DNL (MCap £31 M) 2 Big Drugs close to EMA & FDA approval = MEGA Opp

Biomonster

Junior member
15 0
Diurnal Group has a very low valuation of only £31 Million and attractive drugs in late stage development .This undiscovered stock has significant upside potential , the fair value should be north 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 pharma stock in UK . Lots of news expected during second half 2019 .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: £31Million
Cash: £11 Million
Price: 36p

Shares Out: 84.6 million


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



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.


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.”


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
Octopus Investments Ltd.....181,818





 

Biomonster

Junior member
15 0
this low float stock could jump to 50p very quickly especially on good news like partner deal(s) for the US market and market launch of Alkindi in additional EU countries even buyout is possible at this very low valuation .GLTA

Live Presentation July 9, 2019 (

 

Biomonster

Junior member
15 0
going higher again but with big news like partnership ,which means upfront payments which could be higher than the entire DNL valuation of 32 Million , then this stock will be unstoppable .I think 100p+ before year end is likely .GLTA

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.”
 

Biomonster

Junior member
15 0
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
 

Biomonster

Junior member
15 0
and uuuuup she goes again ,,, but this undiscovered stock is still a pure gift at market cap of 34 million

 

Biomonster

Junior member
15 0
Big US-Partnership news which means upfront payments to DNL could hit the wire anytime now such news could push this low float stock 50-100% because of its very low valuation (£35.5 Million) .GL

"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. "


 

Biomonster

Junior member
15 0
up she goes again now trading at 46.2p or 8.7%+ , and DNL is still heavily underpriced at 39 million valuation .The Big News still to come which could push this undiscovered stock even faster to the upside .


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
 

Biomonster

Junior member
15 0
Shareholders here should put a high gtc sell order in like 100p ,so your shares will not available for shorts and more important it reduces the free shares on market so it helps the stock to make even much bigger jumps on good news . Thank you guys

How to Prevent your Shares Holdings from being Shorted
https://www.contracts-for-difference.com/Borrowing-lending-shares.html

Q:What can you do to prevent your shares holdings from being shorted?

A: Now what can the average personal investor do to stop their own shares being shorted, as believe me your own broker, if approached, WILL sell your own shares that they hold on your behalf as a nominee account.

There are two things you can do, the first is to certificate them but this is not obviously to everyone’s advantage but the alternative solution is simple. All you do is to phone your broker and put an order in saying that you wish to place your shares for sale at, for arguments sake, double today’s price. As they are ‘on order’ they cannot be lent out by your broker and in turn you are reducing the amount of ‘free shares’ out there that can be used for shorting purposes. And don’t forget to move your limit order up when the price starts to recover, then, that way your shares can’t be shorted – not much but helps :D.

Although an individual personal investor will not normally have enough shares to halt a concerted shorting attack, if a large number of holders did this it would reduce the overall amount of shares that they could get their hands on.

In my opinion well worth doing if not only for the knowledge that your own shares cannot and will not be used in a short attack against the very share that you own.
 

Biomonster

Junior member
15 0
love this undiscovered stock its almost everyday in the green ..Market cap still at laughable 40 million makes this one the most attractive and underpriced UK pharma stock and it could hit 100p+ in no time on those news below upfront payments from potential US-Partnership alone could be higher than the entire valuation of DNL .STRONG BUY


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 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."



 

Biomonster

Junior member
15 0
the selloff on the stock markets created a great buying opportunity on this still undiscovered goldmine .GL
--------

Send an email to the company askting if they are still on track for NDA and MAA submission of their drugs and about potential partnerships . Below is the response

Dear Mr XXXXXXXX,

I can answer your questions as far as the information is already in the public domain.

I can confirm the Alkindi NDA submission and Chronocort MAA submission remain on track for Q4 2019.

We have disclosed to the market that we are in US licensing discussions. We have not put a timeline on a deal, other than to comment that we would like to have a commercial partner in place for Alkindi around the time of the NDA submission – so it is possible we could see partnerships before the end of 2019.

We share your frustrations regarding the share price but do expect it to remain volatile until we get closer to potential approvals in the US and Europe.

As I mentioned before, we have a very active investor relations programme, and do announce all significant newsflow as it happens.

Best regards
Richard Bungay
 

Biomonster

Junior member
15 0
back up she goes looks like consolidation is over , with goods news this underpriced low float stock will hit 100p quickly and many big milestones expected during 2H 2019 .GL
 

Biomonster

Junior member
15 0
the good news is there are no sellers here but looks like we have to wait until news hit the wire .DNL still the most attractive and underpriced pharma stock in UK , searching the entire uk healthcare sector and doesnt find a better one than DNL .
 

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