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Karyopharm Therapeutics Inc

Karyopharm Therapeutics Inc (KPTI)

0.9175
-0.0625
(-6.38%)
Closed July 18 4:00PM
0.9175
0.00
( 0.00% )
Pre Market: 7:00AM

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Key stats and details

Current Price
0.9175
Bid
0.90
Ask
0.9175
Volume
2,000
0.00 Day's Range 0.00
0.6174 52 Week Range 1.95
Market Cap
Previous Close
0.9175
Open
-
Last Trade Time
06:37:08
Financial Volume
-
VWAP
-
Average Volume (3m)
1,231,252
Shares Outstanding
117,710,263
Dividend Yield
-
PE Ratio
-0.76
Earnings Per Share (EPS)
-1.22
Revenue
146.03M
Net Profit
-143.1M

About Karyopharm Therapeutics Inc

Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's lead com... Karyopharm Therapeutics Inc. is a commercial-stage pharmaceutical company pioneering novel cancer therapies and dedicated to the discovery, development, and commercialization of first-in-class drugs directed against nuclear export for the treatment of cancer and other diseases. Karyopharm's lead compound, XPOVIO(R) (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade(R) (bortezomib) and dexamethasone for the treatment of adult patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of adult patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma. Show more

Sector
Pharmaceutical Preparations
Industry
Pharmaceutical Preparations
Headquarters
Wilmington, Delaware, USA
Founded
1970
Karyopharm Therapeutics Inc is listed in the Pharmaceutical Preparations sector of the NASDAQ with ticker KPTI. The last closing price for Karyopharm Therapeutics was $0.92. Over the last year, Karyopharm Therapeutics shares have traded in a share price range of $ 0.6174 to $ 1.95.

Karyopharm Therapeutics currently has 117,710,263 shares outstanding. The market capitalization of Karyopharm Therapeutics is $108 million. Karyopharm Therapeutics has a price to earnings ratio (PE ratio) of -0.76.

KPTI Latest News

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) PR Newswire NEWTON, Mass., July 1, 2024 NEWTON, Mass., July 1, 2024 /PRNewswire/ -- Karyopharm Therapeutics...

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4)

Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) PR Newswire NEWTON, Mass., June 3, 2024 NEWTON, Mass., June 3, 2024 /PRNewswire/ --Β Karyopharm Therapeutics...

Karyopharm Presents Updated Exploratory Subgroup Analyses from SIENDO Study in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer During 2024 ASCO Plenary Series: Rapid Abstract Updates

Karyopharm Presents Updated Exploratory Subgroup Analyses from SIENDO Study in Patients with Advanced or Recurrent TP53 Wild-Type Endometrial Cancer During 2024 ASCO Plenary Series: Rapid...

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-0.045-4.675324675320.96251.040.910312749350.9670579CS
4-0.0293-3.094634558510.94681.160.770212457980.93050296CS
12-0.1325-12.6190476191.051.20.770212312521.00777496CS
260.182324.79597388470.73521.950.690414950201.2110104CS
52-0.5325-36.7241379311.451.950.617414515011.20585034CS
156-8.0825-89.8055555556914.730.617421562244.42398638CS
260-7.4725-89.06436233618.3929.610.617419805578.14513085CS

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KPTI Discussion

View Posts
PonkenPlonken PonkenPlonken 3 weeks ago
yawn yawn...
not unreasonable to accuse management of theft
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ilovestocks85 ilovestocks85 4 months ago
Time to start loading again
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Monksdream Monksdream 4 months ago
KPTI under $2
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glenn1919 glenn1919 4 months ago
KPTI..........................................https://stockcharts.com/h-sc/ui?s=KPTI&p=W&b=5&g=0&id=p86431144783
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glenn1919 glenn1919 4 months ago
KPTI.........................................https://stockcharts.com/h-sc/ui?s=KPTI&p=W&b=5&g=0&id=p86431144783
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MilitaryDeals MilitaryDeals 5 months ago
Gsa Capital Partners Lip reports 311.40% increase in ownership of KPTI / Karyopharm Therapeutics Inc.

On February 16, 2024 - Gsa Capital Partners Lip filed a 13F-HR form disclosing ownership of 2,337,985 shares of Karyopharm Therapeutics Inc. (US:KPTI) valued at $2,022,357 USD as of December 31, 2023. The entity filed a previous 13F-HR on November 15, 2023 disclosing 568,298 shares of Karyopharm Therapeutics Inc.. The current value of the position is $3,039,380 USD.
πŸ‘οΈ0
AJ Freely AJ Freely 1 year ago
$KPTI - Up 20% Pre-Market/ Current Price $1.85
Receives FDA Fast Track Designation for Selinexor for the Treatment of Myelofibrosis
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tw0122 tw0122 1 year ago
Karyopharm Gets FDA Fast Track Designation for Myelofibrosis Treatment
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muchogusto muchogusto 1 year ago
Correction β€œseems to be on a perpetual slide”
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muchogusto muchogusto 1 year ago
Dcaf7, what are your current thoughts on KPTI? The stock seems toon a perpetual slide. Is there going to be dilution soon?
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dcaf7 dcaf7 1 year ago
Cara, Iovance, and Karyopharm among biotechs with no exposure to SVB.
https://seekingalpha.com/news/3946617-iovance-allogene-and-karyopharm-among-biotechs-with-no-exposure-to-svb
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dcaf7 dcaf7 1 year ago
Good news for Karyopharm.
Incyte ending phase 3 program evaluating myelofibrosis candidate parsaclisib.
Incyte (NASDAQ:INCY) said it would end a phase 3 program examining its myelofibrosis candidate parsaclisib with Jakafi (ruxolitinib) after an interim analysis showed the study was unlikely to meet its primary endpoint.
https://seekingalpha.com/news/3944167-incyte-ending-phase-3-program-evaluating-myelofibrosis-candidate-parsaclisib
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JohnLocke101 JohnLocke101 3 years ago
Great move on earnings today.
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crudeoil24 crudeoil24 3 years ago
"Driven by acceleration in demand growth for XPOVIO, Karyopharm delivered a strong third quarter, which saw a significant increase in net product revenues versus the second quarter of 2021. XPOVIO continues to move into earlier lines of therapy in multiple myeloma as a new and effective modality that can become the standard of care in second line plus where utilizing new mechanisms is critical to improve patient outcomes," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "With respect to the pipeline, we remain focused on expanding key clinical trials in multiple myeloma, as well as in additional cancer indications such as endometrial cancer, myelodysplastic syndromes and myelofibrosis, as emerging data continue to guide our clinical programs. Looking ahead, we have several key upcoming milestones including reporting top-line data from the Phase 3 SIENDO study in endometrial cancer where recruitment remains on track. Finally, we look forward to hosting an Investor Day in early December to present further details on our commercial and pipeline priorities."
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ipo_dude ipo_dude 3 years ago
$10 yet?
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artfulife artfulife 3 years ago
Waited a while for sp to break above my $9.82 cost basis. Happily holding just over 1000 shares.
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MfridgeV2 MfridgeV2 3 years ago
Might be just you and I… more soon I assume.
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JohnLocke101 JohnLocke101 3 years ago
Mama said there’d be days like this.
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JohnLocke101 JohnLocke101 3 years ago
It’d be a real shame if this broke up over $10

Good Luck!
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JohnLocke101 JohnLocke101 3 years ago
Heavy short interest.

Good Luck!
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JohnLocke101 JohnLocke101 3 years ago
7:09a ET 6/9/2021 - Benzinga
Karyopharm Announces XPOVIO Data to be Presented at the European Hematology Association 2021 Virtual Congress
Mentioned: KPTI
Karyopharm Therapeutics Inc. (NASDAQ:KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that nine abstracts have been selected for virtual presentation, including one oral presentation, at the upcoming European Hematology Association (EHA) 2021 Virtual Congress taking place June 9-17, 2021.

Key abstracts to be presented at the meeting will feature clinical data for XPOVIO® (selinexor), the Company's first in class, oral Selective Inhibitor of Nuclear Export (SINE) compound, including: (i) multiple new subgroup analyses from the pivotal Phase 3 BOSTON study, including data results evaluating XPOVIO treatment for patients over the age of 65 years old, patients with RAS-mutated multiple myeloma, patients previously treated with Revlimid® (lenalidomide), and genomic predictors of efficacy; (ii) updated data from the Kyprolis® (carfilzomib) and Pomalyst® (pomalidomide) arms of the Phase 1b/2 STOMP study evaluating XPOVIO in combination with standard of care agents in previously treated multiple myeloma; (iii) evaluation of XPOVIO combinations in patients with multiple myeloma following treatment with anti-CD38 monoclonal antibodies; (iv) the effect of lymphocyte count on safety and efficacy in the Phase 2b SADAL study evaluating XPOVIO in patients with diffuse large B-cell lymphoma; and (v) updated overall survival data from a Phase 1/2 study evaluating oral eltanexor, the Company's second generation SINE compound, in patients with hypomethylating-agent refractory myelodysplastic syndrome.

"We are pleased to see such a broad display of data from our clinical programs presented at EHA this year. In particular, we are encouraged that updated data from the Kyprolis® arm of the STOMP study was selected for an oral presentation," said Sharon Shacham, PhD, MBA, Chief Scientific Officer of Karyopharm. "More specifically, in the STOMP study, heavily pretreated multiple myeloma patients receiving once weekly XPOVIO in combination with once-weekly Kyprolis® and dexamethasone achieved an overall response rate of 78% (25/32 patients), including 16% (5/32 patients) who achieved a complete response. High response rates were observed whether or not the patients had received prior anti-CD38 monoclonal antibody therapy and adverse events in the study were generally consistent with other previously reported XPOVIO studies in multiple myeloma. We look forward to sharing these results and other XPOVIO data with the broader medical and scientific community."
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JohnLocke101 JohnLocke101 3 years ago
Looking like a good entry point. Selling overdone.
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trendzone trendzone 3 years ago
Major short squeeze setting up better not be taking this short over the weekend, unless you like looking at a big red screen.
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trendzone trendzone 3 years ago
CNBC after hours yesterday, analyst interview on stocks that have very large short positions that are the kind of stocks that could have a GameStop short squeeze attack by traders, this stock was on a list five stocks with the most risk of shorts getting caught in a major short squeeze breakout.
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starbuxsux starbuxsux 4 years ago
Public Offering to raise money

https://investorshub.advfn.com/Public-Offering-Hunters-26348/
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Bcbrasseur Bcbrasseur 4 years ago
Offering?
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starbuxsux starbuxsux 4 years ago
last couple days has been creeping up and could be under radar
Maybe an offering coming...who knows
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Bcbrasseur Bcbrasseur 4 years ago
Huge! How has this not caused the stock to add 30%?! Seriously! This should run to $25 with news!
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starbuxsux starbuxsux 4 years ago
$KPTI - Karyopharm Announces FDA Approval of XPOVIO(R) (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

11:25 AM ET 6/22/20 | GlobeNewswire


Karyopharm Announces FDA Approval of XPOVIO(R) (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

-- XPOVIO is Now the Only Single-Agent, Oral Therapy Approved for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma, Including DLBCL Arising from Follicular Lymphoma --

-- XPOVIO is the First and Only FDA-Approved Drug for Use in Both Multiple Myeloma and DLBCL --

-- Conference Call Scheduled for Today at 12:30 p.m. Eastern Time --

NEWTON, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved oral XPOVIO(R) (selinexor), the Company's first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication was approved based on response rate under the FDA's Accelerated Approval Program, which was developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

XPOVIO will be commercially available immediately in this new indication in the U.S. and Karyopharm will leverage its existing commercial infrastructure to market this second oncology indication. A Marketing Authorization Application for selinexor for relapsed or refractory DLBCL is planned for submission to the European Medicines Agency in 2021.

"The accelerated approval of oral XPOVIO in patients with relapsed or refractory DLBCL is a significant milestone for the patients and families who currently have limited treatment options available for their disease," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "This approval marks the first for an oral agent for patients with previously treated DLBCL and the first approval of any single drug for this highly aggressive type of lymphoma. Additionally, this is now the second commercial oncology indication for XPOVIO, highlighting its novel mechanism of action, ease of administration and ability to produce rapid and durable responses in patients with heavily pretreated disease. We share this tremendous achievement with the patients, employees, caregivers and physicians who have tirelessly contributed to the advancement of XPOVIO from its original discovery and clinical development to today's second FDA approval."

"For the significant number of patients with relapsed or refractory DLBCL, there is an important need for new therapies for this particularly vulnerable patient population. Unfortunately, despite often multiple types of chemotherapy and targeted-drug combination therapy, many patients have disease which continues to progress," said John P. Leonard, MD, the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medicine and an oncologist at NewYork-Presbyterian/Weill Cornell Medical Center.(1) "Single agent, oral XPOVIO demonstrated a clinically meaningful overall response rate of 29%, including a complete response rate of 13%, in the pivotal SADAL study across several disease subtypes. Importantly, some patient responses were durable with 38% of responding patients maintaining a response at 6 months. The clinical profile and tolerability of oral XPOVIO provides physicians and patients with a new treatment alternative to traditional intravenous chemotherapy regimens."

"We will initiate our XPOVIO commercial launch efforts in DLBCL immediately, expanding our reach across the country for cancer patients in need," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "Since our founding in 2008, Karyopharm has been focused on exploring the potential of nuclear transport modulators and we are thrilled to now enter this new chapter of growth with our dual-commercialization of the first and only nuclear export inhibitor approved in the U.S."

About the Phase 2b SADAL Study

The accelerated FDA approval of XPOVIO is based on the results from the multi-center, single-arm Phase 2b SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study (NCT02227251), which evaluated 134 patients (median of 2 prior systemic therapies with a range of 1-5) with relapsed or refractory DLBCL. Patients were administered a fixed 60 mg dose of XPOVIO given orally twice weekly for a four-week cycle. Patients with germinal center B-cell (GCB) or non-GCB subtypes of DLBCL were included in enrollment.

The SADAL study met its primary endpoint of overall response rate (ORR) with an ORR of 29%, including 18 (13%) complete responses (CRs) and 21 (16%) partial responses (PRs).

Key secondary endpoints included a median duration of response (DOR) in the responding patients. In the responding patients, 56% maintained a response at 3 months, 38% at 6 months and 15% at 12 months.

All 134 patients were included in the safety analyses. The most common treatment-related adverse events (AEs) were cytopenias along with gastrointestinal and constitutional symptoms and were generally reversible and managed with dose modifications and/or standard supportive care. The most common non-hematologic AEs were fatigue (63%), nausea (57%), decreased appetite (37%), and diarrhea (37%), and were mostly Grade 1 and 2 events. Grade 3 and 4 laboratory abnormalities in >=15% of patients included thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. Grade 4 laboratory abnormalities in >=5% of patients were thrombocytopenia (18%), lymphopenia (5%), and neutropenia (9%).

As part of the FDA accelerated approval, the FDA has agreed that the XPORT-DLBCL-030 study could serve as the confirmatory trial for evaluating selinexor in DLBCL. This trial will assess the effect of selinexor or placebo added to a standard backbone immunochemotherapy of rituximab-gemcitabine-dexamethasone-platinum (R-GDP) in patients with 1-3 prior treatments for DLBCL. The rationale for this study is based on data from the ongoing Phase 1B study being conducted by the French Lymphoma Academic Research Organization (LYSARC) (NCT02741388). Karyopharm anticipates the XPORT-DLBCL-030 study will begin by the end of 2020.

Conference Call Information

Karyopharm will host a conference call today, Monday, June 22, 2020, at 12:30 p.m. Eastern Time, to discuss the FDA's approval of XPOVIO for the treatment of patients with relapsed or refractory DLBCL. To access the conference call, please dial (855) 437-4406 (local) or (484) 756-4292 (international) at least 10 minutes prior to the start time and refer to conference ID 8794658. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's website, http://investors.karyopharm.com/events-presentations. An archived webcast will be available on the Company's website approximately two hours after the event.

About XPOVIO(R) (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm submitted a supplemental New Drug Application (sNDA) to the FDA requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy based on the positive results from the Phase 3 BOSTON study which evaluated selinexor in combination with Velcade(R) (bortezomib) and low-dose dexamethasone. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm's products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326

Email: medicalinformation@karyopharm.com

IMPORTANT SAFETY INFORMATION

(MORE TO FOLLOW) Dow Jones Newswires

June 22, 2020 11:25 ET (15:25 GMT)

πŸ‘οΈ0
starbuxsux starbuxsux 4 years ago
$KPTI - Karyopharm Announces FDA Approval of XPOVIO(R) (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

11:25 AM ET 6/22/20 | GlobeNewswire


Karyopharm Announces FDA Approval of XPOVIO(R) (selinexor) for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma (DLBCL)

-- XPOVIO is Now the Only Single-Agent, Oral Therapy Approved for the Treatment of Patients with Relapsed or Refractory Diffuse Large B-cell Lymphoma, Including DLBCL Arising from Follicular Lymphoma --

-- XPOVIO is the First and Only FDA-Approved Drug for Use in Both Multiple Myeloma and DLBCL --

-- Conference Call Scheduled for Today at 12:30 p.m. Eastern Time --

NEWTON, Mass., June 22, 2020 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (Nasdaq:KPTI), an innovation-driven pharmaceutical company, today announced that the U.S. Food and Drug Administration (FDA) has approved oral XPOVIO(R) (selinexor), the Company's first-in-class, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least two lines of systemic therapy. This indication was approved based on response rate under the FDA's Accelerated Approval Program, which was developed to allow for expedited approval of drugs that treat serious conditions and that fill an unmet medical need. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial(s).

XPOVIO will be commercially available immediately in this new indication in the U.S. and Karyopharm will leverage its existing commercial infrastructure to market this second oncology indication. A Marketing Authorization Application for selinexor for relapsed or refractory DLBCL is planned for submission to the European Medicines Agency in 2021.

"The accelerated approval of oral XPOVIO in patients with relapsed or refractory DLBCL is a significant milestone for the patients and families who currently have limited treatment options available for their disease," said Sharon Shacham, PhD, MBA, Founder, President and Chief Scientific Officer of Karyopharm. "This approval marks the first for an oral agent for patients with previously treated DLBCL and the first approval of any single drug for this highly aggressive type of lymphoma. Additionally, this is now the second commercial oncology indication for XPOVIO, highlighting its novel mechanism of action, ease of administration and ability to produce rapid and durable responses in patients with heavily pretreated disease. We share this tremendous achievement with the patients, employees, caregivers and physicians who have tirelessly contributed to the advancement of XPOVIO from its original discovery and clinical development to today's second FDA approval."

"For the significant number of patients with relapsed or refractory DLBCL, there is an important need for new therapies for this particularly vulnerable patient population. Unfortunately, despite often multiple types of chemotherapy and targeted-drug combination therapy, many patients have disease which continues to progress," said John P. Leonard, MD, the Richard T. Silver Distinguished Professor of Hematology and Medical Oncology at Weill Cornell Medicine and an oncologist at NewYork-Presbyterian/Weill Cornell Medical Center.(1) "Single agent, oral XPOVIO demonstrated a clinically meaningful overall response rate of 29%, including a complete response rate of 13%, in the pivotal SADAL study across several disease subtypes. Importantly, some patient responses were durable with 38% of responding patients maintaining a response at 6 months. The clinical profile and tolerability of oral XPOVIO provides physicians and patients with a new treatment alternative to traditional intravenous chemotherapy regimens."

"We will initiate our XPOVIO commercial launch efforts in DLBCL immediately, expanding our reach across the country for cancer patients in need," said Michael G. Kauffman, MD, PhD, Chief Executive Officer of Karyopharm. "Since our founding in 2008, Karyopharm has been focused on exploring the potential of nuclear transport modulators and we are thrilled to now enter this new chapter of growth with our dual-commercialization of the first and only nuclear export inhibitor approved in the U.S."

About the Phase 2b SADAL Study

The accelerated FDA approval of XPOVIO is based on the results from the multi-center, single-arm Phase 2b SADAL (Selinexor Against Diffuse Aggressive Lymphoma) study (NCT02227251), which evaluated 134 patients (median of 2 prior systemic therapies with a range of 1-5) with relapsed or refractory DLBCL. Patients were administered a fixed 60 mg dose of XPOVIO given orally twice weekly for a four-week cycle. Patients with germinal center B-cell (GCB) or non-GCB subtypes of DLBCL were included in enrollment.

The SADAL study met its primary endpoint of overall response rate (ORR) with an ORR of 29%, including 18 (13%) complete responses (CRs) and 21 (16%) partial responses (PRs).

Key secondary endpoints included a median duration of response (DOR) in the responding patients. In the responding patients, 56% maintained a response at 3 months, 38% at 6 months and 15% at 12 months.

All 134 patients were included in the safety analyses. The most common treatment-related adverse events (AEs) were cytopenias along with gastrointestinal and constitutional symptoms and were generally reversible and managed with dose modifications and/or standard supportive care. The most common non-hematologic AEs were fatigue (63%), nausea (57%), decreased appetite (37%), and diarrhea (37%), and were mostly Grade 1 and 2 events. Grade 3 and 4 laboratory abnormalities in >=15% of patients included thrombocytopenia, lymphopenia, neutropenia, anemia, and hyponatremia. Grade 4 laboratory abnormalities in >=5% of patients were thrombocytopenia (18%), lymphopenia (5%), and neutropenia (9%).

As part of the FDA accelerated approval, the FDA has agreed that the XPORT-DLBCL-030 study could serve as the confirmatory trial for evaluating selinexor in DLBCL. This trial will assess the effect of selinexor or placebo added to a standard backbone immunochemotherapy of rituximab-gemcitabine-dexamethasone-platinum (R-GDP) in patients with 1-3 prior treatments for DLBCL. The rationale for this study is based on data from the ongoing Phase 1B study being conducted by the French Lymphoma Academic Research Organization (LYSARC) (NCT02741388). Karyopharm anticipates the XPORT-DLBCL-030 study will begin by the end of 2020.

Conference Call Information

Karyopharm will host a conference call today, Monday, June 22, 2020, at 12:30 p.m. Eastern Time, to discuss the FDA's approval of XPOVIO for the treatment of patients with relapsed or refractory DLBCL. To access the conference call, please dial (855) 437-4406 (local) or (484) 756-4292 (international) at least 10 minutes prior to the start time and refer to conference ID 8794658. A live audio webcast of the call will be available under "Events & Presentations" in the Investor section of the Company's website, http://investors.karyopharm.com/events-presentations. An archived webcast will be available on the Company's website approximately two hours after the event.

About XPOVIO(R) (selinexor)

XPOVIO is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. XPOVIO functions by selectively binding to and inhibiting the nuclear export protein exportin 1 (XPO1, also called CRM1). XPOVIO blocks the nuclear export of tumor suppressor, growth regulatory and anti-inflammatory proteins, leading to accumulation of these proteins in the nucleus and enhancing their anti-cancer activity in the cell. The forced nuclear retention of these proteins can counteract a multitude of the oncogenic pathways that, unchecked, allow cancer cells with severe DNA damage to continue to grow and divide in an unrestrained fashion. Karyopharm received accelerated U.S. Food and Drug Administration (FDA) approval of XPOVIO in July 2019 in combination with dexamethasone for the treatment of adult patients with relapsed refractory multiple myeloma (RRMM) who have received at least four prior therapies and whose disease is refractory to at least two proteasome inhibitors, at least two immunomodulatory agents, and an anti-CD38 monoclonal antibody. Karyopharm has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with a request for conditional approval of selinexor in this same RRMM indication. Karyopharm submitted a supplemental New Drug Application (sNDA) to the FDA requesting an expansion of its current indication to include the treatment for patients with multiple myeloma after at least one prior line of therapy based on the positive results from the Phase 3 BOSTON study which evaluated selinexor in combination with Velcade(R) (bortezomib) and low-dose dexamethasone. In June 2020, Karyopharm received accelerated FDA approval of XPOVIO for its second indication in adult patients with relapsed or refractory diffuse large B-cell lymphoma (DLBCL), not otherwise specified, including DLBCL arising from follicular lymphoma, after at least 2 lines of systemic therapy. Selinexor is also being evaluated in several other mid-and later-phase clinical trials across multiple cancer indications, including as a potential backbone therapy in combination with approved myeloma therapies (STOMP), in liposarcoma (SEAL) and in endometrial cancer (SIENDO), among others. Additional Phase 1, Phase 2 and Phase 3 studies are ongoing or currently planned, including multiple studies in combination with approved therapies in a variety of tumor types to further inform Karyopharm's clinical development priorities for selinexor. Additional clinical trial information for selinexor is available at www.clinicaltrials.gov.

For more information about Karyopharm's products or clinical trials, please contact the Medical Information department at:

Tel: +1 (888) 209-9326

Email: medicalinformation@karyopharm.com

IMPORTANT SAFETY INFORMATION

(MORE TO FOLLOW) Dow Jones Newswires

June 22, 2020 11:25 ET (15:25 GMT)

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ClayTrader ClayTrader 4 years ago
* * $KPTI Video Chart 03-02-2020 * *

Link to Video - click here to watch the technical chart video

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Pyramid2 Pyramid2 5 years ago
We trading 16's now just a slow grinder up...
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ClayTrader ClayTrader 5 years ago
* * $KPTI Video Chart 10-08-2019 * *

Link to Video - click here to watch the technical chart video

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Pyramid2 Pyramid2 5 years ago
MM - cleaning house!, stopped out. How low will this go? $9 looking today.

lets see
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ClayTrader ClayTrader 5 years ago
* * $KPTI Video Chart 09-05-2019 * *

Link to Video - click here to watch the technical chart video

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J-Money99 J-Money99 5 years ago
10 by end of month?
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Pyramid2 Pyramid2 5 years ago
We trading 9's now this week no 8's and its only getting better imo, glta.
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DorseyE DorseyE 5 years ago
Why Karyopharm Therapeutics Is Up Today

Motley Fool
Brian Feroldi, The Motley Fool
Motley FoolJuly 23, 2019
What happened

Shares of Karyopharm Therapeutics (NASDAQ: KPTI), a commercial-stage biopharmaceutical company focused on oncology, rose as much as 10% in early-morning trading on Tuesday. Shares were up about 7% as of 11:45 a.m. EST.

So what

Investors can thank Eric Joseph, an analyst at JPMorgan, for today's bullish move. Joseph upgraded Karyopharm's stock to overweight and raised his price target to $16. That's much higher than yesterday's closing price of $8.33.

Joseph's bullishness on Karyopharm's stock is a result of a recent survey of doctors that showed 75% of respondents planned on prescribing its newly FDA-approved multiple myeloma drug Xpovio within the next year.

Traders are cheering in response to the analyst upgrade and the upbeat survey results.
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Pyramid2 Pyramid2 5 years ago
She just broke into the 8's, moving on up.
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ClayTrader ClayTrader 5 years ago
* * $KPTI Video Chart 07-15-2019 * *

Link to Video - click here to watch the technical chart video

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Pyramid2 Pyramid2 5 years ago
Good things happening for sure here, 2x'd my equity position.
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superpsiboy superpsiboy 5 years ago
Yes!
Sales!
Fastest update ever!
And upgrades!
And I hit on my July Calls!
YES
POSITIVV! POSITIVE! POSITIVE!
CROSS YOUR FINGERS!
ZOOM
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Pyramid2 Pyramid2 5 years ago
You like $8 area. mmmmmm, sales started today. CTU.
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opinions opinions 5 years ago
Known b*sher, so you’re incorrect
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opinions opinions 5 years ago
Where you at c. -n T? GXX’ shrs filled for you and stopped b*shing? Come back
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DorseyE DorseyE 5 years ago
Will Karyopharm Therapeutics Continue to Surge Higher?

Zacks
Zacks Equity Research
ZacksJuly 9, 2019
https://finance.yahoo.com/news/karyopharm-therapeutics-continue-surge-higher-113511287.html
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DorseyE DorseyE 5 years ago
I hope you trading a lotta shares with low commissions!
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ivarga ivarga 5 years ago
Where is this piece of garbage going?
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Pyramid2 Pyramid2 5 years ago
Drug sales start no later than 7/10., guess it is a swing trade, to a super nova on a PR. GLTA.
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stock1ace1 stock1ace1 5 years ago
Made several .20 / .10 cent flips today great day :D
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