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Theranexus — Investor Relations & Filings

Ticker · ALTHX ISIN · FR0013286259 LEI · 969500BFCV6IC7MFQP20 PA Manufacturing
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Filings indexed 286 across all filing types
Latest filing 2023-06-14 Earnings Release
Country FR France
Listing PA ALTHX

About Theranexus

https://www.theranexus.com/en/

THX Pharma (formerly Theranexus) is an innovative, clinical-stage biopharmaceutical company that emerged from the French Alternative Energies and Atomic Energy Commission (CEA). The company specializes in developing treatments for rare neurological disorders. It leverages a unique platform for the identification and characterization of advanced therapy drug candidates. Its lead program is a drug candidate in clinical development for Batten disease, a rare neurodegenerative disorder.

Recent filings

Filing Released Lang Actions
Encouraging preliminary 6-month results in the Phase I/II trial of Batten-1 in Batten disease (CLN3)
Earnings Release Classification · 1% confidence The document is a press release announcing preliminary results from a clinical trial (Phase I/II for Batten-1). It contains key highlights, quotes from management (CEO, CMO), details about the drug candidate, trial design, and background information on the disease and involved organizations (Theranexus, BBDF). This format—a formal announcement of recent operational/clinical progress, often released before a full regulatory filing or detailed report—is characteristic of an Earnings Release (ER) or a general press release summarizing significant news. Since it focuses on clinical trial results and operational updates rather than just financial figures (which would lean towards ER), and it is a formal announcement, it fits best under the general category for significant company announcements that aren't specific regulatory forms like 10-K or IR. Given the options, 'Earnings Release' (ER) is often used broadly for periodic performance updates, even if clinical rather than purely financial, but 'Regulatory Filings' (RNS) serves as a strong fallback for press releases announcing material, non-standardized news. However, the content is a direct announcement of results, which strongly aligns with the purpose of an Earnings Release (ER) in a biotech context (announcing trial milestones/results). It is not a transcript (CT), a full interim report (IR), or a presentation (IP). I will classify it as an Earnings Release (ER) as it communicates period-specific performance metrics (6-month results). H1 2023
2023-06-14 English
Theranexus and BBDF granted positive opinion by EMA for the design of Phase III trial to evaluate Batten-1 in CLN3 Batten disease
Regulatory Filings Classification · 1% confidence The document is a press release issued by Theranexus announcing a positive opinion from the EMA regarding the design of a Phase III clinical trial for their drug candidate, Batten-1. It provides details on the trial design, regulatory status, and company background. As it is a general regulatory announcement regarding company operations and clinical trial progress that does not fit into more specific categories like financial results or shareholder voting, it is classified as a Regulatory Filing (RNS).
2023-06-07 English
Theranexus et BBDF obtiennent l'avis positif de l'EMA sur le design de la phase 3 de Batten-1 dans la maladie de Batten CLN3
Regulatory Filings Classification · 1% confidence The document is a press release dated June 7, 2023, announcing that Theranexus and BBDF have received positive feedback from the European Medicines Agency (EMA) regarding the design of their Phase 3 clinical trial (Batten-1) for Batten disease. It details the trial design, endpoints (visual acuity as primary), patient population, and timeline for recruitment. This type of announcement, which communicates significant operational and clinical development milestones, is characteristic of an Earnings Release (ER) if it were summarizing financial results, or more specifically, a general corporate announcement. Since it is not a full financial report (10-K, IR), a transcript (CT), or a specific regulatory filing like DIRS or DIV, it fits best under the general category for corporate news releases that are not explicitly defined elsewhere. Given the content focuses on clinical trial progress and regulatory feedback, it is a significant corporate update. It is not a Report Publication Announcement (RPA) because it is the news itself, not an announcement *about* attaching or publishing a separate report. It is a high-level update on drug development, which often accompanies or precedes formal financial reporting. In the absence of a specific 'Clinical Trial Update' code, 'Regulatory Filings' (RNS) serves as the best general category for significant, non-financial, non-shareholder-vote-related corporate news releases that don't fit other specific codes like MANG or TAR. However, given the nature of the announcement (positive regulatory feedback on a key drug trial), it is a critical piece of investor information. If we must choose from the provided list, and recognizing it's a press release about operational progress, RNS is the most appropriate fallback for significant corporate news not covered by other specific codes.
2023-06-07 French
MISE A DISPOSITION DES INFORMATIONS RELATIVES A L'ASSEMBLÉE GÉNÉRALE DES ACTIONNAIRES DU 8 JUIN 2023
AGM Information Classification · 1% confidence The document is titled "MISE A DISPOSITION DES INFORMATIONS RELATIVES A L'ASSEMBLÉE GÉNÉRALE DES ACTIONNAIRES DU 8 JUIN 2023" (Making available of information relating to the Shareholders' General Meeting of June 8, 2023). It explicitly announces the availability of preparatory documents for the Mixed General Meeting (Assemblée Générale Mixte) scheduled for June 8, 2023, and directs shareholders to where these documents can be consulted. This content strongly aligns with the definition of AGM Information (AGM-R), which covers presentations and materials shared during the Annual General Meeting. Although it is an announcement about the materials, the core subject matter is the AGM itself, making AGM-R the most specific fit over a general Report Publication Announcement (RPA) or Regulatory Filing (RNS). The document length (3737 chars) is short, but the primary focus is the AGM event and its associated materials.
2023-05-24 French
Theranexus and BBDF win FDA approval on efficacy endpoints for the Phase III trial to evaluate Batten-1 in CLN3 Batten disease
Regulatory Filings Classification · 1% confidence The document is a press release dated May 9, 2023, announcing that Theranexus and BBDF received FDA approval for the design and endpoints of their pivotal Phase III trial for Batten-1 in CLN3 Batten disease. It details the trial protocol, endpoints, and next steps, including patient enrollment timelines. This type of announcement, detailing clinical trial progress and regulatory milestones, is characteristic of an Earnings Release (ER) or a general press release regarding corporate/clinical updates. Since it is a formal announcement of key operational/clinical news rather than a full financial report (10-K, IR) or a transcript (CT), the most appropriate classification among the provided options is Earnings Release (ER), as these often contain operational highlights and clinical updates alongside financial results, or it could be classified as a Regulatory Filing (RNS) if it were purely regulatory. Given the focus on clinical trial progress and FDA interaction, it functions as a major corporate update, which often falls under the umbrella of an ER or a general announcement. However, since it is not explicitly an earnings report but a clinical/regulatory update, and it is a full-length document (not a short announcement of a report), 'ER' is a strong candidate for significant corporate news releases. If a more specific clinical trial update category existed, it would fit there. Lacking that, and given its nature as a major corporate announcement, ER is chosen over RNS (which is a fallback).
2023-05-09 English
Theranexus et BBDF obtiennent l'accord de la FDA sur les critères d'efficacité de l'étude de phase 3 de Batten-1 dans la maladie de Batten CLN3
Regulatory Filings Classification · 1% confidence The document is a press release dated May 9, 2023, announcing that Theranexus and BBDF have obtained agreement from the FDA regarding the efficacy endpoints for the Phase 3 clinical trial of Batten-1 for CLN3 Batten disease. It details the trial design, patient population, primary and secondary endpoints, and next steps (recruitment start). This type of announcement, detailing significant clinical trial progress and regulatory feedback, is characteristic of an Earnings Release (ER) or a general press release related to corporate/pipeline updates. Since it focuses on key financial/operational milestones (FDA agreement, trial design) rather than being a full quarterly/annual report (IR/10-K) or a transcript (CT), the most fitting category is Earnings Release (ER), as these often contain pipeline updates alongside financial highlights, or it could be classified as a Regulatory Filing (RNS) if it were a mandatory filing. Given the structure and content (announcing key results/updates), ER is often used for such material news releases. However, since it is a specific announcement about regulatory feedback and trial design, and not explicitly tied to a quarterly earnings period summary, it fits best as a general announcement of material information. In the provided definitions, 'ER' (Earnings Release) is the closest fit for a press release announcing significant operational/clinical milestones, even if it's not strictly quarterly results. If it were purely regulatory, RNS would apply, but this is a proactive communication. Given the focus on clinical trial progress and regulatory interaction, ER is the best fit among the options for a major corporate announcement.
2023-05-09 French

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