Brokers have reduced their ratings on several ASX shares this week.

Let's review. 

NextDC Ltd (ASX: NXT)

The NextDC share price is $5.48, down 4.8% today.

Over the past month, this ASX tech share has more than halved in value.

Morgan Stanley downgraded NextDC shares to a hold rating today.

The broker slashed its 12-month price target from $19 to $6.70.

This still suggests a potential 22% upside ahead.

Ampol Ltd (ASX: ALD)

The Ampol share price is $38.99, down 2.2% today.

Over the past month, this ASX energy stock has lost 12% of its valuation.

RBC Capital downgraded Ampol shares to a hold rating on Monday.

The broker trimmed its 12-month price target from $46.50 to $44.50.

This implies a potential 14% upside ahead.

Cleanaway Waste Management Ltd (ASX: CWY)

Cleanaway Waste Management shares are steady at $3 on Friday.

Morgans downgraded Cleanaway Waste Management shares from buy to hold.

The broker has a share price target of $3.10, suggesting 3% upside ahead.

Cleanaway has agreed to a takeover by EQT Infrastructure for $3.095 per share.

Regis Resources Ltd (ASX: RRL)

The Regis Resources Ltd share price is $6.07, down 4.9% today.

Over the past month, this ASX 200 gold mining stock has fallen 24%.

Morgans downgraded Regis Resources shares to a hold rating on Wednesday.

The broker has a 12-month price target of $6.46.

This implies a potential 4% upside ahead.

FleetPartners Group Ltd (ASX: FPR)

The FleetPartners share price is $5.12, down 0.4% today.

Over the past month, this ASX 200 financial stock has risen 10%.

Ord Minnett downgraded FleetPartners shares to a hold rating on Tuesday.

The broker has a target price of $5.30, which implies 3% upside ahead.

Clinuvel Pharmaceuticals Ltd (ASX: CUV)

Clinuvel Pharmaceuticals shares are $7.02, down 0.7% on Friday.

Over the past month, this ASX healthcare stock has fallen 15%.

Morgans downgraded Clinuvel shares to a hold call this week.

The broker slashed its 12-month price target from $10 to $7.

This implies a potential 1% downside ahead.

The post 6 ASX stocks receiving analyst downgrades this week appeared first on The Motley Fool Australia.

To help narrow things down, let's see what analysts at Morgans are saying about the three named below.

Are they buys, holds, or sells? Here's what you need to know:

Clinuvel Pharmaceuticals Ltd (ASX: CUV)

Morgans notes that this biopharmaceutical company's Scenesse product is facing a major challenge following the release of top line data from a competitor.

In response, the broker has downgraded Clinuvel's shares to a trim rating with a reduced price target of $7.00. It said:

CUV competitor Disc's oral bitopertin swept its EPP Ph3 and is raising US$350m to launch. Its topline data is stronger than Scenesse's pivotal package on cross-trial comparison. Our main concern of a daily tablet supported by stronger data is the scenario we've long flagged as the biggest threat to CUV's only revenue line. 

We now view EPP as a defensive franchise. As a result, we have cut US volume and pricing assumptions. We move to a TRIM rating and reduce our target price to A$7p/s (from A$10 p/s).

NextDC Ltd (ASX: NXT)

Morgans thinks that NextDC shares are looking undervalued following a selloff this week.

While the news about M3 was disappointing, the broker sees an opportunity to buy shares while they are "incredibly cheap".

As a result, Morgans has upgraded NextDC shares to a buy rating with a $7.50 price target. It commented:

NXT have downgraded FY27 EBITDA guidance by ~36% due to M3 power supplier Jemena deferring the increased power supply for M3 due in part to community and stakeholder opposition (aka the Not In My BackYard movement). NXT's share price is below Net Tangible Asset value of ~$7.50 p/share. This pessimism implies concerns around contagion. Management didn't share investor concerns, saying M3 power is now expected to arrive "in FY28" and noting, in the context of debt, they are "in compliance with financial covenants". 

In our view NXT is incredibly cheap and its ~30% discount to NTA is unwarranted if these issues are just short term in nature. However, management needs to de-risk these key concerns for equity investors. This could take some time. We set our Target Price at $7.50 which is broadly in line with NTA and below our valuation. We upgrade to a BUY recommendation, from HOLD. Noting the heightening risks relative to normal operating conditions for the business.

Sigma Healthcare Ltd (ASX: SIG)

The broker is feeling positive about Chemist Warehouse owner Sigma Healthcare following its annual general meeting update.

Following the event, the broker has retained its buy rating on Sigma Healthcare's shares with a $3.19 price target. It said:

At its AGM, SIG provided a solid trading update where domestic LFL sales were in line with consensus at ~+10% and international LFL sales at +15.8% were ahead of consensus. The potential selldown by the co-founders (~5% of issued capital, as disclosed in SIG's July ASX announcement) may be keeping a lid on the share price. 

However, we see this as an opportunity to add to positions in this quality healthcare/retail name. We have made immaterial changes to our forecasts (<1%). We forecast ~18% EPS CAGR over the next three years. We retain our BUY recommendation with a $3.19 price target.

The post Buy, hold, sell: Sigma, Cliunvel, and NextDC shares appeared first on The Motley Fool Australia.

If you're thinking about putting $1,000 into an ASX healthcare stock, Telix Pharmaceuticals Ltd (ASX: TLX) and Clinuvel Pharmaceuticals Ltd (ASX: CUV) are likely on your radar. Both are pioneering companies in Australian biotech with global ambitions, but they have some stark differences. Let's weigh up Telix Pharmaceuticals vs Clinuvel Pharmaceuticals shares to see which one might suit an investor chasing growth, value, or something in between.

The case for Telix Pharmaceuticals

Telix Pharmaceuticals is a commercial-stage biopharma player focused on developing and selling theranostic (both diagnostic and therapeutic) products using targeted radiation. Its key product, Illuccix, is approved for prostate cancer imaging in Australia, the US, and Canada, and the company is pushing for approvals in Europe and the UK. Beyond this, it's running over 20 clinical trials globally across major cancer types including prostate, kidney, brain, and bone marrow conditions. Telix is headquartered in Australia but operates on several continents.

Three stand-out points about Telix from the data:

• It's much larger than Clinuvel, with a market cap of $5.40 billion.
• Year to date, its shares are up an impressive 37.6%.
• The company sports a very high price-to-earnings (P/E) ratio of 108.53, reflecting high investor hopes for future growth rather than current earnings.

It's worth noting that Telix does not pay a dividend, so investors here are backing future growth rather than income.

The case for Clinuvel Pharmaceuticals

Clinuvel Pharmaceuticals is best known for its drug SCENESSE, which helps people with rare genetic disorders causing extreme intolerance to sunlight. Clinuvel focuses on innovative treatments for both genetic and vascular skin disorders, and earns most of its revenue from the US and Europe. Like Telix, it's an Australian company with an international outlook.

Highlights for Clinuvel from the figures:

• It is much smaller in scale than Telix, with a market cap of $413.5 million.
• The company's P/E ratio stands at 12.17, considerably lower than Telix's, indicating the shares are valued far closer to current earnings.
• Dividend-wise, Clinuvel pays a fully franked yield of 0.62%, recently delivering annual dividends of 5 cents per share, all fully franked, which is a rare treat among Aussie biotechs.

However, Clinuvel shares have dropped 34.4% year to date, reflecting a tough patch for the business or perhaps shifts in investor expectations.

Valuation comparison

Here's how the two stack up on main valuation and yield measures:

Note: Clinuvel's reported P/E and EPS are consistent, while Telix's very high P/E reflects its current tiny but positive earnings. Telix does not pay dividends, whereas Clinuvel does, with a fully franked yield.

Recent share price momentum

Comparing recent share price performance up to 7 October 2026:

• Telix Pharmaceuticals closed at $15.87 on 7 October 2026, with a year-to-date return of 37.6%.
• Clinuvel Pharmaceuticals closed at $8.20 on 7 October 2026, with a year-to-date return of -34.4%.
• Over the previous trading week, Telix shares jumped 2.99% on the most recent day, and showed strong overall momentum despite some volatile days.
• Clinuvel shares, in contrast, edged up 0.86% on the same day, but have been trending down for most of the year.

Which is the better buy?

If I was picking between Telix Pharmaceuticals and Clinuvel Pharmaceuticals to invest $1,000 right now, I'd lean toward Telix. The company is much larger, more diversified across major cancer indications, and has clear momentum both in its operational progress and in the share price this year. While Telix is definitely priced for optimism with a sky-high P/E multiple (108.53), its strong pipeline and global approvals for Illuccix are impressive.

Clinuvel does stand out for paying a fully franked dividend—very rare among Australian biotechs—and the shares trade at a far lower P/E ratio (12.17), which could appeal to value-seekers. Yet, the steep year-to-date drop in the share price raises questions. Unless I was after income above all else or felt confident in a turnaround, I'd be more comfortable backing Telix's proven momentum and future-facing pipeline in the current landscape.

The post Telix vs Clinuvel Pharmaceuticals: Which ASX healthcare share deserves your next $1,000 of investment capital? appeared first on The Motley Fool Australia.

What did Clinuvel Pharmaceuticals report?

• Revenue declined slightly to $94.0 million, down 1% from FY2025.
• Net profit after tax was $33.9 million, a 6% decrease year on year.
• Cash reserves rose 12% to $252.1 million.
• Expenses held steady, dropping 0.5% to $53.5 million.
• Basic earnings per share slipped 6% to $0.68.
• A franked final dividend of $0.05 per share was declared, matching last year.

What else do investors need to know?

Clinuvel's profit marks a decade of uninterrupted earnings, which the company credits to disciplined cost controls and strong treatment demand for SCENESSE®. While revenue declined marginally as US sales softened – partly due to competitor programs and a shift in US supply practices – European revenue growth offset this impact.

The balance sheet remains robust, with net tangible assets per share climbing 12%. Operating cash inflow was $36.9 million, and after prepaying income tax, cash reserves still finished notably higher. The steady dividend reflects a commitment to reward shareholders, equating to 9% of free cash generated for the period.

What did Clinuvel Pharmaceuticals management say?

Group Chief Financial Officer Mr Peter Vaughan said:

This position provides us with flexibility to pursue an expansion strategy, continue investing through market cycles in key strategic areas, and allocate capital based on opportunity rather than necessity. As CLINUVEL builds its operations and presence in the capital markets in the United States, we can do so from a position of strength.

What's next for Clinuvel Pharmaceuticals?

Clinuvel aims to use its strong cash and asset base to drive further growth in North America and other markets. Management will continue to invest in core areas like R&D and the Phase III vitiligo program and expects steady business expansion through diversification.

The company remains confident in self-financing its strategy, thanks to disciplined spending and consistent cash flow. Shareholders can also look forward to continued dividends, subject to cash reserves and performance.

Clinuvel Pharmaceuticals share price snapshot

Over the past 12 months, Clinuvel Pharmaceuticals shares have declined 31%, trailing the All Ordinaries Index (ASX: XAO), which is flat over the same period.

View Original Announcement

The post Clinuvel Pharmaceuticals posts 10th consecutive profit and maintains dividend appeared first on The Motley Fool Australia.

The Nasdaq is the world's second-largest stock exchange after the New York Stock Exchange. It is home to many of the world's leading technology and healthcare companies, including Nvidia Corp (NASDAQ: NVDA) and Microsoft Corp (NASDAQ: MSFT).

Clinuvel confirms Nasdaq debut

In an ASX announcement today, the ASX biotech stock said its American Depositary Shares (ADS) are expected to commence trading on the Nasdaq later on Monday (New York time) under the ticker CUVL.

The milestone follows the US Securities and Exchange Commission declaring the company's Form 20-F registration statement effective on 17 July, along with Nasdaq approving the listing.

As part of the move, Clinuvel's existing over-the-counter American Depositary Receipt (ADR) program will be upgraded from a Level I ADR to a Level II ADS listed on Nasdaq. Each ADS will represent one ordinary Clinuvel share listed on the ASX.

Importantly, the company is not raising capital or issuing new shares as part of the listing. This means the move is designed to improve market access rather than fund the business.

Existing holders of Clinuvel's US-traded ADRs also won't need to take any action. Their holdings will automatically transition to the new Nasdaq-listed security.

Why does a Nasdaq listing matter?

A Nasdaq listing can significantly increase a company's visibility among US investors and improve trading liquidity. It also provides access to specialist healthcare and biotechnology investors who are often more familiar with the sector and can broaden the company's shareholder base.

The Nasdaq Global Select Market, where the ASX biotech stock will trade, also offers greater analytical coverage and inclusion in Nasdaq's market ecosystem. This potentially increases awareness among institutional investors.

That said, investors shouldn't expect the listing alone to transform the company's fortunes overnight. Greater visibility could support future growth opportunities and provide access to deeper capital markets if required. However, Clinuvel's long-term success will ultimately depend on executing its commercial strategy.

What did management say?

Clinuvel Chairman Jeffrey Rosenfeld said:

The upgrade of CUVL to the Nasdaq marks an important step for Clinuvel's visibility in U.S. capital markets, as well as reflecting a broader shift of our business towards North America. In the context of all our activities, the gradual shift to the U.S. makes much sense as the Company is maturing.

Foolish Takeaway

Clinuvel already has a commercialised product in SCENESSE®. It is approved in multiple markets, including the United States and Europe.

The Nasdaq listing has the potential to raise the international profile of the ASX biotech stock. It also expands its access to one of the world's deepest pools of healthcare capital.

However, the real driver of long-term shareholder returns will remain business execution.

Despite today's rally, Clinuvel shares are still down around 17% so far this year. This suggests investors are waiting for stronger evidence that the company's next phase of growth is taking shape.

The post This ASX biotech stock just scored a Nasdaq listing. Shares are jumping appeared first on The Motley Fool Australia.

The ASX biotech stock was down 1.3% to $10.28 during Thursday afternoon trading. While shares have climbed 15% over the past month, they remain down 17% in 2026, have slipped 2% over the past year, and have lost almost 65% of their value over the past five years.  

Yet analysts are becoming increasingly optimistic.

The reason? Clinuvel is evolving from a highly profitable one-product company into a business with multiple growth opportunities.

Beyond Scenesse

Clinuvel built its reputation around Scenesse, the world's only approved treatment for the rare genetic disorder erythropoietic protoporphyria (EPP). The therapy continues to generate reliable recurring revenue and strong cash flow. 

Management's attention is now shifting towards a much larger commercial opportunity: vitiligo. Earlier this year, the ASX biotech reached an important regulatory milestone after receiving positive scientific advice from European regulators ahead of its pivotal Phase III vitiligo trial. If successful, Clinuvel could expand its treatment into a condition affecting millions of people worldwide, dramatically increasing its addressable market. 

The company is also advancing a second product candidate, Neuracthel, as it broadens its pipeline beyond Scenesse. For investors, the story is changing. Rather than relying on a single commercial product, Clinuvel is gradually building a diversified biotechnology business with multiple potential growth drivers.

Strong financial foundations

Importantly, Clinuvel has the financial strength to fund that expansion. In its latest half-year result, the company reported record revenue of $36.9 million, while net profit after tax came in at $10.4 million.

Cash and investments increased to approximately $233 million, leaving the company debt free and well funded to continue investing in research, clinical trials, and future product development. 

Although profit declined from the previous corresponding period as research and development spending increased, many investors view the ASX biotech stock as a sensible investment in future growth rather than a deterioration in the underlying business.  

The risks

Clinuvel remains a biotechnology company, and that brings risk. Scenesse still generates the vast majority of revenue, making the business heavily reliant on one commercial product.

Meanwhile, success in clinical trials is never guaranteed. Delays, disappointing results, or regulatory setbacks could significantly affect future earnings expectations and the price of the ASX biotech stock.

That uncertainty explains why biotech shares often experience substantial volatility.

Analysts see substantial upside

Despite those risks, broker sentiment remains highly positive. Bell Potter continues to rate the ASX biotech stock as a buy with a price target of $22.25, implying upside of more than 100% from current levels.

Other analysts are even more optimistic. Consensus forecasts suggest meaningful upside over the next 12 months, with the average price target sitting at $25.80. That points to a potential gain of more than 150%. The most bullish valuation is around $39 per share, implying a 280% upside.

Whether Clinuvel reaches those lofty targets will depend largely on the success of its expanding pipeline. But after years of being viewed as a one-product company, investors are beginning to focus on what the business could become rather than what it is today. 

The post This ASX biotech stock is tipped to double or even triple in value appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that hold them back are listed below. Here's why they are rising:

Clinuvel Pharmaceuticals Ltd (ASX: CUV)

The Clinuvel Pharmaceuticals share price is up 2% to $9.42. This morning, this biotherapeutics company announced that it has publicly filed its Form 20-F Registration Statement with the U.S. Securities and Exchange Commission (SEC). Once reviewed and approved, Clinuvel intends to list an American Depository Share (ADS) on the Nasdaq Stock Market. The company's legal counsel, Benson Chao, said: "Having worked closely with our auditors and counsel, CLINUVEL has addressed all questions posed by the SEC in previous rounds of confidential review and – we believe – can demonstrate compliance with the rigorous U.S. requirements. In the coming weeks we will learn the SEC's feedback and continue our liaison with the Nasdaq team as we move towards a listing of our ADS."

Elevra Lithium Ltd (ASX: ELV)

The Elevra Lithium share price is up 3% to $12.65. This appears to have been driven by a broker note out of Macquarie this morning. According to the note, the broker has upgraded the lithium miner's shares to an outperform rating (from neutral) with an improved price target of $14.50 (from $13.50). This implies potential upside of almost 15% for investors from current levels. Macquarie has boosted its lithium price forecasts, which has led to upgrades to its earnings estimates.

Regis Resources Ltd (ASX: RRL)

The Regis Resources share price is up 2% to $6.77. Investors have been buying this gold miner's shares following a jump in the gold price. Traders were bidding the precious metal higher after a US-Iran peace deal sparked hopes that oil prices will fall and inflation and interest rates won't rise as much as feared. The S&P/ASX All Ordinaries Gold Index is up 1.5% at the time of writing.

Southern Cross Electrical Engineer Ltd (ASX: SXE)

The SCEE share price is up 15% to $4.62. Investors have been buying the specialised electrical provider's shares after a guidance upgrade sparked a bullish broker note out of Bell Potter. Bell Potter responded to the update by retaining its buy rating with an improved price target of $5.40 (from $3.70). It commented: "Our Target Price lifts to $5.40/sh (up from $3.70/sh), given a more optimistic mediumterm revenue growth outlook, underpinned by rising investment momentum in the Data Centre and BESS construction markets. Our upgraded Target Price implies a NTM PE of 27.9x (41% premium to the peer group). This premium is justified given the company's strong prospects of delivering acquisition accretion in the near-term."

The post Why Clinuvel, Elevra Lithium, Regis Resources, and SCEE shares are racing higher today appeared first on The Motley Fool Australia.

That's because if Bell Potter is on the money with its recommendation, this share could be destined to rise over 80% from current levels.

Which ASX 300 share?

The share that has been given the thumbs up by Bell Potter is Clinuvel Pharmaceuticals Ltd (ASX: CUV).

In case you're not familiar with the company, it is the pharmaceutical company behind the Scenesse (afamelanotide) treatment for patients with the rare disease erythropoietic protoporphyria (EPP).

In addition, the ASX 300 share is undertaking clinical trials to expand the approved use of Scenesse to more indications such as vitiligo.

It is the proposed expansion into vitiligo that Bell Potter has been looking at, with phase three data due to be released soon. The broker said:

CUV's first vitiligo Phase 3 trial readout (expected 2H CY26) is one of 2026's most keenly awaited ASX biotech readouts. Success would dramatically de-risk the expansion of Scenesse's approved label from the rare disease EPP (~5k Americans) to also include the far larger vitiligo indication (>2m Americans). In the event of a positive readout, we anticipate a second Phase 3 will be required (commencing in 2H CY26), hence vitiligo approval and subsequent sales would commence from ~2030.

The CUV105 trial randomised 210 patients to either Scenesse plus NB-UVB or NBUVB alone for ~5 months. A successful outcome will heavily depend on achieving a statistically significant outcome on the primary endpoint, at least in the eyes of the FDA for serving as a confirmatory study.

Big potential returns

According to the note, Bell Potter has reaffirmed its speculative buy rating on the ASX 300 share with a trimmed price target of $17.00 (from $19.00).

Based on its current share price of $9.10, this implies potential upside of 87% for investors over the next 12 months.

Bell Potter highlights that the market is attributing little value to the company's vitiligo opportunity. It said:

At an EV of $226m, there is little credit currently attributed to CUV for the vitiligo opportunity. A positive Phase 3 readout would likely see a dramatic resurgence toward our valuation as investors de-risk the path to vitiligo, while a negative readout would likely see the stock trade modestly above cash levels (~$5/sh) given recent sentiment.

Considering the relatively even chance we ascribe to positive/negative outcomes on the primary endpoint, the ~90% upside potential in the positive scenario comfortably exceeds the ~30% downside potential in the event of a failure. Hence we maintain our BUY recommendation but now include a speculative risk warning, not due to any financial instability for CUV (which is very robust), but purely due to the clinical risk profile that is fast approaching.

The post Bell Potter says this ASX 300 share could rise 80%+ appeared first on The Motley Fool Australia.

The Nasdaq is the second-largest stock exchange in the world (after the New York Stock Exchange) and one that has a reputation for providing a platform for some of the world's most innovative companies, including Nvidia, Alphabet, and Microsoft.

A step closer to the US market

Clinuvel confirmed it is continuing discussions with the US Securities and Exchange Commission (SEC) as part of its plan to upgrade its American Depository Receipt (ADR) program from Level I to Level II and list on the Nasdaq.

The company has already gone through multiple rounds of feedback with the SEC and expects the review process to conclude before the end of the 2026 financial year. If successful, Clinuvel would trade on the Nasdaq under a new ticker, opening the door to a deeper pool of institutional capital.

Why this matters

A Nasdaq listing gives greater visibility, liquidity, and provides access to specialist healthcare investors who are often more familiar with biotech business models.

In a sector where funding and sentiment often go hand in hand, that visibility can be valuable for Clinuvel in the event of future capital raises.

Still, investors should keep expectations grounded. Firstly, uplisting alone doesn't change the business fundamentals overnight; the company still needs to bring its vision to life with strong execution.

Secondly, it's not a done deal. The company was clear that the process remains subject to regulatory approval, and there is no guarantee the uplisting will proceed or occur within the expected timeframe.

Foolish bottom line

Clinuvel has a commercial product in SCENESSE®, which is approved in multiple markets, including the US and Europe. The next phase of its story includes greater commercialisation and expanding its investor base.

A Nasdaq listing could elevate the company's profile and open new doors, but strong business execution is still required.

After all, despite today's modest gain, the stock is still down around 27% year to date. It's a reminder that sentiment can shift quickly, and that investors are still waiting for a clearer growth narrative to emerge.

The post This ASX biotech is pushing for a Nasdaq listing. Could it reignite investor interest? appeared first on The Motley Fool Australia.

At the time of writing, the ASX 300 stock is trading 1% higher to $9.13.

What's going on with this ASX 300 stock?

The catalyst for the move higher today appears to be a regulatory update from the United States relating to its lead product, SCENESSE.

According to the release, the U.S. Food and Drug Administration (FDA) has removed a postmarketing requirement for a cardiac safety study, known as a QT study.

This requirement had originally been put in place when SCENESSE received approval in 2019.

The removal of this requirement follows a review of long-term safety data submitted by Clinuvel.

Management noted that the FDA determined the QT study was no longer necessary, as it would not provide additional useful safety information.

This decision reflects the regulator's confidence in the safety profile of SCENESSE, which has now been supported by both clinical and real-world data over several years.

Importance of SCENESSE

SCENESSE is Clinuvel's lead therapy and is approved in the United States for the treatment of adult patients with erythropoietic protoporphyria (EPP), which is a rare metabolic disorder.

It remains the only treatment for EPP approved by major global regulatory agencies, with more than 20,000 doses administered worldwide.

Given its importance to the ASX 300 stock, any regulatory update relating to SCENESSE is likely to be closely watched by the market.

Ongoing engagement with the FDA

Clinuvel also highlighted that it has maintained regular engagement with the US FDA since receiving approval for SCENESSE.

This has included ongoing safety reporting and data submissions, which appear to have supported the regulator's decision to relax its requirements.

Clinuvel's chief scientific officer, Dr Dennis Wright, appeared to be pleased with the news. He commented:

There is an active engagement between the FDA and marketing authorization holders for the life span of a product where patient safety is paramount. Having reliably reported data on SCENESSE since 2019, we are now seeing the agency relax its approach to postmarketing demands, reflecting the safety profile we see in the clinic.

Despite today's move, Clinuvel's shares are now down 16% over the past 12 months.

The post Guess which ASX 300 stock was given a big boost from the US FDA appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that hold them back are listed below. Here's why they are rising:

4DMedical Ltd (ASX: 4DX)

The 4DMedical share price is up 3% to $6.47. This morning, the respiratory imaging technology company revealed that its CT:VQ product has received CE Mark certification for commercial use in the European Union. The company notes that this allows it to immediately commence commercial engagement with healthcare providers, which sets up a pathway for clinical adoption and collaboration with major European hospital networks. 4DMedical's CEO and founder, Andreas Fouras, said: "CE Mark certification for CT:VQ is a significant milestone that opens access to one of the world's largest and most sophisticated healthcare markets. Combined with FDA clearance, 4DMedical now holds regulatory approval to rapidly commercialise CT:VQ across both the U.S. and the EU."

Clinuvel Pharmaceuticals Ltd (ASX: CUV)

The Clinuvel Pharmaceuticals share price is up 1.5% to $9.93. This has been driven by news that the biopharmaceutical company is showcasing at America's largest dermatology conference. Clinuvel's head of North American operations, Dr Linda Teng, said: "Following the success of the 2025 AAD Meeting, our team has refined its approach to ensure maximum engagement with the dermatology community ultimately aimed at helping to treat patients with melanocortin therapies. We know there is great demand from physicians who wish to offer more to their vitiligo patients, while interest in our commercial program for EPP continues to grow as patients seek approved therapy."

Life360 Inc (ASX: 360)

The Life360 share price is up 1.5% to $19.28. This week, Bell Potter put a buy rating and $37.75 price target on its shares. This is almost double its current share price. Commenting on its expectations for the first quarter, the broker said: "After setting expectations relatively low for Q1, there is some chance of a small beat, perhaps more in the adjusted EBITDA margin rather than MAU growth."

Silex Systems Ltd (ASX: SLX)

The Silex Systems share price is up 1% to $5.34. This morning, the laser uranium enrichment technology company advised that Global Laser Enrichment (GLE) has received preliminary approval for a major US government funding package. GLE is the exclusive licensee of the Silex uranium enrichment technology. The performance-based incentives package will provide up to US$98.9 million (A$142.6 million) in tax and other economic incentives.

The post Why 4DMedical, Clinuvel, Life360, and Silex shares are pushing higher today appeared first on The Motley Fool Australia.

Shares in the biopharmaceutical company closed yesterday trading for $9.64. In morning trade on Friday, shares are changing hands for $9.52 apiece, up 0.5%.

For some context, the ASX 300 is down 0.3% at this same time.

This modest outperformance follows a major leadership announcement.

Here's what's happening.

ASX 300 healthcare stock makes CEO decision

In a letter to shareholders released this morning, Clinuvel chairman Jeffrey Rosenfeld highlighted the company's record setting first half year financial results.

"Profitability continues despite the planned increase of expenses. Our cash reserves stand at $233 million as of 31 December," he said. "What matters now is what we do with this position."

Rosenfeld said that after a rigorous review of the company's succession planning and strategic direction, the board has decided that Philippe Wolgen will continue as CEO of the ASX 300 healthcare stock.

"This is not a routine renewal. This is a strategic imperative," Rosenfeld said.

He continued:

The coming 24 to 36 months represent the most critical execution phase in Clinuvel's history. The risks are considerable. We will need to navigate regulatory uncertainty, clinical complexity, and market volatility.

In this environment, a change at the top would not merely delay us, it would set us back a minimum of two to three years. Worse, it could result in outright failure to execute our strategy. The board has examined this question from every angle. We are not willing to incur that cost.

Rosenfeld said the board examined the option of recruiting a United States-based executive and had reviewed candidates. However, he said the board concluded that "recruiting a new CEO would introduce strategic diversion, create unavoidable delays, and carve a void in institutional knowledge".

Wolgen's employment agreement will be extended under new terms currently being negotiated, which are likely to include long-term equity incentives.

"We are treating this exactly as we would treat the recruitment of a new American CEO – except we are retaining someone who already knows how to deliver and financially run a lean company," Rosenfeld said.

What about the struggling Clinuvel share price?

Over the past 12 months, shares in the ASX 300 healthcare stock have slumped 20%

Addressing that decline, Rosenfeld said, "Market data tell a clear story: pre-revenue biotechs often outperform as perception and hope dominates investment decisions, while profitable companies executing quietly can be undervalued."

He added:

The board, market analysts, and sophisticated institutions recognise that our share price does not reflect the company's performance. It reflects a perceived ceiling on further growth. Our job, and Philippe's, is to break through that ceiling.

The post ASX 300 healthcare stock outperforming today on 'strategic' leadership news appeared first on The Motley Fool Australia.

After all, the potential returns from small-cap ASX shares can be significantly greater than those on offer with large caps.

With that in mind, here are two small-cap shares that Morgans thinks could rise strongly from current levels. Let's see what it is recommending:

Clinuvel Pharmaceuticals Ltd (ASX: CUV)

This biopharmaceuticals company disappointed Morgans during the first half, with softer-than-expected revenue growth and higher-than-expected cost growth.

However, the broker remains positive, especially given that this small-cap ASX share trades on lower-than-normal multiples.

As a result, the broker has put a speculative buy rating and $13.00 price target on its shares. This implies potential upside of 30% for investors from current levels. It said:

CUV delivered a softer result that landed below expectations, with top line underperformance and operational cost growth materially outpacing revenue. The combination of slower revenue growth, heavier opex, FX drag, and margin compression makes for an underwhelming print relative to expectations.

While fundamentally cheap with a large cash balance providing valuation support and trading well below historical multiples, the outlook continues to hinge on clinical catalysts and a change in sentiment (strategic direction driven) which we view is unlikely to shift meaningfully in the near term. Minor downgrades due to higher OpEx base and adjustments to WACC. Our target price reduces to A$13 (from A$14) but retain a SPECULATIVE BUY recommendation.

Readytech Holdings Ltd (ASX: RDY)

Another small-cap ASX share that Morgans is positive on is enterprise software company Readytech.

While it also delivered a half-year result that was softer than expected, the broker remains bullish due to its cheap valuation and strong sales pipeline. It has a speculative buy rating and $2.20 price target on Readytech's shares, which suggests that upside of almost 80% is possible over the next 12 months. Morgans said:

RDY's 1H26 result and revised outlook came in softer than expected, with Underlying EBITDA of $17.5m / Cash EBITDA of $7.5m ~6% behind MorgF. Whilst RDY's enterprise strategy remains on track, the group indicated that increased churn in 1H26 along with more protracted implementation/sale conversion have led to an FY26 guidance downgrade and the withdrawal of its longer-term targets.

Whilst we downgrade our FY26-17 EBITDA forecasts by 10-20% reflecting revised guidance, given RDY's robust pipeline, potential catalysts (VIC TAFE decision and likely increased corporate appeal), we move to a SPECULATIVE BUY rating, with a revised price target of $2.20/sh (previously $3.00/sh).

The post Morgans says these small-cap ASX shares could rise 30% to 80% appeared first on The Motley Fool Australia.

The ASX All Ords stock ended the week with a 10% decline to $10.01.

This leaves the biopharmaceutical company's shares trading close to a 52-week low.

While this is disappointing, the team at Bell Potter believes it has created a compelling buying opportunity for investors.

What is the broker saying about this ASX All Ords stock?

Clinuvel is a biopharmaceutical company distributing its lead drug Scenesse (afamelanotide) across Europe, the US, and Israel. It is for patients with the rare disease erythropoietic protoporphyria (EPP).

In addition, Bell Potter notes that the ASX All Ords stock is looking to diversify revenues through undertaking clinical trials to expand the approved use of afamelanotide in additional indications (such as vitiligo) and is developing additional pharmaceutical products.

The broker highlights that Clinuvel's performance during the first half was mixed, with revenue falling short of expectations but earnings coming in stronger than expected. It said:

Revenue increased 4% on pcp to $36.9m but was 2% below our forecast and 3% below VA. Earnings were a $2.2m and $2.4m beat to our forecasts at the EBITDA and NPAT lines, respectively, due to opex reducing materially from the preceding half. The company maintained an impressive >90% gross margin. Closing cash balance was $233m with no debt and increased +$9m from 30-June-2025.

While Bell Potter expects a competing product to be approved for EPP in the near future, it is confident that its growth will continue thanks to new product launches. It adds:

Forecasts are updated to reflect lower topline growth and lower operating expenses. The reduction in opex more than offsets the revenue decrease, hence earnings are increased in the forecast period. As detailed in this note, we continue to expect at least one other EPP market entrant will eventually obtain approval in the future, albeit not for at least another 12 months, thus we currently forecast EPP sales peaking in FY27-28 before ACTH and vitiligo restore growth for CUV.

Huge potential returns

According to the note, the broker has retained its buy rating and $19.00 price target on the ASX All Ords stock.

Based on its current share price of $10.01, this implies potential upside of 90% for investors over the next 12 months. It concludes:

CUV's EPP franchise continues to provide a strong financial foundation, however the key driver of our investment thesis is the opportunity to expand Scenesse into the far larger vitiligo indication. The first vitiligo Phase 3 trial (CUV105) readout is quickly approaching (2H CY26).

A successful readout would drastically de-risk this step-up in market opportunity and see renewed investor enthusiasm. Lastly, the company's ACTH program could come to market in the next ~2 years and provides another interesting avenue for growth and diversification.

The post Why this cheap ASX All Ords stock could rocket 90% appeared first on The Motley Fool Australia.

At the time of writing, the ASX 300 stock is up 6.5% to $13.48.

What's going on with this ASX 300 stock?

Investors have been buying the biotechnology company's shares after it unveiled encouraging progress on a brand new drug delivery platform that could materially expand its long-term growth runway.

According to the release, Clinuvel has commenced dosing in a preclinical study of its controlled-release liquid injectable peptide platform, known as VLRX-L.

This marks the first time one of the ASX 300 stock's next-generation delivery technologies has entered formal preclinical evaluation. This is a milestone that investors have clearly welcomed judging by its share price move on Monday.

What is VLRX-L?

The announcement reveals that VLRX-L has been designed to control the release of peptides, including Clinuvel's melanocortin-based drugs, through a flexible liquid dose.

The current preclinical study is focused on assessing safety, release kinetics, and the reproducibility of drug delivery using in-vitro models. Results from the study are expected in the second half of 2026.

Importantly, this platform has been developed entirely in-house at Clinuvel's Research, Development & Innovation Centre in Singapore. The VLRX-L program follows more than a decade of research into peptides, polymers, and controlled-release delivery systems. Management believes this highlights the depth of capability that the company has quietly been building behind the scenes.

The company's Chief Scientific Officer, Dr Dennis Wright, described the early in-vitro data as encouraging and reproducible. He said:

Through extensive preliminary work and iterative innovation we have arrived at a VLRX-L candidate platform that has demonstrated encouraging, reproduceable results in-vitro. The platform now needs to be challenged in in-vivo models to understand how it may ultimately deliver therapies for patients.

If these initial results are successful in 2026, we will look at the optimal pathways to scale up and commercialise this technology, with a view to extensively expanding our pipeline with our own IP.

Speaking about the ASX 300 stock's long term goal, Dr Wright said:

Long-term, the goal is to establish a suite of delivery platforms for melanocortins, and other peptides, which meet the diverse needs of a range of patient groups, addressing some of the challenges of technologies currently offered on the market. It is exciting that we can now start to unveil the work of our VALLAURIX team and our ambitions for the next generation of CLINUVEL's products.

Clinuvel Pharmaceuticals shares are now up almost 20% since this time last year.

The post This ASX 300 stock is racing 6% higher on exciting news appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that hold them back are listed below. Here's why they are rising:

Artrya Ltd (ASX: AYA)

The Artrya share price is up almost 10% to $3.78. Investors have been buying this medical technology company's shares after it announced its second customer win in the United States. Artrya has signed a commercial agreement with Northeast Georgia Health System for its Salix AI-powered cloud platform. It is used for the near real time, point of care assessment and management of coronary artery disease. The company's co-founder and CEO, John Konstantopoulos, said: "We are proud to secure our second U.S. commercial customer through this three-year commercial agreement with Northeast Georgia Health System, a respected leader in patient care across the U.S. Southeast."

Clinuvel Pharmaceuticals Ltd (ASX: CUV)

The Clinuvel Pharmaceuticals share price is up 4% to $12.81. This morning, this specialty pharmaceuticals company announced a significant expansion of its VALLAURIX Research, Development and Innovation (RD&I) Centre in Singapore. Management notes that this strategic five-year investment solidifies the site's transition into a global hub for developing advanced, long-acting peptide formulations. Clinuvel's chief operating officer, Lachlan Hay, said: "We are grateful for the support from EDB and are committed to building a truly unique, bespoke facility in Singapore. This positions CLINUVEL at the forefront of peptide delivery technologies, enabling us to execute our vision with speed and precision."

Imugene Ltd (ASX: IMU)

The Imugene share price is up 5% to 33.7 cents. This has been driven by news that the immune-oncology company has received written minutes from the US Food and Drug Administration (FDA) following its recent Type C meeting. This is in relation to the registrational pathway for azer-cel. The company notes that the minutes "provide clear alignment across the key elements required to advance azer-cel into a pivotal study and further validate the program's growing clinical and commercial potential."

Pilbara Minerals Ltd (ASX: PLS)

The Pilbara Minerals share price is up 4% to $3.95. This may have been driven by a broker note out of UBS this morning. According to the note, the broker has upgraded the lithium miner's shares to a neutral rating (from sell) with an improved price target of $4.00 (from $2.40). It made the move after upgrading its lithium forecasts on increased demand.

The post Why Artrya, Clinuvel, Imugene, and Pilbara Minerals shares are storming higher today appeared first on The Motley Fool Australia.

The S&P/ASX 200 Health Care Index (ASX:XHJ) has fallen more than 16% year to date. 

However one ASX healthcare stock that broker Bell Potter believes is set to rebound is Clinuvel Pharmaceuticals Ltd (ASX: CUV). 

The company is an Australian-based global biopharmaceutical company developing drugs for the treatment of genetic and vascular disorders.

What's going on with this ASX healthcare stock price?

The Clinuvel Pharmaceuticals share price has fallen more than 18% over the last month. 

This included a single day drop of 16%. This came following the release of its full-year financial results for the 12 months to 30 June (FY 2025).

In the report, Clinuvel revealed a 10% year-on-year revenue growth to $105.3 million from sales of its SCENESSE product. 

SCENESSE is the company's principal product. It is used to treat erythropoietic protoporphyria (EPP) patients, primarily in Europe and the United States.

However, the company also reported a 20% increase in expenses to $53.7 million while net profit after tax (NPAT) grew just 2%. 

What did Bell Potter have to say?

Bell Potter released a report following the results, and said the reported revenue of $95.0m (+8% yoy) was 2% below its forecast. 

Additionally, operating expenses were above the forecast, which was attributed to R&D investment increases.

Finally, the broker also said both EBITDA and NPAT came in below its forecast. 

However it wasn't all negative. 

EBITDA margin remains impressive at 46% albeit down from 51% in FY24. The company continues to accrue a large cash balance of $224m as at 30-June-2025 with no debt.

Price target adjustment

Previously, Bell Potter had a price target of $21.75 on this ASX healthcare stock. 

However, it has reduced this to $19.00.

Despite the reduction, the broker still indicates an enticing upside of over 69% based on yesterday's closing stock price of $11.20. 

The key driver of our BUY recommendation is the potential expansion of Scenesse into vitiligo. The first Phase 3 readout is a major inflection point in achieving this objective and is ~12 months away. Our PT is decreased to $19.00 due to a reduction in our EV/EBITDA multiple to 10x and a decrease in DCF valuation due to lower forecasts.

The broker noted that the commercialisation of SCENESSE in additional indications, as well as the commercialisation of additional pharmaceutical drugs, requires regulatory approval from agencies such as the FDA and EMA.

This is worth monitoring for prospective investors of this ASX healthcare stock.

The post This ASX healthcare stock fell 18% in a month – is it a buy low? appeared first on The Motley Fool Australia.

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

Clinuvel Pharmaceuticals Ltd (ASX: CUV)

The Clinuvel Pharmaceuticals share price is up over 3% to $11.58. Investors have been buying the specialty pharmaceuticals company's shares after the European Medicines Agency (EMA) agreed to amend the label for its photoprotective drug SCENESSE (afamelanotide). This change will allow adult erythropoietic protoporphyria (EPP) patients to receive the treatment every two months, removing the recommended maximum annual dose of four implants per year. Clinuvel's chief scientific officer, Dr Dennis Wright, said: "We are pleased that the CHMP's positive opinion will enable EPP patients to receive year-round treatment for this very debilitating condition. There was a strong logic to removing the maximum dose restriction in Europe, which has now been validated by the CHMP. It also harmonises the label with the USA."

DroneShield Ltd (ASX: DRO)

The DroneShield share price is up 8% to $3.58. This has been driven by news that the counter drone technology company is significantly expanding its research and development (R&D) operations in the United States. DroneShield USA's CEO, Matt McCrann, said: "As we continue to scale our operations globally, this expansion in the U.S. plays a crucial role in enhancing our ability to innovate and deliver advanced solutions for the evolving defense industrial base right here in the U.S. We're investing in the future of defense, and our growing footprint and impact in the U.S. market directly supports that effort."

Nuix Ltd (ASX: NXL)

The Nuix share price is up over 5% to $2.84. This follows the investigative analytics and intelligence software provider's investor day event. At the event, the company talked up its AI opportunity. Its CEO, Jonathan Rubinsztein, said: "The future of Nuix is bright, built on this foundation of excellence in data processing, analysis and a holistic approach to AI. We're excited about the momentum we're building and look forward to continuing to deliver value for our customers and shareholders."

Telix Pharmaceuticals Ltd (ASX: TLX)

The Telix Pharmaceuticals share price is up 7% to $16.02. Investors have been buying this radiopharmaceuticals company's shares following the release of an announcement. Telix revealed that the United States Centers for Medicare & Medicaid Services has granted Transitional Pass-Through payment status for Gozellix. It is Telix's next generation PSMA-PET1 imaging agent for prostate cancer. Telix's CEO of Precision Medicine, Kevin Richardson, said: "Granting TPT status for Gozellix is a strong endorsement of the clinical value of our next-generation imaging agent. Gozellix is already available nationally, and this reimbursement milestone will reduce the out-of-pocket burden for patients, enhance patient access to advanced prostate cancer imaging and simplify payment for providers."

The post Why Clinuvel, DroneShield, Nuix, and Telix shares are storming higher today appeared first on The Motley Fool Australia.

In morning trade, the ASX healthcare stock is up almost 10% to $12.30.

Why is this ASX healthcare stock jumping?

Investors have been buying the global specialty pharmaceuticals company's shares this morning after it released a big announcement.

According to the release, the European Medicines Agency (EMA) has agreed to amend the label for the company's photoprotective drug SCENESSE (afamelanotide).

This change will enable adult erythropoietic protoporphyria (EPP) patients to receive treatment every two months, removing the recommended maximum annual dose of four implants per year.

The company notes that this harmonises the treatment dosage in Europe with the USA, where many patients receive year-round therapy.

Why the change?

The ASX healthcare stock highlights that the EMA's Committee for Medicinal Products for Human Use (CHMP) issued its positive opinion on the benefit-risk profile of year-round SCENESSE treatment following extensive engagement with its team.

The CHMP evaluated data from two Phase III studies (CUV039 and CUV029) and real world evidence that was captured from over 15 years of SCENESSE use under compassionate, special access, and commercial programs.

The data package included a review of the safety and effectiveness profile of SCENESSE in the European patients who have received four or more implants in any one calendar year.

It notes that recognising the clinical need for EPP patients to receive year-round treatment, the committee concluded that there were no significant safety concerns with the ongoing administration of SCENESSE every two months. This variation can now be implemented immediately.

'Strong logic'

The ASX healthcare stock's chief scientific officer, Dr Dennis Wright, was pleased with the news. He said:

A decade after EMA's approval of SCENESSE we have generated a much deeper, richer pool of data helping to define the drug's benefit-risk profile, with a dossier that supports year-round patient dosing.

We have received ongoing requests from EPP expert physicians to facilitate year-round treatment in Europe and we are pleased that the CHMP's positive opinion will enable EPP patients to receive year-round treatment for this very debilitating condition. There was a strong logic to removing the maximum dose restriction in Europe, which has now been validated by the CHMP. It also harmonises the label with the USA.

Since we are administering SCENESSE in vitiligo at higher frequency of one dose every three weeks, it is obvious that both programs – EPP and vitiligo – assist us in compiling our next regulatory dossier with robust safety data.

The post Why is this ASX healthcare stock jumping 10% on Tuesday? appeared first on The Motley Fool Australia.

Four ASX shares that are rising more than most today are listed below. Here's why they are pushing higher:

Clinuvel Pharmaceuticals Ltd (ASX: CUV)

The Clinuvel share price is up 4% to $11.97. This follows the release of data relating to its SCENESSE product and its potential use treating vitiligo. Commenting on the data, director of global clinical affairs, Dr Emilie Rodenburger, said: "Most satisfying is to hear how patients are receiving benefit from treatment and the shared excitement from the treating physicians who may have – for the first time – a therapy that works for patients with extensive vitiligo. We look forward to learning the full study results in 2026." This could be a very lucrative market for the specialty pharmaceuticals company. It estimates that vitiligo represents an addressable market of US$490 million to US$570 million in just the United States. Whereas the global market opportunity sits at an estimated US$4.5 billion according to the company.

CSL Ltd (ASX: CSL)

The CSL share price is up 1% to $200.36. This may have been driven by the release of a broker note out of Citi this morning. According to the note, the broker has retained its buy rating on the biotechnology company's shares with a price target of $265.00. Based on its current share price, this implies potential upside of over 30% for investors between now and this time next year. Citi continues to believe that double-digit earnings growth is possible over the medium term.

Pro Medicus Ltd (ASX: PME)

The Pro Medicus share price is up 6% to $317.30. This may also have been driven by a broker note out of Citi. This morning, the broker has upgraded the health imaging technology company's shares to a buy rating with a vastly improved price target of $350.00. While Citi acknowledges that Pro Medicus shares trade on very high multiples, it believes this is justified due to its strong earnings growth outlook. This is being underpinned by sticky customers and long contracts.

Zip Co Ltd (ASX: ZIP)

The Zip share price is up 3.5% to $4.71. Another broker note could be behind this solid rise on Friday. According to a note out of UBS, its analysts have retained their buy rating on this buy now pay later provider's shares with an improved price target of $5.25. UBS has been looking at app store data and believes it points to strong growth in downloads. It feels that this indicates that momentum is strong and has upgraded its earnings estimates accordingly.

The post Why Clinuvel, CSL, Pro Medicus, and Zip shares are racing higher today appeared first on The Motley Fool Australia.