GenSight Biologics

71 articles with GenSight Biologics

• GenSight Biologics Reports Cash Position as of December 31, 2020 and Provides Operational Update

  1/19/2021

  GenSight Biologics, a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, reported its cash position as of December 31, 2020, and provided an operational update.

• GenSight Biologics Announces its 2021 Financial Calendar

  1/18/2021

  GenSight Biologics (Paris:SIGHT) (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, today announced its financial calendar for 2021.

• GenSight Biologics Announces Publication of Results from LUMEVOQ® RESCUE Pivotal Phase III Trial in AAO journal Ophthalmology®

  1/13/2021

  GenSight Biologics announced that the journal of the American Academy of Ophthalmology, Ophthalmology®, has published results from the RESCUE pivotal Phase III clinical trial of LUMEVOQ® gene therapy in ND4 Leber Hereditary Optic Neuropathy subjects.

• GenSight Biologics Announces Publication of Results from LUMEVOQ® REVERSE Pivotal Phase III Trial and Non-Human Primate Study in Science Translational Medicine

  12/10/2020

  First publication based on Phase III data to document sustained and clinically meaningful bilateral improvement in visual acuity from unilateral injection of a gene therapy

• GenSight Biologics Announces the Partial Conversion of Convertible Bonds and Full Exercise of Share Warrants by Kreos Capital

  12/10/2020

  Regulatory News: GenSight Biologics (Euronext: SIGHT, ISIN: FR0013183985, PEA-PME eligible) (Paris:SIGHT) (the " Company " or " GenSight "), a biopharma company focused on developing and commercializing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announces today that it has received, in connection with its bond agreement entered with Kreos Capital VI (Expert Fund) LP

• Diamond Pharma Services Supports GenSight Biologics in Submitting Its First Marketing Authorisation Application, for Ocular Gene Therapy LUMEVOQ

  10/5/2020

  Diamond Pharma Services has provided EU regulatory, pharmacovigilance, quality and compliance support to GenSight, leading to the Marketing Authorisation Application for LUMEVOQ

• GenSight Biologics Submits EU Marketing Authorisation Application for LUMEVOQ® Gene Therapy to Treat Vision Loss Due to Leber Hereditary Optic Neuropathy (LHON)

  9/15/2020

  GenSight Biologics announced that it has submitted the Marketing Authorisation Application for its lead product LUMEVOQ® to the European Medicines Agency, seeking approval for the treatment of patients with vision loss due to Leber Hereditary Optic Neuropathy caused by mutation in the ND4 mitochondrial gene.

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  BioSpace Global Roundup, July 9

  7/9/2020

  Biopharma and life sciences companies from across the globe provide updates on their pipelines and businesses.

• GenSight Biologics Reports Sustained Efficacy and Safety Among LHON Patients Three Years After LUMEVOQ® Treatment

  7/6/2020

  GenSight Biologics, a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, reported that Leber Hereditary Optical Neuropathy subjects treated with LUMEVOQ® experienced sustained efficacy and safety three years after a single injection with the gene therapy.

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  Clinical Catch-Up: April 13-17

  4/20/2020

  There’s plenty of news related to clinical trials related to COVID-19, but it does seem to be drowning out non-COVID-19-related clinical trials. Here’s a look.
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  BioSpace Global Roundup, April 16

  4/16/2020

  Global pharma and life sciences companies provide updates on their business operations and pipelines.

• GenSight Biologics on Track to Submit LUMEVOQ® for European Approval in September 2020 Following Pre-Submission Meeting with EMA

  4/15/2020

  GenSight Biologics, a biopharma company focused on discovering and developing innovative gene therapies for retinal neurodegenerative diseases and central nervous system disorders, announces the completion of the pre-submission meeting with the European Medicines Agency for the Company’s lead product LUMEVOQ®.

• GenSight Biologics Announces Presentation of Bilateral Visual Recovery From GS010 (LUMEVOQ™) Phase III Trials at the 46th Annual Meeting of NANOS

  3/3/2020

  GenSight Biologics announced that the bilateral visual recovery observed with GS010 in the REVERSE and RESCUE Phase III trials will be presented and discussed at the 46th Annual Meeting of the North American Neuro-Ophthalmology Society - Amelia Island, Florida - March 7-12, 2020.

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  Clinical Catch-Up: December 9-13

  12/16/2019

  It was a particularly busy week in clinical trial news, largely because of the American Society of Hematology Annual Meeting. Here’s a look.

• GenSight Biologics reports findings from REALITY study and REVERSE-RESCUE analysis highlighting positive benefits from LUMEVOQ™ (GS010) compared to LHON natural history

  12/11/2019

  GenSight Biologics reported results from the REALITY registry study and an analysis of REVERSE and RESCUE Phase III data, which further highlight the poor prognosis for patients with loss of vision due to Leber Hereditary Optic Neuropathy associated with the ND4 mutation.

• The Quinze-Vingts Hospital and GenSight Biologics Announce a First Temporary Authorization for Use (ATU) for LUMEVOQ™ (GS010) in France

  12/9/2019

  The National Eye Hospital of the Quinze-Vingts in Paris and GenSight Biologics announced that the French Competent Authority, the National Drug Safety Agency, granted a named patient Temporary Authorization for Use for LUMEVOQ™ to the CHNO of the Quinze-Vingts.

• The Quinze-Vingts Hospital and GenSight Biologics announce a first Temporary Authorization for Use (ATU) for LUMEVOQTM (GS010) in France

  12/9/2019

  The National Eye Hospital of the Quinze- Vingts in Paris and GenSight Biologics announced that the French Competent Authority, the National Drug Safety Agency, granted a named patient Temporary Authorization for Use for LUMEVOQTM to the CHNO of the Quinze-Vingts.

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  BioSpace Global Roundup, Oct. 10

  10/10/2019

  Companies from across the globe provide updates on their business and pipelines.

• GenSight Biologics Reports Evidence of GS010 DNA Transfer to Contralateral Eye of Primates Unilaterally Injected With GS010 Gene Therapy

  10/9/2019

  First study to find direct evidence that therapeutic gene is transferred from the injected eye to the uninjected contralateral eye of primates

• GenSight Biologics Appoints Magali Taiel as Chief Medical Officer

  10/8/2019

  GenSight Biologics announced the appointment of Magali Taiel, MD, as Chief Medical Officer, effective immediately.