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VRTX

Vertex

$174.07

-3.9 (-2.19%)

08:09
07/22/19
07/22
08:09
07/22/19
08:09

Vertex submits VX-445 NDA to FDA

Vertex announced the submission of a new drug application, or NDA, to the FDA for the VX-445, tezacaftor and ivacaftor triple combination regimen. The NDA includes a request for priority review, which, if granted, would shorten the FDA's review of the NDA to eight months from the time of submission, versus a standard review timeline of 12 months from submission. The submission is supported by previously disclosed positive results of two global Phase 3 studies: a 24-week Phase 3 study in people with one F508del mutation and one minimal function mutation and a 4-week Phase 3 study in people with two F508del mutations. Both Phase 3 studies showed statistically significant improvements in lung function, which was the primary endpoint, and in all key secondary endpoints. In these studies, the triple combination regimen was generally well tolerated.

  • 31

    Jul

  • 09

    Sep

VRTX Vertex
$174.07

-3.9 (-2.19%)

05/30/19
PIPR
05/30/19
NO CHANGE
Target $217
PIPR
Overweight
Vertex approval will enable it to treat up to 90% of CF patients, says Piper
Piper Jaffray analyst Edward Tenthoff reiterated an Overweight rating and $217 price target on Vertex after the company selected VX-445 + Symdeko for a new drug application filing in the third quarter in homozygous F508del and heterozygous F508del with minimal function mutation cystic fibrosis patients. In a research note to investors, Tenthoff says the decision to file for VX-445 appears t o be based on overall cleaner safety profile through 24 weeks, and adds that the highly anticipated approval will enable Vertex to treat up to 90% of CF patients. He sees total CF sales growing to $4.51B in 2020 from $3.52B this year.
06/06/19
PIPR
06/06/19
NO CHANGE
Target $20
PIPR
Overweight
New Eloxx data 'bode well' for ELX-02 in Cystic Fibrosis, says Piper Jaffray
After Eloxx Pharmaceuticals (ELOX) presented new data in two oral presentations and one poster at the European Cystic Fibrosis Society Conference, Piper Jaffray analyst Edward Tenthoff said the new ELX-02 data "bode well" for the clinical start of ELX-02 in Cystic Fibrosis. ELX-02 may be able to treat the 10% of CF patients with nonsense mutations currently not addressed by Vertex (VRTX), said Tenthoff, who keeps an Overweight rating and $20 price target on Eloxx shares. In afternoon trading, Eloxx is up 13.5% to $10.02.
06/07/19
PIPR
06/07/19
NO CHANGE
Target $100
PIPR
Overweight
Crispr Therapeutics price target raised to $100 from $75 at Piper Jaffray
Crispr Therapeutics (CRSP) and Vertex (VRTX) expanded their alliance to develop gene editing medicines to treat Duchenne muscular dystrophy and myotonic dystrophy type 1 with Crispr receiving $175M in cash up front and being eligible for $1B in milestones plus tiered royalties, Piper Jaffray analyst Edward Tenthoff tells investors in a research note. Crispr is also advancing a wholly-owned pipeline of allogeneic gene edited CAR-Ts, adds the analyst. He estimates the company now holds pro forma cash of $631M and says it remains a top pick for 2019. Tenthoff boosted his price target for the shares to $100 from $75 and reiterates an Overweight rating on the name. Crispr Therapeutics in premarket trading is up 9% to $40.69.
06/07/19
WELS
06/07/19
NO CHANGE
Target $65
WELS
Outperform
Crispr's expanded Vertex deal validates gene editing platform, says Wells Fargo
Wells Fargo analyst Jim Birchenough reiterated an Outperform rating and $65 price target on Crispr Therapeutics (CRSP) after the company announced an expanded alliance with Vertex (VRTX) to develop gene editing medicines to treat Duchenne muscular dystrophy and myotonic dystrophy type 1. In a research note to investors, Birchenough says he views the expanded collaboration as validating Crispr's CRISPR/CAS9 gene editing platform, providing a meaningful non-dilutive source of capital and future longer-term funding and with significant upside potential in DMD and DM1.

TODAY'S FREE FLY STORIES

ORCL

Oracle

$52.22

-0.65 (-1.23%)

, BOX

Box

$17.23

-0.54 (-3.04%)

14:07
09/18/19
09/18
14:07
09/18/19
14:07
Hot Stocks
Oracle announces collaboration with Box at Openworld »

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ORCL

Oracle

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BOX

Box

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-0.54 (-3.04%)

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SPX

S&P 500

$0.00

(0.00%)

, SPY

SPDR S&P 500 ETF Trust

$299.98

-0.96 (-0.32%)

14:05
09/18/19
09/18
14:05
09/18/19
14:05
General news
Three Fed members voted against today's 25 point cut »

Voting for the…

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S&P 500

$0.00

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SPDR S&P 500 ETF Trust

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SPDR S&P 500 ETF Trust

$300.00

-0.94 (-0.31%)

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S&P 500

$0.00

(0.00%)

14:04
09/18/19
09/18
14:04
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14:04
General news
Fed projections see 1.9% Federal funds rate to end year »

The economic projections…

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SPDR S&P 500 ETF Trust

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S&P 500

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SPDR S&P 500 ETF Trust

$299.94

-1 (-0.33%)

14:02
09/18/19
09/18
14:02
09/18/19
14:02
General news
Fed says economic activity rising at 'moderate rate' »

The Federal Reserve said…

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S&P 500

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14:02
09/18/19
09/18
14:02
09/18/19
14:02
General news
FOMC Meeting Announcement Federal Funds Rate data reported »

FOMC Meeting Announcement…

SPX

S&P 500

$0.00

(0.00%)

, SPY

SPDR S&P 500 ETF Trust

$299.93

-1.01 (-0.34%)

14:01
09/18/19
09/18
14:01
09/18/19
14:01
General news
Fed says 'uncertainties' remain in 2% inflation outlook »

The Federal Reserve says…

SPX

S&P 500

$0.00

(0.00%)

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SPDR S&P 500 ETF Trust

$299.93

-1.01 (-0.34%)

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SPX

S&P 500

$0.00

(0.00%)

, SPY

SPDR S&P 500 ETF Trust

$299.98

-0.96 (-0.32%)

14:00
09/18/19
09/18
14:00
09/18/19
14:00
General news
Breaking General news story on S&P 500, SPDR S&P 500 ETF Trust »

Federal Reserve cuts…

SPX

S&P 500

$0.00

(0.00%)

SPY

SPDR S&P 500 ETF Trust

$299.98

-0.96 (-0.32%)

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MDR

McDermott

$3.00

-2.88 (-48.98%)

13:58
09/18/19
09/18
13:58
09/18/19
13:58
Hot Stocks
McDermott off lows after resuming, still down 44% »

Shares of McDermott (MDR)…

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  • 23

    Sep

CYRX

Cryoport

$17.77

0.02 (0.11%)

13:56
09/18/19
09/18
13:56
09/18/19
13:56
Hot Stocks
Cryoport collaboration with Vineti provides broad-based solution, CEO says »

Cryoport (CYRX) provides…

03/08/13
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NFLX

Netflix

$288.50

-10.09 (-3.38%)

13:56
09/18/19
09/18
13:56
09/18/19
13:56
Periodicals
Netflix plans filmmaker bonus for successful movies, Bloomberg reports »

Netflix plans to pay…

03/08/13
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  • 23

    Sep

  • 16

    Oct

PLUG

Plug Power

$2.80

0.08 (2.94%)

13:55
09/18/19
09/18
13:55
09/18/19
13:55
Conference/Events
House Science, Space & Technology Committee to hold a hearing »

The Energy Subcommittee…

03/08/13
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  • 18

    Sep

13:55
09/18/19
09/18
13:55
09/18/19
13:55
Conference/Events
Joint Economic Committee to hold a hearing »

The Joint Economic…

13:50
09/18/19
09/18
13:50
09/18/19
13:50
General news
Fed SEP forecasts: t »

Fed SEP forecasts: the…

BYND

Beyond Meat

$150.50

-9.87 (-6.15%)

, QSR

Restaurant Brands

$73.02

-0.83 (-1.12%)

13:48
09/18/19
09/18
13:48
09/18/19
13:48
Periodicals
Restaurant Brands tells Bloomberg Tim Horton's Beyond Meat items were LTOs »

Restaurant Brands (QSR)…

BYND

Beyond Meat

$150.50

-9.87 (-6.15%)

QSR

Restaurant Brands

$73.02

-0.83 (-1.12%)

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  • 12

    Nov

CVGI

Commercial Vehicle Group

$7.20

0.02 (0.28%)

13:47
09/18/19
09/18
13:47
09/18/19
13:47
Recommendations
Commercial Vehicle Group analyst commentary  »

Commercial Vehicle Group…

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13:45
09/18/19
09/18
13:45
09/18/19
13:45
General news
Breaking General news story  »

FOMC Forecasts to be…

13:45
09/18/19
09/18
13:45
09/18/19
13:45
General news
FOMC Meeting Announcement Federal Funds Rate to be reported at 14:00 »

FOMC Meeting Announcement…

ACA

Arcosa

$34.14

-0.4 (-1.16%)

13:43
09/18/19
09/18
13:43
09/18/19
13:43
Initiation
Arcosa initiated  »

Arcosa initiated with a…

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  • 13

    Nov

CYRX

Cryoport

$17.95

0.2 (1.13%)

13:40
09/18/19
09/18
13:40
09/18/19
13:40
Hot Stocks
Cryoport focused on providing 'reliable' solutions for life sciences, CEO says »

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MDR

McDermott

$3.00

-2.88 (-48.98%)

13:40
09/18/19
09/18
13:40
09/18/19
13:40
Hot Stocks
Breaking Hot Stocks news story on McDermott »

McDermott: Taking…

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  • 23

    Sep

MDR

McDermott

$3.00

-2.88 (-48.98%)

13:40
09/18/19
09/18
13:40
09/18/19
13:40
Hot Stocks
McDermott says 'routinely hires external advisers' to evaluate opportunities »

McDermott International…

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  • 23

    Sep

MDR

McDermott

$3.00

-2.88 (-48.98%)

13:36
09/18/19
09/18
13:36
09/18/19
13:36
Periodicals
McDermott hires AlixPartners to advise on turnaround, WSJ reports »

Following a second…

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  • 23

    Sep

STX

Seagate

$56.92

0.88 (1.57%)

13:35
09/18/19
09/18
13:35
09/18/19
13:35
Options
Seagate put volume heavy and directionally bearish »

Bearish flow noted in…

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  • 19

    Sep

NLSN

Nielsen

$22.45

-0.13 (-0.58%)

13:34
09/18/19
09/18
13:34
09/18/19
13:34
Periodicals
Nielsen acquires minority stake in brand-safety company Open Slate, WSJ reports »

Nielsen Holdings has…

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BX

Blackstone

$52.93

-0.57 (-1.07%)

13:30
09/18/19
09/18
13:30
09/18/19
13:30
Periodicals
Blackstone near $2.9B deal to buy Great Wolf Resorts, Bloomberg says »

Privately held…

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  • 18

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