DNL.L (Mkap €25 M) Attraktive Medikamente vor der Zulassung (Seite 81)
eröffnet am 15.07.19 22:09:04 von
neuester Beitrag 15.11.22 13:24:57 von
neuester Beitrag 15.11.22 13:24:57 von
Beiträge: 969
ID: 1.307.455
ID: 1.307.455
Aufrufe heute: 3
Gesamt: 134.192
Gesamt: 134.192
Aktive User: 0
ISIN: GB00BDB6Q760 · WKN: A2ACSA
0,2820
EUR
0,00 %
0,0000 EUR
Letzter Kurs 01.11.22 Frankfurt
Neuigkeiten
Werte aus der Branche Dienstleistungen
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 0,5350 | +18,36 | |
| 9,402 | +13,10 | |
| 13,640 | +9,91 | |
| 59.200,00 | +9,83 | |
| 0,5800 | +9,43 |
| Wertpapier | Kurs | Perf. % |
|---|---|---|
| 13,370 | -10,57 | |
| 9,6900 | -11,79 | |
| 0,5100 | -12,82 | |
| 1,5100 | -22,16 | |
| 60,01 | -23,06 |
Beitrag zu dieser Diskussion schreiben
Feedback
Warum eigentlich Panik schieben? Stehen doch noch paar Ergebnisse bzw. Ereignisse bis Q4 aus dachte ich?
Antwort auf Beitrag Nr.: 61.567.002 von hundadoption am 25.09.19 16:39:24 Hi,
nicht die Reissleine gezogen?
Das Ding schmiert doch nur noch ab...........
Hätte ich selbst nicht gedacht.........
An was mag es wohl liegen?
Any Ideas?
M.
nicht die Reissleine gezogen?
Das Ding schmiert doch nur noch ab...........
Hätte ich selbst nicht gedacht.........
An was mag es wohl liegen?
Any Ideas?
M.
Antwort auf Beitrag Nr.: 61.567.002 von hundadoption am 25.09.19 16:39:24
Gut zu wissen 😁
Grüsse aus der Schweiz
Zubi
Gut zu wissen 😁
Grüsse aus der Schweiz
Zubi
Antwort auf Beitrag Nr.: 61.562.397 von zubi1955 am 25.09.19 09:11:38Ich bin auch noch dabei.🤗
Antwort auf Beitrag Nr.: 61.561.125 von borazon am 25.09.19 01:06:51
Da musst du ihn schon selber fragen.
Ich bin noch investiert
Welche Aktie kannst du empfehlen? 😉
Grüsse aus der Schweiz
Zubi
Da musst du ihn schon selber fragen.
Ich bin noch investiert
Welche Aktie kannst du empfehlen? 😉
Grüsse aus der Schweiz
Zubi
Trading Spotlight
Antwort auf Beitrag Nr.: 61.478.201 von zubi1955 am 13.09.19 14:58:42
Biohero has left the building, gehe ich recht in der Annahme?
Der Kurs ist, wo er vorher war.
Natürlich kann aus Diurnal noch was werden.
Aber diese Nummer die letzten Wochen mit einer marktengen Aktie ist mustergültig.
Nur mein Eindruck.
Zitat von zubi1955: Deine Unterstellung ist ja lachhaft
Da kann ich nur sagen kleiner Spassvogel 🤡🤡🤡
Grüsse aus der Schweiz
Zubi
Biohero has left the building, gehe ich recht in der Annahme?
Der Kurs ist, wo er vorher war.
Natürlich kann aus Diurnal noch was werden.
Aber diese Nummer die letzten Wochen mit einer marktengen Aktie ist mustergültig.
Nur mein Eindruck.
Sind eig nicht schlechte Nachrichten, und der Kurs schmiert........
Diurnal Group plc
("Diurnal" or the "Company")
Results for the year ended 30 June 2019
Building on the successful launch of Alkindi(R)
Further key clinical and regulatory milestones expected in the next 12 months
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its audited results for the year ended 30 June 2019.
Operational highlights
Alkindi(R)
-- Successful launch of Alkindi(R) in the UK as the first specifically developed and licensed replacement therapy for paediatric adrenal insufficiency
-- Alkindi(R) pricing agreed in Germany, Italy, Austria, Sweden, Norway, Denmark and Iceland
-- Confirmation of the current clinical and regulatory path for Alkindi(R) in the US with the US Food and Drug Administration, facilitating a New Drug Application (NDA) submission in Q4 2019
-- Progress in the rest of world with Alkindi(R) Marketing Authorisation Application (MAA) submission in Israel and grant of Orphan Drug Designation in Australia
Chronocort(R)
-- MAA submission is on track for Q4 2019: confirmation of the current clinical and regulatory path for Chronocort(R) by the European Medicines Agency (EMA) following completion of European Phase 3 study
o Pivotal study in congenital adrenal hyperplasia, the largest ever interventional study in this disease completed
-- Study missed primary endpoint of superiority of Chronocort(R) to conventional therapy in control of androgens (17-OHP) over the 24-hour period
-- Chronocort achieved significantly better control of androgens (17-OHP) in the period 07:00-15:00
-- Chronocort(R) achieved 24-hour control on the same or lower overall dose of glucocorticoid with fewer patients requiring rescue therapy (sick day rules)
o Scientific Advice from the EMA confirmed no additional clinical studies required
Financial overview
-- Alkindi(R) revenues reached over GBP1 million during the financial year
-- Successful completion of a GBP5.9 million Placing and Open Offer with institutional and private investors to fund further development of Diurnal's late-stage pipeline and commercial roll-out
-- Reduced operating loss of GBP14.5m (2018: GBP16.8m), reflecting completion of the Chronocort European Phase 3 study, implementation of cost-saving measures and increase in revenues
-- Cash and cash equivalents at 30 June 2019 of GBP9.1m (30 June 2018: GBP17.3m)
-- Net cash used in operating activities was GBP13.7m (2018: GBP12.8m), in line with the Board's expectations
Post-period highlights
-- Successful launch of Alkindi(R) in Sweden and Denmark
-- Submission of MAA for Alkindi(R) in Australia following the grant of Orphan Drug Designation
-- Investment in enhanced capsuling capability for Alkindi(R) and Chronocort(R) agreed with manufacturing partner, Glatt Pharmaceutical Services
Martin Whitaker, CEO of Diurnal, commented:
"Diurnal continues to execute on delivering its vision of becoming a world leading endocrinology specialty pharma company. During the year, we made substantial operational and commercial progress, overcoming significant challenges, and remain in a strong position.
"Alkindi(R) , our first commercialised product, demonstrated strong market uptake, which we believe validates our strategy of focusing on the treatment of underserved chronic endocrine diseases, as well as our expertise in developing, registering and commercialising high-quality products. Importantly, we have also built a valuable sales infrastructure in Europe for Alkindi(R) , which we can use to commercialise future products including Chronocort(R) . As further testament to the expert team at Diurnal, we are pleased that following our detailed analysis of data from our Phase 3 clinical programme of Chronocort(R) in Europe and our discussion with the EMA, the product remains on track for submission of an MAA in Q4 2019.
"Additionally, as we look ahead, we expect further country launches in Europe for Alkindi(R) during H2 2019, along with a planned NDA submission of the product in the US during Q4 2019. Diurnal has received strong interest in Alkindi(R) and Chronocort(R) for the US and we are progressing with licensing discussions."
This announcement contains insider information for the purposes of Article 7 of Regulatory (EU) No596/2014.
Quelle: https://de.advfn.com/p.php?pid=nmona&article=80784827
("Diurnal" or the "Company")
Results for the year ended 30 June 2019
Building on the successful launch of Alkindi(R)
Further key clinical and regulatory milestones expected in the next 12 months
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, announces its audited results for the year ended 30 June 2019.
Operational highlights
Alkindi(R)
-- Successful launch of Alkindi(R) in the UK as the first specifically developed and licensed replacement therapy for paediatric adrenal insufficiency
-- Alkindi(R) pricing agreed in Germany, Italy, Austria, Sweden, Norway, Denmark and Iceland
-- Confirmation of the current clinical and regulatory path for Alkindi(R) in the US with the US Food and Drug Administration, facilitating a New Drug Application (NDA) submission in Q4 2019
-- Progress in the rest of world with Alkindi(R) Marketing Authorisation Application (MAA) submission in Israel and grant of Orphan Drug Designation in Australia
Chronocort(R)
-- MAA submission is on track for Q4 2019: confirmation of the current clinical and regulatory path for Chronocort(R) by the European Medicines Agency (EMA) following completion of European Phase 3 study
o Pivotal study in congenital adrenal hyperplasia, the largest ever interventional study in this disease completed
-- Study missed primary endpoint of superiority of Chronocort(R) to conventional therapy in control of androgens (17-OHP) over the 24-hour period
-- Chronocort achieved significantly better control of androgens (17-OHP) in the period 07:00-15:00
-- Chronocort(R) achieved 24-hour control on the same or lower overall dose of glucocorticoid with fewer patients requiring rescue therapy (sick day rules)
o Scientific Advice from the EMA confirmed no additional clinical studies required
Financial overview
-- Alkindi(R) revenues reached over GBP1 million during the financial year
-- Successful completion of a GBP5.9 million Placing and Open Offer with institutional and private investors to fund further development of Diurnal's late-stage pipeline and commercial roll-out
-- Reduced operating loss of GBP14.5m (2018: GBP16.8m), reflecting completion of the Chronocort European Phase 3 study, implementation of cost-saving measures and increase in revenues
-- Cash and cash equivalents at 30 June 2019 of GBP9.1m (30 June 2018: GBP17.3m)
-- Net cash used in operating activities was GBP13.7m (2018: GBP12.8m), in line with the Board's expectations
Post-period highlights
-- Successful launch of Alkindi(R) in Sweden and Denmark
-- Submission of MAA for Alkindi(R) in Australia following the grant of Orphan Drug Designation
-- Investment in enhanced capsuling capability for Alkindi(R) and Chronocort(R) agreed with manufacturing partner, Glatt Pharmaceutical Services
Martin Whitaker, CEO of Diurnal, commented:
"Diurnal continues to execute on delivering its vision of becoming a world leading endocrinology specialty pharma company. During the year, we made substantial operational and commercial progress, overcoming significant challenges, and remain in a strong position.
"Alkindi(R) , our first commercialised product, demonstrated strong market uptake, which we believe validates our strategy of focusing on the treatment of underserved chronic endocrine diseases, as well as our expertise in developing, registering and commercialising high-quality products. Importantly, we have also built a valuable sales infrastructure in Europe for Alkindi(R) , which we can use to commercialise future products including Chronocort(R) . As further testament to the expert team at Diurnal, we are pleased that following our detailed analysis of data from our Phase 3 clinical programme of Chronocort(R) in Europe and our discussion with the EMA, the product remains on track for submission of an MAA in Q4 2019.
"Additionally, as we look ahead, we expect further country launches in Europe for Alkindi(R) during H2 2019, along with a planned NDA submission of the product in the US during Q4 2019. Diurnal has received strong interest in Alkindi(R) and Chronocort(R) for the US and we are progressing with licensing discussions."
This announcement contains insider information for the purposes of Article 7 of Regulatory (EU) No596/2014.
Quelle: https://de.advfn.com/p.php?pid=nmona&article=80784827
!
Dieser Beitrag wurde von MODelfin moderiert. Grund: korrespondierend, bitte wieder zurück zum Threadthema, Danke.!
Dieser Beitrag wurde von MODelfin moderiert. Grund: Bitte Argumentation statt Provokation, Danke.
Durchsuchen
