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Kaaaaaaaaaaaabooooooom and its still a gift at 34 million valuation .enjoy the ride ,like i said before i think that 100p+ before year end is very likely especially on big news like partner deals wich could happen anytime now and the NDA/EMA submission for approval next quarter . HOTTEST PICK in the pharma sector .GL
the downside is very very very limited , DNL is well financed after cap raising a few weeks ago and more cash will come through new Partnerships for the large markets like USA which expected anytime now . Market cap of 32 million is still a pure gift for this company . DNL can go easily above 100p and it would be still cheap .GLTA
Upcoming Milestones
Alkindi launch in additional EU States during 2H 2019
US-NDA submission for Alkindi in Q4 2019
EMA submission for Chronocort approval in Q4 2019
US-Partner Deal for Alkindi could happen anytime now
US-Partner Deal for Chronocort could happen anytime now
Partner Deal(s) for Alkindi and Chronocort for RoW could happen anytime now
“Diurnal also expects additional progress for Alkindi®, with further country launches scheduled during 2019 to accelerate growth of revenues,along with a planned NDA submission in the US during Q4 2019.Diurnal has received strong interest in Alkindi® and Chronocort® for the US and will continue to progress licensing discussions, including the potential for co-development of Chronocort® in the US, both in CAH and AI. The US remains an important market for Diurnal’s late-stage pipeline focused on cortisol deficiency, with a combined market size for the treatment of CAH and paediatric AI estimated at $132m, and a future expansion opportunity in adult AI, which represents a $0.9bn market opportunity in the US.”
major breakout imminent which could push stock to 60-70p quickly
DNL is a MEGA opportunity at current valuation of only 31 Million any good news could change that very quickly and there are lot of news coming within next 4 months even buyout is possible here .GLTA
Based on our clearly stated assumptions, the net present value of the cashflows that could be generated from DNL’s first two products alone equates to £248m. Riskadjustment to take account of their different stages of development in different territories reduces this to £139m, or 225p per share.
“Diurnal also expects additional progress for Alkindi®, with further country launches scheduled during 2019 to accelerate growth of revenues,along with a planned NDA submission in the US during Q4 2019.Diurnal has received strong interest in Alkindi® and Chronocort® for the US and will continue to progress licensing discussions, including the potential for co-development of Chronocort® in the US, both in CAH and AI. The US remains an important market for Diurnal’s late-stage pipeline focused on cortisol deficiency, with a combined market size for the treatment of CAH and paediatric AI estimated at $132m, and a future expansion opportunity in adult AI, which represents a $0.9bn market opportunity in the US.”
up 14%+ what a nice day and thats not even the beginning ...A real potential 10 bagger here
37p now woooooow ,,low float stocks are the best . Valuation still ridiculous at 30 million thats nothing the smaller drug Alkindi which is approved in Europe alone is worth £60-80 million . Again this one is a lifetime opp at current price .GLTA
Big News like US- Partner deal(s) for Chronocort and Alkindi or Alkindi launch in additional Eu countries could happen anytime now which could push this low float stock back above 100p quickly . Market cap of 29 million is a pure gift for this company .GLTA
hi spiderman ,looks like you have a good friend and im sure you will be very happy with this dirt cheap stock .And regarding the drop of the sp look at my post below from Fri 15:53 there is your answer .GLTA
Up almost 10% looks like major breakout in the making ..And market cap is still less than 30 million unbelievable
Despite missing primary endpoint Chronocort its still effective and has advantages over current marketed treatments thats why the EMA said NO clinical trials required just submit the MAA application for approval with the available data .So in fact this stock dropped from over 200p to this ridiculous low level for no reason and thats what most poeple still didnt realize thats why the brutal upside potential here .
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Consequently, Diurnal intends to submit a Marketing Authorisation Application (MAA) for Chronocort® (modified release hydrocortisone) in Q4 2019 based upon the existing clinical data, including data to support Orphan Drug Status in the treatment of CAH. This positive outcome follows the submission of a regulatory package requesting Scientific Advice to the EMA for Chronocort® based on detailed analysis of data from its Phase 3 study, the largest ever clinical trial programme in CAH, and the open-label safety extension study.
Dr Sam Williams, IP Group Managing Partner, Life Sciences, said: "This positive development means that the EMA has not requested a further clinical study of Chronocort, despite the recent Phase 3 not meeting its primary endpoint, and is consistent with Diurnal's intention to file its marketing application this year based on the existing data. This supports IP Group's view that the chances of approval of Chronocort in Europe are very good and, moreover, that there remains the potential for Orphan status, which would give Chronocort significant advantages over existing treatments for CAH."
Again this undiscovered goldmine has monster upside potential and there are many news on the way to push it way higher . Market cap of 27 million is ridiculous it should be at minimum 100 million right now or around £1.20 per share .
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On track to become a world-leading endocrinology specialty pharma company focused on ca. $10bn market opportunity
•Initially targeting >$3bn market in cortisol deficiency
•First product, Alkindi®, launched successfully in Germany and UK and generating revenues for the Company–Sales and marketing infrastructure in place for commercial launches across Europe
•Second product, Chronocort®, completed European Phase III trial in Q3 2018 –European Medicines Agency positive opinion anticipated in 2020
•Seeking commercial partners in US and RoW to enter global markets•Commercial exclusivity until 2034 –orphan drug, regulatory and patents1
Diurnal also expects additionalprogress for Alkindi®, with further country launches scheduled during 2019 to accelerate growth of revenues,along with a planned NDA submission in the US during Q4 2019.Diurnal has received strong interest in Alkindi®and Chronocort®for the US and will continue to progress licensing discussions, including the potential for co-development of Chronocort®in the US, both in CAHand AI. The US remains animportant market for Diurnal’s late-stage pipeline focused on cortisol deficiency, with a combined market size for the treatment of CAH and paediatric AI estimated at $132m, and a future expansion opportunity in adult AI, which represents a $0.9bn market opportunity in the US.
i recommended Futura Medical (FUM) late 2018 on a german forum after cap raising at around 7p (current sp is 45p) now i say strong buy DNL after cap raising and i like this undiscovered stock more than FUM because the Drugs already shows that they are effective , FUMs ED drug still waiting for the large Phase 3 readout likely next quarter .
first of all with the current cash alone they have enough untill mid to late 2020 , they put all programs on hold except for Chronocort and Alkindi for which both the clinical trials are completed thats why the cash burn will fall significantly . More Cash will come through out-licensing of Chronocort and Alkindi especially for the large US & Japan Market . There is already strong interest by potential partners for Alkindi and Chronocort for the US-Rights . They plan to start the US-Phase 3 trial of Chronocort soon but only with a Partner , Alkindi is moving closer to US approval for which they expect to submit the NDA next Quarter.
I think the larger drug Chronocort could bring in $15-20 Million in Upfront payment and for Alkindi between $5-10 Million for the US-Rights ALONE and a partner deal could happen anytime now . Such News like Partnership and the submission of NDA and MAA for approval in USA and Europa expected before year end likely to push this undiscovered and terrible undervalued stock significantly higher . At current valuation of £27 million DNL is even a dirt cheap takeover candidate which is more attractive than to pay royalties and milestones from a potential buyer perspective .
"Diurnal also expects additional progress for Alkindi®, with further country launches scheduled during 2019 to accelerate growth of revenues,along with a planned NDA submission in the US during Q4 2019.Diurnal has received strong interest in Alkindi®and Chronocort®for the US and will continue to progress licensing discussions, including the potential for co-development of Chronocort®in the US, both in CAHand AI. The US remains animportant market for Diurnal’s late-stage pipeline focused on cortisol deficiency, with a combined market size for the treatment of CAH and paediatric AI estimated at $132m, and a future expansion opportunity in adult AI, which represents a $0.9bn market opportunity in the US."
there is a nice presentation on youtube just search for Diurnal group there and you will find it quickly . Looks like links are not allowed here .
Live presentation July 2019
www.youtube.com/watch?v=5AMafzwcnR4
Diurnal Group has a very low valuation of only £25 Million and attractive drugs in late stage development .This undiscovered stock has significant upside potential , the fair value is 100p+ right now and more on approval of Alkindi in USA and Chronocort in Europe both expected next year .Diurnal is definitely one if not the cheapest stock in the pharma sector .GL
Alkindi for the treatment of paediatric adrenal insufficiency is approved in Europe (launched in UK & Germany other EU countries will follow shortly) , US-NDA submission expected in Q4 .
Chronocort for the treament of congenital adrenal hyperplasia (CAH) MAA submission to EMA for European approval in Q4 and Start of US-Phase 3 also expected in 2H 2019
Management already in discussion to partner the Drugs in USA and RoW .
Diurnal Group (DNL)
Market Cap: £25 Million
Cash: £11 Million
Price: 30p
Shares Out: 84.6 million
Product Pipeline
https://www.diurnal.co.uk/non-healthcare-professionals/research/drug-development-pipeline/
Live presentation July 2019
https://www.youtube.com/watch?v=5AMafzwcnR4
interim-results-presentation
https://www.diurnal.co.uk/media/36769/interim-results-presentation-march-2019-pp.pdf
https://www.diurnal.co.uk/non-healthcare-professionals/media/news/placing-open-offer-and-notice-of-general-meeting/
Filing a Market Authorisation Application (MAA) for Chronocort® in Europe by end 2019;
Filing a New Drug Application (NDA) for Alkindi® in the US by end 2019;
Continuing the development of the European commercial organisation and roll-out of Alkindi® in Europe to maximise revenues; and
Progressing licensing discussions for Alkindi® and Chronocort® in the US and the rest of the world
https://www.hardmanandco.com/wp-content/uploads/2019/04/DNL-Interim-update-25-April-2019.pdf
Clarity for Chronocort regulatory pathwayDiurnal (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.
Largest Shareholder:
IP Group Plc /Venture Capital/....34,410,147
Finance Wales Investments Ltd.....11,534,888
Polar Capital LLP....6,622,631
Oceanwood Capital Management LLP....3,115,166
Richard Griffiths and controlled undertakings....4,999,615
Richard John Martin Ross, MD....1,554,925
Rowan Dartington & Co. Ltd. (Broker)....1,245,000
Rathbone Investment Management Ltd.....354,000
Hargreaves Lansdown Stockbrokers Ltd.....216,000
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