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KPTI

Karyopharm

$17.64

0.01 (0.06%)

16:13
08/06/18
08/06
16:13
08/06/18
16:13

Karyopharm completes rolling submission of NDA for Selinexor

Karyopharm Therapeutics announced the completion of the rolling submission of a New Drug Application, or NDA, to the FDA seeking accelerated approval for Selinexor, its novel, oral SINE compound, as a new treatment for patients with penta-refractory multiple myeloma. Patients with penta-refractory myeloma have previously received the two proteasome inhibitors, Velcade and Kyprolis, the two immunomodulatory drugs, Revlimid and Pomalyst, and the anti-CD38 monoclonal antibody Darzalex as well as alkylating agents, and their disease is refractory to at least one PI, at least one IMiD, Darzalex and their most recent therapy. Selinexor has received both Orphan Drug and Fast Track designations from the FDA for this indication.

  • 07

    Aug

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    Aug

KPTI Karyopharm
$17.64

0.01 (0.06%)

05/24/18
WEDB
05/24/18
DOWNGRADE
WEDB
Neutral
Karyopharm downgraded to Neutral from Outperform at Wedbush
05/24/18
05/24/18
DOWNGRADE
Target $19

Neutral
Karyopharm downgraded to Neutral at Wedbush
As previously reported, Wedbush analyst David Nierengarten downgraded Karyopharm to Neutral from Outperform on valuation. The analyst also lowered his price target on the shares to $19 from $20 as he updates his model for the company's offering and for a somewhat shorter duration of therapy based on the STORM duration of response of 4.4 months.
05/24/18
HCWC
05/24/18
NO CHANGE
Target $30
HCWC
Buy
H.C. Wainwright remains bullish Karyopharm after STORM data, license deal
H.C. Wainwright analyst Edward White reiterates a Buy rating and $30 price target for Karyopharm, while pointing out that recent positive Phase 2b STORM data confirmed his expectations for the success of selinexor. The company expects a NDA submission for an accelerated approval of selinexor in patients with penta-refractory multiple myeloma in 2H18, he says, adding that he estimates the addressable peak market size for this population is over $500M in the U.S. The analyst also notes that the company has announced an exclusive license agreement for the development and commercialization of selinexor, eltanexor, verdinexor and KPT-9274 with Antengene Corporation.
05/24/18
05/24/18
DOWNGRADE

On The Fly: Top five analyst downgrades
Catch up on today's top five analyst downgrades with this list compiled by The Fly: 1. AbbVie (ABBV) downgraded to Buy from Conviction Buy at Goldman Sachs with analyst Jami Rubin citing share outperformance. 2. Petrobras (PBR) downgraded to Equal Weight from Overweight at Morgan Stanley, to Neutral from Outperform at Credit Suisse, to Neutral from Buy at BofA/Merrill, and to Market Perform from Outperform at Itau BBA. 3. Karyopharm (KPTI) downgraded to Neutral from Outperform at Wedbush with analyst David Nierengarten citing valuation. 4. Vermillion (VRML) downgraded to Hold from Buy at Canaccord. 5. Generac (GNRC) downgraded to Neutral from Outperform at Baird. This list is just a portion of The Fly's full analyst coverage. To see The Fly's full Street Research coverage, click here.

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DZSI

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DZSI

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CATS

Catasys

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AAPL

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