NEU - Neuren Pharmaceuticals

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It seems the Market is waiting for an update on the orphan status of trofinotide - and expecting the news to be good



At HC they're talking about trials and an upcoming reference to autism. Sure, such a reference would create a stir, but I'm rather skeptical when reading opinions "across the road". As I'm not familiar with the admin and legal aspects of the pharma industry, I can only go by the chart.

 

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It took a while, but the last two announcements could be what we've been waiting for.
http://www.asx.com.au/asx/statistics/displayAnnouncement.do?display=pdf&idsId=01670922
http://www.asx.com.au/asx/statistics/displayAnnouncement.do?display=pdf&idsId=01671358

I am accumulating.

 

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Today's announcement was definitely the one worth waiting for
http://www.asx.com.au/asx/statistics/displayAnnouncement.do?display=pdf&idsId=01693557

Looking back to early August, I placed a sell order for most of my holding at 12.5c, which was taken out before others decided to take profit as well. I kept a free-carried remainder and will consider topping up if she drops back to close the gap.

 

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Can the big gap be considered closed?
okay, it didn't quite drop back sub-10c, but I'm inclined to ignore the 0.1 or 0.5 for now.



After trading the swings, I'm back with one posi, hopefully for longer-term into 13c+ upside.
Good luck to fellow holders

 

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According to today's announcement, NEU will be kicked out of the All Ordinaries.
(my last foray ended with a stop-out when 13c held firm as resistance.)

 

[greggles]

Neuren Pharmaceuticals looks to have bounced off $1 and is now back at $1.42 following the sell-off that commenced on 7 August when NEU announced that it has entered into an exclusive North American License Agreement with ACADIA Pharmaceuticals Inc. for the development and commercialization of trofinetide for Rett syndrome. The sell-off saw the NEU share price collapse from around $2.75 to $1 over a three week period.

The sell-off looks to have been dramatically overdone and I wish I had seen this one last week during the couple of days of consolidation after it touched $1. In the absence of any bad news, I expect it won't take long for Neuren Pharmaceuticals to get back to $2.

If there is something that I am missing about the deal with ACADIA Pharmaceuticals, please let me know.

 

[Ann]

Neuren’s NNZ-2591 drug candidate alleviates Pitt Hopkins and Angelman syndrome symptoms

Neuren Pharmaceuticals (ASX: NEU) has revealed positive pre-clinical results for its NNZ-2591 drug candidate on Pitt Hopkins and Angelman syndromes.

According to Neuren, its NNZ-2591 drug is a synthetic analogue of the neurotrophic peptide cyclic glycine proline, which occurs natural in the brain.

In addition to having a positive effect on Pitt Hopkins and Angelman, Neuren has also demonstrated the drug’s efficacy in pre-clinical models of Parkinson’s disease, stroke, traumatic brain injury, peripheral neuropathy, Fragile X, Phelan-McDermid, memory impairment and multiple sclerosis.

Pitt Hopkins syndrome
Pitt Hopkins syndrome is a neurodevelopment condition in males and females and is caused by the loss of one copy or a mutation of the TCF4 gene on chromosome 18.

The syndrome is characterised by developmental delays with moderate to severe intellectual disability, behavioural differences, hyperventilation, breath holding, seizures, lack of speech, sleep disturbance, gastrointestinal issues, distinctive facial features and stereotypic hand movements.

In these latest pre-clinical test, NNZ-2591 was trialled in the TCF4 mutation mouse model, which exhibits features of Pitt Hopkins in humans.

Normal mice were compared to those with a disrupted TCF4 gene, and its was found after six weeks, NNZ-2591 normalised the deficits in all the tests of hyperactivity, daily living, learning and memory, sociability, motor performance and stereotypy.

“All positive confirmatory measures were statistically significant,” the company stated. More...

Here we see a large volume spike, anyone using a volume spike as a potential buy indicator needs to be cautious as it may be an outflow of money. Here we see the Twiggs weekly money flow indicator showing an outflow of money on the news.

 

[Boggo]

@tech/a
This is a stock you asked about way back in 2007 !
Not the sort of overall chart that I like but similiar in some ways to the IFN consolidation breakout.
It came up in a weekly scan that I usually run mid week (Wed or Thur) to see if any potential candidates have raised their heads. Bought into this before the week finished at 1.78 as its depth behaviour indicated interest.

(click to expand)

 

[barney]

@tech/a
This is a stock you asked about way back in 2007 !

Yeah I saw that … it was a few cents back then. I thought … Tech must be filthy rich … lol

After inspection … Share consolidation in late 2017 at 20:1 …… life goes on

 

[Go Figure]

Neuren trials continue to progress as expected, Trofinetide results are expected in the upcoming quarter the potential to help so many with this drug and have a decent SP upside is notable.

 

[Swervin Mervin]

Neuren trials continue to progress as expected, Trofinetide results are expected in the upcoming quarter the potential to help so many with this drug and have a decent SP upside is notable.

Great call mate! I bought some at the close for $3.25. Looked like it was getting capped at $3.40, hopefully the seller gets bulldozed over the next few days

 

[Swervin Mervin]

Pushed on to touch $4 today. Looking strong. Hopefully it does an NVX or VUL style move in the next couple of weeks

 

[Dona Ferentes]

Too early. I was lining it for the 2022 competition. The recent webinar is interesting.

 

[Dona Ferentes]

I dropped this in, elsewhere on the net

Tuesday, pm: ......
A graph of NEU over the last few years looks like an outline of SW USA landscape, of mesas and buttes in a desert landscape.

On a broad brush, there have been at least 6 times the SP has jumped sometimes more than 100%, and over just a few days. But then the declines have been just as rapid, so we have a 50c stock that has made it to $3 now four times, only to track back to $1 or thereabouts. And that is not taking into account dilutions and cap raisings along the way.

Today there has been a 91% jump, from $1.70 overnight to close at $3.25. All based on favourable Phase III results.

Neuren Pharmaceuticals (ASX: NEU) today reported that its partner for trofinetide in North America, Acadia Pharmaceuticals (Nasdaq: ACAD), has announced positive top-line results from the pivotal, Phase 3 Lavender™ study evaluating the efficacy and safety of trofinetide in 187 girls and young women aged 5 to 20 years with Rett syndrome.

Neuren CEO Jon Pilcher commented:

We are delighted with these robustly positive results and are now eager to see trofinetide progress through the regulatory approval process. We are very grateful to the Rett syndrome community ... the patients, their caregivers, study site personnel, physicians and everyone who participated in the Lavender study, as well as in the two Phase 2 studies from Neuren that paved the way.

and on Wednesday, pm: ....
Neuron stands to receive an automatic upfront payment of $111 million if the US healthcare regulator, the Food and Drug Administration (FDA), approves trofinetide for commercial use, with an additional $US350 million ($492 million) in sales milestones and double digit royalty payments up for grabs on the drug’s commercial sales:

Acadia said they are going to submit the NDA [new drug application] to the FDA mid 2022, CEO Jon Pilcher said. They will have a meeting with the FDA first to go over it all. Because it is an orphan drug it should get priority review, which is only a six month or abbreviated review. So by the end of next year, or very beginning of 2023, they should get approval and be able to launch.

Karst Peak Capital biotech analyst Hashan De Silva said:

We believe that the Neuren share price is significantly undervalued at these levels, with the upside largely derisked following the phase three results of trofinetide. Acadia forecasts peak sales of $US500 million for the Rett indication alone and only in the US market. Assuming a 12 per cent royalty, Neuren would receive [around] $85 million in royalties from Acadia which have a 100 per cent EBIT margin. This income stream alone should be worth over $1 billion using a modest multiple.

 

[Swervin Mervin]

I dropped this in, elsewhere on the net

Tuesday, pm: ......
A graph of NEU over the last few years looks like an outline of SW USA landscape, of mesas and buttes in a desert landscape.

On a broad brush, there have been at least 6 times the SP has jumped sometimes more than 100%, and over just a few days. But then the declines have been just as rapid, so we have a 50c stock that has made it to $3 now four times, only to track back to $1 or thereabouts. And that is not taking into account dilutions and cap raisings along the way.

Today there has been a 91% jump, from $1.70 overnight to close at $3.25. All based on favourable Phase III results.

Neuren Pharmaceuticals (ASX: NEU) today reported that its partner for trofinetide in North America, Acadia Pharmaceuticals (Nasdaq: ACAD), has announced positive top-line results from the pivotal, Phase 3 Lavender™ study evaluating the efficacy and safety of trofinetide in 187 girls and young women aged 5 to 20 years with Rett syndrome.

Neuren CEO Jon Pilcher commented:


and on Wednesday, pm: ....
Neuron stands to receive an automatic upfront payment of $111 million if the US healthcare regulator, the Food and Drug Administration (FDA), approves trofinetide for commercial use, with an additional $US350 million ($492 million) in sales milestones and double digit royalty payments up for grabs on the drug’s commercial sales:


Karst Peak Capital biotech analyst Hashan De Silva said:

Exactly why I don’t think its to early for a VUL or NVX style run. All have similar capital structures and all are way off making any money. I’ll check back in this time next week but I’ll be surprised if it isn’t in the $5 to $6 range by then

 

[peter2]

It's been nine months since the last post on NEU. For most of 2022 the price traded in a range before exploding higher.

I bought the latest BO with a partial position (stupidly) and added to day at 6.75 since price looks likely to go higher.

Noticed an interesting thing in today's closing price auction. Close at 4pm was 6.79 but after the closing auction where several million shares were transacted (triple the days volume), the closing price was 7.18 (+5.7%).

 

[peter2]

The demand for NEU has remained quite strong during the general market selloffs recently. Hit new highs today.

Next FDA news is not due until March 23, but methinks the insiders are happy with the outlook for NEU.

 

[Miner]

The demand for NEU has remained quite strong during the general market selloffs recently. Hit new highs today.

Next FDA news is not due until March 23, but methinks the insiders are happy with the outlook for NEU.

Fda result got published today.
Watch the market for a catapult for an orphan drug and its phase 2 testing. DNH

 

[Miner]

Fda result got published today.
Watch the market for a catapult for an orphan drug and its phase 2 testing. DNH

Put an on market order after previous posting and got it executed at $8.92.
So I'm a holder now. Ironically did not buy 6 months back being apprehensive and not done research then.
With low cash flow, NEU in near term could go for CR

 

[Miner]

Put an on market order after previous posting and got it executed at $8.92.
So I'm a holder now. Ironically did not buy 6 months back being apprehensive and not done research then.
With low cash flow, NEU in near term could go for CR

Gees - it is always when I buy then price drops down no matter how much conviction I had. Interestingly there was a buy order @$8.81 which got executed when the price dropped from a temporary rise of $9 .
So with Miner's luck, NEU will go down further :