Sangamo Therapeutics Inc (SGMO) 銘柄情報

SGMO, under $2

Pounds

SGMO...$1.30...🥳...Off my $1.22 Alert...https://www.businesswire.com/news/home/20250206513390/en/

georgie18

Member Level
Re: georgie18 post# 1002

Friday, January 31, 2025 9:37:17 AM

Post#
1003
of 1003
SGMO...$1.27...🥳...on the Bollie Squeeze...Open Gap in the $2 range...

georgie18

Member Level
Re: None

Thursday, January 30, 2025 2:13:23 PM

Post#
31218
of 31261
SGMO...$1.22... https://schrts.co/IqItbIfD ...Bollie Squeeze setting up here...🥳

SGMO...$1.27...🥳...on the Bollie Squeeze...Open Gap in the $2 range...

georgie18

Member Level
Re: None

Thursday, January 30, 2025 2:13:23 PM

Post#
31218
of 31261
SGMO...$1.22... https://schrts.co/IqItbIfD ...Bollie Squeeze setting up here...🥳

SGMO...$1.22... https://schrts.co/IqItbIfD ...Bollie Squeeze setting up here...🥳

SGMO...$1.45...🥳...Off my $1.03 Dip Alert...

georgie18

Member Level
Re: georgie18 post# 670316

Monday, January 06, 2025 9:52:15 AM

Post#
670503
of 670675
SGMO...$1.35s clearing here off my $1.03 Dip Alert...🥳

georgie18

Member Level
Re: georgie18 post# 996

Friday, January 03, 2025 2:29:51 PM

Post#
997
of 999
SGMO...$1.28s clearing here...🥳...Off the $1.03...Dip Alert...

georgie18

Member Level
Re: georgie18 post# 670026

Friday, January 03, 2025 8:31:17 AM

Post#
670182
of 670314
SGMO...$1.13s clearing here...🥳

georgie18

Member Level
Re: georgie18 post# 985

Thursday, January 02, 2025 9:42:07 AM

Post#
992
of 995
SGMO...$1.03...🥳...Loading down here...Took a dip... Pfizer terminated partnership...

SGMO...$1.35s clearing here off my $1.03 Dip Alert...🥳

georgie18

Member Level
Re: georgie18 post# 996

Friday, January 03, 2025 2:29:51 PM

Post#
997
of 999
SGMO...$1.28s clearing here...🥳...Off the $1.03...Dip Alert...

georgie18

Member Level
Re: georgie18 post# 670026

Friday, January 03, 2025 8:31:17 AM

Post#
670182
of 670314
SGMO...$1.13s clearing here...🥳

georgie18

Member Level
Re: georgie18 post# 985

Thursday, January 02, 2025 9:42:07 AM

Post#
992
of 995
SGMO...$1.03...🥳...Loading down here...Took a dip... Pfizer terminated partnership...

SGMO under $2

sgmo.......................https://stockcharts.com/h-sc/ui?s=sgmo&p=W&b=5&g=0&id=p86431144783

SGMO...$1.28s clearing here...🥳...Off the $1.03...Dip Alert...

georgie18

Member Level
Re: georgie18 post# 670026

Friday, January 03, 2025 8:31:17 AM

Post#
670182
of 670314
SGMO...$1.13s clearing here...🥳

georgie18

Member Level
Re: georgie18 post# 985

Thursday, January 02, 2025 9:42:07 AM

Post#
992
of 995
SGMO...$1.03...🥳...Loading down here...Took a dip... Pfizer terminated partnership...

SGMO...$1.13s clearing here...🥳

georgie18

Member Level
Re: georgie18 post# 985

Thursday, January 02, 2025 9:42:07 AM

Post#
992
of 995
SGMO...$1.03...🥳...Loading down here...Took a dip... Pfizer terminated partnership...

nice year end gift to the shareholders! LOL

mind you Roche and Pfizer both shredded their AAV hem a compounds

Its when they give no roadmap!
instead tout the present - everyone knows
bios run TOWARDS events

SGMO...$1.03...🥳...Loading down here...Took a dip... Pfizer terminated partnership...

Way under

PFE pulled the plug https://www.businesswire.com/news/home/20241230895593/en/Sangamo-Therapeutics-to-Regain-Full-Rights-to-Hemophilia-A-Gene-Therapy-Program-Following-Pfizer%E2%80%99s-Decision-to-Cease-Development-of-Giroctocogene-Fitelparvovec

Maybe a (future) trade for Fabry, but that’s it!

If I've ever seen an over reaction and a buying opportunity before this is Olympic!

New 52wk highs coming soon

SGMO under $3

SGMO...$2.87...🥳Looking for the $3 Breakout...Last run from .30 to $3...

georgie18

Member Level
Re: None

Friday, December 13, 2024 9:33:14 AM

Post#
980
of 984
SGMO...$2.11...Starting up again...🥳

sgmo...............https://stockcharts.com/h-sc/ui?s=sgmo&p=W&b=5&g=0&id=p86431144783

Something going on. Up again. $2.72. Up 3%.

SGMO...$2.66...🥳...on the Breakout...

SGMO...$2.50...🥳...Trying for Upper Bollie Breakout here...

SGMO...$2.11...Starting up again...🥳

Career site shows just 2 temporary positions for weeks?
Maybe has momo till december 9 presentation of the ph3 in HEM A with Pfizer.

May go to 4 first but valuation makes no sense - overbought zinc finger dud.
Smart and extensive promotion campaign by management.

SGMO - Nice day and the start of another uptrend

SGMO...........................https://stockcharts.com/h-sc/ui?s=SGMO&p=W&b=5&g=0&id=p86431144783

Sangamo Therapeutics Announces U.S. FDA Clearance of IND Application for ST-503 for the Treatment of Idiopathic Small Fiber Neuropathy, a Type of Chronic Neuropathic Pain
BUSINESS WIRE 4:15 PM ET 11/19/2024

HC Wainwright & Co. Reiterates Buy on Sangamo Therapeutics, Maintains $10 Price Target
BENZINGA 1:20 PM ET 11/14/2024

sgmo.............................https://stockcharts.com/h-sc/ui?s=SGMO&p=W&b=5&g=0&id=p86431144783

$SGMO > So-So earnings report brings out the sharks ...

Where will it settle ???

SGMO...$2.33...🥳...https://ih.advfn.com/stock-market/NASDAQ/sangamo-therapeutics-SGMO/stock-news/94894589/form-s-3-registration-statement-under-securities

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.

Have a Great Weekend Y'all...🥳

$SGMO earnings 11/12 . After market closes . 🚀🔥🏃💲

Enjoy the holiday weekend . >> M

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.

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.

Another great day 😃

$SGMO

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.

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.

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.

$SGMO at $2.33 is in BEAST mode > 🦍🚀🔥💲

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.

Nice! 😃

$SGMO

SGMO......................................https://stockcharts.com/h-sc/ui?s=SGMO&p=W&b=5&g=0&id=p86431144783

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.

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.