Breaking News Instant updates and real-time market news.

ENDP

Endo

$3.19

0.29 (10.02%)

07:33
09/30/19
09/30
07:33
09/30/19
07:33

Endo: Successful culmination of litigation regarding FDA compounding policy

Endo announced the successful culmination of two litigation matters before the U.S. District Court for the District of Columbia regarding the unlawful compounding of vasopressin from bulk drug substances. In October 2017, Endo initiated a lawsuit against the U.S. FDA challenging the FDA's interim policy authorizing the bulk compounding of drugs. That policy relied on "enforcement discretion" to allow bulk compounding of vasopressin, the active ingredient in Vasostrict, which is manufactured by Endo's subsidiary Par Sterile Products. Endo's lawsuit alleged that the FDA's interim policy violated Section 503B of the Drug Quality and Security Act and other provisions of the Federal Food, Drug, and Cosmetic Act which allow bulk compounding only if FDA first makes a determination that there is a genuine "clinical need" for compounding from a particular bulk drug substance. Shortly after Endo filed its lawsuit, the FDA began to take significant steps to implement the requirements of the DQSA, and in particular issued proposed guidance regarding the statutory "clinical need" requirement which was consistent with the claims in Endo's Complaint. At FDA's and the Department of Justice's request, Endo stayed its lawsuit to allow FDA time to complete this process. FDA ultimately finalized its new guidance and issued a thorough, well-reasoned administrative decision that bulk compounders of vasopressin competing with Vasostrict could not satisfy the statutory "clinical need" requirement. Soon thereafter, a bulk compounder of vasopressin, Athenex, and two related entities, sued the FDA-also in the U.S. District Court in the District of Columbia-seeking to invalidate the FDA's decision regarding vasopressin. Endo intervened in the Athenex lawsuit to defend the case alongside the FDA and the Department of Justice. The defense was successful, with the Court concluding on August 1, 2019 that the "FDA's exclusion of vasopressin from the 'clinical need' list was not arbitrary and capricious," a decision that "forecloses [Athenex] from selling their product." The Court also denied Athenex's subsequent motion for a stay of its ruling pending appeal. Although Athenex initially appealed the Court's ruling, it recently filed a motion to withdraw that appeal. Given FDA's determination removing bulk compounded vasopressin from the market, and FDA's and Endo's success in the Athenex litigation, Endo has agreed with the FDA and the Department of Justice to voluntarily dismiss without prejudice its initial lawsuit against the FDA. That case has been stayed since February 2019, and Endo has now filed with the Court a stipulation to voluntarily dismiss the suit.

ENDP Endo
$3.19

0.29 (10.02%)

07/15/19
MSCO
07/15/19
DOWNGRADE
Target $3
MSCO
Underweight
Endo downgraded to Underweight from Equal Weight at Morgan Stanley
Morgan Stanley analyst David Risinger downgraded Endo International to Underweight from Equal Weight and cut his price target for the shares to $3 from $8.
07/15/19
MSCO
07/15/19
DOWNGRADE
MSCO
Underweight
Endo, Teva downgraded to Underweight on underappreciated risks at Morgan Stanley
As previously reported, Morgan Stanley analyst David Risinger downgraded Endo International (ENDP) and Teva Pharmaceutical (TEVA), both to Underweight from Equal Weight, cut his price target on Endo shares to $3 from $8 and lowered his price target for Teva shares to $6 from $16. In the wake of Amneal's (AMRX) recent 28% EBITDA guidance cut, Risinger noted that Amneal faces company-specific challenges but also said he is concern about potentially worsening U.S. competitive pricing pressure. He is worried that Endo and Teva both face "underappreciated" risks from buying group pressure being worse than expected, increasing competition among generic manufacturers and the fact that opioid litigation is "just getting started" with thousands of lawsuits having been filed. Risinger also cut his earnings estimates for Mylan (MYL) lowered his price target on its shares to $22 from $32, though he maintains an Overweight rating on that generic drugmaker, citing low valuation and the potential for corporate action. Risinger additionally lowered his price target on Amneal shares to $4 from $12.
07/15/19
07/15/19
DOWNGRADE

Fly Intel: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. Teva (TEVA) and Endo (ENDP) downgraded to Underweight from Equal Weight at Morgan Stanley. 2. Marriott (MAR) downgraded to Neutral from Buy at Longbow with analyst Alton Stump citing valuation. 3. General Electric (GE) downgraded to Neutral from Buy at UBS with analyst Damian Karas saying that a "notable" decline in interest rates and the continued weakness in the power market combine toward a "more balanced" upside with downside. 4. WageWorks (WAGE) downgraded to Hold from Buy at Stifel with analyst David Grossman saying he does not envision a competing takeover offer for the company. 5. L Brands (LB) downgraded to Neutral from Buy at Citi with analyst Paul Lejuez saying his former view on the stock was based on the belief that a Victoria's Secret turnaround could be successful if the brand adopted a more inclusive approach. However, with management slow to implement meaningful change, and "cultural norms shifting away from them," it may be "too little too late" for a meaningful turnaround at Victoria's Secret. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.
09/11/19
GUGG
09/11/19
INITIATION
GUGG
Neutral
Endo assumed with a Neutral at Guggenheim
Guggenheim analyst Dana Flanders assumed coverage of Endo International with a Neutral rating and a $2-$4 fair value range. The analyst noted that the upcoming opioid litigation, which Endo has significant exposure to, will be hard to call, but he estimates $3B-$4B in opioid liability paid out over ten years, and believes the risks are already reflected in the stock.

TODAY'S FREE FLY STORIES

09:50
11/14/19
11/14
09:50
11/14/19
09:50
General news
FX Action: USD-CAD »

FX Action: USD-CAD is…

09:48
11/14/19
11/14
09:48
11/14/19
09:48
Conference/Events
Federal Reserve Bank of St. Louis president speaks at a luncheon »

St. Louis Federal Reserve…

LOGM

LogMeln

$69.25

-0.31 (-0.45%)

09:48
11/14/19
11/14
09:48
11/14/19
09:48
Periodicals
LogMeln on watch with 'occasional activist' already involved, Dealreporter says »

Amid 13F filings coming…

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

  • 19

    Nov

NTAP

NetApp

$59.71

-0.33 (-0.55%)

09:47
11/14/19
11/14
09:47
11/14/19
09:47
Recommendations
NetApp analyst commentary  »

NetApp price target…

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

  • 20

    Nov

  • 12

    Dec

APHA

Aphria

$4.19

-0.27 (-6.05%)

09:47
11/14/19
11/14
09:47
11/14/19
09:47
Hot Stocks
Aphria falls -6.1% »

Aphria is down -6.1%, 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

BZH

Beazer Homes

$13.51

-1.16 (-7.91%)

09:47
11/14/19
11/14
09:47
11/14/19
09:47
Hot Stocks
Beazer Homes falls -7.3% »

Beazer Homes 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

CGC

Canopy Growth

$16.01

-2.51 (-13.55%)

09:47
11/14/19
11/14
09:47
11/14/19
09:47
Hot Stocks
Canopy Growth falls -13.4% »

Canopy Growth 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

  • 14

    Nov

  • 19

    Nov

PING

Ping Identity

$20.26

3.76 (22.79%)

09:47
11/14/19
11/14
09:47
11/14/19
09:47
Hot Stocks
Ping Identity rises 23.2% »

Ping Identity 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

  • 19

    Nov

DDS

Dillard's

$81.00

13.2 (19.47%)

09:47
11/14/19
11/14
09:47
11/14/19
09:47
Hot Stocks
Dillard's rises 19.5% »

Dillard's 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

GFF

Griffon

$25.45

3.73 (17.17%)

09:47
11/14/19
11/14
09:47
11/14/19
09:47
Hot Stocks
Griffon rises 15.3% »

Griffon is up 15.3%, 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

09:47
11/14/19
11/14
09:47
11/14/19
09:47
Conference/Events
Federal Reserve Bank of Dallas president delivers opening remarks at a forum »

Dallas Federal Reserve…

BLMN

Bloomin' Brands

$23.20

0.01 (0.04%)

, INST

Instructure

$50.46

(0.00%)

09:45
11/14/19
11/14
09:45
11/14/19
09:45
Hot Stocks
Jana added Bloomin' Brands and Instructure during Q3, sold Falcon Minerals »

Barry Rosenstein's…

BLMN

Bloomin' Brands

$23.20

0.01 (0.04%)

INST

Instructure

$50.46

(0.00%)

FLMN

Falcon Minerals

$6.37

(0.00%)

SPY

SPDR S&P 500 ETF Trust

$308.73

-0.35 (-0.11%)

ZBH

Zimmer Biomet

$144.50

(0.00%)

AXTA

Axalta Coating

$29.58

-0.07 (-0.24%)

HDS

HD Supply

$40.47

(0.00%)

JACK

Jack in the Box

$84.98

0.48 (0.57%)

CAG

Conagra Brands

$28.26

-0.06 (-0.21%)

ELY

Callaway Golf

$20.50

-0.11 (-0.53%)

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

  • 21

    Nov

  • 03

    Dec

  • 09

    Dec

09:45
11/14/19
11/14
09:45
11/14/19
09:45
Conference/Events
Federal Reserve Bank of San Francisco president delivers opening remarks »

San Francisco Federal…

09:45
11/14/19
11/14
09:45
11/14/19
09:45
General news
Breaking General news story  »

Federal Reserve Chairman…

09:45
11/14/19
11/14
09:45
11/14/19
09:45
General news
Breaking General news story  »

Federal Reserve Chairman…

AAL

American Airlines

$28.65

(0.00%)

09:44
11/14/19
11/14
09:44
11/14/19
09:44
Conference/Events
The Wings Club to hold a luncheon meeting »

The Wings Club of New…

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

09:43
11/14/19
11/14
09:43
11/14/19
09:43
Conference/Events
House Committee on the Budget »

The Committee holds a…

CIR

Circor

$41.86

(0.00%)

09:43
11/14/19
11/14
09:43
11/14/19
09:43
Conference/Events
Circor management to meet with Sidoti »

Meeting to be held 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

  • 19

    Nov

EPD

Enterprise Products

$26.50

(0.00%)

, KMI

Kinder Morgan

$20.35

(0.00%)

09:42
11/14/19
11/14
09:42
11/14/19
09:42
Conference/Events
Wolfe Research to hold a tour »

Houston Midstream Bus…

EPD

Enterprise Products

$26.50

(0.00%)

KMI

Kinder Morgan

$20.35

(0.00%)

PAA

Plains All American

$17.48

(0.00%)

RBN

Robbins & Myers

$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

  • 14

    Nov

  • 04

    Feb

CSGS

CSG

$56.29

(0.00%)

09:42
11/14/19
11/14
09:42
11/14/19
09:42
Conference/Events
CSG management to meet with Sidoti »

Meeting to be held 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

  • 19

    Nov

MTSI

Macom

$26.47

(0.00%)

09:41
11/14/19
11/14
09:41
11/14/19
09:41
Recommendations
Macom analyst commentary  »

Macom price target raised…

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

  • 09

    Dec

HCSG

Healthcare Services

$24.88

(0.00%)

09:41
11/14/19
11/14
09:41
11/14/19
09:41
Conference/Events
Healthcare Services management to meet with Sidoti »

Meeting to be held 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

  • 19

    Nov

WYND

Wyndham Destinations

$47.24

(0.00%)

, WYNN

Wynn Resorts

$118.86

(0.00%)

09:41
11/14/19
11/14
09:41
11/14/19
09:41
Conference/Events
Deutsche Bank to hold a conference »

Gaming, Lodging, Leisure…

WYND

Wyndham Destinations

$47.24

(0.00%)

WYNN

Wynn Resorts

$118.86

(0.00%)

WH

Wyndham Hotels & Resorts

$54.13

(0.00%)

WYN

Wyndham

$0.00

(0.00%)

VICI

VICI Properties

$24.34

(0.00%)

TH

Target Hospitality

$4.70

(0.00%)

INN

Summit Hotel Properties

$11.75

0.18 (1.56%)

SGMS

Scientific Games

$30.70

(0.00%)

RHP

Ryman Hospitality

$87.20

(0.00%)

RRR

Red Rock Resorts

$21.30

(0.00%)

RCL

Royal Caribbean

$114.81

(0.00%)

VAC

Marriott Vacations

$117.19

(0.00%)

MGM

MGM Resorts

$31.04

(0.00%)

NCLH

Norwegian Cruise Line

$52.11

(0.00%)

PENN

Penn National

$21.97

(0.00%)

AGS

PlayAGS

$11.66

(0.00%)

LVS

Las Vegas Sands

$62.15

(0.00%)

HLT

Hilton

$97.79

(0.00%)

GDEN

Golden Entertainment

$17.00

(0.00%)

GLPI

Gaming and Leisure Properties

$42.48

(0.00%)

FLL

Full House Resorts

$2.96

(0.00%)

STAY

Extended Stay America

$14.57

(0.00%)

ERI

Eldorado Resorts

$50.80

(0.00%)

DIN

Dine Brands

$79.06

(0.00%)

CPLG

CorePoint Lodging

$9.83

(0.00%)

CLDT

Chatham Lodging

$17.59

(0.00%)

FUN

Cedar Fair

$56.92

(0.00%)

BYD

Boyd Gaming

$29.05

(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

  • 14

    Nov

  • 18

    Nov

  • 02

    Dec

  • 05

    Dec

  • 09

    Dec

SKYW

SkyWest

$63.17

(0.00%)

09:40
11/14/19
11/14
09:40
11/14/19
09:40
Conference/Events
SkyWest management to meet with Sidoti »

Meeting to be held in New…

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

  • 19

    Nov

FCEL

FuelCell

$0.81

(0.00%)

, DIS

Disney

$148.69

(0.00%)

09:40
11/14/19
11/14
09:40
11/14/19
09:40
Options
Unusually active option classes on open November 14th »

Unusual total active…

FCEL

FuelCell

$0.81

(0.00%)

DIS

Disney

$148.69

(0.00%)

TSM

TSMC

$52.88

(0.00%)

TGT

Target

$108.57

(0.00%)

MRVL

Marvell

$28.11

(0.00%)

AVGO

Broadcom

$313.53

(0.00%)

KHC

Kraft Heinz

$32.89

(0.00%)

BYND

Beyond Meat

$78.98

(0.00%)

COST

Costco

$302.79

(0.00%)

M

Macy's

$16.06

(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

  • 20

    Nov

  • 21

    Nov

  • 03

    Dec

  • 12

    Dec

  • 12

    Dec

  • 13

    Dec

  • 06

    Jan

  • 14

    Jan

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.