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GenSight Biologics S.A. — Investor Relations & Filings

Ticker · SIGHT ISIN · FR0013183985 LEI · 549300NK4AB8OUEX1F54 PA Manufacturing
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Filings indexed 628 across all filing types
Latest filing 2024-12-18 Legal Proceedings Report
Country FR France
Listing PA SIGHT

About GenSight Biologics S.A.

https://www.gensight-biologics.com

GenSight Biologics is a clinical-stage biopharmaceutical company focused on discovering, developing, and commercializing innovative gene therapies for patients with neurodegenerative retinal diseases and disorders of the central nervous system. The company's therapeutic approach is based on two core technology platforms: the Mitochondrial Targeting Sequence (MTS) and optogenetics. Its lead product candidate, LUMEVOQ (lenadogene nolparvovec), is a gene therapy in late-stage clinical development for treating vision loss from rare mitochondrial diseases. The company's pipeline also includes GS030, an optogenetic-based therapy in clinical trials for retinal degenerative diseases.

Recent filings

Filing Released Lang Actions
Inside Information / Other news releases
Legal Proceedings Report Classification · 99% confidence The document is a press release dated December 18, 2024, providing an update on regulatory discussions (with ANSM regarding LUMEVOQ®) and the company's financial situation (cash runway until early January 2025). It discusses operational readiness and financing strategy. This type of communication, which provides key operational and financial highlights outside of a formal quarterly or annual report filing, is characteristic of an Earnings Release (ER) or a general corporate update. Since it focuses on financial status and operational milestones rather than just announcing a report's publication, 'ER' (Earnings Release) is the most appropriate fit, as these often include brief financial status updates alongside operational news. It is not a full 10-K, IR, or a specific announcement like DIV or DIRS. Given the content focuses on financial status and operational progress, ER is the best classification.
2024-12-18 English
Informations privilégiées / Autres communiqués
Legal Proceedings Report Classification · 99% confidence The document is a press release ("Communiqué de presse") dated December 18, 2024, providing an update on regulatory discussions (ANSM/AAC for LUMEVOQ®) and the company's financial situation (cash runway until early January 2025, seeking financing). It also mentions the number of shares outstanding. This format, which summarizes key operational and financial developments outside of a formal periodic report (like 10-K or IR), strongly aligns with an Earnings Release (ER) or a general regulatory announcement. Since it focuses on financial status and operational updates following a period of activity, it fits best as an Earnings Release (ER), which typically precedes or accompanies a more detailed report, or an announcement of key results. Given the focus on financial runway and operational milestones, ER is the most appropriate fit among the specific options, as it is an announcement of current status rather than a formal, comprehensive report (like 10-K or IR). It is not a Call Transcript (CT), Investor Presentation (IP), or a formal Audit Report (AR).
2024-12-18 French
Franchissement de seuils et déclaration d'intention
Major Shareholding Notification Classification · 99% confidence The document is titled "Déclaration de franchissement de seuils et déclaration d'intention (article L. 233-7 du code de commerce)" and details changes in share ownership thresholds (5% and 10%) by Invus Public Equities, L.P. in GENSIGHT BIOLOGICS S.A., referencing French commercial code articles related to significant shareholdings. This type of mandatory disclosure regarding changes in major shareholdings is specifically covered by the definition for Major Shareholding Notification (MRQ). Although it involves insider transactions (directors' dealing is DIRS), the primary focus and regulatory trigger here is the crossing of ownership thresholds, which aligns best with MRQ.
2024-11-21 French
Franchissement de seuils
Major Shareholding Notification Classification · 99% confidence The document is titled "Déclaration de franchissement de seuils (article L. 233-7 du code de commerce)" and details that The Goldman Sachs Group, Inc. crossed the 5% threshold of capital and voting rights in GENSIGHT BIOLOGICS S.A. This type of filing, which reports changes in significant share ownership by crossing specific thresholds, directly corresponds to the definition of Major Shareholding Notification (MRQ). The document is a regulatory disclosure concerning ownership changes, not a general regulatory announcement (RNS) or a report itself.
2024-11-13 French
Inside Information / Other news releases
Regulatory Filings Classification · 100% confidence The document is a 'Press Release' announcing the submission of a regulatory file (dossier) for LUMEVOQ® to the French medicines safety agency (ANSM) to support the restart of an early access program. This is not a comprehensive financial report (like 10-K or IR), nor is it a transcript (CT) or a formal dividend notice (DIV). It is an announcement regarding regulatory/legal progress concerning a product. While it touches upon regulatory matters, it is primarily a corporate update about a specific action taken with a regulatory body concerning product access. This type of announcement, which details a specific corporate action or regulatory milestone outside of standard financial reporting cycles, often falls under general Regulatory Filings (RNS) or, if it were about a lawsuit, LTR. Given the context of a press release announcing a specific regulatory submission milestone, RNS (Regulatory Filings - general regulatory announcements and fallback) is the most appropriate category, as it is not explicitly covered by other specific codes like DIRS, DIV, or TAR. It is not an announcement of a report publication (RPA) because it is the substance of the regulatory action itself, not just an announcement that a report is available.
2024-11-13 English
Informations privilégiées / Autres communiqués
Legal Proceedings Report Classification · 99% confidence The document is a press release from GenSight Biologics announcing the submission of an updated regulatory dossier for their drug LUMEVOQ® to the French National Agency for the Safety of Medicines and Health Products (ANSM). The purpose of this submission is specifically to prepare for the resumption of the compassionate access program (AAC) in France. This is an announcement regarding regulatory/legal/product progress, not a full financial report (like 10-K or IR), an earnings release (ER), or a formal shareholder communication (like DEF 14A or AGM-R). Since it details a specific regulatory action concerning product access and compliance, it fits best under the general category of Regulatory Filings (RNS), as it is a formal announcement of a regulatory step, although it is highly specific. Given the options, RNS serves as the best fit for a general regulatory update announcement that isn't explicitly covered by LTR (Legal Proceedings) or ER/IR (Financials). It is not a Report Publication Announcement (RPA) because it is announcing the submission of a dossier for regulatory review, not the publication of a completed financial report.
2024-11-13 French

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