Takeda Announces U.S. FDA Breakthrough Therapy Designation Granted for Pevonedistat for the Treatment of Patients with Higher-Risk Myelodysplastic Syndromes (HR-MDS)
https://www.businesswire.com/news/home/ ... esignation
Pevonedistat - the cause for lower GERN share price?
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Re: Pevonedistat - the cause for lower GERN share price?
This is for higher risk MDS.
Geron is revolutionizing lower risk MDS.
This may be the reason for the Takeda rumors - perhaps Takeda wants to dominate the full spectrum of MDS.
Geron is revolutionizing lower risk MDS.
This may be the reason for the Takeda rumors - perhaps Takeda wants to dominate the full spectrum of MDS.
Re: Pevonedistat - the cause for lower GERN share price?
Interesting.
So not only do they cover multiple disease ares (low risk and high risk) ... but also different modalities/pathways !
Just brilliant!
So not only do they cover multiple disease ares (low risk and high risk) ... but also different modalities/pathways !
Just brilliant!
Re: Pevonedistat - the cause for lower GERN share price?
Does the board have any thoughts as to the PR on 7/01 that said EMA gave a positive opinion Orphan Designation and that Geron believed it would be formally announced or happen by end of July. I haven’t seen the formal announcement. Could the EMA grant the orphan status without public acknowledgement? Or has it just not happened yet? Any thoughts on the implications of that (if any)?
Passage I am referring to from the PR 7/01:
“The Company expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) by the end of July. Imetelstat has already been granted orphan drug designation by the United States Food and Drug Administration as a potential treatment for MDS.“
Thanks for any thoughts!
Lekola
Passage I am referring to from the PR 7/01:
“The Company expects that the European Commission, based on this positive opinion of the COMP, will formally grant the orphan drug designation for the European Union (EU) by the end of July. Imetelstat has already been granted orphan drug designation by the United States Food and Drug Administration as a potential treatment for MDS.“
Thanks for any thoughts!
Lekola
Re: Pevonedistat - the cause for lower GERN share price?
Well, I’ll be darned. Scratch my last post, I believe the PR in question that I mentioned is coming. I assume the CC will broach this Orphan topic. I see this is now up. Better late than never!
Designation number
EU/3/20/2305
name:
ACTIVEEU/3/20/2305
Designation number: EU/3/20/2305
Active substance: Imetelstat sodium
Indication: Treatment of myelodysplastic syndromes
Sponsor: Parexel International GmbH
Spandauer Damm 130, Charlottenburg, 14050 Berlin, Deutschland
Procedure type: Orphan designation
EMA number: EMA/OD/0000031951
Decision number: (2020)5231 of 27 Jul 2020
https://ec.europa.eu/health/documents/c ... /o2305.htm
Designation number
EU/3/20/2305
name:
ACTIVEEU/3/20/2305
Designation number: EU/3/20/2305
Active substance: Imetelstat sodium
Indication: Treatment of myelodysplastic syndromes
Sponsor: Parexel International GmbH
Spandauer Damm 130, Charlottenburg, 14050 Berlin, Deutschland
Procedure type: Orphan designation
EMA number: EMA/OD/0000031951
Decision number: (2020)5231 of 27 Jul 2020
https://ec.europa.eu/health/documents/c ... /o2305.htm