We use cookies to understand how you use our site and to improve your experience. This includes personalizing content and advertising. To learn more, click here. By continuing to use our site, you accept our use of cookies, revised Privacy Policy and Terms of Service.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
Karyopharm Initiates NDA Submission Process for Selinexor
Read MoreHide Full Article
Karyopharm Therapeutics Inc. (KPTI - Free Report) announced that the company has initiated a rolling submission of a New Drug Application (NDA) to the FDA with a request for accelerated approval for its oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor. The company is seeking approval of selinexor for the treatment of patients with penta-refractory multiple myeloma having received at least three prior lines of therapy..
The commencement of this rolling submission for the oral selinexor NDA marks the first-ever application for regulatory approval of an exportin 1 (XPO1) inhibitor and represents a major milestone for the company. The NDA is based on results from positive top line data from the part 2 of the phase IIb STORM study, evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. The company expects the submission to be complete during the second half of 2018.
Year to date, shares of Karyopharm have increased 95% compared with the industry’s gain of 3.1%.
The company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval.
We remind investors that Karyopharm is also evaluating selinexor in several mid- and later-phase studies on multiple cancer indications, the most advanced being the phase III study of the candidate in combination with Takeda Oncology’s Velcade on multiple myeloma patients.
Some better-ranked stocks from the same space are Illumina Inc. (ILMN - Free Report) , Eisai Co. and Alexion Pharmaceuticals, Inc. . While Illumina sports a Zacks Rank #1 (Strong Buy), Alexion and Eisai carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Illumina’s earningsper share estimates have increased from $4.83 to $4.87 for 2018 and from $5.57 to $5.61 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 23.17%. The stock has rallied 40.6% so far this year.
Eisai’s earnings estimates have moved up from $1.93 to $1.94 for 2018 and from $1.38 to $1.39 for 2019 over the past 60 days. The stock has rallied 71.1% so far this year.
Alexion’s stock has surged 13.4% so far this year.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%. And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
Image: Bigstock
Karyopharm Initiates NDA Submission Process for Selinexor
Karyopharm Therapeutics Inc. (KPTI - Free Report) announced that the company has initiated a rolling submission of a New Drug Application (NDA) to the FDA with a request for accelerated approval for its oral Selective Inhibitor of Nuclear Export (SINE) compound selinexor. The company is seeking approval of selinexor for the treatment of patients with penta-refractory multiple myeloma having received at least three prior lines of therapy..
The commencement of this rolling submission for the oral selinexor NDA marks the first-ever application for regulatory approval of an exportin 1 (XPO1) inhibitor and represents a major milestone for the company. The NDA is based on results from positive top line data from the part 2 of the phase IIb STORM study, evaluating selinexor in combination with low-dose dexamethasone in patients with penta-refractory multiple myeloma. Selinexor has been granted Orphan Drug designation in multiple myeloma and Fast Track designation for the patient population evaluated in the STORM study. The company expects the submission to be complete during the second half of 2018.
Year to date, shares of Karyopharm have increased 95% compared with the industry’s gain of 3.1%.
The company also plans to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in early 2019 with a request for conditional approval.
We remind investors that Karyopharm is also evaluating selinexor in several mid- and later-phase studies on multiple cancer indications, the most advanced being the phase III study of the candidate in combination with Takeda Oncology’s Velcade on multiple myeloma patients.
Karyopharm Therapeutics Inc. Price
Karyopharm Therapeutics Inc. Price | Karyopharm Therapeutics Inc. Quote
Zacks Rank & Stocks to Consider
Karyopharm has a Zacks Rank #3 (Hold).
Some better-ranked stocks from the same space are Illumina Inc. (ILMN - Free Report) , Eisai Co. and Alexion Pharmaceuticals, Inc. . While Illumina sports a Zacks Rank #1 (Strong Buy), Alexion and Eisai carries a Zacks Rank #2 (Buy). You can see the complete list of today’s Zacks #1 Rank stocks here.
Illumina’s earningsper share estimates have increased from $4.83 to $4.87 for 2018 and from $5.57 to $5.61 for 2018 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 23.17%. The stock has rallied 40.6% so far this year.
Eisai’s earnings estimates have moved up from $1.93 to $1.94 for 2018 and from $1.38 to $1.39 for 2019 over the past 60 days. The stock has rallied 71.1% so far this year.
Alexion’s stock has surged 13.4% so far this year.
Today's Stocks from Zacks' Hottest Strategies
It's hard to believe, even for us at Zacks. But while the market gained +21.9% in 2017, our top stock-picking screens have returned +115.0%, +109.3%, +104.9%, +98.6%, and +67.1%. And this outperformance has not just been a recent phenomenon. Over the years it has been remarkably consistent. From 2000 - 2017, the composite yearly average gain for these strategies has beaten the market more than 19X over. Maybe even more remarkable is the fact that we're willing to share their latest stocks with you without cost or obligation.
See Them Free>>