Reneuron Share Discussion Threads

[ssrover] 26/4/2019 12:08

Sold my 3 day trade here... reckon the volume and price will tail off over the coming days.



Bought WDC as Next mulitbagger... Has an MXO type feel to it.

[supernumerary] 26/4/2019 12:02

I think we've all understood the effect of the statuses for some time; it's the results that could speed progress to market...

[stevedd] 26/4/2019 12:00

Thanks supernumerary. So with the various orphan, fast track etc. statuses that they have managed to obtain the route to approved drug in the market could be sooner than originally thought.

[supernumerary] 26/4/2019 11:54

stevedd - yes, there is. There is a Conditional Approval procedure by the European Medicines Agency, about which it has been said:

'between 2006 and 2016 the
EMA granted conditional approval to 30 medicines on the basis of 58 pivotal studies. The regulator reports that over half of these studies were preliminary phase II studies (30, including phases I/II and IIb); only a third (21) were phase III trials, and many of these were short term or analysed before completion of the study.'

So there is plenty of scope for early approval. The EMA themselves say:

'Conditional marketing authorisations may be granted if the CHMP finds that all the following requirements are met:

- the benefit-risk balance of the product is positive;
- it is likely that the applicant will be able to provide comprehensive data;
- unmet medical needs will be fulfilled;
- the benefit to public health of the medicinal product's immediate availability on the market outweighs the risks due to need for further data.'

As far as I can see, RENE's hRPC treatment would amply fulfil these criteria.

The USA is more nuanced, and although I believe it might be possible there too, I suspect it would need shepherding through the FDA by a big pharma partner.

[lauders] 26/4/2019 11:28

Great news today and real hope for those who need some form of effective treatment. Would be excellent if the BOD decided to buy even more shares now as well. Weekend press could also be quite extensive and bring the company further into the limelight. Glad I did not reduce my holding, not that it is very large to begin with!

[martinfrench] 26/4/2019 11:21

A's will show up later i would think, prob some serious order filling going on.

[rayrac] 26/4/2019 11:20

There’s not much room for anything else really Bantam...Woodford funds have a great wedge of these. The ‘O’ trades are presumably pi’s, so not much space left for the institutions?

Which is nice for a change?

[bantam175] 26/4/2019 11:05

Odd that there are only type 'O' trades so far today.

[dickbush] 26/4/2019 10:47

"An improvement of at least +15 letters from baseline on the ETDRS chart is considered to be clinically meaningful by the US Food and Drug Administration (FDA), as stated in their recent guidance on gene therapy for retinal disorders."

Two of the three patients have gone from +14 and +15 to 20-plus.

So, this is a very significant change.


The big one day moves invite profit-taking by traders. But this is now a biotech company with really positive results, not just hope. As long as these continue and the market doesn't take a nose dive, the shares can go to a silly price.

[someuwin] 26/4/2019 10:39

N+1 singer

"Further data from RP trial: improvement in visual acuity sustained

The additional follow-up data on the first cohort in the in Retinitis Pigmentosa (RP) Phase I/II trial confirms a sustained and clinically meaningful improvement in visual acuity (an average 23-point improvement on the ETDRS chart vs. an average 5-point improvement in placebo-treated eyes). In our view, the emerging results from the Phase I/II trial are highly encouraging and indicative of a clinically meaningful effect. We note that ReNeuron’s hRPC programme in RP benefits from both Orphan designation (in the US and Europe) and FDA Fast Track Status. As previously announced, dosing has commenced in the second 3-patient cohort, and we expect further clinical data on both cohorts to be released over the coming months. We reiterate our highly positive stance."

[stevedd] 26/4/2019 10:20

Given the scale of the improvement in vision and the fact that it is a less subjective reading than for some conditions does anybody know if there is the possibility for approval without a full phase 3 trial?

[grum3still] 26/4/2019 10:11

i read it as a slight improvement but that is very good. For all three patients, there has been further positive development in the last 60 days. regeneration I guess not being a medic. The nice thing about this is the other eye is acting as the placebo so data cannot be questioned.a long way to go though.

[rrb] 26/4/2019 10:06

Good question. I read it as 20 -> 21. Point is more that the effects are not only sustained but there is slight improvement, instead of the fear that the effects would dissipate after a period.

[verger] 26/4/2019 10:05

And there I was thinking I had paid top price of 300p this morning. Heading for 350p quicker than I thought.

[martinfrench] 26/4/2019 10:01

quick question to those on the board that have read the results in detail

are the further[2] improvements + 21 over and above the initial[1] +20 therefore a move from 21 to 41 OR is it a slight improvement from 20 to 21?

only talking first patient here.

Would think its 20 to 21 as prob not enough letters on the chart for 41!

either way awesome

[rrb] 26/4/2019 09:57

buywell3 - care to clarify? There have been many false dawns here but licensing deal + clinical data (which btw is far better than most people expected) + enough cash = fantastic position for more licensing deals and shareholder value creation.

If you think this is being 'pumped' and it will 'dump', you should short it. Good luck with that.

[someuwin] 26/4/2019 09:55

ReNeuron transitioning to the league of the billion dollar companies.

From 11/April/2019

"Open season on cellular therapies

After the acquisition of two US chimeric antigen receptor T-cell (CAR-T) companies, Kite and Juno, in 2017 for $12bn and $8bn, respectively, cellular therapies have become a rich source of licensing and acquisition transactions. With two products in two clinical studies and an exosome platform, it was probably only a matter of time before ReNeuron announced its first deal of 2019. While ReNeuron’s first transaction covers two products for the Chinese market, the rest of the world remains available and it is unlikely that this will be the last such transaction it announces."

[martinfrench] 26/4/2019 09:51

yes, just slightly

[rayrac] 26/4/2019 09:28

You’ve got this one wrong bywrong.

[someuwin] 26/4/2019 09:25

And of course, Today's news makes the recently announced China deal all the more valuable.

ReNeuron to receive upfront, near term and estimated success-based milestone payments of GBP80.0 million (US$104.8 million) AND double-digit royalties on sales.

[eggy6198] 26/4/2019 09:21

Morning buywell what do rene do and why has it risen?

[buywell3] 26/4/2019 09:13

Some pump this has been …



Goes to show if you throw enough money at a little share … big spikes happen

What goes up …

What the lord giveth …

[eggy6198] 26/4/2019 09:08

6 quid within 2 weeks is my prediction. The conference will have potential buyers and partners looking at data so low ball offer this year is very realistic. Next results wont be long and then its off to the races

[top tips] 26/4/2019 09:05

Great results. £7 realistic.

[someuwin] 26/4/2019 08:55

Agreed Bantam. This has to rapidly get up to fair value (which has to be over £10 now) or it will be taken over.

Three pipelines...

Blindness

Stroke

And the underlying Exosome technology platform