karyopharm therapeutics (kpti)

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Re: Karyopharm Therapeutics : KPTI

Berichtdoor frikandel75 » 24 Mei 2018 16:47

Ze geven hun goudhaantje uit handen :o



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Re: Karyopharm Therapeutics : KPTI

Berichtdoor frikandel75 » 30 Mei 2018 13:49

Koers herstellende ... :geek:

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Re: Karyopharm Therapeutics : KPTI

Berichtdoor frikandel75 » 01 Jun 2018 16:23

Asco blijkbaar niet direct een push-up :|

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Re: Karyopharm Therapeutics : KPTI

Berichtdoor frikandel75 » 18 Jul 2018 13:09

Topaandeel imho :clap:
alles kan beter liked last!

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Re: Karyopharm Therapeutics : KPTI

Berichtdoor alles kan beter » 18 Jul 2018 15:19

July 18 (Reuters) - Karyopharm Therapeutics Inc :
* KARYOPHARM INITIATES ROLLING SUBMISSION OF NEW DRUG
APPLICATION
TO U.S. FOOD AND DRUG ADMINISTRATION FOR SELINEXOR AS A
TREATMENT FOR PATIENTS WITH PENTA-REFRACTORY MULTIPLE MYELOMA
* KARYOPHARM THERAPEUTICS INC - COMPANY PLANS TO COMPLETE
SUBMISSION DURING SECOND HALF OF 2018
* KARYOPHARM THERAPEUTICS INC - PENDING MARKETING APPROVAL
BY FDA,
KARYOPHARM PLANS TO COMMERCIALIZE SELINEXOR IN U.S
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Re: Karyopharm Therapeutics : KPTI

Berichtdoor frikandel75 » 20 Jul 2018 02:40

Eerder flauwe reactie op fundamenteel goed nieuws :wtf:

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karyopharm therapeutics (kpti)

Berichtdoor alles kan beter » 07 Aug 2018 06:52

ISIN: US48576U1060

bedrijf heeft een aanvraag tot goedkeuring lopen bij de fda, persbericht van 6/8/18 :

KARYOPHARM COMPLETES ROLLING SUBMISSION OF NEW DRUG
APPLICATION
TO U.S. FOOD AND DRUG ADMINISTRATION FOR SELINEXOR AS A
TREATMENT FOR PATIENTS WITH PENTA-REFRACTORY MULTIPLE MYELOMA
* KARYOPHARM THERAPEUTICS INC - KARYOPHARM PLANS TO
COMMERCIALIZE
SELINEXOR IN U.
* KARYOPHARM THERAPEUTICS- SHOULD APPLICATION BE APPROVED BY
FDA,
SELINEXOR COULD BECOME AVAILABLE IN H1 2019
* KARYOPHARM THERAPEUTICS INC - PLANS TO SUBMIT MARKETING
AUTHORIZATION APPLICATION TO EMA IN EARLY 2019
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Re: karyopharm therapeutics (kpti)

Berichtdoor alles kan beter » 18 Aug 2018 07:02

We have entered into an Open Market Sales AgreementSM, or sales agreement, with Jefferies LLC, or Jefferies, dated August 17, 2018, relating to the sale of shares of our common stock offered by this prospectus supplement and the accompanying prospectus. In accordance with the terms of the sales agreement, under this prospectus supplement we may offer and sell shares of our common stock, $0.0001 par value per share, having an aggregate offering price of up to $75,000,000 from time to time through Jefferies, acting as our agent.
We are an “emerging growth company” under federal securities laws and are subject to reduced public company disclosure standards. See “Prospectus Supplement Summary—Implications of Being an Emerging Growth Company.”
Sales of our common stock, if any, under this prospectus supplement and the accompanying prospectus may be made by any method permitted that is deemed an “at the market offering” as defined in Rule 415(a)(4) promulgated under the Securities Act of 1933, as amended, or the Securities Act, including sales made directly on or through The Nasdaq Global Select Market, the existing trading market for our common stock. Jefferies is not required to sell any specific amount, but will act as our sales agent using commercially reasonable efforts consistent with its normal trading and sales practices. There is no arrangement for funds to be received in any escrow, trust or similar arrangement.
Jefferies will be entitled to compensation at a commission rate of up to 3.0% of the gross sales price per share sold under the sales agreement. See “Plan of Distribution” beginning on page S-15 for additional information regarding the compensation to be paid to Jefferies. In connection with the sale of our common stock on our behalf, Jefferies will be deemed to be an “underwriter” within the meaning of the Securities Act and the compensation of Jefferies will be deemed to be underwriting commissions or discounts. We have also agreed to provide indemnification and contribution to Jefferies with respect to certain liabilities, including liabilities under the Securities Act
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Re: karyopharm therapeutics (kpti)

Berichtdoor alles kan beter » 14 Sep 2018 06:26

Management to Host Conference Call Tomorrow, September 14, 2018 at 8:00 a.m. ET --
NEWTON, Mass., Sept. 13, 2018 (GLOBE NEWSWIRE) -- Karyopharm Therapeutics Inc. (KPTI), a clinical-stage pharmaceutical company, today announced that updated clinical data from the Phase 2b STORM (Selinexor Treatment of Refractory Myeloma) study evaluating selinexor, the Company’s lead, oral Selective Inhibitor of Nuclear Export (SINE) compound, in heavily pretreated patients with penta-refractory multiple myeloma, were presented during an oral session at the Society of Hematologic Oncology (SOHO) 2018 Annual Meeting on September 13, 2018, in Houston. Sundar Jagannath, MD, Director of the Multiple Myeloma Program, Professor of Medicine (Hematology and Medical Oncology) at Tisch Cancer Institute at Mount Sinai School of Medicine, and principal investigator of the STORM study, presented the data in a session entitled, “Phase 2b Results of the STORM Study: Oral Selinexor plus Low Dose Dexamethasone (Sd) in Patients with Penta-Refractory Myeloma.”
“The additional Phase 2b clinical results presented today are very encouraging for the patients suffering from penta-refractory multiple myeloma and their families. Most notably, the overall response rate (ORR) for patients treated with oral selinexor and dexamethasone (dex; Sd) was 26.2% with median duration of response (DOR) of 4.4 months based on the Independent Review Committee (IRC) assessment, along with a median overall survival (OS) across the entire study of 8.6 months,” said Dr. Jagannath. “Of particular significance, for the nearly 40% of patients who had a minimal response (MR) or better, the median survival was 15.6 months, which provided the opportunity for a meaningful clinical benefit for patients on the STORM study with advanced penta-refractory myeloma that is difficult to treat.”
Dan Vogl, MD, MSCE, Assistant Professor of Medicine at the Hospital of the University of Pennsylvania, commented, “The results from the Phase 2b STORM study showed that selinexor resulted in a meaningful clinical benefit in this heavily pretreated patient population. This includes patients treated with the most modern combination therapies and most exciting experimental therapies. For example, the overall response rate was 29.1% in patients who had previously been treated with daratumumab combination regimens, and the two patients on the STORM study who had previously received investigational CAR-T cell therapy both achieved partial responses on selinexor and dexamethasone. These results provide further evidence that selective inhibition of nuclear export could be an effective strategy for myeloma therapy and of selinexor's potential to be a new option for patients with penta-refractory multiple myeloma.”
“Patients with highly resistant myeloma have very few treatment options available, which underscores the urgent need for the advancement of therapies with novel mechanisms, like selinexor,” said Sharon Shacham, PhD, Founder, President and Chief Scientific Officer of Karyopharm. “The 26.2% ORR from the STORM study is particularly meaningful considering that 96% of the patients had myeloma refractory to Kyprolis®, Pomalyst® and Darzalex®, and nearly 70% of patients had disease that was confirmed to be refractory to all five of the standard of care myeloma drugs, Revlimid®, Velcade®, Pomalyst®, Kyprolis®, and Darzalex®. These results reinforce the potential of selinexor in this difficult to treat patient population. Following our recent submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for selinexor with low dose dexamethasone, we are making great strides in building our key commercial capabilities as we prepare for a potential initial market launch, which could be as early as the first half of 2019. We also remain on track to submit a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) in the first quarter of 2019 for conditional approval in the same disease indication.”
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