GlobeNewswire by notified

Saniona uppdaterar om pågående granskning av tesofensin i Mexiko

Dela

PRESSMEDDELANDE

25 juni 2021

Saniona (OMX: SANION), ett biofarmaceutiskt företag med klinisk utveckling fokuserad på sällsynta sjukdomar, meddelar idag att dess partner Productos Medix, S.A de S.V, (Medix) har gett Saniona en uppdatering om den mexikanska tillsynsmyndigheten Comisión Federal para la Protección contra Riesgos Sanitarios (COFEPRIS) pågående granskning av tesofensin för behandling av fetma.

Enligt Medix har ansökan för tesofensin granskats som en del av den pågående granskningsprocessen av en teknisk kommitté hos COFEPRIS för nya molekyler (El Comité de Moléculas Nuevas). Kommittén kunde i nuläget inte ge ett fullt positivt yttrande om tesofensin och nämnde behovet av mer information om vissa ämnen, inklusive viktminskningshantering. Medix informerade Saniona att de kommer att samla in den begärda informationen och fortsätta diskussionerna med kommittén så snart möjligt samt att de avser fortsätta arbetet med att söka godkännande för tesofensin. Medix meddelade dock att de fortsatta diskussionerna med kommittén kan försena det förväntade slutgiltiga beslutet från COFEPRIS till 2022.

Medix licensierade rättigheterna att utveckla och kommersialisera tesofensin i Mexiko och Argentina från Saniona 2016. Saniona behåller alla rättigheter till tesofensin i resten av världen.

För ytterligare information, vänligen kontakta
Trista Morrison, Chief Communications Officer, Saniona. Kontor: + 1 (781) 810-9227. E-post: trista.morrison@saniona.com

Informationen lämnades, genom ovanstående kontaktpersons försorg, för offentliggörande 25 juni 2021 kl. 19.45 CEST.

Om Saniona
Saniona är ett biofarmaceutiskt företag som fokuserar på att upptäcka, utveckla och leverera innovativa behandlingar för patienter med sällsynta sjukdomar världen över. För bolagets huvudkandidat, Tesomet, genomförs kliniska studier i mellanfas avseende de sällsynta sjukdomarna hypotalamisk fetma och Prader-Willis syndrom, allvarliga sällsynta sjukdomar som kännetecknas av okontrollerbar hunger och svårhanterlig viktuppgång. Sanionas robusta plattform för läkemedelsupptäckt har genererat ett bibliotek av mer än 20 000 proprietära jonkanalsmodulatorer - en i huvudsak outnyttjad läkemedelsklass som är vetenskapligt validerad. Läkemedelskandidaten SAN711 ska inleda fas 1-studier på sällsynta neuropatiska sjukdomar, och SAN 903 mot sällsynta inflammatoriska och fibrotiska sjukdomar avanceras i prekliniska studier. Under ledning av ett erfaret vetenskapligt och operativt team har Saniona en etablerad forskningsorganisation i Köpenhamn och huvudkontor nära Boston, Massachusetts, USA. Bolagets aktie är listad på Nasdaq Stockholm Small Cap (OMX: SANION). Läs mer på www.saniona.com.

Bilaga

För att se det här innehållet från www.globenewswire.com måste du ge ditt medgivande sidans topp.
För att se det här innehållet från ml-eu.globenewswire.com måste du ge ditt medgivande sidans topp.

Om

GlobeNewswire by notified
GlobeNewswire by notified
One Liberty Plaza - 165 Broadway
NY 10006 New York

https://notified.com

GlobeNewswire by notified is one of the world's largest newswire distribution networks, specializing in the delivery of corporate press releases financial disclosures and multimedia content to the media, investment community, individual investors and the general public.

Följ GlobeNewswire by notified

Abonnera på våra pressmeddelanden. Endast mejladress behövs och den används bara här. Du kan avanmäla dig när som helst.

Senaste pressmeddelandena från GlobeNewswire by notified

Oxurion Receives Transparency Notification from Atlas Special Opportunities LLC28.3.2024 19:00:00 CET | Press release

Oxurion Receives Transparency Notification from Atlas Special Opportunities LLC Leuven, BELGIUM – March 28, 2024 – 07:00 PM CET Oxurion NV (Euronext Brussels: OXUR), a biopharmaceutical company headquartered in Leuven, today announced that, pursuant to Belgian Transparency legislation1 it has received transparency notifications as follows: Oxurion received a transparency notification on March 27, 2024, from Atlas Special Opportunities, LLC indicating that as of March 19, 2024, it held 0 (zero) shares of the then outstanding 5,753,951,723 shares, and therefore crossed below the threshold (3%) by virtue of the sale of voting securities. See Annex 1. About Oxurion Oxurion (Euronext Brussels: OXUR) is engaged in developing next-generation standard of care ophthalmic therapies for the treatment of retinal disease. Oxurion is based in Leuven, Belgium. More information is available at www.oxurion.com. Important information about forward-looking statements Certain statements in this press rele

C.K. McWhorter: Running to a Solution Of Equality and Sustainability28.3.2024 18:48:29 CET | Press release

MIAMI, March 28, 2024 (GLOBE NEWSWIRE) -- In a groundbreaking endeavor, C.K. McWhorter, renowned for his pioneering spirit in luxury and finance, is embarking on a transformative journey to reshape the narrative of desirability. By harnessing the allure of luxury, McWhorter aims to catalyze a paradigm shift towards equality and sustainability, ensuring that these principles become the most coveted and revered ideals worldwide. With a profound understanding of the power of influence, McWhorter recognizes that luxury sets the standard for aspiration and desire. Leveraging this influence, he seeks to redefine what it means to truly desire and value, shifting the focus from just material possessions to ethical principles that benefit humanity and the planet. "Luxury has long been synonymous with opulence and exclusivity, but it's time for us to redefine its meaning," says McWhorter. "True luxury is in equality and sustainability – in knowing that our desires are aligned with values that up

Multitude Group Annual Report 2023 published - on track for substantial profitable growth in 2024 and beyond28.3.2024 18:30:00 CET | Press release

Multitude Group Annual Report 2023 published - on track for substantial profitable growth in 2024 and beyond Guidance for 2023 achieved: EBIT plus 44.8% to EUR 45.6 million Revenue up 8.5 % to EUR 230.5 millionNet profit jumped to EUR 16.4 million, basic earnings per share amount to EUR 0.51 Loans to customers and debt investments increased by 20.8% to EUR 638.1 million, impaired loan coverage ratio decreased to 16.6%Dividend proposal of EUR 0.19 per shareStrong confidence for outlook: 2024: EBIT guidance of EUR 67.5 million Mid-term 2026: net profit growth to EUR 30 million Helsinki, 28 March 2024 – Multitude SE, a listed European FinTech company, offering digital lending and online banking services to consumers, small and medium-sized businesses, and other FinTechs (ISIN: FI4000106299, WKN: A1W9NS) (“Multitude”, “Company” or “Group”) announces that the Group's Annual Report, Corporate Governance Statement and Remuneration Report for the financial year ended 31 December 2023 have been

NOTICE TO CONVENE MULTITUDE SE’S ANNUAL GENERAL MEETING OF SHAREHOLDERS28.3.2024 18:30:00 CET | Press release

NOTICE TO CONVENE MULTITUDE SE’S ANNUAL GENERAL MEETING OF SHAREHOLDERS Notice is given to the shareholders of Multitude SE (Company) that the Annual General Meeting of the Company is to be held on 25 April 2024 at 10:00 a.m. (EEST / Finnish time) at the offices of Castrén & Snellman Attorneys Ltd, Eteläesplanadi 14, Helsinki, Finland. The reception of persons who have registered for the meeting and the distribution of voting tickets will start at 9:30 a.m. (EEST / Finnish time). Shareholders may also exercise their voting rights by voting in advance. Instructions concerning advance voting are provided in Section 3.4 of this notice. It will not be possible to participate in the meeting or follow the meeting via an online stream or otherwise in real time by the use of telecommunication connections or technical means. The meeting will be held in the English language. 1 MATTERS ON THE AGENDA OF THE GENERAL MEETING OF SHAREHOLDERS At the General Meeting of Shareholders, the following matte

Sword Group: NOTICE OF CONVOCATION TO THE SHAREHOLDERS FOR THE ANNUAL ORDINARY GENERAL MEETING OF THE COMPANY28.3.2024 18:00:00 CET | Press release

General Meeting on April 29, 2024, at 11:00 am at the registered office to deliberate on the following agenda: Under the authority of the General Meeting acting under the quorum and majority conditions of an Ordinary General Meeting: - Reading of the management report of the Board of Directors including the group management report and feedback on the conclusion of agreements referred to in article L.441-7 of the amended law of August 10, 1915, for the financial year ended December 31, 2023; - Reading of the report of the approved statutory auditor on the 2023 annual accounts, the group's consolidated financial statements, and on the execution of its mission; - Approval of the statutory accounts as of December 31, 2023; - Approval of the consolidated accounts as of December 31, 2023; - Allocation of the statutory exercise results as of December 31, 2023; - Discharge to the directors for their management for the financial year 2023; - Renewal of Mr. Jacques Mottard's director term; - Ren

HiddenA line styled icon from Orion Icon Library.Eye