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Farmas USA

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#129057

Re: Farmas USA

IOVA 
Sí, acaba de "dimitir", imagino que se la han cargado. He entrado con muy poquitas a $17.2.
#129058

Re: Farmas USA

IOVA wow, que market cap os sale ahora? en mi broker dice 3,5 en finviz 3,9 pero si calculo. 2,5bn
ARK estan dentro a saco... se pone interesante, veremos si hoy compran, venden, o que hacen, y mañana a ver que tal
#129059

Re: Farmas USA

si fallaba el equipo de gestión la entrada de un nuevo CEO puede impulsarla
IOVA
#129060

Re: Farmas USA

IOVA

En el mío pone 2.6B

"Le haré una oferta que no rechazará" - Vito Corleone (Marlon Brando) El Padrino

#129061

Re: Farmas USA

Yo por el momento no me planteo entrada. Quizás más abajo pero no por el momento.NO es solo el problema el equipo de gestión. Es algo largo y complicado de explicar y técnico pero en resumen, no lo veo claro. LOL
Si, ARK estaba dentro, esto y las criptos, le hacen un buen roto. Menuda rachita  llevan 
IOVA
#129062

Re: Farmas USA


YMAB

Acuerdo de distribución para Danyelza y Omburtamab en Latinoamérica. Distribución y registro a cuenta de Adium
https://sec.report/Document/0001104659-21-069337/

«Después de nada, o después de todo/ supe que todo no era más que nada.»

#129063

Re: Farmas USA

KPTI

Presentaciones en la ASCO

sixteen abstracts have been selected for virtual presentation, including one oral presentation, at the upcoming 2021 American Society of Clinical Oncology (ASCO) Annual Meeting taking place June 4-8, 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 and patients with RAS-mutated multiple myeloma; (ii) updated data from the Pomalyst® (pomalidomide) and Kyprolis® (carfilzomib) arms of the Phase 1b/2 STOMP study evaluating XPOVIO in combination with backbone therapies in patients with relapsed or refractory multiple myeloma; (iii) new results from a Phase 1 study evaluating the combination of XPOVIO and pembrolizumab in advanced RAS mutant and RAS wild type colorectal cancer; (iv) results from gene set enrichment analyses identifying molecular predictors of response to XPOVIO from the Phase 2/3 SEAL study in patients with dedifferentiated liposarcoma (DDLS); and (v) updated overall survival (OS) 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 (MDS).


Select Abstracts Featuring XPOVIO® (selinexor) in Multiple Myeloma

1. Title: Survival Among Older Patients with Previously Treated Multiple Myeloma Treated with Selinexor, Bortezomib, and Dexamethasone (XVd) in the BOSTON study

Presenter: Thierry Facon, University Hospital
Abstract #: 8019
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: In an older patient population with a poor prognosis, XVd compared to Vd was associated with an OS benefit, improved progression-free survival (PFS) and an increased overall response rate (ORR) with reduced peripheral neuropathy and requires relatively short and infrequent clinic visits. XVd may be an effective regimen for patients 65 years of age or older. Adverse events (AEs) in this study were generally consistent with other previously reported selinexor studies in multiple myeloma.

2. Title: Effects of Weekly Selinexor, Bortezomib, Dexamethasone (XVd) Versus Standard Twice Weekly bortezomib and dexamethasone (Vd) on RAS-mutated previously treated multiple myeloma (MM)

Presenter: Christopher J. Walker, Karyopharm Therapeutics Inc.
Abstract #: 8027
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: Despite typically having the worst outcomes, patients with MM with any (K-, H- or N-) RAS mutation had a similar benefit from XVd as RAS wild-type MM, showing that the XVd combination can overcome therapy resistance characteristic of RAS-mutated MM. Mechanistically, selinexor induced down regulation of germinal center kinase and enhanced killing of RAS-mutated MM cells. With a manageable safety profile, the XVd regimen was able to overcome the therapeutic resistance of RAS-mutated multiple myeloma and improved PFS and OS in patients with RAS-mutated MM, and the data suggest that selinexor-containing regimens could be active in other RAS-mutant cancers. AEs in this study were generally consistent with other previously reported selinexor studies in MM.

3. Title: Effects of Refractory Status to Lenalidomide on Safety and Efficacy of Selinexor, Bortezomib, and Dexamethasone (XVd) Versus Bortezomib and Dexamethasone (Vd) in Patients with Previously Treated Multiple Myeloma

Presenter: Xavier Leleu, CHU de Poitiers, Hôpital La Mileterie
Abstract #: 8024
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: In patients with previously treated multiple myeloma, PFS, ORR, and time to next treatment were significantly improved regardless of documented refractory status to any immunomodulatory drug (IMiD) or to lenalidomide specifically. These analyses support the use of the XVd combination for patients with disease refractory to lenalidomide and likely to any IMiD. AEs in this study were generally consistent with other previously reported selinexor studies in multiple myeloma.

4. Title: Oral Selinexor, Pomalidomide, and Dexamethasone (XPd) at Recommended Phase 2 Dose in Relapsed Refractory Multiple Myeloma (MM)

Presenter: Darrell White, QEII Health Sciences Center, Dalhousie University
Abstract #: 8018
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster Discussion Presentation
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: Once-weekly selinexor was shown in this Phase 1b/2 study to  be safely combined with Pomalyst® (pomalidomide) and low-dose dexamethasone (XPd) in patients with heavily pretreated MM. This all-oral XPd combination is highly active with an ORR of 65% at the recommended Phase 2 dose in 20 patients, compared to the expected ORR of ≤30% for the combination of Pomalyst® and dexamethasone (Pd) or selinexor and dexamethasone, and has thus far produced durable responses with a median PFS of 12.2 months. The data suggest that the regimen was active even in patients with daratumumab-refractory MM. AEs in this study were generally consistent with other previously reported selinexor studies in multiple myeloma.

5. Title: Once Weekly Selinexor, Carfilzomib, and Dexamethasone (XKd) in Carfilzomib Nonrefractory Multiple Myeloma (MM) Patients

Presenter: Cristina Gasparetto, Duke University Cancer Center
Abstract #: 8038
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia
Highlights: In 27 patients with heavily pretreated MM (median of 4 lines of prior therapy), weekly XKd is highly active with an ORR of 78% and deep responses (≥VGPR 41%) with an overall PFS of 15 months; activity was strong even in patients with daratumumab refractory disease. AEs in this Phase 1/2b study were generally consistent with other previously reported selinexor studies in MM.

6. Title: Selinexor Containing Regimens in Patients with Multiple Myeloma (MM) Previously Treated with anti-CD38 Monoclonal Antibodies (aCD38 mAbs)

Presenter: Cristina Gasparetto, Duke University Cancer Center
Abstract #: e20020
Session type: Online abstract
Highlights: Selinexor-containing triplet combinations in 47 patients with MM previously treated with anti-CD38 mAb, most of whom had triple-class refractory MM, exhibit tolerability and comparable effectiveness to their most recent anti-CD38 mAb-containing regimens in this retrospective analysis. Compared to historical controls who did not receive selinexor, median OS was much longer among these patients. The results show that selinexor-containing regimens maintain high levels of anti-MM activity, even in patients whose disease is refractory to daratumumab, immunomodulatory drugs and proteasome inhibitors. AEs in this study were generally consistent with other previously reported selinexor studies in multiple myeloma.

Select Abstracts Featuring XPOVIO (selinexor) in Solid Tumors

7. Title: Molecular Predictors of Response to Selinexor in Advanced Unresectable De-differentiated Liposarcoma (DDLS)

Presenter: Christopher J. Walker, Karyopharm Therapeutics Inc.
Abstract #: 11509
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Oral presentation
Session: Emerging Trends in Sarcoma Precision Medicine
Highlights: The randomized Phase 3 SEAL study of selinexor versus placebo in patients with heavily pretreated  DDLS showed a significant improvement in PFS for selinexor. The molecular analyses reported here demonstrate that DDLS tumors responding to selinexor showed low expression of CALB1 and high GRM1. If validated, patients with DDLS whose tumors match this expression profile are especially likely to benefit from selinexor.

8. Title: Open-Label Phase 1 Study Evaluating the Tolerability and Anti-Tumor Activity of Selinexor and Pembrolizumab in Colorectal Cancer

Presenter: Talia Golan, Oncology Department Center Sheba Medical Center at Tel Hashomer
Session type: Online abstract
Abstract #: e15579
Highlights: Selinexor in combination with pembrolizumab has demonstrated disease control in patients with chemotherapy refractory, advanced/metastatic, microsatellite stable colorectal cancer (CRC). Greater anti-tumor activity was observed in patients with RAS mutations despite the absence of high microsatellite instability and/or deficient in mismatch repair. The therapy was well tolerated with no unanticipated adverse events observed.

9. Title: Selinexor in Combination with Weekly Paclitaxel in Patients with Advanced or Metastatic Solid Tumors: Results of an Open Label, Single-Center, Multi-arm Phase 1b Study

Presenter: Shannon Westin, The University of Texas MD Anderson Cancer Center
Abstract #: 5565
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Gynecologic Cancer
Highlights: Among 24 evaluable patients with heavily pretreated ovarian cancer, oral selinexor in combination with weekly paclitaxel resulted in an ORR of 17% and a clinical benefit rate (response + stable disease >12 weeks) of 58%. With prior taxane therapy, the ORR was 10% and with no prior taxane therapy, the ORR was 23%. The combination demonstrated promising clinical activity with manageable toxicity.

Abstracts Featuring Eltanexor in MDS

10. Title: Updated Overall Survival of Eltanexor for the Treatment of Patients with Hypomethylating Agent Refractory Myelodysplastic Syndrome

Presenter: Sangmin Lee, Weill Cornell Medical College
Abstract #: e19037
Session type: Online abstract
Highlights: Single-agent oral eltanexor was active in patients with high-risk, hypomethylating agent refractory MDS. Of the 20 enrolled patients, seven (35%) had marrow complete response (mCR), and five (25%) had stable disease (SD) for a total disease control (mCR+SD) rate of 60%. Of the 15 patients evaluable for efficacy, seven (47%) had mCR and five (33%) had SD. Patients who reached mCR (n=7) had significantly longer median OS than patients without mCR (n=8) or with progressive disease (n=3). Side effects were consistent with other studies of eltanexor without solid organ toxicity. Further evaluation of eltanexor in MDS as a single agent and in combination with other agents is ongoing.

Additional Abstracts to be Presented

11. Title: A Randomized, Open-label, Phase 3 Study of Low-dose Selinexor and Lenalidomide (Len) Versus Len Maintenance Post Autologous Stem Cell Transplant (ASCT) for Newly Diagnosed Multiple Myeloma (NDMM): ALLG MM23: Sealand

Presenter: Hang Quach, St. Vincent Hospital
Abstract #: TPS8055
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type: Poster
Session: Hematologic Malignancies—Plasma Cell Dyscrasia

12. Title: U.S. Budget Impact (BI) Model for Selinexor, Bortezomib, and Dexamethasone (XVd) for the Treatment of Patients with Previously Treated Multiple Myeloma (MM)

Presenter: Mike Dolph, McGill University
Abstract #: e18839
Session type: Online abstract

13. Title: SIENDO/ENGOT-EN5/GOG-3055: A Randomized Phase 3 Trial of Maintenance Selinexor Versus Placebo After Combination Platinum-based Chemotherapy in Advanced or Recurrent Endometrial Cancer

Presenter: Ignace Vergote, BGOG and University Hospitals Leuven, Leuven Cancer Institute
Abstract #: TPS5610
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Gynecologic Cancer

14. Title: A Phase 1/2 Study of Selinexor in Combination with Standard of Care Therapy for Newly Diagnosed or Recurrent Glioblastoma

Presenter: Yazmin Odia, Miami Cancer Institute, Baptist Health South Florida (BHSF)
Abstract #: TPS2071
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Central Nervous System Tumors

15. Title: Digital Measurement of Functional Status of Patients with Glioblastoma

Presenter: Yasaman Demastani, Karyopharm Therapeutics Inc.
Abstract #: 2016
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Central Nervous System Tumors 

16. Title: A Phase 1b/2 Study of Selinexor in Combination with Imatinib in Patients with Advanced Gastrointestinal
Stromal Tumor (GIST): SeliGIST/GEIS-41 Trial

Presenter: Cesar Serrano, West Virginia University School of Medicine Neurology & Neurosurgery
Abstract #: 11534
Date and time: Friday, June 4, 2021; 9:00 a.m. ET
Session type:  Poster
Session: Sarcoma

«Después de nada, o después de todo/ supe que todo no era más que nada.»

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