65 (17.74%)

CDXC

ChromaDex

$3.19

0.19 (6.33%)

AXSM

Axsome Therapeutics

$20.68

0.03 (0.15%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 22

    Oct

  • 24

    Oct

  • 25

    Oct

  • 26

    Oct

  • 27

    Oct

  • 28

    Oct

  • 29

    Oct

  • 29

    Oct

  • 30

    Oct

  • 30

    Oct

  • 19

    Nov

ADBE

Adobe

$267.83

-11.57 (-4.14%)

, AYI

Acuity Brands

$122.30

-2.51 (-2.01%)

10:20
10/16/19
10/16
10:20
10/16/19
10:20
Downgrade
Fly Intel: Top five analyst downgrades »

Catch up on today's…

ADBE

Adobe

$267.83

-11.57 (-4.14%)

AYI

Acuity Brands

$122.30

-2.51 (-2.01%)

COST

Costco

$296.18

-2.24 (-0.75%)

NOW

ServiceNow

$251.66

-22.94 (-8.35%)

XOG

Extraction Oil & Gas

$2.47

-0.18 (-6.79%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 23

    Oct

  • 23

    Oct

  • 27

    Oct

  • 29

    Oct

  • 04

    Nov

  • 07

    Nov

  • 12

    Dec

JNJ

Johnson & Johnson

$135.77

2.93 (2.21%)

, FMC

FMC Corporation

$84.39

1.33 (1.60%)

10:20
10/16/19
10/16
10:20
10/16/19
10:20
Upgrade
Fly Intel: Top five analyst upgrades »

Catch up on today's…

JNJ

Johnson & Johnson

$135.77

2.93 (2.21%)

FMC

FMC Corporation

$84.39

1.33 (1.60%)

PSTG

Pure Storage

$17.92

0.27 (1.53%)

PDFS

PDF Solutions

$14.29

1.08 (8.18%)

BLDR

Builders FirstSource

$22.13

0.59 (2.74%)

BMCH

BMC Stock Holdings

$26.94

0.79 (3.02%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 30

    Oct

  • 01

    Nov

  • 05

    Nov

  • 13

    Nov

  • 14

    Nov

  • 12

    Dec

  • 17

    Dec

WE

We Company

$0.00

(0.00%)

, SFTBF

SoftBank

$0.00

(0.00%)

10:20
10/16/19
10/16
10:20
10/16/19
10:20
Periodicals
SoftBank to give We Company $5B financing, won't take majority stake, NAR says »

SoftBank Group (SFTBF)…

WE

We Company

$0.00

(0.00%)

SFTBF

SoftBank

$0.00

(0.00%)

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

CRLBF

Cresco Labs

$0.00

(0.00%)

10:18
10/16/19
10/16
10:18
10/16/19
10:18
Hot Stocks
Cresco Labs receives adult-use approval for all five Illinois dispensaries »

Cresco Labs announced…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 14

    Nov

$NSD

NASDAQ Market Internals

$0.00

(0.00%)

10:17
10/16/19
10/16
10:17
10/16/19
10:17
Technical Analysis
NASDAQ market internals summary »

Volume is average for…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

$NYE

NYSE Market Internals

$0.00

(0.00%)

10:16
10/16/19
10/16
10:16
10/16/19
10:16
Technical Analysis
NYSE market internals summary »

Volume is average for…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

WORK

Slack Technologies

$22.90

-1.84 (-7.44%)

10:15
10/16/19
10/16
10:15
10/16/19
10:15
Options
Slack put volume heavy and directionally bearish »

Bearish flow noted in…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

10:15
10/16/19
10/16
10:15
10/16/19
10:15
General news
U.S. NAHB housing market index jumped 3 points to 71 in October »

U.S. NAHB housing market…

10:15
10/16/19
10/16
10:15
10/16/19
10:15
General news
U.S. business inventories were unchanged in August, with sales up 0.2% »

U.S. business inventories…

MKGAF

Merck KGaA

$0.00

(0.00%)

10:13
10/16/19
10/16
10:13
10/16/19
10:13
Conference/Events
Merck KGaA participates in a conference call with JPMorgan »

European Pharmaceuticals…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

10:10
10/16/19
10/16
10:10
10/16/19
10:10
General news
FX Action: The dollar »

FX Action: The dollar was…

10:07
10/16/19
10/16
10:07
10/16/19
10:07
General news
Atlanta Fed Business Inflation Expectations Bus Infl Exp % Yr/Yr data reported »

October Atlanta Fed…

APLS

Apellis

$28.15

1.71 (6.47%)

10:06
10/16/19
10/16
10:06
10/16/19
10:06
Conference/Events
Apellis participates in a conference call with JPMorgan »

SMid Biotechnology…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 17

    Oct

AEP

American Electric

$91.59

-0.14 (-0.15%)

10:06
10/16/19
10/16
10:06
10/16/19
10:06
Hot Stocks
American Electric names Julius Cox SVP, chief human resources officer »

American Electric Power…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 24

    Oct

  • 10

    Nov

  • 12

    Nov

AEO

American Eagle

$15.07

0.115 (0.77%)

10:05
10/16/19
10/16
10:05
10/16/19
10:05
Hot Stocks
American Eagle to hire roughly 10,000 part-time seasonal brand ambassadors »

American Eagle Outfitters…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

10:02
10/16/19
10/16
10:02
10/16/19
10:02
General news
Business Inventories data reported »

August Business…

10:02
10/16/19
10/16
10:02
10/16/19
10:02
General news
Housing Market Index data reported »

October Housing Market…

VRRM

Verra Mobility

$13.89

-0.14 (-1.00%)

10:01
10/16/19
10/16
10:01
10/16/19
10:01
Hot Stocks
Verra Mobility to acquire Pagatelia, terms not disclosed »

Verra Mobility announced…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 06

    Nov

  • 07

    Nov

  • 13

    Nov

  • 14

    Nov

TIGR

UP Fintech

$3.90

-0.16 (-3.94%)

10:00
10/16/19
10/16
10:00
10/16/19
10:00
Periodicals
UP Fintech accused by GeoInvesting of 'illegal money laundering scheme' »

GeoInvesting has…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

MERC

Mercer

$11.20

0.03 (0.27%)

10:00
10/16/19
10/16
10:00
10/16/19
10:00
Conference/Events
Mercer participates in a conference call with JPMorgan »

LatAm Pulp & Paper…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

AYX

Alteryx

$104.75

-7.58 (-6.75%)

10:00
10/16/19
10/16
10:00
10/16/19
10:00
Hot Stocks
Alteryx falls -6.8% »

Alteryx is down -6.8%, or…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 31

    Oct

  • 06

    Nov

CPS

Cooper-Standard

$33.60

-2.77 (-7.62%)

10:00
10/16/19
10/16
10:00
10/16/19
10:00
Hot Stocks
Cooper-Standard falls -7.7% »

Cooper-Standard is down…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

AVD

American Vanguard

$13.50

-1.76 (-11.53%)

10:00
10/16/19
10/16
10:00
10/16/19
10:00
Hot Stocks
American Vanguard falls -12.2% »

American Vanguard is down…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

  • 05

    Nov

  • 19

    Nov

  • 20

    Nov

OMI

Owens & Minor

$6.85

0.42 (6.53%)

10:00
10/16/19
10/16
10:00
10/16/19
10:00
Hot Stocks
Owens & Minor rises 6.2% »

Owens & Minor is up…

03/08/13
Wedge Partners
03/08/13
Credit Suisse
03/06/13
Citigroup
03/06/13
Barclays

See Street Research during your Free Trial

Get Full Fly Access

Breaking market intelligence sent straight to you
Our team of experts analyze every news story and filter out the noise to deliver real-time market moving news.
Up-to-date information on important industry events
Get real-time updates on events that are moving the market—from conferences and calls to syndicate announcements.
News focused on the companies in your portfolio
Create up to 12 portfolios with 150 stocks each, and see how active they are in market news.