La conferencia me ha parecido fantástica y muy profesional.
Dejo aquí los catalizadores.
- final additional monitoring data requested by EMA from the STORM study in patients with advanced refractory myeloma in September.
- BOSTON data to the EMA in the fourth quarter of this year. The exact timing of potential regulatory decisions based on both the STORM and BOSTON data will be determined following feedback from EMA.
- SIENDO study that should read out the end of next year in uterine cancer in the adjuvant settings and in patients with advanced uterine cancer.
-additional trials ongoing in glioblastoma multiforme, both now in the front line in combination with radiation plus or minus temozolomide and in the second-line in combination with alkylator therapy.
-additional studies that are also ongoing now, both investigator and company-sponsored in colorectal cancer and in lung cancer,
-we hope to be sharing some additional data in other solid tumors toward the end of this year
First, we plan to submit additional STORM data and the full BOSTON data to EMA in the coming months. We hope to have greater clarity on the timing of future EMA regulatory decisions, following feedback from the agency. Next, we expect to share top line Phase 3 data from the SEAL study, evaluating selinexor in liposarcoma. Assuming positive results on the primary endpoint of PFS, we plan to file subsequent regulatory submissions. And finally, we anticipate initiating a confirmatory Phase 3 study of XPOVIO and DLBCL in support of our recent accelerated approval. And of course, we will work diligently through the remainder of the year to support our sNDA based on the BOSTON study as well as explore potential next steps for selinexor development in patients with severe COVID-19.
As we look forward to the next several years, we will increasingly expand our activities in solid tumors, both as a single agent and in combination. These include uterine cancer with the ongoing Phase 3 SIENDO study, glioblastoma multiforme, both alone and in combination, colon cancer and lung cancer.
Edito: dentro otro paquete a 15.56. Media 15.71
#123686
Re: Farmas USA
in 15,77 KPTI
#123687
Re: Farmas USA
KPTI Inicié posición ayer a 15,75. Me guardo algún tiro por si le da por seguir bajando..
