Four ASX shares that have failed to follow the market higher today are listed below. Here's why they are falling:

Aeris Resources Ltd (ASX: AIS)

The Aeris Resources share price is down 6% to 52 cents. This may have been driven by the copper miner's recent capital raising. Last week, Aeris revealed that it received total applications in excess of $21.6 million for its $10 million share purchase plan. It decided to increase the offer and accept all valid applications. This means that approximately 48 million new shares were issued to shareholders this morning at 45 cents per new share. It looks like some investors have decided to cash in their new shares for a quick profit.

Capricorn Metals Ltd (ASX: CMM)

The Capricorn Metals share price is down 3% to $14.35. This is despite the gold miner announcing an acquisition this morning. It has signed a binding agreement with Tempest Minerals Ltd (ASX: TEM) to acquire the prospective Yalgoo Project tenement package. It notes that the Yalgoo Project covers approximately 1,000 square kilometres of tenure located contiguous to Capricorn's Golden Range and Fields Find tenure. It is considered highly prospective for gold mineralisation, featuring multiple settings conducive to hosting economic gold deposits.

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

The Paradigm Biopharmaceuticals share price is down 1.5% to 31.5 cents. Investors have been selling the late-stage drug development company's shares despite it releasing an update on its Phase 3 PARA_OA_012 clinical trial in knee osteoarthritis. Paradigm revealed that it has achieved 25% of its recruitment milestone for the trial. However, some participants will not commence dosing until the new year due to temporary shutdowns. Nevertheless, management notes that "the interim analysis remains on track for mid-calendar year 2026, with primary endpoint analysis for the full cohort expected in Q4 CY2026."

Silver Mines Ltd (ASX: SVL)

The Silver Mines share price is down 23% to 17.7 cents. This has been driven by the release of an update on its Bowdens Silver Project. Back in 2024, the NSW Court of Appeal voided the project's approval and it appears to be struggling to have that overturned. Silver Mines' managing director, Jo Battershill, said: "Since the Court Decision in August 2024, the Company has remained strongly focused on advancing the redetermination of the Bowdens Project Development Application. […] The result of this has been for the Company to agree to refreshing its ecological surveys and prepare an updated biodiversity assessment in accordance with the Biodiversity Conservation Act. While this approach extends the overall assessment timeframe, we believe it positions the Bowdens Project on a stronger footing for a successful and robust redetermination."

The post Why Aeris Resources, Capricorn Metals, Paradigm, and Silver Mines shares are sinking today appeared first on The Motley Fool Australia.

That's because analysts at Bell Potter believe that its shares could rise materially over the next 12 months.

Which ASX stock?

The stock that is being tipped as a buy is Paradigm Biopharmaceuticals Ltd (ASX: PAR).

It is an Australian biotechnology company focused on repurposing Pentosan Polysulfate Sodium (PPS) for the treatment of osteoarthritis (OA) in the knee.

Bell Potter notes that the global market for a safe, effective treatment that provides superior patient outcomes compared to the standard of care is a multiple blockbuster. And the good news is that the recently completed phase II study produced some highly encouraging results that are worthy of further clinical trials.

Speaking of which, enrolments are now underway for a phase 3 approval study. Bell Potter commented:

Patient enrolments in the Phase 3 approval study are now undergoing dosing at sites in the United States and Australia. PARA_OA_012 is a phase 3 randomised, controlled and blinded study to evaluate the safety and efficacy of iPPS in the treatment of osteoarthritis of the knee. The trial will enrol 466 patients randomised 1:1. Up to 65 sites will be involved once site activation processes are completed imminently.

If all goes to plan, this ASX stock would have a huge market opportunity to grow into. Bell Potter highlights:

In the US along the incidence of moderate to severe osteoarthritis is estimated at 30m persons. The pricing of the drug will ultimately be determined by the economic benefit associated with its use as well as the cost of other therapies. The conservative estimate is US$2,500 per year which places the addressable market in the tens of billions of US$.

Big returns

According to the note, the broker has reaffirmed its speculative buy rating on the company's shares with a trimmed price target of 65 cents (from 73 cents).

Based on its current share price of 34 cents, this implies potential upside of 91% for investors over the next 12 months.

Commenting on its buy recommendation, Bell Potter said:

Changes to FY26/FY27 earnings are not material. Valuation is amended to $0.65 following amendment to shares on issue following prospective new equity. The major catalyst is the interim efficacy data from PARA_OA_012 due in mid CY2026, albeit we expect minimal detail so as not to prejudice the outcome of the trial. The interim data is likely to be available under NDA for the purposes of partnering discussions.

The post Why this exciting ASX stock could rocket 90%! appeared first on The Motley Fool Australia.

Will the market be able to bounce back from this on Wednesday? Here are five things to watch:

ASX 200 expected to fall

The Australian share market looks set to edge lower on Wednesday despite a solid night of trade on Wall Street. According to the latest SPI futures, the ASX 200 is expected to open the day 6 points lower this morning. In the United States, the Dow Jones was up 0.2%, the S&P 500 rose 0.4%, and the Nasdaq pushed 0.3% higher.

Oil prices drop

ASX 200 energy shares Beach Energy Ltd (ASX: BPT) and Santos Ltd (ASX: STO) could have a tough day after oil prices dropped again overnight. According to Bloomberg, the WTI crude oil price is down 1.5% to US$62.50 a barrel and the Brent crude oil price is down 1.3% to US$67.06 a barrel. Traders were selling oil ahead of an expected increase in OPEC supply and the resumption of exports from Iraq's Kurdistan region.

Shares going ex-dividend

A couple of shares will be going ex-dividend this morning and could trade lower. This includes property company Cedar Woods Properties Ltd (ASX: CWP) and furniture retailer Nick Scali Limited (ASX: NCK). Cedar Woods will be paying a 19 cents per share fully franked dividend on 31 October and Nick Scali will be paying a fully franked 33 cents per share dividend a few days earlier on 28 October.

Gold price rises

It looks set to be a positive session for ASX 200 gold shares such as Newmont Corporation (ASX: NEM) and Northern Star Resources Ltd (ASX: NST) on Wednesday after the gold price pushed higher again. According to CNBC, the gold futures price is up 0.75% to US$3,884.1 an ounce. This was driven by concerns over a potential US government shutdown.

Buy Paradigm shares

Paradigm Biopharmaceuticals Ltd (ASX: PAR) shares could be a good option for investors with a high risk tolerance according to Bell Potter. This morning, the broker has retained its speculative buy rating on the biotechnology company's shares with a trimmed price target of 65 cents. Speaking about its potential osteoarthritis therapy, it said: "In the US along the incidence of moderate to severe osteoarthritis is estimated at 30m persons. The pricing of the drug will ultimately be determined by the economic benefit associated with its use as well as the cost of other therapies. The conservative estimate is US$2,500 per year which places the addressable market in the tens of billions of US$."

The post 5 things to watch on the ASX 200 on Wednesday 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:

DroneShield Ltd (ASX: DRO)

The DroneShield share price is up a further 7.5% to $2.30. Investors have been fighting to get hold of this counter drone technology company's shares this week after it announced its largest single order in its history. DroneShield has received a package of three standalone follow-on contracts worth $61.6 million from a European military customer. DroneShield's CEO, Oleg Vornik, said: "In succession to the $32.2 million repeat order announced on 14 April 2025 for another customer, DroneShield products are now being purchased in material quantities. The scale and frequency of orders has been increasing as leading Military customers are moving from testing hardware to broader rollouts. DroneShield is well placed to meet the increasing demand." This morning, Bell Potter responded by putting a buy rating and $2.60 price target on its shares.

Neuren Pharmaceuticals Ltd (ASX: NEU)

The Neuren Pharmaceuticals share price is up 11% to $13.91. This morning, this pharmaceuticals company revealed that the United States Patent and Trademark Office has allowed Neuren's patent application covering the use of NNZ-2591 to treat Pitt Hopkins syndrome (PTHS) for issuance as a patent. Neuren notes that there are currently no approved treatments for PTHS, which has a severely debilitating impact on the lives of patients. The US Food and Drug Administration (FDA) has previously granted Orphan Drug designation and Fast Track designation to Neuren's development program for NNZ-2591 in PTHS.

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

The Paradigm share price is up 3% to 32.5 cents. This has been driven by news that the biopharmaceuticals company has announced the acquisition of Proteobioactive. This gives Paradigm exclusive global rights to develop and commercialise a patented oral combination of pentosan polysulfate sodium (PPS) and a COX-2 inhibitor (Coxib) for the treatment of pain and inflammation. Paradigm is paying $500,000 up front and then up to $16 million in add-ons.

Pilbara Minerals Ltd (ASX: PLS)

The Pilbara Minerals share price is up 9% to $1.36. This is despite there being no news out of the lithium miner today. However, it is worth noting that a number of beaten down lithium stocks are racing higher on Thursday. Investors may believe that they have been oversold and are in the bargain bin right now. For example, despite today's strong gain, the Pilbara Minerals share price is down approximately 58% since this time last year.

The post Why DroneShield, Neuren, Paradigm, and Pilbara Minerals shares are roaring higher today appeared first on The Motley Fool Australia.

Let's see why investors are bidding them higher today:

Neuren Pharmaceuticals Ltd (ASX: NEU)

The Neuren share price is up almost 12% to $14.00. This has been driven by a patent announcement from the pharmaceuticals company this morning.

According to the release, the United States Patent and Trademark Office has allowed Neuren's patent application covering the use of NNZ-2591 to treat Pitt Hopkins syndrome (PTHS) for issuance as a patent.

The ASX healthcare stock notes that after issue the expiry date of the patent will be in April 2040.

Neuren highlights that there are currently no approved treatments for PTHS, which has a severely debilitating impact on the lives of patients, as well as their parents and siblings. The US Food and Drug Administration (FDA) has granted Orphan Drug designation and Fast Track designation to Neuren's development program for NNZ-2591 in PTHS.

The good news is that in Neuren's multi-centre Phase 2 clinical trial of treatment with NNZ-2591 for 13 weeks, improvements were seen in clinically important aspects of PTHS. This includes communication, social interaction, cognition and motor abilities. It notes that 9 out of 11 children showed improvement assessed by clinicians and 8 out of 11 children showed improvement assessed by caregivers.

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

The Paradigm share price is up 6% to 33.5 cents. The catalyst for this has been news that the late-stage drug development company has announced the acquisition of Proteobioactive.

It is a company founded by Professor Peter Ghosh and based on his research into pentosan polysulfate sodium (PPS).

According to the release, this acquisition means that the ASX healthcare stock obtains exclusive global rights to develop and commercialise a patented oral combination of PPS and a COX-2 inhibitor (Coxib) for the treatment of pain and inflammation.

Paradigm is paying $500,000 up front and up to $16 million in add-ons.

Commenting on the news, the ASX healthcare stock's managing director, Paul Rennie, said:

Our immediate focus remains on the successful execution of our ongoing Phase 3 clinical trial for injectable PPS in knee osteoarthritis. The acquisition of this oral combination IP allows us to broaden our long-term strategy.

We anticipate initial development activities will concentrate on the veterinary field, where there is a clear and timely opportunity. Importantly, through this veterinary development program, we expect to generate valuable preclinical and field data that will ultimately support our transition to human clinical development. This staged approach enables us to responsibly expand our OA portfolio while maintaining strict capital discipline and focus on our core late-stage phase 3 asset.

The post 2 ASX healthcare stocks making huge moves on big news appeared first on The Motley Fool Australia.

Here are three of the best-performing ASX healthcare shares and why they are rising on Friday.

3 ASX healthcare shares zooming higher on positive news

4DMedical Ltd (ASX: 4DX)

The 4DMedical share price is up 7.9% at 61 cents per share at the time of writing.

The respiratory imaging technology company's shares are lifting on news of a commercial agreement with Qscan Radiology Clinics (QScan).

The contract follows a successful pilot of 4DMedical's products with Qscan, which is a leading provider of diagnostic imaging services in Queensland.

Under the deal, Qscan will offer 4DMedical's respiratory imaging solutions at select practices in Brisbane.

This is the first Australian contract for 4DMedical that incorporates products from both its pulmonary function and pulmonary structure suites, including CT LVAS.

4DMedical CEO and founder Andreas Fouras said:

Momentum continues to build with the commercialisation of our technology across the US and Australia.

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

The Paradigm Biopharmaceuticals share price is 5.7% higher at 47 cents per share.

Paradigm is an ASX biotech that is focused on repurposing Pentosan Polysulfate Sodium (PPS) for the treatment of knee osteoarthritis.

The company announced today that it has received a $6,300,438 research and development (R&D) tax incentive refund from the Australian Government for the 2024 financial year.

This raises the company's current cash balance to approximately $31 million.

Paradigm managing director Paul Rennie commented:

With our cash position further boosted with this incentive refund, we are well-positioned to progress our Phase 3 clinical trial activities and subject recruitment in Australia.

The R&D tax incentive program is designed to encourage innovation through R&D activities in
Australia. Eligible companies can receive refundable cash offsets of 43.5% for qualifying R&D costs.

Somnomed Ltd (ASX: SOM)

The Somnomed share price is 6.7% higher at 64 cents per share.

Somnomed designs and manufactures oral treatments for sleep-related breathing disorders and obstructive sleep apnea.

The company released its December quarter activities report and FY25 guidance update today.

Somnomed reported 2Q FY25 revenue of $28.5 million, up 19.8% on the prior corresponding period (pcp).

Net cash inflow from operating activities was positive at $1.5 million.

The cash balance at the end of the quarter was $18.5 million, with a $1 million unsecured loan facility in Europe fully drawn.

For FY25, the company now expects revenue of approximately $105 million and earnings before interest, taxes, depreciation, and amortisation (EBITDA) of between $7 million and $9 million.

It expects capex costs of between $3 million to $4 million.

The post 3 ASX healthcare stocks soaring on positive company updates appeared first on The Motley Fool Australia.

That's because they have just been named as buys and tipped to rise materially from current levels.

Here's what analysts are saying about these small caps in January:

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

The first small cap ASX share for investors to look at is Paradigm Biopharmaceuticals.

It is a biotechnology company that is focused on repurposing Pentosan Polysulfate Sodium (PPS) for the treatment of osteoarthritis (OA) in the knee.

The team at Bell Potter believes the company would have a lucrative market opportunity if it is approved. IT notes that the "global market for a safe, effective treatment that provides superior patient outcomes compared to the standard of care is a multiple blockbuster." The broker adds:

In the US along the incidence of moderate to severe osteoarthritis is estimated at 30m persons. The pricing of the drug will ultimately be determined by the economic benefit associated with its use as well as the cost of other therapies. The conservative estimate is US$2,500 per year which places the addressable market in the tens of billions of US$.

Bell Potter has a speculative buy rating and 80 cents price target on its shares last week. Based on its current share price of 46.5 cents, this implies potential upside of approximately 72% for investors over the next 12 months.

Readytech Holdings Ltd (ASX: RDY)

Another small cap ASX share that could be a buy according to analysts is Readytech.

Readytech is a software as a service (SaaS) provider of mission critical software to the tertiary education, government, justice, and enterprise markets.

The team at Morgans believes that the company would be a great option for investors right now due to its strong earnings growth outlook and attractive valuation. It explains:

Its products include student management, payroll and HR solutions, and enterprise resource planning (ERP) to local government and legal case management. RDY's recent organic growth trajectory demonstrates its ability to deliver our forecast 14.5% CAGR EBITDA growth over coming years.

Despite this, the company is trading at a ~20% discount to its historic average EBITDA multiple of ~11x, which we believe represents compelling value.

Morgans has an add rating and $3.74 price target on its shares. This implies potential upside of 19% for investors over the next 12 months.

The post Why these small cap ASX shares could deliver very big returns in 2025 appeared first on The Motley Fool Australia.

Meantime, some brokers changed their ratings on various ASX stocks before heading off on holidays.

Here are six ASX All Ords shares that market analysts on the CommSec trading platform upgraded to a consensus 'strong buy' rating last month.

6 ASX All Ords shares lifted to 'strong buy' status

Telstra Group Ltd (ASX: TLS)

Analysts upgraded their consensus rating on Telstra shares to a strong buy on 23 December.

The Telstra share price is $4.02, up 0.25%.

Goldman Sachs has a buy rating on Telstra with a 12-month share price target of $4.50. This implies a potential 12% upside for investors in 2025.

In a new note, analysts Kate Hannan and Annabel Li discussed the recent sale of Foxtel to global sports streaming platform, DAZN for $3.4 billion.

Under the deal, Telstra will also sell its minority stake in Foxtel. It will receive $128 million in cash to repay a loan, as well as an approximate 3% shareholding in DAZN.

Hannan and Li explained their buy rating on Telstra shares:

We believe the low risk earnings (and dividend) growth that Telstra is delivering across FY22-25, underpinned through its mobile business, is attractive.

We also believe that Telstra has a meaningful medium term opportunity to crystallise value through commencing the process to monetize its InfraCo Fixed assets — which we estimate could be worth between A$22-33bn.

The ASX All All Ords telecommunications share is up 1.01% over the past 12 months.

Liberty Group (ASX: LFG)

Analysts upgraded their consensus rating on Liberty Group shares to a strong buy on 13 December.

The Liberty share price is currently steady at $3.32.

The ASX All Ords financial share is down 19.2% over the past 12 months.

Integral Diagnostics Ltd (ASX: IDX)

Analysts upgraded their consensus rating on Integral Diagnostics shares on 27 December.

The Integral Diagnostics share price is trading at $2.91 on Thursday.

Bell Potter is among the analysts with a buy rating on this ASX All Ords healthcare stock.

The broker has a 12-month price target of $3.87, implying a potential upside of 33% for the medical imaging company in 2025.

The ASX All Ords healthcare share is up 50.7% over the past 12 months.

Helloworld Travel Ltd (ASX: HLO)

Analysts on CommSec upgraded their consensus rating on Helloworld shares on 13 December.

The Helloworld Travel share price is currently $1.97, up 0.87%.

The ASX All All Ords travel share is down 19.2% over the past 12 months.

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

Analysts upgraded their consensus rating on Paradigm shares to a strong buy on 13 December.

The Paradigm Biopharmaceuticals share price is 39 cents, up 2.67% on Thursday.

Bell Potter has a speculative buy rating on the biotech, which is focused on repurposing Pentosan Polysulfate Sodium (PPS) for the treatment of knee osteoarthritis.

The broker is encouraged by trial data and the possibility of phase 3 studies starting in the new year. Its 12-month price target is 80 cents per share, suggesting a potential upside of 105% in 2025.

The ASX All Ords healthcare share is down 14.4% over the past 12 months.

Cobram Estate Olives Ltd (ASX: CBO)

Analysts upgraded their consensus rating on Cobram shares to a strong buy on 16 December.

The Cobram Estate share price is $2.13, down 0.93% on Thursday.

This ASX All Ords consumer staples share is up 21.7% over the past 12 months.

The post 6 ASX All Ords shares lifted to 'strong buy' consensus ratings for the new year 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:

ANZ Group Holdings Ltd (ASX: ANZ)

The ANZ share price is down 3% to $30.18. This follows news that the banking giant's CEO, Shayne Elliott, is stepping down from the role next year. The big four bank has already found Elliott's replacement. It has appointed Nuno Matos as its new CEO from 3 July 2025 on a $2.5 million a year deal. The market appears concerned by the timing of the change given that ANZ has just completed the acquisition of Suncorp Bank for $4.9 billion. Commenting on the appointment, ANZ's chair, Paul O'Sullivan, said: "We are very pleased an international banker of Nuno's calibre and extensive experience will be joining ANZ as our new Chief Executive to lead the execution of our strategy."

Calix Ltd (ASX: CXL)

The Calix share price is down almost 12% to 79.5 cents. This morning, this environmental technology company announced the completion of an institutional placement that raised $20 million at 75 cents per new share. This represents a 16.7% discount to its last close price. Calix will also push ahead with a share purchase plan that aims to raise $5 million on the same terms. Calix CEO, Phil Hodgson said: "This equity raise is designed to provide the capital and time needed to maintain momentum in commercialisation for a minimum of 18 months."

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

The Paradigm Biopharmaceuticals share price is down over 16% to 48.5 cents. This has also been driven by a capital raising this morning. The biopharmaceuticals company has received firm commitments to raise $16 million through a placement to institutional and sophisticated investors. These funds were raised at a 31% discount of 40 cents per new share. Management notes that the funds raised will primarily be used to support its global phase 3 trials for osteoarthritis treatment with iPPS in 2025.

Platinum Asset Management Ltd (ASX: PTM)

The Platinum share price is down 14% to 89.5 cents. Investors have been selling this struggling fund manager's shares after its potential takeover by Regal Partners Ltd (ASX: RPL) collapsed. In addition, the company released a funds under management (FUM) update after the market on Friday which revealed that its FUM took a large hit in November. Not even the announcement of a 20 cents per share special dividend has been enough to support its shares today.

The post Why ANZ, Calix, Paradigm, and Platinum shares are tumbling today appeared first on The Motley Fool Australia.

In morning trade, the ASX healthcare stock is down 26% to 43 cents.

Why is this ASX healthcare stock crashing deep into the red?

The catalyst for today's selling has been news that the biopharmaceuticals company has received firm commitments to raise $16 million through a placement to institutional and sophisticated investors.

The placement received strong interest from new and existing institutional and sophisticated investors both domestically and internationally.

According to the release, the company will issue 40 million shares at a sizeable 31% discount of 40 cents per new share.

The company also plans to issue shareholders one loyalty option for every four shares held at the record date. These will be exercisable at 65 cents per share within 12 months from the record date. If successful, these options could raise up to an additional ~$63 million by early 2026, which it believes enhances shareholder value.

For now, the ASX healthcare stock will have approximately $26.9 million following the capital raising, which it believes provides it with a runway into the second half of next year.

Management notes that the funds raised will primarily be used to support its global phase 3 trials for osteoarthritis (OA) treatment with iPPS. These trials begin in Australia the first quarter of 2025 and then expand to key U.S. sites in the second quarter of 2025.

Management commentary

The ASX healthcare stock's managing director, Paul Rennie, was pleased with the capital raising. He said:

The capital raise, priced at $0.40, represents a 3% premium to the 30 VWAP. The size of the raise of $16M provides Paradigm with sufficient cash reserves to commence the start-up of the Phase 3 clinical trial and working capital into 2H CY2025. We received support from our current and new investors which highlights the strength of our clinical programs and positions Paradigm to immediately advance our global phase 3 clinical trial setup and deliver on critical milestones.

We chose to reward all shareholders with a loyalty option with the record date likely to be mid – late January 2025. 2024 has been an important year of dealing with regulatory agencies and now we are looking forward to the execution of our phase 3 clinical trials to move ever closer to bringing iPPS to those suffering seriously debilitating pain and dysfunction. We are grateful for the continued support and enthusiasm of our shareholders.

The post Why is this ASX healthcare stock crashing 26% today? appeared first on The Motley Fool Australia.

That's because they have just been named as buys with major upside potential. Here's what analysts are saying about them:

Ai-Media Technologies Ltd (ASX: AIM)

The first small cap ASX share that is being tipped as a buy is Ai-Media Technologies. It is a technology company that allows many of the world's leading brands to caption their TV broadcasts, live streams, events, virtual meetings and more.

It notes that its technology delivers over 7 million minutes of captioning, transcription, and translation for live and recorded media content, online events, and web streams every month.

Morgans rates the company as a buy. Last week, its analysts said:

Technology led captioning is the bulk of AIM's gross profit today and should exceed 90% within the next 12 months. Management has highlighted it will now aggressively pursue growth, targeting $60m of EBITDA by FY29, with the requirement of upfront investment in sales and product development.

We see substantial share price upside if management achieve its target. We estimate that $60m of EBITDA in FY29 is worth $2.91 in FY29 or $1.44 today. This equates to a ~40% IRR, leaving substantial margin for error. The reward is, in our view, well worth the risk.

Morgans has an add rating and $1.00 price target on its shares. This suggests that its shares could rise 27% from current levels.

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

Another small cap ASX share that is highly rated is Paradigm Biopharmaceuticals.

It is a biotechnology company focused on repurposing Pentosan Polysulfate Sodium (PPS) for the treatment of Osteoarthritis (OA) in the knee. If approved the drug will have the brand name Zilosul.

Bell Potter notes that the "global market for a safe, effective treatment that provides superior patient outcomes compared to the standard of care is a multiple blockbuster." It adds:

In the US along the incidence of moderate to severe osteoarthritis is estimated at 30m persons. The pricing of the drug will ultimately be determined by the economic benefit associated with its use as well as the cost of other therapies. The conservative estimate is US$2,500 per year which places the addressable market in the tens of billions of US$.

In light of this, the broker is highly encouraged by recent trial data and the prospect of phase 3 studies starting next year.

As a result, Bell Potter put a speculative buy rating and 80 cents price target on its shares last week. This implies potential upside of 38% for investors over the next 12 months.

The post These small cap ASX shares could surge 27% to 38% higher appeared first on The Motley Fool Australia.

But the drug development company has requested a pause in the trading of its shares before the open on Thursday.

Before the halt, Paradigm shares finished the session on Wednesday at 58 cents. Let's take a closer look.

ASX healthcare stock on ice

Paradigm requested its shares be put on ice starting Thursday, saying that it intends to update the market on a capital raising in the coming days.

The pause in trading is expected to remain in place until next Monday, December 9, but trading will resume earlier if the ASX healthcare stock provides an update beforehand.

While the specifics are still under wraps, the news comes at an important time in the biotech company's history.

Investors have flooded into Paradigm shares in recent weeks, with prices exploding on optimism surrounding its flagship drug candidate, Zilosul.

The injectable solution contains an ingredient known as 'pentosan polysulfate sodium (iPPS)', and is being developed as a potential treatment for knee osteoarthritis (OA).

This is also a condition with an estimated $3 billion market in the United States alone, according to Bell Potter.

What's driving Paradigm's meteoric rise?

A few catalysts have fueled the recent rally in the ASX healthcare stock. They all centre around the Zilosul label.

Last week, the company confirmed it had not received feedback from the US Food and Drug Administration (FDA) regarding its revised Phase 3 clinical trial protocol for Zilosul.

According to my colleague James, investors interpreted this silence as a positive signal that the FDA might greenlight the trial.

"The next few weeks should be very interesting for this biotech stock", he also said. Too right.

Bell Potter was also bullish on the news, describing it as "significant."

Analysts say the risk of clinical trial failure is reduced, after Paradigm opened an investigational new drug (IND) application in the US.

It has a buy rating and price target of 80 cents on the ASX healthcare stock, 38% upside from Paradigm's current share price.

Meanwhile, Paradigm is also awaiting a response from Australia's Therapeutic Goods Administration (TGA) on its 'Determination Application'.

If approved, this could pave the way for the approval of Zilosul in Australia.

Foolish takeout

This ASX healthcare stock is on ice today after the company requested a trading halt. The company intends to update the market on a capital raising in the coming days.

Zooming out, Paradigm shares are now up 47% in the past year. They closed at 52-week lows of 17.5 cents apiece on September 25.

The post This ASX healthcare stock is up 160% in a month! Here's why it's just entered a trading halt appeared first on The Motley Fool Australia.

That's because the two small cap ASX shares listed below have just been named as buys and tipped to rise strongly from current levels.

Here's what brokers are saying about these shares:

Bluebet Holdings Ltd (ASX: BBT)

This sports betting company's shares could be a buy according to analysts at Morgans.

The broker was pleased with its recently annual general meeting update, noting that management continues to expect to achieve positive EBITDA during the first half. It also highlights that the small cap ASX share is performing materially ahead of the prior corresponding period. It said:

BlueBet Holdings (BBT) delivered an AGM address yesterday where it indicated that the business remains on track to achieve monthly EBITDA profitability before the end of 1H25. November trading month-to-date is materially ahead of prior year and encouragingly, BBT says it is well positioned to be normalised EBITDA-positive for FY25 (MorgansF: $4.1m).

Business momentum has been driven by a strong Spring Racing Carnival period, which looks to have been supportive to all bookies given many of the favourites fell well short of the mark. While disclosure was limited, BBT indicated that it achieved a net win margin of 15.8% across the four days at Flemington. As a result, we've bumped our 2Q25 net win margin to 10.2%.

Morgans has retained its add rating with an improved price target of 35 cents. This implies potential upside of 32% for investors from current levels.

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

Another small cap ASX share that has been named as a buy is biopharmaceuticals company Paradigm.

Bell Potter has lifted its valuation of the company materially after some big news last week. That news revealed that Paradigm may now commence recruitment of the phase 3 U.S. trials for Zilosul in the treatment of knee osteoarthritis (OA).

This is "significant" news according to Bell Potter, which highlights that the company has a huge market opportunity. It said:

The size of the prize for approval the Osteoarthritis market is highly lucrative to say the least. The US market is at least $3bn annually on conservative estimates and likely multiple times larger.

The opening of the IND in the US is significant step forward. The risk of clinical trial failure is substantially reduced and the recent move in share price is a reasonable representation of this change. Valuation is amended to $0.80 following changes to funding assumptions in the financial model which assumes further equity issuance and a partnering deal ahead of approval in ~3 years time.

Bell Potter has put a speculative buy rating and 80 cents price target on its shares. This implies potential upside of 52% for investors from current levels.

The post Analysts say these small cap ASX shares could rise 30% and 50% appeared first on The Motley Fool Australia.

The ASX biotech stock ended the session almost 42% higher at 46 cents.

At one stage, the biopharmaceutical company's shares were up as much as 52% to a 52-week high of 49.5 cents.

Why did this ASX biotech stock rocket?

Investors were bidding the company's shares higher today despite there being no news out of it.

Though, interestingly, the lack of news was arguably the trigger for this rampant buying, with investors deeming no news to be very good news.

The buying was so strong that it even led to the Australian stock exchange operator giving the ASX biotech stock a speeding ticket. It said:

Is PAR aware of any information concerning it that has not been announced to the market which, if known by some in the market, could explain the recent trading in its securities?

In response, the biotech said:

No, the Company is not aware of any information concerning it that has not been announced to the market which, if known, could explain recent trading in the Company's securities.

What else did it say?

Every speeding ticket that the Australian stock exchange operator issues includes a section asking for an opinion on why a certain share might be making a large and unexpected move.

The ASX biotech stock revealed that the buying could be due to the company not yet receiving feedback from the US Food and Drug Administration in relation to the submission of its revised Phase 3 clinical trial protocol for evaluating injectable pentosan polysulfate sodium as a treatment for knee osteoarthritis.

Given that it has not received any feedback so close to the review deadline, investors appear to be interpreting this as a sign that the regulator hasn't found anything wrong and is about to give the trial the thumbs up.

The company's response states:

Paradigm Biopharmaceuticals has provided an update to the ASX on October 31, 2024, announcing the submission of its revised Phase 3 clinical trial protocol to the U.S. Food and Drug Administration (FDA). The FDA's standard review period for such submissions is 30 days, concluding on November 28, 2024. As of this date 25 November 2024, the company has not received any feedback or communication from the FDA. In the absence of a response within the designated review period, Paradigm anticipates initiating start-up activities for its Phase 3 pivotal clinical trial evaluating injectable pentosan polysulfate sodium (iPPS) as a treatment for knee osteoarthritis (OA).

There are also developments closer to home that are nearing a conclusion. It adds:

Paradigm Biopharmaceuticals also informed the ASX on October 31, 2024, that it expects a response to its Determination Application submitted to the Therapeutic Goods Administration (TGA) during the December quarter. This application is a critical step toward advancing the submission for provisional approval of iPPS for the treatment of knee OA in Australia. Achieving this determination represents significant progress in securing regulatory approval within the region.

The next few weeks should be very interesting for this biotech stock.

The post Why did this ASX biotech stock explode 52% higher on Monday? appeared first on The Motley Fool Australia.

One is racing ahead of the 0.2% losses posted by the All Ordinaries Index (ASX: XAO) in early afternoon trade on Thursday, while the other is decidedly lagging.

Which companies are we talking about?

Read on!

All Ords ASX healthcare share tumbles on cash burn

Turning to the laggard first, the Imugene Ltd (ASX: IMU) share price is down 8.5% at the time of writing, with shares trading for 4.3 cents apiece. That leaves the share price up 8% since this time last year. But shares have now tumbled a painful 61% in 2024.

The All Ords ASX healthcare share could be under added pressure today after reporting cash or equivalents of $54.3 million at the end of the September quarter. That's down from $93.1 million reported at the end of the June quarter.

The company said that net cash used in operating activities for the quarter amounted to $24 million, along with a milestone payment to Precision Biosciences for $14.4 million.

Highlights from the quarter included three complete responses in the company's azer-Cel Allogeneic CD19 CAR T Phase 1b trial in blood cancer (Diffuse Large B-Cell Lymphoma). The trial, conducted across 15 cancer centres in the United States and with plans to expand into Australia, aims to address patients who have relapsed after multiple prior treatments.

The quarter also saw the ASX healthcare share receive US Food and Drug Administration (FDA) Orphan Drug Designation for its VAXINIA product, which treats bile tract cancer.

And the first patient was dosed in a Phase 1 bile tract cancer expansion trial at St. Vincent's Hospital, Melbourne, with 10 patients set to be enrolled.

Which brings us to…

Paradigm share price lifts off on trial progress

The Paradigm Biopharmaceuticals Ltd (ASX: PAR) share price is up 2.5% at the time of writing, having earlier posted gains of 17.5%. Shares are currently changing hands for 20.5 cents apiece. That leaves the All Ords ASX healthcare share down 51% since this time last year.

Investors have been bidding up the Paradigm share price after the company reported on the "substantial progress" it made over the quarter in its Phase 3 clinical trial preparations for the treatment of knee osteoarthritis with its iPPS product.

Commenting on the recent achievements, Paradigm Biopharmaceuticals managing director Paul Rennie said, "The submission of our phase 3 protocol to the FDA is a significant milestone for Paradigm."

Rennie continued:

It represents the culmination of extensive work by our team and close collaboration with the FDA. We are confident that this progress, combined with the anticipated TGA [Therapeutic Goods Administration] response and our ongoing engagement with funding partners, positions us strongly as we move into this pivotal phase.

Our focus remains on delivering outcomes that will benefit patients and create long-term value for our shareholders.

As at 30 September, the ASX healthcare share had cash and equivalents of $13.14 million, down from $17.8 million at 30 June. Paradigm said it allocated "a significant portion" of its expenditure on research and development (R&D), focusing on advancing the Phase 3 clinical trial.

The company expects to receive $5 million to $6 million as part of its R&D incentive rebate.

The post 2 All Ords ASX healthcare shares making BIG moves on quarterly updates appeared first on The Motley Fool Australia.

In morning trade, the ASX biotech stock is up 11% to 29 cents.

Why is this ASX biotech stock surging?

Investors have been buying the late-stage drug development company's shares this morning after it made a big announcement.

According to the release, Paradigm has received a detailed response from the U.S. Food and Drug Administration (FDA) following the Type D meeting response submitted to the agency in April.

The company advised that the response from the FDA comprises a detailed set of comments that provides a pathway for progression of its phase 3 clinical program for knee osteoarthritis (OA).

What was the FDA's response?

The release reveals that the FDA has confirmed that Paradigm's phase 2 clinical data (PARA_005 and PARA_OA_008) supported the safety and tolerability of the twice weekly 2 mg/Kg dose, and that the clinical monitoring for adrenal effects will continue.

The regulator has also provided detailed guidance for the use of the company's selected dosing regimen of 2mg/kg injectable pentosan polysulfate sodium (iPPS) administered twice weekly.

Management believes this is a "significant outcome" for Paradigm. This is because it feels that based on the clinical data generated to date, with a dosing regimen of 2mg/kg iPPS administered twice weekly, the phase 3 clinical trial is best set up for success.

In addition to feedback on the dosing regimen, the FDA has provided feedback on amendments to the monitoring and mitigation plan, and statistical guidance. The good news is that management believes these changes were supported by clinical and nonclinical data generated in its clinical development programs to date. As a result, it intends to implement these changes and submit the updated protocol under the open Investigational New Drug (IND) application currently in place with the FDA.

Once the protocol is submitted, Paradigm expects a 30-day review period before proceeding with enrolment for the PARA_OA_012 trial.

'One step closer'

Commenting on the news, the ASX biotech stock's managing director, Paul Rennie, said:

I understand that many investors are eager to know the dosage that will be used in the pivotal phase 3 clinical trial. I am pleased to announce that the FDA has indicated our clinical data supports the safety and tolerability of the twice-weekly administration of 2 mg/kg, the same dosing regimen Paradigm used in its phase 2 clinical studies (PARA_005 and PARA_OA_008). We would like to extend our gratitude to the US FDA for their valuable guidance on the phase 3 protocol.

Paradigm's chief medical officer, Dr Donna Skerrett, added:

I believe the clarity provided by the FDA's response has brought us one step closer to entering the pivotal phase of the program. We now have a clearer and more certain path forward, enabling us to optimize the clinical protocol. We are incredibly proud of the collaborative efforts and hard work that have led us to this point, and we are excited to move forward with a protocol designed to maximise our chances of success. The alignment with the FDA's guidance further strengthens our confidence as we progress towards a successful outcome, bringing us closer to achieving our goal of securing approval for iPPS.

The post Guess which ASX biotech stock is surging 11% on big FDA news appeared first on The Motley Fool Australia.

That's the view of analysts at Bell Potter, which believe the ASX biotech stock could be a great option for investors with a high tolerance for risk.

What is Paradigm Biopharmaceuticals?

Paradigm Biopharmaceuticals is a biotechnology company focused on repurposing Pentosan Polysulfate Sodium (PPS) for the treatment of osteoarthritis (OA) in the knee.

Bell Potter believes that the global market for a safe, effective treatment that provides superior patient outcomes compared to the standard of care is a "multiple blockbuster."

In fact, it has suggested that market estimates of US$10 billion in annual revenues are likely conservative.

The good news is that the company's recently completed phase II study produced some highly encouraging results, which are worthy of further clinical trials.

What is the broker saying about this ASX biotech stock?

Bell Potter notes that the coming weeks will be pivotal for this ASX biotech stock. This is because it is expecting to receive feedback from the US FDA in relation to its pathway for its treatment. It said:

PAR has a major short term catalyst within weeks being FDA feedback from its recent meeting to discuss the pathway for iPPS. A key discussion point was the design of the proposed phase 3 and confirmatory study for iPPS in osteoarthritis (OA) including the minimal effective dose (2mg twice weekly for 6 weeks). Recent studies in lower doses proved ineffective in the management of pain, hence there is no alternative to this optimal dose. Other than efficacy, the key considerations are toxicity and safety.

The data from several hundred patients treated in various clinical studies, the Special Access Scheme in Australia and non-clinical studies has shown iPPS at the optimal dose to be exceptionally safe with no serious adverse events. Accordingly, we are confident the FDA will approve the minimal effective dose and the proposed trial design.

In light of the above, this morning the broker has reaffirmed its speculative buy rating on the company's shares with a 47 cents price target. Based on its current share price, this implies over 80% upside for investors over the next 12 months.

Though, it is worth remembering that Bell Potter's speculative rating means this is a high risk play. So, investors with a low or normal risk tolerance may want to stay well clear of the ASX biotech stock and focus on more appropriate investment options.

The post Bell Potter says this ASX biotech stock could rocket 80% appeared first on The Motley Fool Australia.

But these three ASX healthcare shares are knocking it out of the park on this otherwise lacklustre day.

Here's why.

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

ASX healthcare share Paradigm Biopharmaceuticals is up 5.88% to 27 cents per share at the time of writing. This follows the release of the company's quarterly activities report. Paradigm revealed a cash balance of $26.2 million as of 31 March, down from $33.5 million on 31 December. Paradigm spent $13.1 million on research and development, down from $27.06 million in the previous quarter. Net cash outflow for the quarter was $6.8 million, which was less than the $8 million to $11 million guidance. The company revised its cash outflow guidance for the June quarter to a range of $7 million to $10 million.

Paradigm shares are down 39% in the year to date. Over the past 12 months, the ASX healthcare share has fallen 72%.

Imugene Ltd (ASX: IMU)

The Imugene share price is up 2.44% to 8.4 cents per share at the time of writing. The clinical-stage immuno‐oncology company has also released its quarterly activities report today. The highlights include a cash or equivalents balance of $114.1 million. Net cash used in operating activities amounted to $25.2 million, with direct research and development costs accounting for 49% of costs.

This ASX healthcare share is down 23% in the year to date. Over the past 12 months, the Imugene share price has fallen 35%.

Aroa Biosurgery Ltd (ASX: ARX)

ASX healthcare share Aroa Biosurgery is currently up 3.09% to 50 cents per share. In its quarterly update today, Aroa reported strong cash receipts from customers of NZ$18 million, reflecting a continued increase in Myriad and OviTex / OviTex PRS sales. There were positive net cash inflows from operations of NZ$300,000, exceeding Q4 breakeven expectations. Net cash outflows from investing activities were down to NZ$700,000, reflecting continued planned investment into additional manufacturing plants and equipment. Completion is expected by Q3 FY25. Aroa booked a 71% reduction in quarterly cash burn to about NZ$1 million, ending the year with a strong closing cash balance of NZ$29.5 million.

Aroa shares are down 39% in the year to date. Over the past 12 months, the ASX healthcare share has dropped 53%.

ASX healthcare shares vs. ASX 200

ASX healthcare stocks have fallen 0.5% in the year to date and are down 5.1% over the past 12 months.

By comparison, the ASX 200 has risen 0.35% in 2023 so far and is up 4.4% over the past year.

The post 3 ASX healthcare shares outperforming on quarterly updates appeared first on The Motley Fool Australia.

Four ASX shares that are not letting that hold them back today and are avoiding the market selloff are listed below. Here's why they are rising:

Fiducian Group Ltd (ASX: FID)

The Fiducian Group share price is up 6% to $8.04. This follows the release of an update from the financial services company. The company revealed that net inflows to the core Fiducian platform for the quarter ending 31 March 2024 were $53 million. This brings its year to date net inflows to $139 million. This means that the company's funds under management, administration and advice were $13.7 billion at the end of March. This is up 11.4% year on year from $12.3 billion.

Northern Star Resources Ltd (ASX: NST)

The Northern Star share price is up 4% to $15.90. Investors have been buying Northern Star and other gold miners today after investors rotated out of risk assets and into risk off/safe haven assets. This has been driven by reports claiming that Israel has retaliated to the recent Iranian attacks with strikes of its own. Demand has been so strong for safe haven assets that the S&P/ASX All Ordinaries Gold index is up almost 3% this afternoon.

Paradigm Biopharmaceuticals Ltd (ASX: PAR)

The Paradigm Biopharmaceuticals share price is up 3.5% to 29.5 cents. This morning, this biopharmaceuticals company announced the submission of key documents to the US Food and Drug Agency (FDA) for review and agreement on the progression of the phase 3 clinical program in osteoarthritis. Paradigm's managing director, Paul Rennie, commented: "This is important progress for Paradigm as we deliver a significant amount of new data to the US FDA for review to progress to the next stage of the phase 3 OA program."

Santos Ltd (ASX: STO)

The Santos share price is up 3% to $7.93. This has also been driven by news that Israel has retaliated and attacked Iranian sites with missiles. In response to the news, oil prices have jumped almost 4% amid concerns that this could disrupt oil supply in the region. According to CNBC, at the time of writing, the WTI crude oil price is up 4% to US$86.06 a barrel and the Brent crude oil price is up 3.9% to US$90.50 a barrel. The S&P/ASX 200 Energy index is up 0.8% in afternoon trade.

The post Why Fiducian Group, Northern Star, Paradigm, and Santos shares are charging higher appeared first on The Motley Fool Australia.

However, it is worth remembering that the risks are also very high.

So, the (potentially) cheap stock that I am going to talk about in this article would only be suitable for investors with a high tolerance for risk.

That stock is Paradigm Biopharmaceuticals Ltd (ASX: PAR), which is currently trading at 32.5 cents. This is well short of the late-stage drug development company's 52-week high of $1.68.

But one broker that believes it has the potential to return close to those lofty levels is Bell Potter.

According to a recent note, the broker has a speculative buy rating and $1.40 price target on its shares. This implies potential upside of approximately 325% for investors over the next 12 months.

To put that into context, if Bell Potter is on the money with its recommendation, a $10,000 investment would turn into $42,500.

Why could Paradigm be a cheap ASX stock?

Bell Potter highlights that the company is well funded and not far off launching its treatment for osteo arthritis of the knee.

In respect to its treatment, the broker appears very excited by its potential. It said:

MRI quantitative data demonstrated that compared to placebo, patients on drug experience a) an increase in cartilage volume and thickness from baseline, most notably in the medial compartment where the highest proportion (72%) of knee OA occurs; b) an average 17% reduction in bone marrow lesion volume; and c) a reduction in inflammation (synovitis). As far as we are aware no other molecule has demonstrated a capability to apparently halt disease progression, let alone regenerate cartilage.

In our view the findings are strongly supportive of future commercial adoption and are likely to enhance upcoming discussion with both regulators and commercialisation partners.

In light of this, the broker believes the risk/reward from an investment in this cheap ASX stock is compelling for investors. It concludes:

PAR continues to expect to commence dosing in the phase 3 program in 1Q CY24. The company is funded though 1Q CY2024 and is yet to partner in a single region or indication. PAR intends to proceed with a provisional approval application for iPPS in Australia, which if successful may see the drug on market in 2025. Valuation is maintained at $1.40 and we retain our Buy (Speculative rating). There are no changes to earnings. The next major catalysts include potential non dilutive funding deal(s).

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