ADVFN Logo ADVFN

We could not find any results for:
Make sure your spelling is correct or try broadening your search.

Trending Now

Toplists

It looks like you aren't logged in.
Click the button below to log in and view your recent history.

Hot Features

Registration Strip Icon for smarter Trade smarter, not harder: Unleash your inner pro with our toolkit and live discussions.
Karyopharm Therapeutics Inc

Karyopharm Therapeutics Inc (KPTI)

1.05
-0.01
(-0.94%)
At close: April 26 4:00PM
1.06
0.00
( 0.00% )
After Hours: 4:00PM

Unlock more advanced trading tools

Join ADVFN today

Key stats and details

Current Price
1.06
Bid
1.03
Ask
1.08
Volume
657,783
1.02 Day's Range 1.08
0.6174 52 Week Range 3.865
Market Cap
Previous Close
1.06
Open
1.05
Last Trade Time
16:02:02
Financial Volume
$ 688,512
VWAP
1.0467
Average Volume (3m)
1,831,730
Shares Outstanding
115,067,083
Dividend Yield
-
PE Ratio
-0.85
Earnings Per Share (EPS)
-1.24
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 $1.06. Over the last year, Karyopharm Therapeutics shares have traded in a share price range of $ 0.6174 to $ 3.865.

Karyopharm Therapeutics currently has 115,067,083 shares outstanding. The market capitalization of Karyopharm Therapeutics is $121.97 million. Karyopharm Therapeutics has a price to earnings ratio (PE ratio) of -0.85.

KPTI Latest News

Karyopharm Announces Presentations in Endometrial Cancer and Myelofibrosis at the 2024 American Society of Clinical Oncology Annual Meeting

Karyopharm Announces Presentations in Endometrial Cancer and Myelofibrosis at the 2024 American Society of Clinical Oncology Annual Meeting PR Newswire NEWTON, Mass., April 24, 2024 Invited to...

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., April 1, 2024 NEWTON, Mass., April 1, 2024 /PRNewswire/ -- Karyopharm...

Karyopharm to Participate at Barclays 26th Annual Global Healthcare and Leerink Partners Global Biopharma Conferences

Karyopharm to Participate at Barclays 26th Annual Global Healthcare and Leerink Partners Global Biopharma Conferences PR Newswire NEWTON, Mass., March 6, 2024 NEWTON, Mass., March 6, 2024...

PeriodChangeChange %OpenHighLowAvg. Daily VolVWAP
1-0.2-15.8730158731.261.3051.0211297541.11464652CS
4-0.45-29.80132450331.511.651.0211654351.27265722CS
120.1516.48351648350.911.950.860118317301.37732859CS
260.2327.71084337350.831.950.617414834341.13125308CS
52-2.71-71.88328912473.773.8650.617419349161.61084781CS
156-8.32-88.69936034129.3814.730.617421765794.85358198CS
260-3.74-77.91666666674.829.610.617420235888.3122401CS

Market Movers

View all
  • Most Active
  • % Gainers
  • % Losers
SymbolPriceVol.
AAGRAfrican Agriculture Holdings Inc
$ 0.00
(0.00%)
0
AADRAdvisorShares Dorsey Wright ADR ETF
$ 0.00
(0.00%)
0
AADIAadi Bioscience Inc
$ 0.00
(0.00%)
0
AACIArmada Acquisition Corporation I
$ 0.00
(0.00%)
0
AACGATA Creativity Global
$ 0.00
(0.00%)
0
AAGRAfrican Agriculture Holdings Inc
$ 0.00
(0.00%)
0
AADRAdvisorShares Dorsey Wright ADR ETF
$ 0.00
(0.00%)
0
AADIAadi Bioscience Inc
$ 0.00
(0.00%)
0
AACIArmada Acquisition Corporation I
$ 0.00
(0.00%)
0
AACGATA Creativity Global
$ 0.00
(0.00%)
0
AAGRAfrican Agriculture Holdings Inc
$ 0.00
(0.00%)
0
AADRAdvisorShares Dorsey Wright ADR ETF
$ 0.00
(0.00%)
0
AADIAadi Bioscience Inc
$ 0.00
(0.00%)
0
AACIArmada Acquisition Corporation I
$ 0.00
(0.00%)
0
AACGATA Creativity Global
$ 0.00
(0.00%)
0

KPTI Discussion

View Posts
ilovestocks85 ilovestocks85 4 weeks ago
Time to start loading again
πŸ‘οΈ0
Monksdream Monksdream 4 weeks ago
KPTI under $2
πŸ‘οΈ0
glenn1919 glenn1919 4 weeks ago
KPTI..........................................https://stockcharts.com/h-sc/ui?s=KPTI&p=W&b=5&g=0&id=p86431144783
πŸ‘οΈ0
glenn1919 glenn1919 2 months ago
KPTI.........................................https://stockcharts.com/h-sc/ui?s=KPTI&p=W&b=5&g=0&id=p86431144783
πŸ‘οΈ0
MilitaryDeals MilitaryDeals 2 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 9 months ago
$KPTI - Up 20% Pre-Market/ Current Price $1.85
Receives FDA Fast Track Designation for Selinexor for the Treatment of Myelofibrosis
πŸ‘οΈ0
tw0122 tw0122 9 months ago
Karyopharm Gets FDA Fast Track Designation for Myelofibrosis Treatment
πŸ‘οΈ0
muchogusto muchogusto 10 months ago
Correction β€œseems to be on a perpetual slide”
πŸ‘οΈ0
muchogusto muchogusto 10 months ago
Dcaf7, what are your current thoughts on KPTI? The stock seems toon a perpetual slide. Is there going to be dilution soon?
πŸ‘οΈ0
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
πŸ‘οΈ0
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
πŸ‘οΈ0
JohnLocke101 JohnLocke101 2 years ago
Great move on earnings today.
πŸ‘οΈ0
crudeoil24 crudeoil24 2 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."
πŸ‘οΈ0
ipo_dude ipo_dude 3 years ago
$10 yet?
πŸ‘οΈ0
artfulife artfulife 3 years ago
Waited a while for sp to break above my $9.82 cost basis. Happily holding just over 1000 shares.
πŸ‘οΈ0
MfridgeV2 MfridgeV2 3 years ago
Might be just you and I… more soon I assume.
πŸ‘οΈ0
JohnLocke101 JohnLocke101 3 years ago
Mama said there’d be days like this.
πŸ‘οΈ0
JohnLocke101 JohnLocke101 3 years ago
It’d be a real shame if this broke up over $10

Good Luck!
πŸ‘οΈ0
JohnLocke101 JohnLocke101 3 years ago
Heavy short interest.

Good Luck!
πŸ‘οΈ0
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."
πŸ‘οΈ0
JohnLocke101 JohnLocke101 3 years ago
Looking like a good entry point. Selling overdone.
πŸ‘οΈ0
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.
πŸ‘οΈ0
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.
πŸ‘οΈ0
starbuxsux starbuxsux 4 years ago
Public Offering to raise money

https://investorshub.advfn.com/Public-Offering-Hunters-26348/
πŸ‘οΈ0
Bcbrasseur Bcbrasseur 4 years ago
Offering?
πŸ‘οΈ0
starbuxsux starbuxsux 4 years ago
last couple days has been creeping up and could be under radar
Maybe an offering coming...who knows
πŸ‘οΈ0
Bcbrasseur Bcbrasseur 4 years ago
Huge! How has this not caused the stock to add 30%?! Seriously! This should run to $25 with news!
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)

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)

πŸ‘οΈ0
ClayTrader ClayTrader 4 years ago
* * $KPTI Video Chart 03-02-2020 * *

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

πŸ‘οΈ0
Pyramid2 Pyramid2 4 years ago
We trading 16's now just a slow grinder up...
πŸ‘οΈ0
ClayTrader ClayTrader 5 years ago
* * $KPTI Video Chart 10-08-2019 * *

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

πŸ‘οΈ0
Pyramid2 Pyramid2 5 years ago
MM - cleaning house!, stopped out. How low will this go? $9 looking today.

lets see
πŸ‘οΈ0
ClayTrader ClayTrader 5 years ago
* * $KPTI Video Chart 09-05-2019 * *

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

πŸ‘οΈ0
J-Money99 J-Money99 5 years ago
10 by end of month?
πŸ‘οΈ0
Pyramid2 Pyramid2 5 years ago
We trading 9's now this week no 8's and its only getting better imo, glta.
πŸ‘οΈ0
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.
πŸ‘οΈ0
Pyramid2 Pyramid2 5 years ago
She just broke into the 8's, moving on up.
πŸ‘οΈ0
ClayTrader ClayTrader 5 years ago
* * $KPTI Video Chart 07-15-2019 * *

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

πŸ‘οΈ0
Pyramid2 Pyramid2 5 years ago
Good things happening for sure here, 2x'd my equity position.
πŸ‘οΈ0
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
πŸ‘οΈ0
Pyramid2 Pyramid2 5 years ago
You like $8 area. mmmmmm, sales started today. CTU.
πŸ‘οΈ0
opinions opinions 5 years ago
Known b*sher, so you’re incorrect
πŸ‘οΈ0
opinions opinions 5 years ago
Where you at c. -n T? GXX’ shrs filled for you and stopped b*shing? Come back
πŸ‘οΈ0
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
πŸ‘οΈ0
DorseyE DorseyE 5 years ago
I hope you trading a lotta shares with low commissions!
πŸ‘οΈ0
ivarga ivarga 5 years ago
Where is this piece of garbage going?
πŸ‘οΈ0
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.
πŸ‘οΈ0
stock1ace1 stock1ace1 5 years ago
Made several .20 / .10 cent flips today great day :D
πŸ‘οΈ0
DorseyE DorseyE 5 years ago
Revisiting Karyopharm Therapeutics

Jul. 8, 2019 2:57 PM ET | About: Karyopharm Therapeutics Inc. (KPTI)

Summary
One of the biggest risers in the market last week was a small oncology concern called Karyopharm Therapeutics, which was up some 45%.

An early and unexpected FDA approval triggered the big rise in the shares.

We revisit Karyopharm in the paragraphs below and highlight some other potential catalysts on the horizon.

Looking for a portfolio of ideas like this one? Members of The Busted IPO Forum get exclusive access to our model portfolio. Get started today »

"A ship is safe in harbor, but that's not what ships are for." - John A. Shedd
One of the big winners in the market last week and for the model portfolio of The Busted IPO Forum was a small-cap oncology concern named Karyopharm Therapeutics (KPTI). The stock soared just over 45% this week on the unexpected early FDA approval for its primary drug candidate selinexor.



Today, we revisit the investment case for Karyopharm now that a major uncertainty has been removed for the company.

Company Overview

Karyopharm Therapeutics is a now a "Tier 3" biotech concern based in Massachusetts. The firm is focused on creating novel, first-in-class drugs directed against nuclear transport and related targets for the treatment of cancer and other diseases. With last week's rally, the stock currently has a market capitalization of just under $550 million and trades just south of $9.00 share.

FDA Approval

On Wednesday, the FDA approved selinexor whose brand name will be XPOVIO for the treatment of penta-refractory multiple myeloma. XPOVIO will be "list" priced at $22,000 per month and will start being marketed this month. Approval on July 3rd was unexpected given the PDUFA date was July 6th. In addition, the Ad Comm Panel for XPOVIO voted 8-5 to delay recommendation for approval until results of a large-scale study known as "BOSTON" came out. This data will not be disclosed until late this year or early 2020.

Source: Company Presentation

XPOVIO is an oral, first-in-class, reversible, potent, selective inhibitor of nuclear export (SINE) that specifically blocks XPO1

Source: Company Presentation

The myeloma market is quite large with multiple players and an annual spend north of $17 billion annually. The niche Karyopharm is targeting is already significant and projected to grow rapidly in the coming years.

Analyst Commentary & Balance Sheet

On Friday, H.C. Wainwright reiterated its Buy rating and $32 price target on KPTI with the following updated view on the company:

"We find the label compelling and in line with expectations. Commercial launch for Xpovio expected next week. Karyopharm has developed a strategic plan going forward in order to ensure a successful launch of Xpovio, which management believes gives support to future launches in other indications as well. The company hired over 70 employees, with an average of about 20 years pharmaceutical experience and approximately five years of MM experience, in sales and nursing liaison positions in January 2019. The sales team plans on educating professionals and patients regarding how to effectively administer the drug and guiding them through the drug's side effect profile. Karyopharm is working with payors and is attempting to minimize access barriers for appropriate patients as well as helping them stay on treatment."
Wedbush also reissued its Buy rating Friday, but with a more subdued $11 price target. In addition, William R. Baird boosted its target by 10 bucks a share to $25. The analyst there is modeling $150 million peak annual sales for the later-line approval and states that accelerated approval de-risks the market in second-line relapsed multiple myeloma which is more meaningful market.

RBC Capital also maintained its buy rating on KPTI, but raised its target to $22 from $16 previously. RBC's analyst noted "the label includes no boxed warning, a win, and while it describes in detail the many AEs (adverse events) associated with Xpovio and the need for monitoring, it provides clear dose- adjustment schemes and guidelines for AE management."

The company ended the first quarter with approximately $265 million in cash and marketable securities on the balance sheet.

Verdict

Source: Company Presentation

Thanks to approval, the investment case for Karyopharm is now considerably derisked. The company also has several potential catalysts on the horizon. Obviously, the BOSTON data will be heavily scrutinized when it comes out. Karyopharm also plans to file an NDA for XPOVIO to treat cancer - diffuse large B-cell lymphoma (DLBCL) in the first half of 2020.

In addition, top line Phase 3 data for XPOVIO studies for treating Dedifferentiated liposarcoma should be out sometime in 2020 as well. While the stock had a good rally this week, the shares are still significantly below 52-week price targets as well as recently revised analyst price targets. This investment story could have further to go in the weeks and months ahead.

Option Strategy

Image result for Stock Purchase

An efficient way to add exposure or to KPTI is via a Buy-Write order. Using the November $10 call strikes, fashion a Buy-Write order with a net debit in the $6.80 to $7.00 range (net stock price - option premium). This mitigates some downside risk and sets up a more than solid potential return for its just over four month hold period.

"So we shall let the reader answer this question for himself: who is the happier man, he who has braved the storm of life and lived or he who has stayed securely on shore and merely existed?" - Hunter S. Thompson
Busted IPO Forum writes on Seeking Alpha and runs The Busted IPO Forum on the Seeking Alpha Marketplace, our platform for guided investing communities and research services.

Bret Jensen is the Founder of and authors articles for the Biotech Forum, Busted IPO Forum and Insiders Forum.

Busted IPO Forum writes on Seeking Alpha and runs The Busted IPO Forum on the Seeking Alpha Marketplace, our platform for guided investing communities and research services. Here’s a little bit about the service.
Author's note: I present and update my best small-cap Busted IPO stock ideas only to subscribers of my exclusive marketplace, The Busted IPO Forum. Try a free 2-week trial today by clicking on our logo below! As of market close 07/05/2019, our 18 stock model portfolio has generated an overall return of 31.22% since its launch in the summer of 2017. The Russell 2000 has produced a return of 4.17% over the same time frame.

Disclosure: I am/we are long KPTI. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article.
πŸ‘οΈ0

Your Recent History

Delayed Upgrade Clock