This followed the biotech company announcing a new commercial milestone for its flagship Rett syndrome therapy.

For investors, it was a welcome reprieve. But the ASX biotech stock is still down more than 30% since the start of 2026, leaving some long-term holders wondering if now is the time to step back in.

A fresh commercial milestone

A new commercial milestone for Neuren's lead Rett syndrome therapy DAYBUE drove Wednesday's lift. Partnered with US biotech giant ACADIA Pharmaceuticals Inc. (NASDAQ: ACAD), Neuren confirmed its DAYBUE STIX powder formulation is now widely available across the US.

The therapy, approved by the US Food and Drug Administration in December, first launched on a limited basis during the March quarter. The expanded rollout means more patients and caregivers now have access to the treatment.

The powder formulation gives families greater flexibility in dosing and taste as they can mix the powder with water-based liquids. This small change can make a meaningful difference in managing Rett syndrome day to day.

Increasing royalty income

Neuren receives royalties on all global net sales of trofinetide under its licensing agreement with ACADIA. Historically, commercial milestones like this one tend to have an immediate impact on the price of the ASX biotech stock.

At its FY25 results, Neuren reported $65 million in royalty income and expects further growth in 2026 as DAYBUE sales expand. ACADIA has guided for DAYBUE net sales of US$460–490 million this year, implying another strong year of royalty growth for Neuren.

Strengths and risks

Neuren's strengths are clear. Its lead therapy addresses an underserved rare disease market, and the royalty model gives it high-margin, recurring income with minimal operational risk. The broader rollout also demonstrates increasing commercial traction, which can help restore investor confidence.

That said, risks remain. The fortunes of the ASX biotech stock are tightly linked to ACADIA's commercial execution. Any delays, pricing pressures, or regulatory hurdles could weigh on revenue.

The company also operates in the volatile biotech sector, where investor sentiment can swing sharply on clinical or regulatory news.

Analyst snapshot

Bell Potter remains bullish. The broker recently reaffirmed its buy rating and $22.00 price target. At the current share price of $13.00, this implies potential upside of roughly 70% over the next 12 months.

TradingView data show that brokers are upbeat on the ASX biotech stock. The most bullish average 12-month price target is $29.00, which points to a 123% upside, while the most conservative forecast comes in at $18.40. That still suggests a potential gain of 41%.

Foolish Takeaway

For investors willing to tolerate biotech volatility, Neuren's recent milestone, strong royalty pipeline, and underappreciated market potential could make this battered ASX biotech stock one to watch closely.

The post Is this battered ASX biotech stock ready to rocket higher? appeared first on The Motley Fool Australia.

This comes after the biotech company announced a new commercial milestone for its lead Rett syndrome therapy.

In early afternoon trade, the Neuren share price is up 6.75% to $13.13. By comparison, the S&P/ASX 200 Index (ASX: XJO) is rocketing 2.6% higher to 8,957 points.

Today's rise stands out because the stock is still down roughly 30% since the start of 2026.

Let's take a closer look at the release.

DAYBUE STIX rollout reaches the next stage

The catalyst for Wednesday's gain is a fresh commercial milestone from ACADIA Pharmaceuticals Inc (NASDAQ: ACAD), Neuren's US partner for DAYBUE.

According to the release, DAYBUE STIX is now broadly available across the United States for patients with Rett syndrome.

The new powder formulation was approved by the US Food and Drug Administration (FDA) in December and first launched on a limited basis during the March quarter.

This update confirms the rollout has now moved into wider commercial distribution, giving more patients and caregivers access to the therapy.

The new formulation gives families more flexibility because it can be mixed with water-based liquids, making it easier to adjust taste and dose volume.

Management also pointed to encouraging early caregiver feedback from the limited launch, with more than 80% of surveyed users reporting satisfaction.

Broader rollout supports the royalty outlook

Neuren receives royalties on all global net sales of trofinetide under its licensing agreement with Acadia. As a result, commercial rollout milestones usually have a direct impact on the share price.

At its FY25 result, the company reported royalty income of $65 million and guided to a further lift in 2026 as DAYBUE sales continue to expand.

Acadia's 2026 guidance previously pointed to DAYBUE net sales of US$460 million to US$490 million, which implies another year of solid revenue growth for Neuren.

With a market capitalisation of roughly $1.56 billion, the stock remains well below the peaks seen in 2025.

Foolish Takeaway

Neuren's latest gain follows broader US access to DAYBUE STIX, a rollout step that could support patient growth and future royalties.

Based on the company's strong February result and Acadia's 2026 sales guidance, I still see Neuren as one of the more compelling ASX biotech investments.

The combination of DAYBUE revenue growth and progress across the NNZ-2591 pipeline continues to reinforce the long-term opportunity.

After a difficult start to 2026, today's move may be an early sign that confidence is rebuilding around the company's revenue outlook.

The post Why Neuren shares are rebounding on Wednesday after a brutal 2026 sell-off appeared first on The Motley Fool Australia.

By the time trading wrapped up today, the ASX 200 had gained a healthy 1.09% after initially rallying even harder this morning (up 2% at one point). This session's rise leaves the index at 8,692.6 points.

This happy Tuesday for the Australian markets follows an optimistic start to the American trading week in the early hours of this morning (our time).

The Dow Jones Industrial Average Index (DJX: .DJI) returned from the weekend with a spring in its step, rising 0.5%.

The tech-heavy Nasdaq Composite Index (NASDAQ: .IXIC) was even more enthusiastic, gaining a rosy 1.38%.

But let's return to the local markets now and take stock of how the different ASX sectors were lifted, or not, by today's market tide.

The post Here are the top 10 ASX 200 shares today appeared first on The Motley Fool Australia.

While that is a fantastic return, it pales in comparison to the potential return on offer with the ASX 200 stock in this article.

That's because Bell Potter believes this stock is dirt cheap and could be destined to rocket from current levels.

Which ASX 200 stock?

The stock that Bell Potter is bullish on is Neuren Pharmaceuticals Ltd (ASX: NEU).

It is a biotechnology company with two novel drug assets. The most advanced is Daybue (trofinetide), which has been licensed to Acadia (NASDAQ: ACAD) for commercialisation.

Neuren's second asset, NNZ-2591, is under development for multiple rare diseases, the most advanced of which is Phelan McDermid syndrome.

The ASX 200 stock is currently conducting a Phase 3 trial in Phelan McDermid syndrome and has conducted Phase 2 trials in three other rare neurological conditions.

What is the broker saying?

Bell Potter was pleased with the ASX 200 stock's performance in FY 2025, highlighting that it is profitable from its existing royalty stream alone. It said:

The FY25 result demonstrated NEU remains comfortably profitable based on the existing royalty stream from Daybue more than offsetting R&D spend on the company's second asset, NNZ-2591. Royalty revenue of $64.6m (+15%) plus interest income of $12.2m was well above opex of $42.6m, resulting in NPAT of $30.4m. Cash balance is a mighty $296m as at 31-Dec-2025 with no debt. This is after the $50m buyback over the last ~15 months, which NEU announced will resume from 2nd of March.

Should you invest?

According to the note, the broker has reaffirmed its buy rating and $22.00 price target on the company's shares.

Based on its current share price of $12.21, this implies potential upside of 80% for investors over the next 12 months.

Commenting on its recommendation, the broker said:

We have increased our Daybue licensing income forecast but are still below Acadia's guidance range. While the recent EU approval setback clouded NEU's near-term catalyst, the company's balance sheet remains impeccable and will continue to be supplemented by ongoing royalties and possible milestones.

The biggest upside opportunity still lies in the company's second asset, NNZ-2591, for which the Phase 3 trial in Phelan McDermid syndrome is now recruiting. Results from the Phase 3 trial are still ~18 months away but represent the key inflection opportunity for NEU. We maintain our BUY recommendation and make no change to our $22.00 PT.

The post Why this cheap ASX 200 stock could rise 80% appeared first on The Motley Fool Australia.

The analyst team at Macquarie have an outperform rating on the stock and a bullish share price target, which we'll get to shortly.

Firstly, let's look at the news that has been coming out of the company recently.

Solid profit result

Neuren in late February reported its full-year financial results, showing it had generated $65 million in royalty income and a profit after tax of $30 million.

The royalty income came from the company's Daybue drug, with the royalty figure up 15% from 2024.

Neuren said it had now earned $510 million from Daybue since it was launched in 2023, and the company had $296 million in cash and short-term investments on hand at the end of December.

The company had also completed a $50 million share buyback and was starting another one, kicking off on March 2.

Neuren Chief Executive Officer John Pilcher said it was a formative year for the company.

He added:

In 2025 we achieved a critical milestone for Neuren's value creation strategy with the commencement of our Koala Phase 3 clinical trial of NNZ-2591 in Phelan McDermid syndrome. There is so much to look forward to this year as we continue to execute that program towards a New Drug Application and in parallel advance NNZ-2591 for Pitt Hopkins syndrome and HIE. All of this is self-funded by our growing revenue from Daybue, which has now reached $510 million since launch in 2023. We are very excited to watch the impact of the recent launch of Daybue Stix in the US as a potentially attractive new option for Rett syndrome patients and their families.

The company also said this week that its partner Acadia Pharmaceuticals would request a re-examination of Daybue for marketing approval in Europe, after being knocked back previously.

The drug is approved in the United States, Canada, and Israel, where it represents the first and only treatment approved for Rett syndrome, Neuren said.

Neuren shares looking cheap

The Macquarie team, in a research note sent to clients, said the Daybue royalties were in line with expectations, while noting that the company said a record number of patients were receiving Daybue shipments in the last quarter of the year.

Macquarie has reduced its price target on Neuren shares by $1.10 to $19.10, driven by changes to assumptions around Daybue earnings and the European regulatory process.

This price target, if achieved, would represent a 52.1% return.

The post Macquarie thinks this biotech company's shares could jump more than 50% appeared first on The Motley Fool Australia.

Four ASX shares that are falling more than most today are listed below. Here's why they are dropping:

Capstone Copper Corp (ASX: CSC)

The Capstone Copper share price is down 8% to $13.29. This morning, this copper miner revealed full-year production growth of 22% to 224,764 tonnes with a cash cost of $2.44 per pound. However, it also provided guidance for FY 2026, which revealed that it expects production of just 200,000 to 230,000 tonnes with cash costs of $2.45 to $2.75 per pound. The higher costs are expected to be driven by modest inflation and the impact of lower-grade zones driven by mine sequence at Mantos Blancos and Pinto Valley.

Life360 Inc (ASX: 360)

The Life360 share price is down 10% to $22.10. Investors have been selling this family safety technology company's shares following the release of its full-year results. At one stage today, Life360's shares were up as much as 15% before making a significant U-turn. Interestingly, this is despite Life360 delivering earnings ahead of expectations and reiterating its guidance for FY 2026. However, it is worth noting that the tech sector is a sea of red today.

Neuren Pharmaceuticals Ltd (ASX: NEU)

The Neuren Pharmaceuticals share price is down 7.5% to $12.73. This morning, this pharmaceuticals company confirmed that European regulators have rejected its application for trofinetide for the treatment of Rett syndrome. Its partner, Acadia Pharmaceuticals (NASDAQ: ACAD), commented: "While we are disappointed by the CHMP's recommendation to refuse approval, we continue to be encouraged by the meaningful benefits trofinetide has demonstrated for people living with Rett syndrome. The strong engagement and positive feedback we have seen from patients, caregivers, and clinicians in the Rett community reinforce our belief in the treatment's clinical value. We remain committed to working constructively with EU regulators to explore next steps and to bring this therapy to patients."

St George Mining Ltd (ASX: SGQ)

The St George Mining share price is down 15.5% to 13.5 cents. This is despite the rare earths explorer announcing a substantial increase in the size and quality of the mineral resource estimate at its 100%-owned Araxa Project. Management believes this confirms the tier one status of the rare earths and niobium deposit in the world's premier niobium-producing region. However, it seems that investors were expecting stronger numbers.

The post Why Capstone Copper, Life360, Neuren, and St George Mining shares are falling today appeared first on The Motley Fool Australia.

In morning trade, the ASX 200 stock is down over 6% to $12.89.

Why is this ASX 200 stock under pressure?

This morning, Neuren advised that its partner, Acadia Pharmaceuticals (NASDAQ: ACAD), has confirmed that it plans to request re-examination of the opinion adopted by the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA).

This is in relation to the marketing authorisation application for trofinetide for the treatment of Rett syndrome in patients two years of age and older.

Neuren also confirmed that, as was anticipated, the previously announced CHMP trend vote was confirmed in a formal vote, blocking its immediate approval.

Trofinetide is approved in the United States, Canada and Israel, where it represents the first and only treatment approved for Rett syndrome.

Acadia's CEO, Catherine Owen Adams, commented:

While we are disappointed by the CHMP's recommendation to refuse approval, we continue to be encouraged by the meaningful benefits trofinetide has demonstrated for people living with Rett syndrome. The strong engagement and positive feedback we have seen from patients, caregivers, and clinicians in the Rett community reinforce our belief in the treatment's clinical value. We remain committed to working constructively with EU regulators to explore next steps and to bring this therapy to patients.

Why was approval denied?

The ASX 200 stock highlights that while the pivotal LAVENDER clinical trial successfully met its co-primary and key secondary endpoints, the CHMP issued a refusal based on perceived deficits.

This includes the treatment effect observed with trofinetide after 12 weeks, while measurable, was viewed as limited in magnitude. It also notes that the study did not capture all core symptoms of Rett syndrome and that assessment of longer‑term outcomes was influenced by patient discontinuations over time.

Acadia believes this feedback provides important information as it considers the intended re-examination.

Commenting on the news, the ASX 200 stock's CEO, Jon Pilcher, said:

Neuren fully supports a re-examination of the CHMP opinion. Trofinetide has been making a difference for patients for nearly three years in approved markets and the unmet medical need in Europe remains substantial and urgent.

Following today's weakness, the Neuren share price is now down by a disappointing 30% since the start of the year. However, it is trading relatively flat on an annual basis.

The post Why is this ASX 200 stock sinking 6% today? appeared first on The Motley Fool Australia.

In early afternoon trade, the Neuren share price is down 0.37% to $13.39.

Let's take a closer look at what Neuren reported for the financial year.

Underlying royalties rise but total income declines

For the 12 months to 31 December 2025, Neuren generated royalty income of $65 million from DAYBUE, up 15% from $56 million in 2024.

Interest income also increased to $12 million from $11 million.

However, total income fell to $85 million from $228 million in 2024. The prior year included significant one-off revenue, including a milestone payment and proceeds from the sale of a rare paediatric disease priority review voucher.

Research and development expenditure increased to $36 million, up from $33 million, reflecting investment in the Phase 3 Koala trial of NNZ-2591 in Phelan-McDermid syndrome.

Neuren reported profit before tax of $39 million and net profit after tax (NPAT) of $30 million. This compares with $142 million in net profit in 2024, which again included the benefit of one-off items.

Cash position strengthens as buybacks continue

Neuren finished the year with $296 million in cash and short-term investments as at 31 December 2025, up from $222 million a year earlier.

Net cash generated from operating activities totalled $125 million during the year.

The company completed a $50 million on-market share buyback during 2025 and has announced a further buyback to commence in early March 2026.

Management said that growing cash flows from DAYBUE continue to fund development programs across Phelan-McDermid syndrome, Pitt Hopkins syndrome, and hypoxic-ischaemic encephalopathy.

US sales growth drives higher royalty outlook

DAYBUE, marketed by partner Acadia Pharmaceuticals in the United States, delivered net sales of US$391 million in 2025, up 12% from 2024.

Neuren's royalty income from DAYBUE reflects tiered royalty rates on those sales.

Patient numbers continued to trend higher during the year, with more than 1,000 patients receiving treatment in the fourth quarter. Persistence rates at 12 months were reported at approximately 55%.

In December 2025, the US Food and Drug Administration (FDA) approved a new powder formulation, DAYBUE STIX. The company said that a broader commercial launch is being targeted for sometime early this year.

Acadia has guided to 2026 net sales of US$460 million to US$490 million. Based on current exchange rates, Neuren expects royalty income of $70 million to $77 million in 2026.

Phase 3 trial underway

Neuren's second drug candidate, NNZ-2591, made progress during the year.

The Phase 3 Koala study in Phelan-McDermid syndrome began dosing patients in early 2026. This followed agreement with the US FDA on the trial design and the key measures of success.

The program has also received Orphan Drug and Fast Track status in the United States.

Neuren is continuing development of NNZ-2591 in Pitt Hopkins syndrome and hypoxic-ischaemic encephalopathy, with discussions ongoing with regulators.

The post Neuren shares dip after FY25 result. Here's what stood out appeared first on The Motley Fool Australia.

What did Neuren Pharmaceuticals report?

• 2025 royalty income from DAYBUE® was A$65 million, up 15% from 2024
• Net profit after tax came in at A$30 million
• Cash and short-term investments stood at A$296 million at year end
• Completed A$50 million share buy-back; new buy-back program starts March 2026
• DAYBUE net sales reached US$391 million, up 12% year on year
• Cumulative DAYBUE income since launch now A$510 million

What else do investors need to know?

Neuren's partnership with Acadia Pharmaceuticals continues to deliver, with DAYBUE gaining approval for the new powder formulation (DAYBUE STIX) and a growing patient base in the US. Acadia's guidance for 2026 points to net sales of US$460–490 million, with potential Neuren royalties of A$70–77 million.

Development is progressing on Neuren's second drug, NNZ-2591, with the Koala Phase 3 trial in Phelan-McDermid syndrome now underway and FDA Fast Track designation secured. Neuren has also expanded its clinical pipeline and added the rare SYNGAP1-related disorder to its targets.

What did Neuren Pharmaceuticals management say?

Neuren CEO Jon Pilcher said:

In 2025 we achieved a critical milestone for Neuren's value creation strategy with the commencement of our Koala Phase 3 clinical trial of NNZ-2591 in Phelan-McDermid syndrome. There is so much to look forward to this year as we continue to execute that program towards a New Drug Application and in parallel advance NNZ-2591 for Pitt Hopkins syndrome and HIE. All of this is self-funded by our growing revenue from DAYBUE, which has now reached A$510 million since launch in 2023. We are very excited to watch the impact of the recent launch of DAYBUE STIX in the US as a potentially attractive new option for Rett syndrome patients and their families.

What's next for Neuren Pharmaceuticals?

Looking ahead, Neuren expects ongoing revenue growth from DAYBUE, especially with the broader US rollout of DAYBUE STIX and new regional market opportunities. The company remains well-funded to back its clinical programs, including the pivotal Phase 3 trial for NNZ-2591 and further indications.

A new share buy-back will launch in March 2026, with management highlighting confidence in Neuren's outlook and financial strength. Investors can watch for updates on European regulatory decisions, Japanese trial results, and further pipeline progress throughout the year.

Neuren Pharmaceuticals share price snapshot

Over the past 12 months, Neuren shares have declined 5%, trailing the S&P/ASX 200 Index (ASX: XJO) which has risen 11% over the same period.

View Original Announcement

The post Neuren Pharmaceuticals earnings: Profits up, pipeline builds in 2025 appeared first on The Motley Fool Australia.

At the time of writing, the Neuren share price is up 6.37% to $13.52.

Let's take a closer look at what is driving the move.

Sales forecast points higher

According to the release, Neuren confirmed that updated projections for DAYBUE suggest global net sales could reach around US$700 million by 2028.

DAYBUE is approved in the United States for the treatment of Rett syndrome, a rare neurological disorder that mostly affects young girls. It remains the first and only approved treatment for this condition.

Neuren does not sell the drug itself. Instead, it earns royalties from Acadia on sales. That means when sales increase, Neuren receives a larger share of revenue without having to fund manufacturing or marketing.

Recent quarterly updates from Acadia have shown solid growth in DAYBUE sales. Quarterly revenue has exceeded US$100 million, and royalty income to Neuren has continued to increase year over year.

Pipeline adds longer-term potential

While DAYBUE is currently the main source of revenue, Neuren also has another drug candidate in development called NNZ 2591.

This treatment is being studied for several rare childhood neurological disorders, including Phelan McDermid syndrome, Pitt Hopkins syndrome and Angelman syndrome.

Earlier this month, Neuren began a Phase 3 clinical trial in the United States for Phelan McDermid syndrome. Phase 3 studies are typically the final stage before a company seeks regulatory approval.

If successful, NNZ 2591 could open the door to additional commercial products and new royalty streams.

However, it is important to remember that drug development carries significant risk. Clinical trials take time, and outcomes are never guaranteed.

Europe remains a watchpoint

Neuren shares have been volatile in recent weeks.

Earlier this month, challenges emerged in the European approval process for trofinetide, the active ingredient in DAYBUE. That update weighed heavily on the stock, which shed around 25% in a matter of days.

Although the long-term opportunity remains significant, regulatory decisions in major markets such as Europe can have a meaningful impact on sentiment.

Foolish bottom line

The lift in the Neuren share price reflects renewed confidence in the growth outlook for DAYBUE and the strength of the company's royalty model.

With rising United States sales and a late-stage pipeline advancing through trials, Neuren stands out among ASX biotechnology companies.

That said, shareholders should expect continued volatility. Updates on sales performance, regulatory decisions and clinical trial results are likely to influence the next moves in the share price.

The post Why Neuren shares are jumping more than 6% today appeared first on The Motley Fool Australia.

What did Neuren Pharmaceuticals report?

• Trading in Neuren Pharmaceuticals shares has been paused by the ASX from 26 February 2026.
• The company is yet to issue a further announcement explaining the reason for the pause.
• No financial or operational results were reported in this particular market release.
• Investors are awaiting more information from Neuren Pharmaceuticals management or the ASX.

What else do investors need to know?

A trading pause generally means the company is preparing a significant update or announcement. Until this announcement is made, shares will not trade on the ASX.

This could relate to a range of matters including financial results, a capital raise, or a market-sensitive development affecting the Neuren Pharmaceuticals share price.

What's next for Neuren Pharmaceuticals?

Investors should keep a close eye on the ASX platform for Neuren's next update. The pause will likely be lifted once the expected announcement is released.

We'll bring you the latest as soon as more details become available.

Neuren Pharmaceuticals share price snapshot

Over the past 12 months, Neuren Pharmaceuticals shares have declined 3%, trailing the S&P/ASX 200 Index (ASX: XJO) which has risen 11% over the same period.

View Original Announcement

The post Neuren Pharmaceuticals shares paused ahead of company announcement appeared first on The Motley Fool Australia.

Telix Pharmaceuticals Ltd (ASX: TLX) and Neuren Pharmaceuticals Ltd (ASX: NEU) shares have lost 21% and 31% respectively this year so far.

However, both ASX healthcare shares offer exposure to innovative healthcare solutions with meaningful growth runways. Brokers tip explosive upside for the ASX biotech shares. Let's find out why.

Telix Pharmaceuticals

The price of this ASX healthcare share has delivered standout gains over the past 12 months, peaking at $31.97 almost a year ago. Since then, Telix has dropped 67% in value to $8.84 at the time of writing.

Telix develops radiopharmaceuticals for cancer diagnosis and treatment, blending biotech innovation with specialised manufacturing and global distribution.

What sets Telix apart is its shift from development-stage hopeful to commercial operator. As approvals turn into broader clinical use, revenue can ramp quickly, without rebuilding the platform each time.

Growth now hinges on adoption and market penetration, not economic cycles. That brings volatility. But it also gives investors exposure to a healthcare niche where innovation can flow straight through to earnings.

Investors have been drawn to the company's accelerating revenue from its prostate cancer imaging product, Illuccix. Recent financial results showed strong revenue growth and improving profitability.

However, the risks are real. Biotech companies remain vulnerable to regulatory hurdles, trial delays, and shifting investor sentiment. The ASX healthcare share also continues to invest heavily in research and development. This means earnings can fluctuate as it balances growth with cost discipline.

Most brokers have a positive recommendation on the ASX healthcare share. Citi just reiterated its buy rating on Telix with a price target of $34. This suggests a massive 285% upside.

TD Cowen also has a buy rating but lowered its price target from $25 to $20, which still points to a possible gain of 126%.

Neuren Pharmaceuticals

Neuren's path has been more uneven. After reaching significant highs in 2024, the $2 billion ASX healthcare share retreated sharply. Since reaching a 52-week high of $22.99 in October, it has lost 44% to $12.80 at the time of writing.

Despite this, the company has continued to generate royalty income from DAYBUE, its approved therapy for Rett syndrome. Growing royalties provide a meaningful revenue base and help distinguish Neuren from earlier-stage biotech peers that rely purely on trial outcomes.

Looking ahead, much of Neuren's investment case rests on its broader pipeline, particularly the development of NNZ-2591 for multiple rare neurological disorders. Phase 3 trial progress and further regulatory engagement could act as powerful share price catalysts if results are positive.

Yet the risks are equally clear. Biotech valuations can swing dramatically on clinical updates, and pipeline programs remain inherently uncertain. Neuren's share price volatility over the past year is a reminder that even companies with approved products are not immune to market re-rating.

Most brokers see the ASX biotech stock as a strong buy. They have set a 12-month price target of $23.74, which points to an 85.5% plus.

Analysts at Bell Potter see significant value in this ASX healthcare share at current levels. Last week, the broker reaffirmed its buy rating with a $22 price target. This implies potential upside of 71% for investors over the next 12 months.

The post These 2 ASX healthcare shares could jump well over 80% appeared first on The Motley Fool Australia.

At the time of writing, the Neuren share price is down 0.60% to $13.35.

The decline comes despite the company unveiling a new capital management initiative.

Here is what was announced.

Neuren launches on market share buyback

According to the release, Neuren confirmed it will commence a new on-market share buyback program.

The buyback will run for up to 12 months and will be carried out under New Zealand corporate law. The company said it may purchase up to 5% of its issued shares over that period.

Any shares bought back will be cancelled, which reduces the total number of shares on issue. A lower share count is likely to improve earnings per share (EPS) and support shareholder returns over time.

Management said the decision reflects the board's view that the current share price does not fully reflect the company's underlying value. However, the buyback will be conducted at the company's discretion and may be paused during blackout periods, including the lead-up to financial results.

Neuren is scheduled to release its 2025 full-year results on 27 February 2026.

How Neuren makes its money

Neuren is a biopharmaceutical company focused on treatments for serious neurological disorders that appear in early childhood.

Its main source of revenue comes from Daybue, also known as trofinetide. The treatment was approved by the US Food and Drug Administration in 2023 for Rett syndrome and is commercialised in the United States by Acadia Pharmaceuticals under a global licence agreement.

Neuren earns royalty and milestone payments linked to sales performance. Since launch, Daybue has become a key driver of the company's financial results.

The company is also developing NNZ 2591, a drug candidate currently in clinical trials. It is being studied across several rare childhood conditions, including Phelan McDermid syndrome, Pitt Hopkins syndrome, and Angelman syndrome.

What investors will be watching next

In the near term, attention will likely turn to Neuren's upcoming full-year results later this month.

Investors will be looking for updates on Daybue sales trends, royalty income, cash position and progress across the NNZ 2591 trials.

While today's share price movement is modest, the announcement signals that management is prepared to return capital and support the stock at current levels.

Keep in mind that with biotech companies, future performance depends heavily on regulatory milestones, clinical data and commercial execution.

The post Why Neuren shares are edging lower on Thursday appeared first on The Motley Fool Australia.

What did Neuren Pharmaceuticals report?

• Announced a new 12-month on-market buy-back for up to 5% of shares on issue
• Buy-back to be conducted under section 65 of the NZ Companies Act 1993
• Strong cash position backed by growing DAYBUE® cash flows
• Buy-back discretionary, can be varied, suspended or terminated any time
• Development programs for NNZ-2591 well funded alongside buy-back

What else do investors need to know?

The buy-back will not occur during designated blackout periods – importantly, this includes the period before full-year results are announced. The 2025 full-year results are scheduled for release on 27 February 2026.

Shares purchased will be cancelled on acquisition, reducing total shares on issue and potentially boosting per-share value for remaining shareholders. The buy-back is within regulatory limits and will not require shareholder approval.

Neuren continues to advance its promising drug pipeline, including NNZ-2591 development for rare neurodevelopmental disorders, and holds orphan drug status for several programs in the US and EU.

What did Neuren Pharmaceuticals management say?

Neuren Chair Patrick Davies commented:

The Board views the current share price as materially undervaluing Neuren's assets, relative to internal analyses and the range of recently published analyst valuations. Neuren has a very strong cash position, supported by growing cash flows from the DAYBUE® franchise. Neuren's NNZ-2591 development programs for Phelan-McDermid syndrome, Pitt Hopkins syndrome and HIE all are, and will remain, well funded alongside the buy-back.

What's next for Neuren Pharmaceuticals?

Neuren plans to monitor market conditions and its operational performance to guide the pace and timing of its buy-back over the next 12 months. The company intends to keep investors updated on shares bought and prices paid.

Ongoing product development and expansion of its neurodevelopmental drug portfolio, including the progression of NNZ-2591 through major clinical milestones, remain in focus, backed by healthy cash flow.

Neuren Pharmaceuticals share price snapshot

Over the past 12 months, Neuren Pharmaceuticals shares have risen 1%, trailing the S&P/ASX 200 Index (ASX: XJO) which has risen 6% over the same period.

View Original Announcement

The post Neuren Pharmaceuticals unveils on-market buy-back supported by strong cash flows appeared first on The Motley Fool Australia.

They have just been named as buys and tipped to rise very strongly from current levels. Here's what you need to know:

Neuren Pharmaceuticals Ltd (ASX: NEU)

Analysts at Bell Potter see significant value in this ASX 200 share at current levels.

Last week, the broker reaffirmed its buy rating on the pharmaceutical company's shares with a $22.00 price target. Based on its current share price of $12.52, this implies potential upside of 75% for investors over the next 12 months.

While approval delays in Europe are disappointing and have hit sentiment, Bell Potter remains positive. It explains:

We have reduced the PoS assumption for Daybue EU approval and delayed first EU sales to CY27 for conservatism. We think there is still a possibility that, following reevaluation, the CHMP reverses its initial decision, however the risk to EU approval has increased considerably. Changes to CY26 forecasts are mainly from delaying the risk-adjusted milestone upon first EU sales into CY27.

NEU remains attractively valued based on the upside potential from its second drug candidate, NNZ-2591, hence we maintain our BUY. The Phase 3 trial for NNZ-2591 still has ~18 months until its readout, so investors will require patience to see through to this catalyst. Royalties from Daybue in the US alone will generate ~A$65m in CY26 income by our estimate, so NEU's balance sheet remains very healthy regardless of the EU decision.

Pinnacle Investment Management Group Ltd (ASX: PNI)

The team at Morgans thinks this ASX 200 share could be undervalued following a pullback last week.

In response to its half year results, which fell short of expectations, the broker upgraded this investment company's shares to a buy rating with a $23.21 price target. Based on its current share price of $17.49, this implies potential upside of 33% for investors.

While the headline result missed expectations, Morgans saw a number of positives from the release. It explains:

PNI's 1H26 NPAT (~A$67m, -11% on the pcp) came in -4% below consensus, but it was more in line excluding one-offs (e.g. mark-to-market investment impacts). Overall, we saw the 1H26 result as compositionally stronger than the headline numbers suggested, and positively accompanied with a move-the-dial acquisition.

We reduce FY26F EPS by -7% on a softer-than-expected 1H26 "reported" result, and dilution from the PAM equity issue. Conversely, FY27F EPS rises +8% on PAM earnings benefits and a broader review of our assumptions. Our price target falls to A$23.21 (from A$26.30). We move to a BUY recommendation (previously Accumulate) with >20% upside existing to our PT.

The post These ASX 200 shares could rise 30% to 75% appeared first on The Motley Fool Australia.

What did Neuren Pharmaceuticals report?

• First patient has commenced dosing in the Koala Phase 3 trial of NNZ-2591 for PMS
• Trial will enrol around 160 children aged 3–12 years with PMS
• 25 families referred so far; demand strong with 37 more families on waitlists
• US FDA Fast Track, Rare Pediatric Disease, and Orphan Drug designations for NNZ-2591
• Continues as Presenting Sponsor for the 2026 PMSF Family Conference in Colorado

What else do investors need to know?

The Koala trial is a randomised, double-blind, placebo-controlled study, testing the safety and effectiveness of NNZ-2591. Right now, only two US sites are active, but over 20 more sites are expected to launch through the first half of 2026, supporting broader trial access for families.

Phelan-McDermid syndrome currently has no approved treatment options. The high level of interest from families and clinicians supports strong trial recruitment. Neuren's commitment includes ongoing support of awareness through community initiatives like the upcoming PMS Foundation conference.

What did Neuren Pharmaceuticals management say?

Neuren CEO Jon Pilcher said:

We are excited to have started the treatment phase of our Koala Phase 3 study and are very encouraged by the level of interest in the PMS community. We are proud to be the presenting sponsor of the PMSF Family Conference in July and we anticipate strong momentum for Koala as trial sites around the US progressively activate during the first half of this year.

What's next for Neuren Pharmaceuticals?

Looking ahead, Neuren plans to ramp up trial site activation, aiming for 20+ locations across the US by mid-year. This should pave the way for faster patient recruitment and strengthen Neuren's position in rare paediatric neurological disorders.

Neuren's strategy remains focused on addressing urgent unmet medical needs in childhood neurological conditions, with NNZ-2591 also being developed for other neurodevelopmental disorders besides PMS.

Neuren Pharmaceuticals share price snapshot

Over the past 12 month, Neuren Pharmaceuticals shares have declined 5%, trailing the S&P/ASX 200 Index (ASX: XJO) which has risen 4% over the same period.

View Original Announcement

The post Neuren Pharmaceuticals kicks off Phase 3 trial in rare syndrome appeared first on The Motley Fool Australia.

Since this time last week, the ASX 200 healthcare stock is down 20%.

Is this a buying opportunity? Let's see what Bell Potter is saying about the pharmaceuticals company.

What is the broker saying about this ASX 200 healthcare stock?

Bell Potter notes that Neuren was given some surprising and bad news out of Europe this week relating to its Daybue (trofinetide) drug. It said:

The EU's drug advisory body, the CHMP, has adopted a "negative trend vote" on the marketing application for Daybue (trofinetide) in Europe. In other words, when the formal CHMP recommendation is passed down at the end of February, it will almost certainly be to not recommend Daybue for approval in Europe. The CHMP decision clouds what was the key near-term catalyst for NEU.

What's next?

The broker acknowledges that this has created a lot of uncertainty, with a number of potential outcomes. It estimates that the probability of Acadia having the decision reversed in the first instance sits at around 25% to 50%. It explains:

Best case: NEU's partner, Acadia, seek re-examination which leads to reversal of the CHMP's initial decision and Daybue is approved in ~June-July 2026 with a label in Rett patients aged >2yrs. Middle case: Re-examination leads to reversal of CHMP decision and Daybue is approved but with restricted label limited only to patients aged >5 years (as opposed to > 2years), which was the age group included in the Phase 3 trial. Worst case: CHMP does not change its negative decision after a reexamination and Acadia would likely be required to provide further additional evidence to support approval, potentially including additional clinical data.

There are precedents for CHMP reversals: recent examples include Rezurock in GVHD (Jan 2026) and lecanemab and donanemab for Alzheimer's (Nov 2024 and July 2025). Our best guess is the CHMP's negative view in this instance was most likely related to scrutiny of the RSBQ co-primary endpoint used in the Phase 3 trial rather than safety concerns. While difficult to predict based on the very limited detail, we tentatively ascribe a ~25-50% chance of a CHMP reversal in the first instance.

Should you buy the dip?

Bell Potter has responded to the news by retaining its buy rating on the ASX 200 healthcare stock with a reduced price target of $22.00 (from $25.00).

Based on its current share price of $13.27, this implies potential upside of 66% for investors over the next 12 months.

It concludes:

NEU remains attractively valued based on the upside potential from its second drug candidate, NNZ-2591, hence we maintain our BUY. The Phase 3 trial for NNZ-2591 still has ~18 months until its readout, so investors will require patience to see through to this catalyst. Royalties from Daybue in the US alone will generate ~A$65m in CY26 income by our estimate, so NEU's balance sheet remains very healthy regardless of the EU decision.

The post Why this beaten down ASX 200 healthcare stock could rebound 66% appeared first on The Motley Fool Australia.

Four ASX shares that are falling more than most today are listed below. Here's why they are dropping:

Beach Energy Ltd (ASX: BPT)

The Beach Energy share price is down over 4% to $1.20. This follows the release of the energy producer's half-year results. Beach Energy reported a 1% decline in sales revenue to $981.7 million and a 32% drop in net profit after tax to $150.2 million. This reflects a combination of production declines and weaker oil and liquids prices. Beach Energy's CEO, Brett Woods, spoke positively about the second half. He said: "Our steady financial footing and safe operational performance through a challenging half positions Beach for an active second half, particularly as Waitsia ramps up and offshore campaigns progress."

Elders Ltd (ASX: ELD)

The Elders share price is down 4% to $7.04. Investors have been selling this agribusiness company's shares after it announced a change of leadership. Elders has named Rene Dedoncker as its new CEO, commencing 1 October 2026. He will be replacing long-serving CEO, Mark Allison. Elders' chair, Glenn Davis, said: "We are delighted to welcome Rene as our next CEO. He brings deep agricultural roots and outstanding leadership experience to Elders. He has proven expertise from his years with Fonterra and Mars, where he drove operational excellence and strategic growth on a global scale. The Board has great confidence in his ability to lead Elders into its next phase of success."

Maas Group Holdings Ltd (ASX: MGH)

The Maas Group share price is down 23% to $4.30. This has been driven by news that the construction materials, equipment and service provider is selling its construction business for $1.7 billion. The company believes the deal will help fund a strategic shift into digital assets. It said: "Just as the Group positioned itself early into renewables-related infrastructure, MGH is now positioning to participate in the next wave of infrastructure investment, combining digital, AI, and electrification opportunities. The Australian data-centre and electrification markets present scalable, high-value opportunities aligned with MGH's execution DNA, integrated capabilities, and program-based delivery."

Neuren Pharmaceuticals Ltd (ASX: NEU)

The Neuren share price is down 10% to $13.19. This follows the release of an update on its NNZ-2591 product candidate. While the US FDA has given Neuren a pathway forward for advancing NNZ-2591 in two rare neurological conditions, some additional work will be required. This could mean it takes longer than expected for approval.

The post Why Beach Energy, Elders, Maas, and Neuren shares are dropping today appeared first on The Motley Fool Australia.

In morning trade, the ASX 200 pharma stock is down 9% to $13.30.

Why is this ASX 200 stock sinking?

Investors have been selling the pharmaceuticals company's shares on Thursday after it provided an update from the US Food and Drug Administration (FDA) on the next steps for its second drug candidate, NNZ-2591.

According to the release, the FDA has given Neuren a clear pathway forward for advancing NNZ-2591 in two rare neurological conditions, though some additional work will be required.

What is NNZ-2591?

NNZ-2591 is the ASX 200 stock's follow-on drug behind trofinetide (DAYBUE), which is already approved in the US for Rett syndrome.

It is being developed for multiple serious childhood neurological disorders, including hypoxic ischemic encephalopathy (HIE) and Pitt Hopkins syndrome (PTHS).

Neuren recently met with the US Food and Drug Administration to clarify what is required to move these programs into later-stage clinical development.

For HIE, which is a severe form of brain injury in newborns, Neuren plans to submit an Investigational New Drug (IND) application so it can begin clinical trials in infants.

The FDA generally agreed with Neuren's proposed initial study design and dosing. However, it asked the company to provide additional juvenile animal study data to better support dosing in newborn babies before trials can begin.

Neuren said it plans to generate this data before submitting the IND and still expects to commence the first HIE clinical study later in 2026. Importantly, management said this feedback does not materially change the cost or funding position of the program.

Pitt Hopkins

Pitt Hopkins syndrome is an extremely rare and severe neurodevelopmental disorder.

The FDA has provided guidance on how the ASX 200 stock could structure a future trial to prove NNZ-2591 works.

The regulator indicated that Neuren may use a condition-specific clinical global assessment, as long as it is paired with an observer-reported functional measure. This is similar to the approach already being used in Neuren's ongoing Phase 3 trial for Phelan-McDermid syndrome.

Because Pitt Hopkins is rarer and more disabling than related conditions, Neuren is still assessing the best trial design and expects further discussions with the FDA. Even so, the company still plans to initiate the next Pitt Hopkins trial in 2026.

Disappointment continues

This update comes just two days after the ASX 200 stock fell sharply following news that its partner, Acadia Pharmaceuticals (NASDAQ: ACAD), received a negative trend vote from European regulators for trofinetide in Rett syndrome.

That development weighed on sentiment, even though trofinetide is already approved and generating revenue in the US and other markets.

The post ASX 200 healthcare stock sinks 9% on FDA update appeared first on The Motley Fool Australia.

Will the market be able to build on this on Thursday? Here are five things to watch:

ASX 200 to fall

The Australian share market looks set to fall on Thursday following a mixed night on Wall Street. According to the latest SPI futures, the ASX 200 is expected to open the day 35 points or 0.4% lower this morning. In late trade in the United States, the Dow Jones is up 0.4%, but the S&P 500 is down 0.4% and the Nasdaq is down 1.4%.

Oil prices rise

ASX 200 energy shares including Beach Energy Ltd (ASX: BPT) and Santos Ltd (ASX: STO) could have a good session on Thursday after oil prices charged higher overnight. According to Bloomberg, the WTI crude oil price is up 3.1% to US$65.15 a barrel and the Brent crude oil price is up 3.2% to US$69.47 a barrel. Traders were buying oil in response to reports that US-Iran talks are collapsing.

Neuren shares on watch

Neuren Pharmaceuticals Ltd (ASX: NEU) shares will be on watch today after the pharmaceuticals company released an announcement after the market close on Wednesday. That announcement reveals that Neuren has received US FDA meeting feedback for NNZ-2591 clinical development in hypoxic ischemic encephalopathy (HIE) and Pitt Hopkins syndrome. It said: "We received useful guidance from FDA for our programs in Pitt Hopkins syndrome and HIE and are incorporating the feedback into our plans, although we were disappointed that in both cases the guidance was received as Written Responses Only and was delayed relative to FDA's goal dates."

Gold price rises

ASX 200 gold shares Newmont Corporation (ASX: NEM) and Northern Star Resources Ltd (ASX: NST) could have a decent session on Thursday after the gold price edged higher overnight. According to CNBC, the gold futures price is up 0.35% to US$4,951.7 an ounce. Traders have been buying the precious metal after a significant pullback earlier this week.

Buy Nufarm shares

Nufarm Ltd (ASX: NUF) shares could be undervalued according to analysts at Bell Potter. This morning, the broker has retained its buy rating and $3.60 price target on the agricultural chemicals company's shares. It said: "NUF continues to trade at a material discount to global peers (crop inputs ~9.3x FY26e EBITDA and seeds at ~10.0x FY26e EBITDA), despite favourable indicators for omega-3 returns in FY26e and demand indicators in the higher margin northern hemisphere crop protection markets looking generally supportive."

The post 5 things to watch on the ASX 200 on Thursday appeared first on The Motley Fool Australia.