Breaking News Instant updates and real-time market news.

KPTI

Karyopharm

$7.49

-1.47 (-16.41%)

12:48
02/22/19
02/22
12:48
02/22/19
12:48

Karyopharm drops 40% after FDA posts Selinexor meeting briefing docs

Shares of Karyopharm are moving sharply lower after the FDA posted briefing documents for the Oncologic Drugs Advisory Committee Meeting planned for February 26 to review the New Drug Application for Selinexor. Selinexor is indicated in combination with dexamethasone for the treatment of patients with relapsed refractory multiple myeloma, or RRMM, who have received at least three prior therapies and whose disease is refractory to at least one proteasome inhibitor (PI), at least one immunomodulatory agent, and an antiCD38 monoclonal antibody. In the "Issues" section of the document, FDA staff state: "STORM was a single arm trial evaluating the combination of selinexor and dexamethasone. Given that historical studies have shown response rates of 10-27% to high-dose dexamethasone for RRMM and selinexor did not demonstrate single agent activity in RRMM in the phase 1 trial KCP-330-001, it is difficult to isolate the treatment effect of selinexor...Treatment with selinexor is associated with significant toxicity...As a monotherapy, selinexor yielded only one response in 56 patients with RRMM in the phase 1 dose escalation and expansion study KCP-330-001...The proposed starting dose was not well tolerated in the phase 2 trial given that 88.6% the patients in Part 2 of STORM required at least one dose modification due to a TEAE and 28.5% of patients discontinued treatment with selinexor-dexamethasone due to a TEAE." In the "Conclusions" section, the FDA staff wrote: "Given the limited efficacy and significant toxicity demonstrated in this population, it is unclear whether treatment with selinexor-dexamethasone provides a clinically meaningful benefit that outweighs the risks of treatment. The limitations of interpreting safety and efficacy from a single arm trial, and lack of single agent activity of selinexor coupled with historical data showing activity of dexamethasone in RRMM, add to the challenges in interpreting the results of the pivotal study...The RWD analyses of the FHAD population were not prespecified and have major methodological issues. The results of Study KS-50039 are difficult to interpret due these limitations, and therefore, are not acceptable as supportive evidence for the NDA." Following a trading pause for volatility, Karyopharm shares are down $3.54, or nearly 40%, to $5.43. Reference Link

  • 26

    Feb

  • 28

    Feb

  • 06

    Apr

KPTI Karyopharm
$7.49

-1.47 (-16.41%)

02/22/19
HCWC
02/22/19
NO CHANGE
HCWC
H.C. Wainwright sees selinexor approval as next Karyopharm catalyst
H.C. Wainwright analyst Edward White reiterated a Buy rating on Karyopharm and kept a $30 price target on the stock. The next catalyst the analyst sees for the stock is the April 6 PDUFA date for selinexor in patients with penta-refractory multiple myeloma, and he continues to believe that selinexor will be approved on or before the PDUFA date, with a launch anticipated in the first half of 2019.
02/06/19
JEFF
02/06/19
NO CHANGE
JEFF
Jefferies highlights Karyopharm, Reata as stocks to focus on in 2019
Jefferies analyst Maury Raycroft highlights Karyopharm Therapeutics (KPTI) and Reata Pharmaceuticals (RETA) as two stocks to focus on in 2019. Karyopharm has important regulatory updates upcoming with an expected FDA panel for selinexor in penta-refractory multiple myeloma and then an FDA action date scheduled for April 6, Raycroft tells investors in a research note. And Reata is expected to report initial, awaited focal segmental glomerulosclerosis data in the first half of 2019 and then two pivotal readouts in the second half in Alport syndrome and Friedreich's ataxia, adds the analyst. He believes the current share weakness offers an "appealing entry point" for Karyopharm.
01/03/19
01/03/19
UPGRADE
Target $15

Neutral
Karyopharm upgraded to Neutral at BofA/Merrill
As previously reported, BofA/Merrill upgraded Karyopharm to Neutral from Underperform with a $15 price target. Analyst Ying Huang cites selinexor's encouraging efficacy and expectation of FDA approval in penta-refectory for the upgrade.
01/03/19
BOFA
01/03/19
UPGRADE
BOFA
Neutral
Karyopharm upgraded to Neutral from Underperform at BofA/Merrill

TODAY'S FREE FLY STORIES

21:25
03/25/19
03/25
21:25
03/25/19
21:25
General news
Fed's Rosengren warned that U.S. Q1 growth is likely to be weak »

Fed's Rosengren…

BBBY

Bed Bath & Beyond

$13.87

0.17 (1.24%)

20:44
03/25/19
03/25
20:44
03/25/19
20:44
Periodicals
Activist firms seek to replace Bed Bath & Beyond board, CEO, WSJ says »

Activist funds -Legion…

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

    Apr

RTN

Raytheon

$180.58

-0.82 (-0.45%)

, BA

Boeing

$370.52

8.37 (2.31%)

20:36
03/25/19
03/25
20:36
03/25/19
20:36
Hot Stocks
Raytheon kill vehicle hits ICBM target in first dual-salvo test »

For the first time, the…

RTN

Raytheon

$180.58

-0.82 (-0.45%)

BA

Boeing

$370.52

8.37 (2.31%)

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

  • 28

    May

20:35
03/25/19
03/25
20:35
03/25/19
20:35
General news
The "Summary of Opinions" from the BoJ's March meeting »

The "Summary of…

WHD

Cactus

$36.03

1.225 (3.52%)

20:27
03/25/19
03/25
20:27
03/25/19
20:27
Hot Stocks
Cactus VP of Operations sells 229K shares of common stock »

In a regulatory filing,…

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

CCL

Carnival

$56.67

-0.065 (-0.11%)

, MKC

McCormick

$143.88

1.58 (1.11%)

20:25
03/25/19
03/25
20:25
03/25/19
20:25
Earnings
Notable companies reporting before tomorrow's open »

Notable companies…

CCL

Carnival

$56.67

-0.065 (-0.11%)

MKC

McCormick

$143.88

1.58 (1.11%)

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

  • 26

    Mar

  • 26

    Mar

  • 27

    Mar

CRTO

Criteo

$21.99

-3.4 (-13.39%)

20:19
03/25/19
03/25
20:19
03/25/19
20:19
Downgrade
Criteo rating change at KeyBanc »

Criteo downgraded to…

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

SSNLF

Samsung

$0.00

(0.00%)

20:02
03/25/19
03/25
20:02
03/25/19
20:02
Periodicals
Samsung sees weaker environment for display, memory in Q1, Bloomberg says »

In a regulatory filing,…

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

BA

Boeing

$370.52

8.37 (2.31%)

19:51
03/25/19
03/25
19:51
03/25/19
19:51
Hot Stocks
U.S. MDA and Boeing Complete Historic Missile Defense Test »

The U.S. Missile Defense…

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

  • 28

    May

MCD

McDonald's

$185.66

-1.11 (-0.59%)

19:49
03/25/19
03/25
19:49
03/25/19
19:49
Periodicals
McDonald's purchase price of Dynamic Yield above $300M, Bloomberg says »

The purchase of Dynamic…

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

    Apr

  • 28

    May

SSNLF

Samsung

$0.00

(0.00%)

19:32
03/25/19
03/25
19:32
03/25/19
19:32
Periodicals
Breaking Periodicals news story on Samsung »

Samsung sees Q1 below…

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

AWR

American States Water

$71.51

0.505 (0.71%)

19:22
03/25/19
03/25
19:22
03/25/19
19:22
Hot Stocks
American States Water CEO sells 12.4K shares of common stock »

In a regulatory filing,…

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

MEOH

Methanex

$56.35

-1.38 (-2.39%)

19:10
03/25/19
03/25
19:10
03/25/19
19:10
Hot Stocks
Methanex confirms receipt of director nominees notice from M&G »

Methanex Corporation…

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

BECN

Beacon Roofing

$34.14

0.81 (2.43%)

, SAEX

SAExploration

$4.03

0.13 (3.33%)

18:55
03/25/19
03/25
18:55
03/25/19
18:55
Hot Stocks
Fly Intel: After Hours Movers »

DOWN AFTER EARNINGS:…

BECN

Beacon Roofing

$34.14

0.81 (2.43%)

SAEX

SAExploration

$4.03

0.13 (3.33%)

IQ

iQIYI

$24.01

-0.86 (-3.46%)

MYOK

MyoKardia

$51.87

-2.44 (-4.49%)

CTMX

CytomX Therapeutics

$10.76

0.33 (3.16%)

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

  • 26

    Mar

  • 26

    Mar

  • 21

    May

  • 27

    Mar

HPQ

HP Inc.

$18.97

-0.4 (-2.07%)

18:48
03/25/19
03/25
18:48
03/25/19
18:48
Periodicals
HP lawyer tells court Autonomy's Lynch inflated sales data, Reuters says »

A lawyer for HP told a…

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

    Apr

PEGA

Pegasystems

$63.61

-0.27 (-0.42%)

18:45
03/25/19
03/25
18:45
03/25/19
18:45
Hot Stocks
Pegasystems CEO: We are massively changing our marketing strategy »

In an interview on…

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

    May

SMTC

Semtech

$52.59

-0.38 (-0.72%)

18:32
03/25/19
03/25
18:32
03/25/19
18:32
Hot Stocks
Semtech CEO sells 25K shares of common stock »

In a regulatory filing,…

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

  • 25

    Mar

TMO

Thermo Fisher

$268.89

5.015 (1.90%)

18:24
03/25/19
03/25
18:24
03/25/19
18:24
Hot Stocks
Thermo Fisher CEO: We have a very disciplined M&A process »

In an interview on…

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

DJX

Dow Jones Industrial Average

$0.00

(0.00%)

, SPX

S&P 500

$0.00

(0.00%)

18:24
03/25/19
03/25
18:24
03/25/19
18:24
Periodicals
Parliament forces votes on Brexit plan options, Bloomberg reports »

Lawmakers of U.K.…

DJX

Dow Jones Industrial Average

$0.00

(0.00%)

SPX

S&P 500

$0.00

(0.00%)

SPY

SPDR S&P 500 ETF Trust

$278.99

-0.56 (-0.20%)

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

MCD

McDonald's

$185.66

-1.11 (-0.59%)

18:23
03/25/19
03/25
18:23
03/25/19
18:23
Hot Stocks
McDonald's to acquire Dynamic Yield, terms not stated »

McDonald's 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

  • 30

    Apr

  • 28

    May

BA

Boeing

$370.52

8.37 (2.31%)

18:22
03/25/19
03/25
18:22
03/25/19
18:22
Periodicals
Boeing software fix to prevent repeated activiation of MCAS, Reuters says »

A Boeing software repair…

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

  • 28

    May

ACHC

Acadia

$29.47

-0.59 (-1.96%)

17:58
03/25/19
03/25
17:58
03/25/19
17:58
Hot Stocks
Acadia says President Brett Turner leaving by mutual agreement »

Brent Turner, President…

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

AAPL

Apple

$188.78

-2.33 (-1.22%)

17:41
03/25/19
03/25
17:41
03/25/19
17:41
Recommendations
Apple analyst commentary at Piper Jaffray »

Apple 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

  • 25

    Mar

  • 03

    Jun

ZFGN

Zafgen

$2.70

-0.15 (-5.26%)

17:38
03/25/19
03/25
17:38
03/25/19
17:38
Hot Stocks
Armistice Capital reports 5.6% passive stake in Zafgen »

In a regulatory filing,…

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

NOC

Northrop Grumman

$268.56

0.27 (0.10%)

17:36
03/25/19
03/25
17:36
03/25/19
17:36
Hot Stocks
Northrop Grumman awarded $245.05M Navy contract modification »

Northrop Grumman has been…

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.