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CPRX

Catalyst Pharmaceuticals

$3.85

0.18 (4.90%)

07:35
06/14/19
06/14
07:35
06/14/19
07:35

Cantor reiterates Overweight on Catalyst Pharmaceuticals after FDA lawsuit

Cantor Fitzgerald analyst Charles Duncan reiterates an Overweight rating on Catalyst Pharmaceuticals with a $10 price target after the company filed a lawsuit against the FDA challenging the recent approval of Jacobus' Ruzurgi. The approval of Ruzurgi appears to ignore the reasoning behind the Orphan Drug Act and its potential to drive innovation for future therapies, Duncan tells investors in a research note. Ruzurgi is, on the surface, priced lower than Catalyst's Firdapse, at $175,000 per year versus $375,000 per year, the analyst points out. However, if only used for the pediatric indication, Ruzurgi would be unlikely to significantly infringe on Firdapse's market share, says Duncan, who estimates the pediatric population consists of less than 5 % of the prevalent Lambert-Eaton myasthenic sydrome population. The potential concern stems from Jacobus' marketing the drug for off-label use and physicians prescribing the drug off-label to adult LEMS patients, due to lower direct drug pricing, the analyst adds. "Clearly, someone at the FDA must have conducted this calculus and, in our opinion, ignored the purpose and meaning of the Act," says Duncan.

CPRX Catalyst Pharmaceuticals
$3.85

0.18 (4.90%)

05/06/19
PIPR
05/06/19
NO CHANGE
Target $7.5
PIPR
Overweight
Ruzurgi approval to pressure Catalyst Pharmaceuticals, says Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro kept his Overweight rating and $7.50 price target on Catalyst Pharmaceuticals but warned that the stock could come under pressure after the FDA's "unexpected" approval of Jacobus' amifampridine, or Ruzurgi, for the treatment of pediatric LEMS patients. Shares of Catalyst Pharmaceuticals were down over 41% after hours, and the analyst expressed uncertainty over whether the company's Firdapse would be able to maintain the orphan drug price point set at launch. Catanzaro expects the management of Catalyst Pharmaceuticals to comment on the development.
05/07/19
CANT
05/07/19
NO CHANGE
Target $10
CANT
Overweight
Jacobus approval should not impact Catalyst's Firdapse, says Cantor Fitzgerald
The FDA last night approved private company Jacobus' Ruzurgi for the treatment of Lambert-Eaton myasthenic syndrome in patients six to less than 17 years of age, Cantor Fitzgerald analyst Charles Duncan tells investors in a research note. This is the first drug approved for pediatric LEMS, the analyst points out. Catalyst Pharmaceuticals' slightly different salt form of amifampridine, marketed as Firdapse, was the first drug approved for LEMS, but for adults only, he notes. The analyst does not see the approval of Ruzurgi as having a large impact in Firdapse's market potential. He estimates that the pediatric population consists of less than 5% of the prevalent LEMS population. Duncan reiterates an Overweight rating on Catalyst shares with a $10 price target.
05/13/19
PIPR
05/13/19
NO CHANGE
Target $7.5
PIPR
Overweight
Piper says Catalyst's 'impressive' Firdapse sales clouded by Jacobus uncertainty
Piper Jaffray analyst Joseph Catanzaro raised his 2019 Firdapse estimates after the "impressive" results reported by Catalyst Pharmaceuticals in the first quarter of sales for the drug, but he also noted that the recent unexpected approval of Jacobus' Ruzurgi for the treatment of pediatric patients with LEMS puts his Firdapse estimates at risk. While acknowledging the potential implications of a Ruzurgi launch, the analyst raised his FY19 Firdapse sales estimate to $72.5M from $41.0M. Catalyst management said they expects Firdapse revenue to "substantially increase" in Q2 over Q1, but would not give 2019 guidance due to last week's news about Ruzurgi, noted Catanzaro, who keeps an Overweight rating and $7.50 price target on Catalyst shares.
06/12/19
PIPR
06/12/19
NO CHANGE
Target $7.5
PIPR
Overweight
Catalyst accuses FDA of 'playing favorites' in lawsuit, says Piper Jaffray
Piper Jaffray analyst Joseph Catanzaro maintained an Overweight rating and $7.50 price target on Catalyst Pharmaceuticals after the company filed a lawsuit against the FDA in relation to the approval of Jacobus' Ruzurgi for the treatment of pediatric LEMS. In a research note to investors, Catanzaro says the suit calls out Ruzurgi's labeling, specifically highlighting that all efficacy data supporting the drug's pediatric approval appears to have been generated in adult patients, and accuses the FDA of "playing favorites" because of pricing considerations. The analyst tells investors that he thinks establishing a precedent that finds Ruzurgi's approval acceptable could nullify many of the incentives in the orphan drug act to develop drugs for orphan indications with unmet need.

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GrubHub

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AmerisourceBergen

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Cardinal Health

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McKesson

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RTN

Raytheon

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United Technologies

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Raytheon

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United Technologies

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GRUB

GrubHub

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Amazon.com

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GrubHub

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Amazon.com

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GOOGL

Alphabet Class A

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Alphabet Class A

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FB

Facebook

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McDonald's

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JPMorgan

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Bank of America

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BlackRock

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Blackstone

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AVGO

Broadcom

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Apple

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Raytheon

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TLRY

Tilray

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APHA

Aphria

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ACB

Aurora Cannabis

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Cronos Group

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General Cannabis

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MediPharm Labs

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Zynerba

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AbbVie

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Abiomed

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AbbVie

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Abiomed

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Bristol-Myers

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Celgene

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Eli Lilly

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Johnson & Johnson

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Novartis

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Pfizer

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Procter & Gamble

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Sanofi

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Unilever; also tag UN

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BMY

Bristol-Myers

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GlaxoSmithKline

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Bristol-Myers

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GlaxoSmithKline

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Pfizer

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Eli Lilly

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AbbVie

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Novartis

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Roche

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Biogen

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Amgen

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Sanofi

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Celgene

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Gilead

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Regeneron

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ABT

Abbott

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Amgen

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Abbott

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AMGN

Amgen

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BSX

Boston Scientific

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PFE

Pfizer

$42.75

0.24 (0.56%)

CRY

CryoLife

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EW

Edwards Lifesciences

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ELGX

Endologix

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0.2 (2.70%)

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IAC

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HCA

HCA Healthcare

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LeMaitre

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Organogenesis

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0.02 (0.27%)

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Osiris

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Penumbra

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2.93 (1.79%)

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ShockWave Medical

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Wolters Kluwer

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AbbVie

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Incyte

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AbbVie

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INCY

Incyte

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ARQL

ArQule

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Amgen

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ALXN

Alexion

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AGIO

Agios Pharmaceuticals

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AZN

AstraZeneca

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BLUE

Bluebird Bio

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BMY

Bristol-Myers

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CELG

Celgene

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Novartis

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NanoString

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Karyopharm

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Jazz Pharmaceuticals

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GlaxoSmithKline

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GILD

Gilead

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DSNKY

Daiichi Sankyo

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PFE

Pfizer

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PTLA

Portola Pharmaceuticals

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QGEN

Qiagen

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RHHBY

Roche

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RIGL

Rigel Pharmaceuticals

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SNY

Sanofi

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SGEN

Seattle Genetics

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STML

Stemline

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VSTM

Verastem

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CNC

Centene

$53.52

-0.26 (-0.48%)

, WCG

WellCare

$287.16

0.145 (0.05%)

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Centene CEO: Medicare for all will not work »

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CNC

Centene

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WCG

WellCare

$287.16

0.145 (0.05%)

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HMC

Honda

$25.34

-0.405 (-1.57%)

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Honda recalls all 2016-2019 model year Pioneer vehicles »

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RH

RH

$111.28

1.42 (1.29%)

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RH CEO: We think our stock is massively undervalued »

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DISH

Dish

$37.54

-0.35 (-0.92%)

, S

Sprint

$7.01

0.2 (2.94%)

18:08
06/14/19
06/14
18:08
06/14/19
18:08
Periodicals
Dish leads bidding for Sprint, T-Mobile assets, WSJ reports »

Dish Network (DISH) is…

DISH

Dish

$37.54

-0.35 (-0.92%)

S

Sprint

$7.01

0.2 (2.94%)

TMUS

T-Mobile

$74.90

0.44 (0.59%)

CHTR

Charter

$392.20

2.76 (0.71%)

ATUS

Altice USA

$23.82

0.15 (0.63%)

03/08/13
Wedge Partners
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AAL

American Airlines

$32.69

-0.39 (-1.18%)

17:31
06/14/19
06/14
17:31
06/14/19
17:31
Periodicals
American Air asks court to end 'devastating' work slowdown, Bloomberg says »

American Airlines urged a…

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ROLL

RBC Bearings

$150.43

-3.38 (-2.20%)

17:16
06/14/19
06/14
17:16
06/14/19
17:16
Hot Stocks
RBC Bearings CEO sells over 5,000 common shares »

In a regulatory filing,…

03/08/13
Wedge Partners
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FTNW

FTE Networks

$1.25

(0.00%)

17:14
06/14/19
06/14
17:14
06/14/19
17:14
Hot Stocks
FTE Networks granted financial viability exception by NYSE regulation »

FTE Networks announced…

03/08/13
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BA

Boeing

$347.19

-1.54 (-0.44%)

17:14
06/14/19
06/14
17:14
06/14/19
17:14
Hot Stocks
Boeing awarded Air Force contract modification, increases ceiling by $6.53B »

Boeing has been awarded a…

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  • 17

    Jun

  • 09

    Jul

MDR

McDermott

$7.60

-0.12 (-1.55%)

17:11
06/14/19
06/14
17:11
06/14/19
17:11
Hot Stocks
Chatterjee Fund Management reports 5.6% passive stake in McDermott »

In a regulatory filing,…

03/08/13
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PZZA

Papa John's

$50.74

0.28 (0.55%)

17:09
06/14/19
06/14
17:09
06/14/19
17:09
Hot Stocks
Papa John's dismisses KPMG as auditors, hires Ernst & Young »

In a regulatory filing,…

03/08/13
Wedge Partners
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Citigroup
03/06/13
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  • 17

    Jun

  • 20

    Jun

  • 20

    Jun

  • 13

    Nov

EPZM

Epizyme

$11.62

-0.36 (-3.01%)

16:55
06/14/19
06/14
16:55
06/14/19
16:55
Conference/Events
Epizyme to hold a conference call »

Conference call to…

03/08/13
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  • 21

    Jun

CACI

CACI

$202.80

-1.205 (-0.59%)

16:54
06/14/19
06/14
16:54
06/14/19
16:54
Conference/Events
CACI to hold a conference call »

Management holds a fiscal…

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  • 20

    Jun

HCR

Hi-Crush Inc.

$2.84

0.115 (4.22%)

16:53
06/14/19
06/14
16:53
06/14/19
16:53
Syndicate
Hi-Crush Inc files $1B mixed securities shelf »

The company also files to…

03/08/13
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SHIP

Seanergy Marine

$0.63

-0.0381 (-5.70%)

16:51
06/14/19
06/14
16:51
06/14/19
16:51
Earnings
Seanergy Marine reports Q1 EPS ($3.23), two estimates ($2.85) »

Reports Q1 revenue…

03/08/13
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