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KPTI

Karyopharm

$5.75

0.33 (6.09%)

07:11
06/14/19
06/14
07:11
06/14/19
07:11

Karyopharm to present new data on SDd, SPd arm in Phase 1b/2 STOMP study

Karyopharm Therapeutics announced three presentations highlighting new and updated data from the Phase 1b/2 STOMP study evaluating selinexor, the company's first-in-class, oral Selective Inhibitor of Nuclear Export compound, and dexamethasone in combination with standard approved multiple myeloma therapies, Kyprolis Darzalex, or Pomalyst, in patients with previously treated multiple myeloma. Updates on Phase 1b/2 STOMP Study: SDd and SPd The data will be featured in oral and poster presentations at the European Hematology Association 2019 Annual Meeting. In this arm of the Phase 1b/2 STOMP study, oral selinexor is being evaluated in combination with Darzalex in patients with relapsed or refractory MM who received at least three prior lines of therapy, including a PI and an IMiD, or patients with MM refractory to both a PI and an IMiD. Despite the heavily pretreated nature of the patients in the study, with 100% of the patients having dual--refractory disease, only one patient did not have at least a minimal response. Median progression-free survival has not been reached. Among patients with at least a PR, the median time on treatment was 7.7 months, while the median time on study for all evaluable patients was 4.8 months. Median time to response was 1.0 month. Based on published data, the expected ORR for Darzalex therapy without selinexor in the Darzalex-naive population is ~29%. Thus, the ORR of 73% continues to provide a basis for further evaluation of the SDd combination. Among the 31 patients evaluated for safety as of the data cutoff date, the most common treatment-related AEs were cytopenias, along with gastrointestinal and constitutional symptoms; most manageable with dose modifications and/or standard supportive care. The most common non-hematologic treatment-related AEs were nausea, fatigue, anorexia, insomnia, diarrhea, hyponatremia, and vomiting, and were mostly Grade 1 and 2 events. As expected, the most common Grade 3 and 4 treatment-related AEs were hematologic AEs and included thrombocytopenia, anemia, leukopenia and neutropenia. No Grade 5 AEs were reported. Based on these tolerability and efficacy data, the recommended RP2D of SDd is selinexor, Darzalex and dex.

  • 06

    Jul

KPTI Karyopharm
$5.75

0.33 (6.09%)

02/27/19
WEDB
02/27/19
NO CHANGE
Target $6
WEDB
Outperform
Karyopharm price target lowered to $6 from $14 at Wedbush
Wedbush analyst David Nierengarten lowered his price target for Karyopharm to $6 from $14 following the outcome of the FDA Advisory Committee Meeting regarding the potential approval of selinexor in penta-refractory multiple myeloma by the PDUFA date of April 6, 2019. The analyst notes that the panel voted 8 yes to 5 no to the question of "Should the approval of selinexor be delayed until results of the randomized phase 3 trial, BOSTON, are available?," as key concerns around safety, dose reductions and study design previously introduced in the published briefing docs prevailed, although the vote also indicated a receptiveness, particularly among treating physicians, for a novel drug like selinexor that could help serve this highly refractory patient population with limited treatment options. Nierengarten reiterates an Outperform rating on the shares.
02/28/19
HCWC
02/28/19
NO CHANGE
Target $30
HCWC
Buy
H.C. Wainwright says selinexor expectations not changed by ODAC recommendation
After the FDA's Oncologic Drugs Advisory Committee, or ODAC, voted on February 26 to recommend that the FDA wait for the Phase 3 BOSTON trial results before deciding on selinexor's NDA application, H.C. Wainwright analyst Edward White noted that the decision was not unanimous and said "the FDA typically but does not always follow the ODAC panel's recommendations." It is possible that a delay to wait for the BOSTON data could push out a selinexor launch by one year or more, but the ODAC recommendation is "not changing our expectations," stated White, who keeps a Buy rating and $30 price target on shares of Karyopharm.
03/01/19
JPMS
03/01/19
DOWNGRADE
Target $7
JPMS
Neutral
Karyopharm downgraded to Neutral from Overweight at JPMorgan
JPMorgan analyst Eric Joseph downgraded Karyopharm Therapeutics to Neutral and lowered his price target for the shares to $7 from $21. The analyst sees a "rocky regulatory road" forward for the company.
03/15/19
WEDB
03/15/19
NO CHANGE
WEDB
Wedbush views Karyopharm 's PDUFA date extension as a positive
Wedbush analyst David Nierengarten maintained an Outperform rating and $6 price target on Karyopharm. In a note titled "FDA Extends PDUFA by Three Months," he said he is inclined to view the extension as a positive for the company "given the negative sentiment on the name and general belief that an April 6, 2019 approval was unlikely."

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  • 17

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  • 20

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Slack Technologies

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GNLN

Greenlane

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CCL

Carnival

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CTST

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, CURR

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KKR

KKR

$24.52

0.23 (0.95%)

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