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Aandeel OpGen OTC:OPGN.Q, US68373L4068

  • 0,598 22 apr 2024 22:00
  • 0,000 (0,00%) Dagrange 0,000 - 0,000
  • 2 Gem. (3M) 1,7M

Curetis/Opgen 2021 - wie boeit het nog ?

91 Posts
Pagina: 1 2 3 4 5 »» | Laatste | Omlaag ↓
  1. forum rang 4 Pitmans 11 februari 2021 18:52
    Toch maar een nieuw draadje, genoeg nieuws te melden.
    Het leek er even op dat de koers begin deze week meeveerde met een ander Nasdaq-fonds met de bijna zelfde ticker OCGN, dat financiering rondkreeg voor een Covid gerelateerde ontwikkeling.
    Toch blijkt ook Opgen zelf nieuws te hebben. Want ook Opgen heeft nieuwe financiering geregeld in een constructie vergelijkbaar met de vorige, waarbij $25miljoen werd opgehaald door emissie van stukken tegen $2. Dit keer zijn de voorwaarden gunstiger, emissie tegen $3.
    Dat heeft net als vorige keer voor een flinke koerstrigger gezorgd, maar ook net als vorige keer, na een paar dagen staat nu de koers juist onder die emissiekoers.Vorige keer duikelde de koers (uit het hoofd) naar $1.60, om daarna weer op te veren tot ruim boven $2.
    Het zal spannend worden of het verloop dit keer hetzelfde zal zijn en, indien ja, wat nu de bodem wordt. Koers op moment van schrijven $2.915, met een day low van $2.9

    ir.opgen.com/news-releases/news-relea...

    OpGen, Inc. Announces $25 Million Registered Direct Offering Priced At-the-Market Under NASDAQ Rules
    02.09.21
    Download PDF

    GAITHERSBURG, Md., Feb. 09, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, today announced it has entered into a definitive agreement with a single U.S.- based, healthcare-focused institutional investor for the purchase of (i) 2,784,184 shares of common stock (ii) 5,549,149 pre-funded warrants (the “Pre-Funded Warrants”), with each Pre-Funded Warrant exercisable for one share of common stock. The Company has also agreed to issue to the investor, in a concurrent private placement, unregistered common share purchase warrants (the “Common Warrants”) to purchase 4,166,666 shares of the Company’s common stock. Each share of common stock and accompanying Common Warrant are being sold together at a combined offering price of $3.00, and each Pre-Funded Warrant and accompanying Common Warrant are being sold together at a combined offering price of $2.99, pursuant to a registered direct offering, priced at-the-market under Nasdaq rules. The Pre-Funded Warrants are immediately exercisable, at an exercise price of $0.01, and may be exercised at any time until all of the Pre-Funded Warrants are exercised in full. The Common Warrants will have an exercise price of $3.55 per share, will be exercisable commencing on the six-month anniversary of the date of issuance, and will expire five and one half (5.5) years from the date of issuance (collectively, the “Offering”).

    The closing of the Offering is expected to occur on or about February 11, 2021, subject to the satisfaction of customary closing conditions.

    A.G.P./Alliance Global Partners is acting as sole placement agent for the Offering.
  2. forum rang 4 Pitmans 1 maart 2021 15:38
    Geen idee waarom onderstaande niet tot een koersexplosie voorbeurs heeft geleid, $180mio gegarandeerde omzet gewonnen. Het lijkt zowaar nog een succesje te gaan worden...

    ir.opgen.com/news-releases/news-relea...

    OpGen Wins Chinese NMPA Approval for the Curetis Unyvero System
    03.01.21
    Download PDF

    Chinese regulatory authority NMPA completes registration of Unyvero instrument system as IVD for Chinese market
    Application of Unyvero cartridge for pneumonia is under review and pending NMPA approval
    OpGen’s subsidiary Curetis and its Chinese partner Beijing Clear Biotech continue working with the NMPA towards approval of pneumonia test in China

    GAITHERSBURG, Md., March 01, 2021 (GLOBE NEWSWIRE) -- OpGen, Inc. (Nasdaq: OPGN, “OpGen”), a precision medicine company harnessing the power of molecular diagnostics and bioinformatics to help combat infectious disease, announced today that it has recently received regulatory approval of the Curetis Unyvero System as an in vitro diagnostics (IVD) instrument system in China from the Chinese authorities (National Medical Products Administration, NMPA). The Medical Device Registration Certificate has been issued under the Registration number 20213220019.

    Since filing the submission dossier for the complete Unyvero System, consisting of the Unyvero A50 Analyzer, the Unyvero L4 Lysator and the Unyvero C8 Cockpit in February 2019, NMPA has been actively engaged in an interactive review process with OpGen’s subsidiary Curetis and its Chinese partner Beijing Clear Biotech (BCB) prior to this approval decision. The parties continue to interact closely with the NMPA during the interactive review of the submission and filing for the Unyvero A50 pneumonia cartridge as their first Unyvero-based diagnostic application for the Chinese market. A dossier for the review and potential future approval of the pneumonia cartridge was submitted in February 2019, which includes comprehensive data from various clinical trials and regulatory submissions of the Unyvero LRT and LRT BAL products (which are FDA cleared in the USA) and the Unyvero HPN cartridge for hospitalized pneumonia patients (which is CE-IVD marked in Europe). Timelines for NMPA response submissions and review had been extended by several months in 2020 due to the COVID-19 pandemic. The start of commercialization of the Unyvero platform in China remains subject to also getting approval of the pneumonia cartridge.

    Oliver Schacht, CEO of OpGen commented, “We are truly excited to see the Chinese regulators approve our Unyvero System based on the A50 Analyzer as a diagnostic instrument for the Chinese market. We have been working very closely with the NMPA and our partner BCB for several years towards this key milestone. Once we also receive NMPA approval for the Unyvero pneumonia cartridge for the Chinese market we expect a swift commercial launch in China by our partners BCB with tremendous growth potential for many years to come.”

    Zeeman Zhang, CEO of Beijing Clear Biotech (BCB) added, “Pneumonia remains one of the leading causes of death in hospitalized patients with severe infections and is the number two cause of death in children in China. We believe there is a large unmet medical need for faster and better diagnostics of the pathogens as well as their antimicrobial resistance marker profile. With Unyvero, we have a first-in-class platform that has been developed and is made in Germany and it has been sold in Europe and the U.S. for many years. We are delighted to bring this exciting new platform to China, to the benefit of doctors and patients alike in our hospitals, improving clinical outcomes and antibiotic stewardship.”

    OpGen’s subsidiary Curetis and BCB are parties to an exclusive multi-year distribution agreement for the Unyvero platform and cartridges in China. Once NMPA approves the products, BCB has agreed to contractual minimum purchases of 360 Unyvero systems and more than 1.5 million cartridges cumulative over an 8-year exclusivity period which at current transfer prices between the parties is expected to amount to approximately $180 million in revenue to OpGen at current exchange rates.
91 Posts
Pagina: 1 2 3 4 5 »» | Laatste |Omhoog ↑

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