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Abliva — Investor Relations & Filings

Ticker · ABLI ISIN · SE0002575340 LEI · 5493005YV22OTMUHZ183 ST Manufacturing
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Filings indexed 594 across all filing types
Latest filing 2018-09-06 Regulatory Filings
Country SE Sweden
Listing ST ABLI

About Abliva

https://abliva.com

Abliva is a biopharmaceutical company that discovers and develops medicines for the treatment of primary mitochondrial diseases. These are rare, congenital, and often severe genetic disorders that occur when the cell's energy converters, the mitochondria, are dysfunctional. The company's research and development is focused on creating novel therapies aimed at restoring mitochondrial function and addressing the significant unmet medical needs of patients. Abliva's primary goal is to deliver treatments that provide meaningful clinical benefits for individuals suffering from these debilitating conditions.

Recent filings

Filing Released Lang Actions
NeuroVive receives positive FDA feedback on its NeuroSTAT TBI development plan
Regulatory Filings Classification · 1% confidence The document is an announcement titled "NeuroVive receives positive FDA feedback on its NeuroSTAT TBI development plan." It details positive feedback received from the FDA regarding a clinical development plan and outlines the next regulatory steps (IND submission). It is not a full financial report (10-K, IR), an earnings release (ER), or a transcript (CT). It is a specific update concerning regulatory/clinical progress, which often falls under general investor relations communication. Since it is a specific announcement about regulatory feedback and clinical planning, and not a general regulatory filing (RNS) or a specific financial report, it best fits the category for general investor/regulatory updates. Given the options, this type of press release announcing clinical/regulatory milestones is most closely aligned with general Regulatory Filings (RNS) if a more specific category like 'Clinical Trial Update' is unavailable, or it could be considered a general Investor Relations document. However, since the content is a direct announcement of regulatory feedback and next steps, and it is not a formal financial report, RNS (Regulatory Filings - general fallback) is the most appropriate fit among the provided codes, as it is a material event disclosure.
2018-09-06 English
NeuroVive får positivt utlåtande från FDA om sin utvecklingsplan för NeuroSTAT mot TBI
Regulatory Filings Classification · 1% confidence The document is a press release from NeuroVive Pharmaceutical AB dated September 6, 2018. It announces receiving a positive statement from the FDA regarding the clinical development plan for their drug NeuroSTAT for Traumatic Brain Injury (TBI). The text details regulatory steps (IND application, Phase II study design) and includes quotes from management. Crucially, the closing paragraph states: "Denna information är sådan information som NeuroVive Pharmaceutical AB (publ) är skyldigt att offentliggöra enligt EU:s marknadsmissbruksförordning." (This information is information that NeuroVive Pharmaceutical AB (publ) is required to disclose pursuant to the EU Market Abuse Regulation). This structure—a brief announcement of a significant regulatory/development update, mandated disclosure under market abuse rules, and contact information—is characteristic of a general regulatory announcement, often categorized as a Regulatory Filing (RNS) or sometimes an Earnings Release (ER) if it contained financial results. Since this is specifically about a regulatory interaction (FDA feedback) and not a full financial report (10-K, IR) or a management discussion (MDA), RNS is the most appropriate general regulatory fallback category for such an announcement that doesn't fit the more specific categories like DIV, CAP, or DIRS. It is not an Earnings Release (ER) as it contains no period-specific financial results, nor is it a Report Publication Announcement (RPA) as it is the news itself, not an announcement *about* publishing a separate report.
2018-09-06 Swedish
Earnings Release 2018
Earnings Release Classification · 1% confidence The document is titled "Delårsrapport januari - juni 2018" (Interim Report January - June 2018) and contains detailed financial figures for the second quarter (April-June 2018) and the first half of the year (January-June 2018), including Net Sales, Profit before tax, and Earnings per share. It also includes a CEO commentary and updates on various drug development projects (KL1333, NeuroSTAT®, NVP015, etc.). This structure—a comprehensive report covering a period shorter than a full year with detailed financial statements and operational reviews—is characteristic of an Interim Report or Quarterly Report. The Swedish term 'Delårsrapport' directly translates to Interim Report. Therefore, the appropriate classification code is IR. H2 2018
2018-08-21 Swedish
Interim / Quarterly Report 2018
Interim / Quarterly Report Classification · 1% confidence The document is titled 'Interim report January - June 2018' and contains detailed financial statements (Net revenues, loss before tax, loss per share) for both the second quarter and the first six months of 2018. It also includes management commentary, project status updates, and operational highlights. This meets the criteria for an Interim/Quarterly Report (IR) as it provides substantive financial data and analysis for a period shorter than a full fiscal year. H2 2018
2018-08-21 English
NeuroVive out-licenses targeted LHON therapy to BridgeBio Pharma’s new subsidiary Fortify Therapeutics
Capital/Financing Update Classification · 1% confidence The document announces a significant business transaction: NeuroVive out-licensing a therapy program (NVP015 subset) to BridgeBio Pharma's subsidiary, Fortify Therapeutics, for a specific indication (LHON). This involves exclusive licensing, financial commitments, milestone payments, and royalties. This type of corporate action, detailing strategic partnerships, licensing deals, and financing structures related to drug development assets, falls under Capital/Financing Updates (CAP) or potentially Regulatory Filings (RNS) if it were a mandatory disclosure without a better fit. Since it details a major licensing agreement and associated financial structure (deal value, milestones), it is best classified as a Capital/Financing Update (CAP), as it directly relates to the company's financing and asset monetization strategy. It is not an earnings release (ER), an interim report (IR), or a full annual report (10-K). It is a specific corporate transaction announcement.
2018-06-18 English
NeuroVive utlicensierar målinriktad behandling av LHON till BridgeBio Pharmas nya dotterföretag Fortify Therapeutics
Regulatory Filings Classification · 1% confidence The document is a press release dated June 18, 2018, announcing a licensing agreement between NeuroVive Pharmaceutical AB and BridgeBio Pharma (via its new subsidiary Fortify Therapeutics) for a subset of NeuroVive's NVP015 program related to LHON treatment. The text details the financial terms (up to $60 million total value), the scientific background, and the strategic implications. It concludes with a statement indicating that the information is being made public according to EU market abuse regulation ('EU:s förordning om marknadsmissbruk'). This structure—a formal announcement of a significant corporate/financial event (licensing deal) released via press wire—is characteristic of a general regulatory announcement or press release that doesn't fit the specific financial report categories (like 10-K, IR, ER). Since it is a formal announcement required for market transparency, and it doesn't fit the specific definitions for M&A (TAR), Capital Change (CAP), or Director Dealing (DIRS), the most appropriate general category for such a regulatory disclosure is Regulatory Filings (RNS). It is not an Earnings Release (ER) or an Interim Report (IR) as it focuses on a specific transaction, not period results.
2018-06-18 Swedish

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