20:03 , Feb 15, 2019 |  BC Week In Review  |  Clinical News

GenSight's GS010 misses in second Phase III for Leber hereditary optic neuropathy

GenSight Biologics S.A. (Euronext:SIGHT) reported that GS010 (rAAV2/2-ND4) missed the primary endpoint of improving visual acuity in the Phase III RESCUE trial to treat Leber hereditary optic neuropathy (LHON). On the 39-patient trial's primary endpoint,...
23:07 , Jul 20, 2018 |  BioCentury  |  Regulation

FDA’s positive reinforcement

Companies are still sifting through a half dozen gene therapy guidance documents issued by FDA, but so far it appears the recommendations support the paths taken by some of the most advanced clinical candidates for...
14:47 , Apr 6, 2018 |  BC Week In Review  |  Clinical News

GenSight's GS010 misses in Phase III for neuropathy

GenSight Biologics S.A. (Euronext:SIGHT) reported that GS010 (rAAV2/2-ND4) missed the primary endpoint of improving visual acuity in the Phase III REVERSE trial to treat Leber's hereditary optic neuropathy (LHON). On the 37-patient trial's primary endpoint,...
21:35 , Apr 4, 2018 |  BC Extra  |  Clinical News

GenSight falls after Phase III neuropathy miss

GenSight Biologics S.A. (Euronext:SIGHT) fell €2.71 (48%) to €2.97 on Wednesday after reporting that GS010 (rAAV2/2-ND4) missed the primary endpoint of improving visual acuity in the Phase III REVERSE trial to treat Leber's hereditary optic...
02:05 , Feb 22, 2017 |  BC Week In Review  |  Clinical News

GS010: Completed Ph III REVERSE enrollment

GenSight completed enrollment of 36 patients in the double-blind, sham-controlled, international Phase III REVERSE trial evaluating a single intravitreal injection of GS010. The trial enrolled patients with an onset of vision loss of 7-12 months...
07:00 , Sep 19, 2016 |  BC Week In Review  |  Clinical News

RAAV2/2_ND4: Phase III amended

GenSight amended the ongoing, double-blind, sham-controlled, international Phase III REVERSE trial evaluating single intravitreal injections of GS010 to include patients ages 15-18. The trial now plans to enroll about 36 patients ages >=15 with an...
07:00 , Sep 19, 2016 |  BC Week In Review  |  Clinical News

RAAV2/2_ND4: Phase III amended

GenSight amended the ongoing, double-blind, sham-controlled, international Phase III RESCUE trial evaluating single intravitreal injections of GS010 to include patients ages 15-18. The trial now plans to enroll about 36 patients ages >=15 with an...
00:30 , Jul 14, 2016 |  BC Extra  |  Financial News

GenSight raises EUR 40M in Euronext IPO

Gene therapy company GenSight Biologics S.A. (Euronext:SIGHT) raised EUR 40 million ($44.1 million) through the sale of 5 million shares at EUR 8 in an IPO on Euronext Paris. The offering valued the company at...
00:28 , Jul 9, 2016 |  BC Extra  |  Financial News

GenSight now eying Euronext

Gene therapy company GenSight Biologics S.A. (Paris, France) is proposing to raise about EUR 40 million ($44.3 million) in a listing on Euronext Paris. The company is targeting a price range of EUR 7.80-EUR 9.20...
00:08 , Apr 15, 2016 |  BC Extra  |  Financial News

GenSight withdraws U.S. listing

Gene therapy company GenSight Biologics S.A. (Paris, France) withdrew its proposed NASDAQ listing, citing market conditions. In July 2015, the company filed to raise up to $100 million through an offering of ADSs (see BioCentury...