DNL.L (Mkap €25 M) Attraktive Medikamente vor der Zulassung (Seite 69)
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Diurnal Group PLC - DNL
Business and trading update
Released 07:00 20-Jan-2020

RNS Number : 2383A
Diurnal Group PLC
20 January 2020
20 January 2020
Diurnal Group plc
("Diurnal" or the "Company")
Business and trading update
Strong revenue performance ahead of further country launches in Europe
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today provides a business and unaudited trading update for the six months ended 31 December 2019.
Financial highlights:
· Alkindi® revenues for the six months ended 31 December 2019 were £1.1m. This compares to £0.2m for the six months ended 31 December 2018 (year on year growth of c. 450%) representing strong performance ahead of further launches expected in European countries this calendar year
· Cash position at 31 December 2019: £4.6m before an outstanding R&D tax credit claim of £2.1m in respect of 2019 financial year which the company expects to receive during 2020
Operational highlights
· Alkindi® now launched in UK, Germany, Austria, Sweden, Norway, Denmark and Iceland, with further launches planned in Italy, Netherlands and Spain for 2020
· Submission of Marketing Authorisation Application (MAA) for Chronocort® to the European Medicines Agency (EMA) in December 2019
· US partnering discussions progressing following Alkindi® New Drug Application (NDA) submission in November 2019
Martin Whitaker, Chief Executive Officer of Diurnal, commented:
"Diurnal starts 2020 in a strong position, with regulatory submissions completed during 2019 for Alkindi® in the US, Israel and Australia and for Chronocort® in Europe. We are pleased that Alkindi® revenues continue to grow strongly and look forward to further launches during the first half of 2020 in Italy and the Netherlands, following agreement of pricing, and in Spain in the second half of 2020. We are also pleased with the continued progress in our US licensing discussions following the submission of our NDA for Alkindi® in late 2019, and believe we remain on track to announce a licensing partner in H1 2020."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please visit www.diurnal.co.uk or contact:
Diurnal Group plc
+44 (0)20 3727 1000
Martin Whitaker, Chief Executive Officer
Richard Bungay, Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker)
+44 (0)20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns
Cantor Fitzgerald Europe (Joint Broker)
+44 (0)20 7894 7000
Corporate Finance: Phil Davies, Will Goode, Michael Boot
Healthcare Equity Sales: Andrew Keith
FTI Consulting (Media and Investor Relations)
+44 (0)20 3727 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Diurnal Group plc
Founded in 2004, Diurnal is a UK-based specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including Congenital Adrenal Hyperplasia and Adrenal Insufficiency. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.
For further information about Diurnal, please visit www.diurnal.co.uk
Date of Preparation: January 2020 Code: CORP-GB-0047
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
END
TSTFLFERLRIALII
CLOSE
London Stock Exchange plc is not responsible for and does not check content on this Website. Website users are responsible for checking content. Any news item (including any prospectus) which is addressed solely to the persons and countries specified therein should not be relied upon other than by such persons and/or outside the specified countries. Terms and conditions, including restrictions on use and distribution apply.©2014 London Stock Exchange plc. All rights reserved
Business and trading update - RNS
Diurnal Group PLC - DNL
Business and trading update
Released 07:00 20-Jan-2020

RNS Number : 2383A
Diurnal Group PLC
20 January 2020
20 January 2020
Diurnal Group plc
("Diurnal" or the "Company")
Business and trading update
Strong revenue performance ahead of further country launches in Europe
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, today provides a business and unaudited trading update for the six months ended 31 December 2019.
Financial highlights:
· Alkindi® revenues for the six months ended 31 December 2019 were £1.1m. This compares to £0.2m for the six months ended 31 December 2018 (year on year growth of c. 450%) representing strong performance ahead of further launches expected in European countries this calendar year
· Cash position at 31 December 2019: £4.6m before an outstanding R&D tax credit claim of £2.1m in respect of 2019 financial year which the company expects to receive during 2020
Operational highlights
· Alkindi® now launched in UK, Germany, Austria, Sweden, Norway, Denmark and Iceland, with further launches planned in Italy, Netherlands and Spain for 2020
· Submission of Marketing Authorisation Application (MAA) for Chronocort® to the European Medicines Agency (EMA) in December 2019
· US partnering discussions progressing following Alkindi® New Drug Application (NDA) submission in November 2019
Martin Whitaker, Chief Executive Officer of Diurnal, commented:
"Diurnal starts 2020 in a strong position, with regulatory submissions completed during 2019 for Alkindi® in the US, Israel and Australia and for Chronocort® in Europe. We are pleased that Alkindi® revenues continue to grow strongly and look forward to further launches during the first half of 2020 in Italy and the Netherlands, following agreement of pricing, and in Spain in the second half of 2020. We are also pleased with the continued progress in our US licensing discussions following the submission of our NDA for Alkindi® in late 2019, and believe we remain on track to announce a licensing partner in H1 2020."
This announcement contains inside information for the purposes of Article 7 of Regulation (EU) 596/2014 (MAR).
For further information, please visit www.diurnal.co.uk or contact:
Diurnal Group plc
+44 (0)20 3727 1000
Martin Whitaker, Chief Executive Officer
Richard Bungay, Chief Financial Officer
Panmure Gordon (UK) Limited (Nominated Adviser and Joint Broker)
+44 (0)20 7886 2500
Corporate Finance: Freddy Crossley, Emma Earl
Corporate Broking: James Stearns
Cantor Fitzgerald Europe (Joint Broker)
+44 (0)20 7894 7000
Corporate Finance: Phil Davies, Will Goode, Michael Boot
Healthcare Equity Sales: Andrew Keith
FTI Consulting (Media and Investor Relations)
+44 (0)20 3727 1000
Simon Conway
Victoria Foster Mitchell
Notes to Editors
About Diurnal Group plc
Founded in 2004, Diurnal is a UK-based specialty pharma company developing high quality products for the global market for the life-long treatment of chronic endocrine conditions, including Congenital Adrenal Hyperplasia and Adrenal Insufficiency. Its expertise and innovative research activities focus on circadian-based endocrinology to yield novel product candidates in the rare and chronic endocrine disease arena.
For further information about Diurnal, please visit www.diurnal.co.uk
Date of Preparation: January 2020 Code: CORP-GB-0047
This information is provided by RNS, the news service of the London Stock Exchange. RNS is approved by the Financial Conduct Authority to act as a Primary Information Provider in the United Kingdom. Terms and conditions relating to the use and distribution of this information may apply. For further information, please contact rns@lseg.com or visit www.rns.com.
END
TSTFLFERLRIALII
CLOSE
London Stock Exchange plc is not responsible for and does not check content on this Website. Website users are responsible for checking content. Any news item (including any prospectus) which is addressed solely to the persons and countries specified therein should not be relied upon other than by such persons and/or outside the specified countries. Terms and conditions, including restrictions on use and distribution apply.©2014 London Stock Exchange plc. All rights reserved
Business and trading update - RNS
Antwort auf Beitrag Nr.: 61.031.551 von Biohero am 15.07.19 22:09:04
Jetzt zurück auf Los bei 0,27 - wäre ja ein guter Startpunkt für die Rallye. Hatte Mitte 2019 den Ausstieg verpasst und bin auch nach wie vor zu 0,28 dabei.
Viel Erfolg allen!
Zitat von Biohero: Wieder eine sehr interessante ,massivst unterbewertete und sogut wie unbekannte Aktie aus UK . Diurnal wurde ähnlich wie Futura übelst niedergeprügelt die Aktie kommt von über 200p und steht aktuell bei 27p nachdem das Medikament Chronocort für die behandlung von adrenogenitalen Syndroms den primären Endpunkt in der Phase 3 Studie verfehlt hatte .Jetzt kommt das interessante obwohl Endpunkt nicht erreicht wurde hat Chronocort trotzdem einige Vorteile gegenüber der Standarttherapie und vor 3 monaten gab es auch gute Nachrichten von der EMA Zulassungsbehörde die keine neue klinische Studie verlangt hat und die bereits vorhandenen Daten für einen Zulassungsantrag für ausreichend hält welches nächstes Quartal eingereicht wird .Die Aktie hätte alleine schon wegen dieser News sich mindestens verdreifachen müssen aber wie gesagt die Aktie ist kaum bekannt .
Diurnal hat bereits seit letztes Jahr ein zugelassenes Medikament(Alkindi) in Europa bisher wurde dieses nur in Deutschland und UK gelauncht weitere EU-Staaten folgen bald ,für Australien und Israel wurden im 1H die Zulassungsanträge eingereicht und im Q4 folgt der Zulassungsantrag für USA .
Die Firma hat vor wenigen Wochen eine KE durchgeführt und ca £6 million eingenommen . Die US-Rechte für Alkindi (Zulassungsantrag im 4Q) und Chronocort (Start Phase 3 in kürze) sollen auslizenziert werden .Der US und EU Markt für Alkindi (Nebenniereninsuffizienz) liegt bei über $80 Million und für Chronocort bei über $400 Million .
DNL ist massivst unterbewertet und könnte sich prozentual gesehen ähnlich wie FUM entwickeln .
Diurnal (DNL)
Marktkap: £22,84 Million (= €25,4 Million)
Cash:ca £11,5 Million
Kurs: 27p
Aktienanzahl: 84,6 Million
Positive Scientific Advice from European Medicines Agency for Chronocort® ..Thursday, 11/Apr/2019
https://www.diurnal.co.uk/non-healthcare-professionals/media…
DIURNAL GROUP----Clarity for Chronocort regulatory pathway
https://www.hardmanandco.com/wp-content/uploads/2019/04/DNL-…
Diurnal (DNL) is a commercial-stage specialty pharmaceutical company focused on diseases of the endocrine system. Its two lead products are targeting rare conditions where medical need is currently unmet, with the aim of building a long-term ‘Adrenal Franchise’. The first product, Alkindi®, is being launched in key EU markets, and this was expected to be followed by the adult version, Chronocort®. After unexpected Phase III results, positive feedback from the EMA has cleared the path for regulatory submission of Chronocort for adult CAH in Europe before the end of 2019, and allowed DNL to revise the primary endpoint in theprotocol for the US Phase III trial.
Presentation
https://www.diurnal.co.uk/media/36769/interim-results-presen…
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Diurnal (DNL) - Martin Whitaker, CEO .....09.07.2019
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Europa
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USA
Jetzt zurück auf Los bei 0,27 - wäre ja ein guter Startpunkt für die Rallye. Hatte Mitte 2019 den Ausstieg verpasst und bin auch nach wie vor zu 0,28 dabei.
Viel Erfolg allen!
Antwort auf Beitrag Nr.: 62.407.334 von Reinerle am 17.01.20 15:12:02Wichtiger ist der US NDA akzeptanz das innerhalbvon 2 Wochen kommen sollte das denke ich sollte der Aktie etwas auftrieb geben ist immerhin ihr allererster NDA antrag . Hab gestern weitere Stücke gekauft in der Hoffnung das mit der NDA Akzeptanz endlich Schwung reinkommt . Marktkap von €27 million ist einfach super niedrig fürdie Firma.
Was soll am 11.2. schon groß raus kommen? Nichts !!!
Antwort auf Beitrag Nr.: 62.378.654 von kelev_ra am 15.01.20 09:12:27
Noch jemand dabei bis zu den Ergebnissen? Beim Kurs schlafen einem aktuell ja die Füße ein. Hoffe dass dieser vor dem 11. noch etwas anzieht...
Zitat von kelev_ra: Wird spannend...
13 January 2020
Diurnal Group plc
("Diurnal" or the "Company")
Notice of Interim Results
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, will announce its financial results for the six months ended 31 December 2019 on Tuesday 11 February 2020 at 09:30am.
Noch jemand dabei bis zu den Ergebnissen? Beim Kurs schlafen einem aktuell ja die Füße ein. Hoffe dass dieser vor dem 11. noch etwas anzieht...
Trading Spotlight
Wird spannend...
13 January 2020
Diurnal Group plc
("Diurnal" or the "Company")
Notice of Interim Results
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, will announce its financial results for the six months ended 31 December 2019 on Tuesday 11 February 2020 at 09:30am.
13 January 2020
Diurnal Group plc
("Diurnal" or the "Company")
Notice of Interim Results
Diurnal Group plc (AIM: DNL), the specialty pharmaceutical company targeting patient needs in chronic endocrine (hormonal) diseases, will announce its financial results for the six months ended 31 December 2019 on Tuesday 11 February 2020 at 09:30am.
Antwort auf Beitrag Nr.: 62.354.993 von BTRRR am 13.01.20 09:21:19
Kaufe nie bestens
Gebe immer Briefkus ein, wenn er für mich stimmt
Bis jetzt nie Probleme
Habe am Freitag für 28 penc gekauft 😀
Grüsse aus der Schweiz
Zubi
Kaufe nie bestens
Gebe immer Briefkus ein, wenn er für mich stimmt
Bis jetzt nie Probleme
Habe am Freitag für 28 penc gekauft 😀
Grüsse aus der Schweiz
Zubi
Ich habe immer das Selbe Problem an der Londonerbörse. Ich gebe immer Market (bestens) ein aber der Auftrag wird nicht aufgelöst. Hat jemand die selben Problemen? Ich handle über Swissquote.
Dieses Chronocort wurde in Phase 3 abgelehnt? Und jetzt ein 2. Versuch?
Bitte beschreib die Mängel...
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