georgie18
1月前
SGMO...$2.53...Fins after close...🥳
georgie18
Member Level
Re: georgie18 post# 664188
Friday, November 08, 2024 11:09:45 AM
Post#
664225
of 664553
SGMO...$3.10s clearing here...🥳
georgie18
Member Level
Re: georgie18 post# 385366
Friday, November 08, 2024 9:21:06 AM
Post#
385382
of 385395
SGMO...$3...🥳...Been waiting for this ..."W" in play here...$6 target for me...
georgie18
Member Level
Re: georgie18 post# 663989
Thursday, November 07, 2024 2:23:36 PM
Post#
664113
of 664186
SGMO...$2.83...🥳
georgie18
Member Level
Re: georgie18 post# 385311
Thursday, November 07, 2024 9:59:59 AM
Post#
385341
of 385365
SGMO...$2.65s clearing here...This was as low as .30 in July...🥳
georgie18
Member Level
Re: georgie18 post# 663756
Wednesday, November 06, 2024 2:50:09 PM
Post#
663878
of 663987
SGMO...$2.45...HOD..."W" Pattern in play here...Target $6...🥳https://schrts.co/dEUXVUBf
SGMO...$2.25...🥳
georgie18
Member Level
Re: georgie18 post# 663703
Tuesday, November 05, 2024 3:35:51 PM
Post#
663735
of 663755
SGMO...$2.14...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 663630
Tuesday, November 05, 2024 1:25:37 PM
Post#
663703
of 663733
SGMO...$2.02...🥳...On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
Member Level
Re: georgie18 post# 663012
Monday, November 04, 2024 4:27:39 PM
Post#
663630
of 663703
SGMO...$1.77...Fins will be announced after close on Nov 12,2024...🥳
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
georgie18
1月前
SGMO...$3.10s clearing here...🥳
georgie18
Member Level
Re: georgie18 post# 385366
Friday, November 08, 2024 9:21:06 AM
Post#
385382
of 385395
SGMO...$3...🥳...Been waiting for this ..."W" in play here...$6 target for me...
georgie18
Member Level
Re: georgie18 post# 663989
Thursday, November 07, 2024 2:23:36 PM
Post#
664113
of 664186
SGMO...$2.83...🥳
georgie18
Member Level
Re: georgie18 post# 385311
Thursday, November 07, 2024 9:59:59 AM
Post#
385341
of 385365
SGMO...$2.65s clearing here...This was as low as .30 in July...🥳
georgie18
Member Level
Re: georgie18 post# 663756
Wednesday, November 06, 2024 2:50:09 PM
Post#
663878
of 663987
SGMO...$2.45...HOD..."W" Pattern in play here...Target $6...🥳https://schrts.co/dEUXVUBf
SGMO...$2.25...🥳
georgie18
Member Level
Re: georgie18 post# 663703
Tuesday, November 05, 2024 3:35:51 PM
Post#
663735
of 663755
SGMO...$2.14...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 663630
Tuesday, November 05, 2024 1:25:37 PM
Post#
663703
of 663733
SGMO...$2.02...🥳...On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
Member Level
Re: georgie18 post# 663012
Monday, November 04, 2024 4:27:39 PM
Post#
663630
of 663703
SGMO...$1.77...Fins will be announced after close on Nov 12,2024...🥳
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
georgie18
1月前
SGMO...$3...🥳...Been waiting for this ..."W" in play here...$6 target for me...
georgie18
Member Level
Re: georgie18 post# 663989
Thursday, November 07, 2024 2:23:36 PM
Post#
664113
of 664186
SGMO...$2.83...🥳
georgie18
Member Level
Re: georgie18 post# 385311
Thursday, November 07, 2024 9:59:59 AM
Post#
385341
of 385365
SGMO...$2.65s clearing here...This was as low as .30 in July...🥳
georgie18
Member Level
Re: georgie18 post# 663756
Wednesday, November 06, 2024 2:50:09 PM
Post#
663878
of 663987
SGMO...$2.45...HOD..."W" Pattern in play here...Target $6...🥳https://schrts.co/dEUXVUBf
SGMO...$2.25...🥳
georgie18
Member Level
Re: georgie18 post# 663703
Tuesday, November 05, 2024 3:35:51 PM
Post#
663735
of 663755
SGMO...$2.14...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 663630
Tuesday, November 05, 2024 1:25:37 PM
Post#
663703
of 663733
SGMO...$2.02...🥳...On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
Member Level
Re: georgie18 post# 663012
Monday, November 04, 2024 4:27:39 PM
Post#
663630
of 663703
SGMO...$1.77...Fins will be announced after close on Nov 12,2024...🥳
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
georgie18
1月前
SGMO...$2.83...🥳
georgie18
Member Level
Re: georgie18 post# 385311
Thursday, November 07, 2024 9:59:59 AM
Post#
385341
of 385365
SGMO...$2.65s clearing here...This was as low as .30 in July...🥳
georgie18
Member Level
Re: georgie18 post# 663756
Wednesday, November 06, 2024 2:50:09 PM
Post#
663878
of 663987
SGMO...$2.45...HOD..."W" Pattern in play here...Target $6...🥳https://schrts.co/dEUXVUBf
SGMO...$2.25...🥳
georgie18
Member Level
Re: georgie18 post# 663703
Tuesday, November 05, 2024 3:35:51 PM
Post#
663735
of 663755
SGMO...$2.14...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 663630
Tuesday, November 05, 2024 1:25:37 PM
Post#
663703
of 663733
SGMO...$2.02...🥳...On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
Member Level
Re: georgie18 post# 663012
Monday, November 04, 2024 4:27:39 PM
Post#
663630
of 663703
SGMO...$1.77...Fins will be announced after close on Nov 12,2024...🥳
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
georgie18
1月前
SGMO...$2.65s clearing here...This was as low as .30 in July...🥳
georgie18
Member Level
Re: georgie18 post# 663756
Wednesday, November 06, 2024 2:50:09 PM
Post#
663878
of 663987
SGMO...$2.45...HOD..."W" Pattern in play here...Target $6...🥳https://schrts.co/dEUXVUBf
SGMO...$2.25...🥳
georgie18
Member Level
Re: georgie18 post# 663703
Tuesday, November 05, 2024 3:35:51 PM
Post#
663735
of 663755
SGMO...$2.14...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 663630
Tuesday, November 05, 2024 1:25:37 PM
Post#
663703
of 663733
SGMO...$2.02...🥳...On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
Member Level
Re: georgie18 post# 663012
Monday, November 04, 2024 4:27:39 PM
Post#
663630
of 663703
SGMO...$1.77...Fins will be announced after close on Nov 12,2024...🥳
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
georgie18
1月前
SGMO...$2.45...HOD..."W" Pattern in play here...Target $6...🥳https://schrts.co/dEUXVUBf
SGMO...$2.25...🥳
georgie18
Member Level
Re: georgie18 post# 663703
Tuesday, November 05, 2024 3:35:51 PM
Post#
663735
of 663755
SGMO...$2.14...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 663630
Tuesday, November 05, 2024 1:25:37 PM
Post#
663703
of 663733
SGMO...$2.02...🥳...On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
Member Level
Re: georgie18 post# 663012
Monday, November 04, 2024 4:27:39 PM
Post#
663630
of 663703
SGMO...$1.77...Fins will be announced after close on Nov 12,2024...🥳
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
georgie18
1月前
SGMO...$2.25...🥳
georgie18
Member Level
Re: georgie18 post# 663703
Tuesday, November 05, 2024 3:35:51 PM
Post#
663735
of 663755
SGMO...$2.14...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 663630
Tuesday, November 05, 2024 1:25:37 PM
Post#
663703
of 663733
SGMO...$2.02...🥳...On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
Member Level
Re: georgie18 post# 663012
Monday, November 04, 2024 4:27:39 PM
Post#
663630
of 663703
SGMO...$1.77...Fins will be announced after close on Nov 12,2024...🥳
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
georgie18
1月前
SGMO...$2.14...HOD...🥳
georgie18
Member Level
Re: georgie18 post# 663630
Tuesday, November 05, 2024 1:25:37 PM
Post#
663703
of 663733
SGMO...$2.02...🥳...On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
Member Level
Re: georgie18 post# 663012
Monday, November 04, 2024 4:27:39 PM
Post#
663630
of 663703
SGMO...$1.77...Fins will be announced after close on Nov 12,2024...🥳
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
georgie18
1月前
SGMO...$2.02...🥳...On Tuesday, H.C. Wainwright adjusted its outlook on shares of Sangamo BioSciences (NASDAQ:SGMO), raising the price target to $10 from the previous $5, while maintaining a Buy rating on the company's stock. The revision follows Sangamo's announcement on October 22, 2024, regarding a productive Type B meeting with the FDA about its gene therapy program for Fabry disease, isaralgagene civaparvovec (ST-920 or isa-vec).
The FDA has acknowledged that data from the ongoing Phase 1/2 STAAR trial could serve as the primary evidence for an accelerated approval process. This development could lead to a faster and more cost-effective path to submitting a Biologics License Application (BLA) than initially anticipated.
Member Level
Re: georgie18 post# 663012
Monday, November 04, 2024 4:27:39 PM
Post#
663630
of 663703
SGMO...$1.77...Fins will be announced after close on Nov 12,2024...🥳
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
INV4
2月前
Good morning and thank you jondoeuk. Many of these types of companies struggle at first, but when they have a 'hit', things can turn around quickly. We'll have to wait and see IMHO.
Unless they upgrade their tech to include additional tools
News Release:
Sangamo Therapeutics Announces Alignment With FDA on Accelerated Approval Pathway for ST-920 in Fabry Disease With BLA Submission Expected in 2025
October 22, 2024
- U.S. Food and Drug Administration (FDA) provides a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec using data from ongoing Phase 1/2 STAAR study, avoiding requirement for additional registrational study and accelerating estimated time to potential approval by approximately three years.
- FDA confirms that estimated glomerular filtration rate (eGFR) slope data at one year across all Phase 1/2 patients can serve as primary basis for approval under Accelerated Approval pathway.
- Data to support Accelerated Approval pathway available in first half of 2025, with a potential Biologics License Application (BLA) submission expected in the second half of 2025.
RICHMOND, Calif.--(BUSINESS WIRE)--Oct. 22, 2024-- Sangamo Therapeutics, Inc. (Nasdaq: SGMO), a genomic medicine company, today announced the outcome of a recent successful interaction with the U.S. FDA, providing a clear regulatory pathway to Accelerated Approval for isaralgagene civaparvovec, or ST-920, its wholly owned gene therapy product candidate for the treatment of Fabry disease...
https://investor.sangamo.com/news-releases/news-release-details/sangamo-therapeutics-announces-alignment-fda-accelerated
$SGMO
jondoeuk
2月前
Pioneering the future of genomic medicine? The company was founded in 1995. Gene editing has evolved. Unless they upgrade their tech to include additional tools I can't seem them being a meaningful player in any way. Too many failures* in their long history. Another issue is the management.
* This includes diabetic neuropathy, HIV, IVPRP, TDT/SCD, oncology (with GILD), and CNS (with BIIB and NVS). Investments in CAR-Tregs (and elsewhere) were written off. Also, programs in Huntington's, ALS, and others that still have not gotten off the ground. They were touting base editing at one point. But not to worry, they pivoted again!
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