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KPTI

Karyopharm

$10.52

-0.34 (-3.13%)

07:07
09/20/17
09/20
07:07
09/20/17
07:07

Karyopharm: 'successful' outcome from Phase 2 portion of Phase 2/3 SEAL study

Karyopharm reported a successful outcome from the Phase 2 portion of the SEAL study evaluating the activity of selinexor, the company's lead, novel, oral Selective Inhibitor of Nuclear Export / SINE compound, in 57 patients with previously treated, advanced unresectable dedifferentiated liposarcoma. For the SEAL study's primary endpoint of progression-free survival, or PFS, oral selinexor showed superiority over placebo, achieving a hazard ratio, or HR, of 0.60, representing a 40% reduction in the risk of progression or death. PFS was assessed by Independent Central Radiological Review, or ICRR, based on RECIST v1.1. In this randomized, blinded Phase 2 portion of the study, oral selinexor demonstrated an expected and manageable safety profile, primarily with nausea, anorexia and fatigue, low levels of Grade 3/4 cytopenias, and no new or unexpected safety signals identified. The majority of treatment-related adverse events, or AEs, were low grade and reversible with dose modifications and/or standard supportive care. Importantly, the incidence of infections in the selinexor arm was less than that reported in the placebo arm. Additional efficacy assessments included PFS by World Health Organization, or WHO, response criteria, effects on metabolic parameters via PET Scans, and PFS according to Choi Criteria. PFS per WHO criteria achieved a HR of 0.84; the WHO response criteria will not be included as part of the Phase 3 study objectives. Karyopharm intends to submit detailed results from the Phase 2 portion of the SEAL study for presentation at a future medical meeting.

  • 25

    Sep

KPTI Karyopharm
$10.52

-0.34 (-3.13%)

09/14/17
RBCM
09/14/17
INITIATION
Target $14
RBCM
Outperform
Karyopharm initiated with an Outperform at RBC Capital
RBC Capital analyst Brian Abrahams started Karyopharm Therapeutics with an Outperform rating and $14 price target. The analyst believes the company's lead drug selinexor has a "differentiated target and profile" that is underappreciated by the Street.
05/15/17
05/15/17
INITIATION

On The Fly: Top five analyst initiations
Catch up on today's top five analyst initiations with this list compiled by The Fly: 1. Jazz Pharmaceuticals (JAZZ) initiated with an Outperform at RBC Capital. 2. Visteon (VC) initiated with a Sector Perform at RBC Capital. 3. Allscripts (MDRX) initiated with a Neutral at BofA/Merrill. 4. Independent Bank (INDB) initiated with a Neutral at Piper Jaffray. 5. Karyopharm (KPTI) initiated with an Overweight at Cantor. This list is just a portion of The Fly's analyst coverage. To see The Fly's full Street Research coverage, click here.
05/15/17
CANT
05/15/17
INITIATION
CANT
Overweight
Karyopharm initiated with an Overweight at Cantor
Cantor analyst Mara Goldstein started coverage of Karyopharm with an $18 price target and an Overweight rating. She is upbeat on the clinical performance of its lead drug candidate, selinexor. The analyst says that the drug "has broad applications in cancer, as well as potentially other areas such as infectious and inflammatory disease."
03/13/17
JMPS
03/13/17
NO CHANGE
JMPS
Karyopharm clinical hold likely to be resolved shortly, says JMP Securities
JMP Securities analyst Michael King says that the partial clinical hold placed on Karyopharm's selinexor trials was triggered by "incomplete information" in the investigator's brochure. The analyst expects the issue to be "resolved shortly." He keeps a $22 price target and an Outperform rating on the stock.

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