Panion's epilepsy product candidate for gene therapy in the dog: FDA has established an Investigational New Animal Drug (INAD) file.
Panion Animal Health AB ("Panion") has in Q4-17 requested the FDA to open an Investigational New Animal Drug application file to carry out the development of our new product for use in the dog. Panion plans to develop and gain approval for the use of CG-01-canine, a recombinant adeno-associated virus vector expressing neuropeptide Y and receptor peptide Y2 to treat drug refractory idiopathic epilepsy in the dog via intracranial injection.
A summary of the scientific rationale for the therapy and the preliminary work completed to date was submitted and the FDA accepted this with a response letter, which was received from our US consultant on January 02, 2018. Because a MUMS status for Panion development product has been granted, in which the Sponsor User Fee was waived, the application is free of charge for Panion.
The opening of the INAD means that Panion may request a meeting with the FDA and propose a detailed plan of development for discussion with the authorities. In addition, the INAD is prerequisite for shipping of the investigational drug product to the clinical trial investigators in US.
"It is great to see that we are making progress in these regulatory areas, because this is the pathway to authorization of a product" says Anja Holm, CEO of Panion.
JANUARY 03 2018
Anja E. H. Holm, CEO
+ 45-22 94 66 00
Bolaget ska utveckla och kommersialisera genterapi för behandling av epilepsiliknande tillstånd hos hundar och andra djur, samt utveckla och kommersialisera andra veterinärmedicinska produkter och nya behandlingsformer som kan ge sjuka djur bättre livskvalitet.
Panion will develop and commercialize a gene therapy treatment for dogs with drug refractory epilepsy, and other new animal health products and treatments that improve the quality of life for animals suffering from chronic diseases.
Panion is attracting interest from the agribusiness intelligence and animal health media Animal Pharm, where journalist Sian Lazell yesterday, 31.st of January 2019, noted the news on financing of the development program from Panion: https://bit.ly/2t1tgeK "Panion secures extra funding to back R&D. The financing round was carried out through the issuance of notes with warrants attached to Yorkville Advisors Global, that have a principal amount of SEK 100,000 each.
Panion Animal Health AB ("Panion") kallar på en andra tranche från den investeringsfond som förvaltas av Yorkville Advisors Global ("Yorkville").
Panion Animal Health AB ("Panion") draws down a second tranche from the investment fund managed by Yorkville Advisors Global ("Yorkville").
The rights issue in Panion Animal Health AB has been registered by the Swedish Companies Registration Office
The rights issue which was decided by the Board of Panion Animal Health AB, with the authorization of the Annual General Meeting of 29 May 2018, has now been registered by the Swedish Companies Registration Office. Shares and share capital after the registration by the Swedish Companies Registration Office amount to SEK 1,137,110.723254 divided into 24,399,487 shares.
Panion Animal Health AB
Marknadsplats: Spotlight Stock Market
Interim Report Q3 2018
2019-02-22 Delårsrapport Q4 2018