initial public offerings (IPOs) trading on American exchanges
Showing posts with label KPTI. Show all posts
Showing posts with label KPTI. Show all posts

Wednesday, July 3, 2019

-=Karyopharm Therapeutics (KPTI) prices blood cancer treatment after FDA approval



July 3 (Reuters) - Karyopharm Therapeutics Inc on Wednesday set a list-price for its blood cancer treatment Xpovio at $22,000 per month, following accelerated approval from the U.S. Food and Drug Administration.
Karyopharm said it expects Xpovio to become commercially available in the United States by July 10.
The list price is for all four available dosing packages, a company spokesman told Reuters.
Xpovio was approved in combination with dexamethasone for multiple myeloma patients who have received at least four prior therapies and who failed to respond to certain other treatments, the FDA said.
A late-stage study, currently testing Xpovio in combination with Takeda Pharmaceutical Co Ltd's Velcade and low-dose dexamethasone, will serve as a confirmatory trial, the company said.
Separately, in a regulatory filing https://www.sec.gov/Archives/edgar/data/1503802/000119312519189004/d694413d8k.htm on Wednesday, Karyopharm disclosed that its Chief Commercial Officer Anand Varadan, who joined the company last year, will depart effective July 5.
Xpovio's approval on Wednesday was based on results from a mid-stage study of 122 multiple myeloma patients who had previously received three or more treatment regimens, Karyopharm said.
The drug, chemically known as selinexor, binds to and inhibits a protein called XPO1, leading to the accumulation of cancer-suppressing proteins in the cells.
The FDA was to initially decide on the treatment's approval in April, but pushed back the date by three months to review additional data submitted by the company.
Multiple myeloma is estimated to cause nearly 13,000 deaths in the United States in 2019, according to the American Cancer Society.
Selinexor is also being tested in other types of cancer including lymphoma and endometrial cancer.
Karyopharm's shares closed up 36% on Wednesday.

Sunday, June 15, 2014

Karyopharm Therapeutics (KPTI) : 7-month performance


Karyopharm Therapeutics (NASDAQ: KPTI  ) surging incessantly throughout the day, and ending higher by 93.5% after announcing phase 1 data of its investigational drug selinexor in combination with low-dose dexamethasone in heavily pretreated multiple myeloma patients. Initial results of its study demonstrated that the overall response rate was 50%, with a clinical benefit rate of 75%. What's incredible about these results is that the average patient had received 5.5 prior lines of therapy. Also, adverse events associated with the combo therapy were generally low-grade in nature, meaning it was well-tolerated.

Simply put, most patients often don't have much of an overall response in the later stages of multiple myeloma, so Karyopharm's impressive response rate is turning some heads. Keep in mind, though, that we're only talking about a handful of patients here, and we may want to reserve judgment until we have a bigger patient pool to study.

Wednesday, January 22, 2014

Karyopharm Therapeutics (KPTI) began trading on the NASDAQ on 6 November 2013

Jan 2014 update


Description

Karyopharm Therapeutics Inc. is a clinical-stage pharmaceutical company focused on the discovery and development of drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. The Company has discovered and developed small molecule, Selective Inhibitors of Nuclear Export (SINE), compounds that inhibit the nuclear export protein XPO1. The Company’s drug candidate, Selinexor (KPT-330), is an XPO1 inhibitor, evaluated in multiple open-label Phase 1 clinical trials in patients with heavily pretreated relapsed or refractory hematological and solid tumor malignancies. As of September 20, 2013, the Company had administered Selinexor to over 170 patients in these trials.

Address

2 Mercer Road
NATICK, MA 01760
United States

Key stats and ratios

Q2 (Jun '13)2012
Net profit margin-3409.84%-2505.99%
Operating margin-3410.11%-2506.31%
EBITD margin--2487.07%
Return on average assets--372.30%
Return on average equity--
Employees23