DNL.L (Mkap €25 M) Attraktive Medikamente vor der Zulassung (Seite 60)
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Beitrag zu dieser Diskussion schreiben
Antwort auf Beitrag Nr.: 62.666.116 von Naggn am 13.02.20 09:42:39Sorry dafür....wollte keine Gerüchte streuen! Läuft nun bei mir, aber natürlich wenig 😂
Also die Aktie ist so träge auf aim. Ich halte von am einfach gar nichts, absolute crap stock exchange
Hast natürlich recht. Ich bin meiner Zeit vorraus Bid aktuell dennoch bei 27, Ask bei 30. Hoffe das läuft noch etwas weiter hoch.
Läuft ja auch garnicht, tradinghalt? Oder spinnt mein Broker?
Antwort auf Beitrag Nr.: 62.666.065 von kelev_ra am 13.02.20 09:37:07
ich dachte die Londoner Börse operiert erst ab 9 Uhr Ortszeit, das wäre hier 10 Uhr... ?!
Zitat von kelev_ra: Auch dieses mal interessieren die News keinen. Schade...
ich dachte die Londoner Börse operiert erst ab 9 Uhr Ortszeit, das wäre hier 10 Uhr... ?!
Auch dieses mal interessieren die News keinen. Schade...
Sehr gut, dann hoffe ich mal, dass es wieder dauerhaft über die 0,30 GBP geht. Kann doch nicht sein, dass ausschließlich US Titel hochgehyped werden...
Antwort auf Beitrag Nr.: 62.664.865 von jokba am 13.02.20 08:09:17Link geht leider nicht:
US FDA Accepts NDA Application for Alkindi
US FDA Accepts NDA Application for Alkindi
Diurnal Group plc
("Diurnal" or the "Company")
US FDA Accepts for Review Diurnal's New Drug Application for Alkindi® Sprinkle
Application seeks approval of Alkindi® Sprinkle as a replacement therapy of adrenal insufficiency in infants, children and adolescents
NDA could potentially be approved in Q3 2020
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that its New Drug Application (NDA) for Alkindi® (hydrocortisone granules in capsules for opening), to be known in the US as Alkindi® Sprinkle, has been accepted for review by the US Food and Drug Administration (FDA). Diurnal is seeking approval of Alkindi® Sprinkle as a replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents (from birth to <17 years old) in the US.
Paediatric AI is a condition characterised by deficiency in cortisol, an essential hormone in regulating growth, metabolism and the response to stress. Paediatric AI has been identified as an orphan disease in the US where there are estimated to over 4,000 sufferers under the age of 17. Untreated, the disease is associated with significant morbidity and increased mortality.
The NDA for Alkindi® Sprinkle was submitted in November 2019 following a positive meeting with the FDA in Q1 2019 which confirmed Diurnal's clinical and regulatory pathway for the product in the US. The PDUFA date set by the FDA, which would be the earliest date at which approval could occur, is 29 September 2020.
Martin Whitaker, CEO of Diurnal, commented:
"We are pleased to announce that our NDA for Alkindi® Sprinkle in the US has been accepted for review by the FDA. If approved, Alkindi® Sprinkle will provide a major breakthrough in the US as the only licensed treatment specifically designed for use in children with adrenal insufficiency, where there is a significant unmet patient need."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
("Diurnal" or the "Company")
US FDA Accepts for Review Diurnal's New Drug Application for Alkindi® Sprinkle
Application seeks approval of Alkindi® Sprinkle as a replacement therapy of adrenal insufficiency in infants, children and adolescents
NDA could potentially be approved in Q3 2020
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces that its New Drug Application (NDA) for Alkindi® (hydrocortisone granules in capsules for opening), to be known in the US as Alkindi® Sprinkle, has been accepted for review by the US Food and Drug Administration (FDA). Diurnal is seeking approval of Alkindi® Sprinkle as a replacement therapy of adrenal insufficiency (AI) in infants, children and adolescents (from birth to <17 years old) in the US.
Paediatric AI is a condition characterised by deficiency in cortisol, an essential hormone in regulating growth, metabolism and the response to stress. Paediatric AI has been identified as an orphan disease in the US where there are estimated to over 4,000 sufferers under the age of 17. Untreated, the disease is associated with significant morbidity and increased mortality.
The NDA for Alkindi® Sprinkle was submitted in November 2019 following a positive meeting with the FDA in Q1 2019 which confirmed Diurnal's clinical and regulatory pathway for the product in the US. The PDUFA date set by the FDA, which would be the earliest date at which approval could occur, is 29 September 2020.
Martin Whitaker, CEO of Diurnal, commented:
"We are pleased to announce that our NDA for Alkindi® Sprinkle in the US has been accepted for review by the FDA. If approved, Alkindi® Sprinkle will provide a major breakthrough in the US as the only licensed treatment specifically designed for use in children with adrenal insufficiency, where there is a significant unmet patient need."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).