KARYOPHARM THERAPEUTICS WKN: A1W77U ISIN: US48576U1060 Kürzel: 25K Forum: Aktien Thema: Hauptdiskussion

Jan. 24, 2022 Press Releases Karyopharm Receives Orphan Drug Designation from FDA for Eltanexor for the Treatment of Myelodysplastic Syndromes Karyopharm Therapeutics Inc. (Nasdaq: KPTI), a commercial-stage pharmaceutical company pioneering novel cancer therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted orphan drug designation for eltanexor, a novel oral, Selective Inhibitor of Nuclear Export (SINE) compound, for the treatment of myelodysplastic syndromes (MDS). MDS are a group of diseases characterized by ineffective production of the components of the blood due to poor bone marrow function with a risk of progression to acute myeloid leukemia. Karyopharm is currently investigating eltanexor in an ongoing open-label Phase 1/2 study as a single-agent or in combination with approved and investigational agents in patients with several types of hematologic and solid tumor cancers (KCP-8602-801; NCT02649790). Previously, Karyopharm reported positive data from an investigator-sponsored Phase 1 study evaluating single-agent eltanexor in patients with hypomethylating agent (HMA)-refractory MDS, where eltanexor demonstrated a 53% overall response rate and median overall survival of 9.9 months. This compares favorably to historical survival of four to six months for HMA-refractory MDS patients. Approximately 15,000 people are diagnosed with intermediate-to-high risk MDS each year in the U.S.1 HMAs are the current standard of care for newly diagnosed, higher-risk MDS patients. However, only 40-60% of patients respond, with these responses typically lasting less than two years.2 The prognosis in HMA-refractory disease is poor, with a median overall survival of four to six months.3,4 There are currently no approved therapies for HMA- refractory MDS. "We are pleased to receive the FDA's orphan drug designation for eltanexor in MDS and believe it reinforces eltanexor's potential to improve clinical outcomes for patients with HMA-refractory MDS," said Richard Paulson, President and Chief Executive Officer of Karyopharm. "We are focused on advancing our ongoing clinical trials and remain steadfast in our commitment to bringing this new treatment option to patients and their families." Orphan drug designation by the FDA is granted to promote the development of drugs that target conditions affecting 200,000 or fewer U.S. patients annually and are expected to provide a significant therapeutic advantage over existing treatments. Orphan designation qualifies a company for certain incentives that apply across all stages of drug development, including the potential for seven years of market exclusivity following marketing approval, tax credits on qualified U.S. clinical trials, eligibility for orphan drug grants, and exemption from certain administrative fees. [...] https://investors.karyopharm.com/2022-01-24-Karyopharm-Receives-Orphan-Drug-Designation-from-FDA-for-Eltanexor-for-the-Treatment-of-Myelodysplastic-Syndromes

Press Releases https://investors.karyopharm.com/press-releases Jan 24, 2022 Karyopharm Receives Orphan Drug Designation from FDA for Eltanexor for the Treatment of Myelodysplastic Syndromes Jan 21, 2022 Karyopharm to Present at B. Riley Securities Oncology Investor Conference Jan 10, 2022 Karyopharm Promotes Sohanya Cheng to Chief Commercial Officer Jan 10, 2022 Karyopharm Announces Preliminary Unaudited Fourth Quarter and Full Year 2021 Net Product Revenues and Outlines 2022 Objectives Jan 4, 2022 Karyopharm to Present at 40th Annual J.P. Morgan Healthcare Conference Jan 3, 2022 Karyopharm Therapeutics Reports Inducement Grants Under Nasdaq Listing Rule 5635(c)(4) Dec 21, 2021 Karyopharm and Menarini Group Enter into Exclusive License Agreement to Commercialize NEXPOVIO® (selinexor) in Europe and Other Key Global Territories Dec 17, 2021 Karyopharm's Partner Antengene Receives Approval in China for XPOVIO® (selinexor) for the Treatment of Patients with Relapsed or Refractory Multiple Myeloma Dec 11, 2021 Karyopharm Announces Presentation of Updated Phase 2 Selinexor Data in Patients with Myelofibrosis at the American Society of Hematology 2021 Annual Meeting and Exposition Dec 6, 2021 Karyopharm Announces the Appointment of Peter K Honig, MD, MPH to its Board of Directors

Published: Nov 09, 2021 Antengene to Release Preliminary Results of Selinexor for the Treatment of Peripheral T-Cell Lymphoma and NK/T-Cell Lymphoma at the 2021 ASH Annual Meeting SHANGHAI and HONG KONG,  Nov. 9, 2021 /PRNewswire/ --  Antengene Corporation Limited ("Antengene", SEHK: 6996.HK), a leading innovative global biopharmaceutical company dedicated to discovering, developing and commercializing first-in-class and/or best-in-class therapeutics in hematology and oncology, today announced the acceptance of an abstract at the upcoming 2021 American Society of Hematology (ASH) Annual Meeting, which will be held from December 11-14, 2021, both in Atlanta, Georgia, and virtually at https://www.hematology.org/meetings/annual-meeting. Antengene will release preliminary results of this Company-sponsored open-label Phase 1b study with selinexor (ATG-010) for the treatment of peripheral T-cell lymphoma and NK/T-cell lymphoma, in an offline poster presentation (full text of the abstract available at: https://ash.confex.com/ash/2021/webprogram/Paper147100.html). Meanwhile, another seventeen abstracts related to selinexor and eltanexor will be presented at the 2021 ASH Annual Meeting as announced by Antengene's partner, Karyopharm Therapeutics, Inc. (Karyopharm) (see below for details of these abstracts). "We are very pleased that the poster related to Antengene's selinexor (ATG-010) T-Cell Lymphoma program has been accepted at the 2021 ASH Annual Meeting," said Jay Mei, M.D., Ph.D., Founder, Chairman and Chief Executive Officer of Antengene. "Selinexor is Antengene's first commercial stage product. We look forward to sharing more about this program following the poster session." https://www.biospace.com/article/releases/antengene-to-release-preliminary-results-of-selinexor-for-the-treatment-of-peripheral-t-cell-lymphoma-and-nk-t-cell-lymphoma-at-the-2021-ash-annual-meeting/

Donnerstag, 04. November 2021 20:38 (EST) Karyopharm Therapeutics Inc (NASDAQ: KPTI), ein Unternehmen aus Newton Center, Massachusetts, schloss am Donnerstag bei $7,97, nachdem es bei einem Volumen von 5.065.163 Aktien um $0,03 (0,38%) zugelegt hatte. Die Aktie bewegte sich zwischen einem Höchststand von $8,42 und einem Tiefststand von $7,30, während die Marktkapitalisierung von Karyopharm jetzt bei $601.713.154 liegt. Über Karyopharm Therapeutics Inc. Karyopharm Therapeutics Inc. ist ein pharmazeutisches Unternehmen im kommerziellen Stadium, das Pionierarbeit bei neuartigen Krebstherapien leistet und sich der Entdeckung, Entwicklung und Vermarktung neuartiger First-in-Class-Medikamente widmet, die sich gegen den Kernexport und verwandte Ziele zur Behandlung von Krebs und anderen schweren Krankheiten richten. Karyopharm's selektiver Inhibitor des Nuklearexports (SINE) wirkt durch Bindung und Hemmung des Nuklearexportproteins XPO1 (oder CRM1). Die Leitsubstanz von Karyopharm, XPOVIO® (Selinexor), ist in den USA für mehrere hämatologische Malignom-Indikationen zugelassen, darunter in Kombination mit Velcade® (Bortezomib) und Dexamethason für die Behandlung von Patienten mit multiplem Myelom nach mindestens einer vorangegangenen Therapie, in Kombination mit Dexamethason für die Behandlung von Patienten mit stark vorbehandeltem multiplem Myelom und als Monotherapie für die Behandlung von Patienten mit rezidiviertem oder refraktärem diffusem großzelligem B-Zell-Lymphom. Ein Zulassungsantrag für NEXPOVIO® (Selinexor) zur Behandlung von Patienten mit stark vorbehandeltem multiplem Myelom wird derzeit auch von der Europäischen Arzneimittelagentur geprüft. Neben der Wirksamkeit von Einzel- und Kombinationspräparaten gegen eine Reihe von Krebserkrankungen beim Menschen haben die SINE-Präparate auch biologische Aktivität in Modellen für Neurodegeneration, Entzündungen, Autoimmunerkrankungen, bestimmte Viren und Wundheilung gezeigt. Karyopharm hat mehrere Forschungsprogramme in der klinischen oder präklinischen Entwicklung. Besuchen Sie das Profil von Karyopharm Therapeutics Inc. für weitere Informationen. https://www.equities.com/news/karyopharm-kpti-gains-0-38-in-active-trading-on-november-4

Thursday, 04 November 2021 20:38 (EST) Karyopharm Therapeutics Inc (NASDAQ: KPTI), a Newton Center, Massachusetts, company, gained to close at $7.97 Thursday after gaining $0.03 (0.38%) on volume of 5,065,163 shares. The stock ranged from a high of $8.42 to a low of $7.30 while Karyopharm’s market cap now stands at $601,713,154. 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 novel first-in-class drugs directed against nuclear export and related targets for the treatment of cancer and other major diseases. Karyopharm's Selective Inhibitor of Nuclear Export (SINE) compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). Karyopharm's lead compound, XPOVIO® (selinexor), is approved in the U.S. in multiple hematologic malignancy indications, including in combination with Velcade® (bortezomib) and dexamethasone for the treatment of patients with multiple myeloma after at least one prior therapy, in combination with dexamethasone for the treatment of patients with heavily pretreated multiple myeloma and as a monotherapy for the treatment of patients with relapsed or refractory diffuse large B-cell lymphoma. A Marketing Authorization Application for NEXPOVIO® (selinexor) for patients with heavily pretreated multiple myeloma is also currently under review by the European Medicines Agency. In addition to single-agent and combination activity against a variety of human cancers, SINE compounds have also shown biological activity in models of neurodegeneration, inflammation, autoimmune disease, certain viruses and wound-healing. Karyopharm has several investigational programs in clinical or preclinical development. Visit Karyopharm Therapeutics Inc’s profile for more information. https://www.equities.com/news/karyopharm-kpti-gains-0-38-in-active-trading-on-november-4

4 Health Care Stocks For Your November 2021 Watchlist Best Health Care Stocks To Buy [Or Sell] This Month ▪︎ Regeneron Pharmaceuticals Inc. (NASDAQ: REGN) ▪︎ iRhythm Technologies Inc. (NASDAQ: IRTC) ▪︎ KaryoPharm Therapeutics Inc. (NASDAQ: KPTI) ▪︎ Tyra Biosciences Inc. (NASDAQ: TYRA) Karyopharm Therapeutics Inc. Following that, we have Karyopharm Therapeutics. The company is a commercial-stage pharmaceutical company that pioneers novel cancer therapies and is dedicated to the development of novel first-in-class drugs that targets the treatment of cancer and other major diseases. KPTI stock currently trades at $7.94 as of 10:53 a.m. ET. On Wednesday, the company’s share price was up by over 30%. This comes after the company had reported a strong third-quarter. Firstly, its XPOVIO net revenue was $26.7 million, up by 32% sequentially. It also had top-line data from its Phase 3 Siendo Study in endometrial cancer. It also had expansions in key clinical trials in multiple myeloma, and myelofibrosis. “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 that being said, will you consider buying KPTI stock? Josh Dylan  StockMarket.com NOV 4, 2021 12:30PM EDT https://www.google.com/amp/s/www.nasdaq.com/articles/4-health-care-stocks-for-your-november-2021-watchlist-2021-11-04%3famp

Karyopharm Announces New Interim Phase 2 Selinexor Data in Myelofibrosis Selected for Oral Presentation at the American Society of Hematology 2021 Annual Meeting and Exposition -- 33% of Patients Who Received at Least 24 Weeks of Selinexor Treatment Achieved a Response, Defined as ≥35% Spleen Volume Reduction (SVR) -- -- Patients on Study had a Median Duration of 22 months of Prior JAK Inhibitor Therapy with 11 out of 12 Patients Having Disease Refractory to Ruxolitinib -- -- Total of 17 Abstracts Selected for Presentation at the Meeting, Including Five Oral Presentations -- NEWS PROVIDED BY Karyopharm Therapeutics Inc.  Nov 04, 2021, 10:30 ET https://www.prnewswire.com/news-releases/karyopharm-announces-new-interim-phase-2-selinexor-data-in-myelofibrosis-selected-for-oral-presentation-at-the-american-society-of-hematology-2021-annual-meeting-and-exposition-301416725.html

Na endlich bewegt sich da etwas in die richtige Richtung nach den neusten News und Releases. Vielleicht hätte ich doch mal meinen EK ausbessern sollen, nachdem der Sommer und die letzten Q2 Zahlen den Kurs halbiert haben. ^^ naja. Vielleicht reicht Geduld auch aus

Drittes Quartal 2021 und aktuelle Highlights Kommerzielle Leistung von XPOVIO - Erzielung eines US-Nettoproduktumsatzes von 26,7 Millionen US-Dollar im dritten Quartal 2021. Dies entspricht einem Wachstum von 32 % im Vergleich zum zweiten Quartal 2021 und 25 % im Vergleich zum dritten Quartal 2020. - Übergang zu früheren Behandlungslinien und zunehmender Einsatz des einmal wöchentlich verabreichten XPOVIO-basierten Dreierschemas. - Wachsende Breite und Tiefe der Akzeptanz und wachsendes Vertrauen der Ärzte in die neue, einmal wöchentlich verabreichte, niedriger dosierte XPOVIO-basierte Dreierkombination. - Die Abdeckung durch die Kostenträger ist mit 97% weiterhin robust.

Presse Mitteilungen Karyopharm meldet starke Finanzergebnisse für das dritte Quartal 2021 und gibt geschäftliche Highlights bekannt -- Netto-Produktumsatz von XPOVIO® (Selinexor) im dritten Quartal 2021 in Höhe von 26,7 Millionen US-Dollar, ein Plus von 32 % gegenüber dem Vorquartal und 25 % gegenüber dem Vorjahresquartal -- -- Meilenstein-getriebenes viertes Quartal mit Top-Line-Daten aus der Phase-3-Studie SIENDO bei Endometriumkrebs und fortgesetzter Einleitung und Ausweitung wichtiger klinischer Studien bei Multiplem Myelom, myelodysplastischen Syndromen und Myelofibrose -- -- Telefonkonferenz für heute um 8:30 Uhr ET angesetzt -- -- Das Unternehmen wird am 8. Dezember 2021 einen virtuellen Investorentag veranstalten, um die kommerziellen und Pipeline-Prioritäten und -Ziele zu erläutern --

Third Quarter 2021 and Recent Highlights XPOVIO Commercial Performance • Achieved U.S. net product revenue for the third quarter of 2021 of $26.7 million. This represents 32% growth compared to the second quarter of 2021 and 25% growth compared to the third quarter of 2020. • Moving into earlier lines of treatment and increasing use of once weekly XPOVIO-based triplet regimen. • Growing breadth and depth of adoption and building physician confidence in the community with the new, once weekly, lower dose XPOVIO-based triplet regimen. • Payer coverage remains robust at 97%.

Press Releases Karyopharm Reports Strong Third Quarter 2021 Financial Results and Provides Business Highlights -- Third Quarter 2021 XPOVIO® (selinexor) Net Product Revenues of $26.7 Million, Up 32% Sequential Quarter-Over-Quarter and 25% Year-Over-Year -- -- Milestone-Driven Q4 with Top-Line Data From Phase 3 SIENDO Study in Endometrial Cancer and Continued Initiation and Expansion of Key Clinical Trials in Multiple Myeloma, Myelodysplastic Syndromes and Myelofibrosis -- -- Conference Call Scheduled for Today at 8:30 a.m. ET -- -- Company to Host Virtual Investor Day on December 8, 2021 to Outline Commercial and Pipeline Priorities and Objectives --