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Specifically chasing out esophageal adenocarcinoma, Proteomics reports its PromarkerEso blood test showed 98.9% specificity in a clinical validation study. The condition is typically caused by acid reflux.

The study from which these claims are borne recruited 259 participants and was published in the journal Proteomes.

Now, the company expects commercialisation in Australia “shortly.”

The name of the blood test harks back to ‘biomarkers,’ which are proteins or other naturally occurring compounds in the human body that express themselves in higher levels when a cancer is present.

One well-known and simple example is that in some types of blood cancers, early detection can be spotted when certain immune cells start to proliferate above baseline averages.

In other instances, it can be more difficult, tracking specific proteins that may only spike in certain cancers attached to certain organs.

In this case, Proteomics is now intending to deliver such a product for a specific type of targeted throat cancer (esophageal adenocarcinoma).

Esophageal cancers, broadly, Proteomics relayed on Thursday, rank seventh in cancer-related mortality globally. Survival rates are, perhaps unsurprisingly for where the cancer originates, low. Less than 20% across a five-year span, and one study cites a “median survival time less than one year.”

Herein is the value prop of Proteomics’ news on Thursday – early detection offers more time for other treatments to potentially mitigate severity. That, and the blood test is less invasive than any kind of physical inspection of the oesophagus.

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“PromarkerEso has the potential to revolutionise how doctors manage the risk of esophageal cancer – offering a standard blood test that could reduce reliance on invasive procedures and improve early detection rates,” company chief Dr. Richard Lipscombe said.

PIQ last traded at 42cps.

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The Australian biotech company raised $10.8 million with a non-renounceable entitlement offer that offered one RCE share at 28 cents each for every six held.

The key raise was rounded out with a $5 million private placement closed in April.

All this — which HotCopper understands will settle on June 6 — gives Recce licence to continue its multi-phase clinical trials and commercialisation efforts, which will now be backed by as much as $16 million in operating funds.

Recce will use the cash to complete the third phase of its diabetic foot infection registrational topical clinical trial in Indonesia, wrap up its acute bacterial skin and skin structure infections registrational topical clinical trial in Australia, and eventually “pursue any new clinical activities” that may also arise.

The former is particularly key for the biotech enterprise; its Indonesian trials are expected to be a revenue catalyst for the company as early as next year.

All this, Recce chairman Dr John Prendergast said, demonstrates “clear value.”

“[This raise] supports a critical step forward as we commence our Phase Three trials,” he explained on Tuesday. With cash in hand and trials now spinning into motion, the company has come to a “potential major inflection point.”

Importantly, he said, there’s an “opportunity to advance a new standard of care in infectious diseases, offering long-sought-after improved outcomes for patients.”

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Recce CEO James Graham celebrated the raise too: “This successful shortfall placement is very gratifying for Recce, particularly given the more challenging environment for raising capital for biotechnology companies.

“We are delighted to achieve our intended capital raise and receive this ongoing support from our existing institutional and sophisticated shareholders.”

RCE will open Wednesday at 32.5cps after dipping 5.8% through yesterday.

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The site will be located at Sportsmed Biologic in Melbourne, and directed by specialist sports physician Dr Phillip Bloom, who has more than two decades of clinical experience in osteoarthritis management.

This will be the first of 11 Australian sites earmarked for participation in the PARA_OA_012 study. Paradigm has also received informed consent from its first Australian patient, who will take part in the trial.

Alongside the Oz component, there will also be 48 sites in the States that are currently in advanced preparations for activation under the centralised ethics approval.

Managing director Paul Rennie said these were significant milestones for the Paradigm.

“The activation of our first site in Australia and the consenting of our first patients in Australia, with the US soon to follow, mark a significant operational achievement for the company,” Mr Rennie said.

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He continued: “I am particularly pleased to see the high level of engagement from leading clinical investigators and trial sites.

“I am also pleased that the company is progressing in line with our intended schedule.”

PAR has been trading at 30.5 cents.

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That relates to its flagship ‘Conneqt Pulse’ device, which is ultimately a smartphone-compatible cardiovascular health biometrics tracking product.

“The Pulse is a world-first clinical-grade vascular biometric monitoring device designed for use in both clinical and remote patient monitoring or at-home … it enables the capture of a broad range of arterial health biomarkers, including central blood pressure and arterial stiffness,” Cardiex wrote on Monday.

Last month, Cardiex got a key app onto the Apple app store, which was met with little fanfare from investors. But two major approvals later – one from the TGA, and more importantly, an earlier approval from the USA’s FDA – and the company’s share price is looking somewhat healthier.

(Worth noting is that there’s far less hurdles to tackle getting the TGA to approve a health device as opposed to a new drug.)

Still, that Australian landscape isn’t necessarily Cardiex’s foremost market of interest.

“While the U.S. remains our primary focus at this stage, we’re excited to begin laying the foundation for growth in Australia,” CDX chief Craig Cooper said.

“TGA approval of the Pulse is another milestone for Cardiex as we expand our regulatory and commercial opportunities.”

The question, of course, is whether Conneqt Pulse can stand out in a well-established market of biometrics devices.

CDX last traded at 4.7cps.

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The company’s ACTION 3 trial stands for: “Angiotensin II Type 1 Receptor (AT1R) & Chemokine Receptor 2 (CCR2) Targets for Inflammatory Nephrosis.”

It’s a Phase 3 trial looking at patients taking an angiotensin II receptor blocker and who present with a kidney disease called FSGS. Anybody who satisfies all of those requirements will be taking DXB’s “DMX200,” the flagship drug of interest being developed by Dimerix.

Phase 3 trials are the big kahunas when it comes to most countries’ health regulatory bureaucracies; indeed, the company is hoping the data it gets from ACTION3 ultimately locks in its path to a world where it can sell DMX200.

As part of its trial, Dimerix will also receive $4.3M from a partner on milestone grounds.

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“Opening the first clinical site in Japan is another major step forward for our global ACTION3 clinical program, as we aim to bring much-needed and new treatments to patients with FSGS around the world,” DXB CEO Dr. Nina Webster said.

“This milestone reflects the strength of our data to date, the rigour of our clinical trial design, and the expertise from our local partner in Japan, FUSO.”

DXB last traded at 58cps.

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The “pleased” Auckland healthcare company, dual-listed on the ASX and NZX, updated shareholders on the Hikma agreement extension on Monday.

Under the new 2025 deal, Hikma will now “take over all channels” for AFT Pharma’s Combogesic Rapid pain relief medicine across the U.S. (except for several regions already covered by an existing deal with Alexso Inc.).

Hikma had already been responsible for selling Combogesic IV in the States.

That standing agreement has been reshuffled slightly too: AFT Pharma and Hikma have shaken hands on a new profit-sharing arrangement, which was mainly drawn up to remove a milestone sales had to meet before sharing started.

In the same fineprint overhaul, AFT Pharma is now jointly responsible for sales and marketing for both Combogesic IV and Rapid — both operationally and financially.

(It’s worth noting, most Aussies would actually know Combogesic as “Maxigesic.”)

The newly-re-upped deal is a win, AFT Pharma boss Dr Hartley Atkinson explained, not least because it means the NZ biotech company can best answer a rising demand in the U.S. for other Combogesic options.

“Feedback from the U.S. has been that clinicians wish to follow non-opioid intravenous relief of mild to moderate pain with the tablet therapy — an approach that offers non-opioid relief through all stages of recovery,” Dr Atkinson said.

“In doing so [expanding offerings],” he added, “we can not only help clinicians to offer comprehensive non-opioid pain relief, but can maximise the opportunity.”

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This expansion will also reduce abuse risks, Dr Hartley added, keeping in mind “U.S. healthcare costs associated with opioid abuse are estimated at $11 billion a year.

“With 6% of patients administered an opioid postoperatively going on to consume the medicine chronically, the two forms of Combogesic offer clinicians an opportunity to reduce the [associated] risks,” he suggested.

AFP has been selling at $2.45/sh through Monday trade.

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The biggest whack came on Wednesday, when Mayne suffered its worst ASX trading day in 16 years, down -30%. Today has been a little better; just -4% lost to 3pm.

The nosedive came after Cosette Pharmaceuticals this week opened a review into its long-proposed $672 million Mayne Pharma acquisition. The reason, the U.S.-based company said, was mainly “material adverse changes.”

These “changes” (read: huge market volatility) now set several wheels in motion.

For Mayne, only one really matters, though: A 10-day consultation period.

Mayne and Cosette are now sitting down to talk through the blockbuster deal and what the aforementioned “material adverse changes” — a term HotCopper understands is boiled into the acquisition paperwork — mean for both parties.

Notable pain points in the drawing room talks will be Mayne’s nine-month trading halt as well as a recent letter from the U.S. Food and Drug Administration.

Cosette specifically pointed to “circumstances associated” with the Oz-based pharma company’s April 22 earnings update. Also mentioned was previous litigation from TherapeuticsMD over a licensing deal.

Mayne has already rejected that all these issues are big enough for Cosette to back out.

While things may come up rosy again, investors have already balked; it’s been a bloodbath for MYX stock since Wednesday morning. Shares are at $4.34 right now.

That’s particularly notable because Cosette’s offered buy price was $7.40/sh.

Much of the heavy lifting (or rather, sharp diving) was done on Wednesday, May 21, which now stands as the single worst day the Australian pharmaceutical company has seen on the bourse since as far back as early March 2009.

Not helping matters price-wise for Mayne is the fact that the ASX has also now queried why the recent slap from U.S. regulator the FDA was not disclosed.

The letter accused Mayne of “misrepresenting” the safety of its Nextstellis contraceptive.

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Mayne shareholders had already had June circled on their calendars, with the vote on the scheme of agreement originally pencilled in for June 18.

With Cosette now more likely to wash their hands of the whole thing when discussions wrap up, June may instead mark a clear exit month for some Mayne holders.

Now, it all comes down to whether Cosette can find what it sees as a “satisfactory outcome” — though at this stage, this HotCopper writer suspects the North Carolina company sees its most “satisfactory outcome” being the deal being scrapped.

Keep your eyes peeled for a termination notice; if it comes, it will be before May 31.

Heading into close on Thursday afternoon, MYX has been at $4.34/sh.

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The company unveiled its financial report for the year ending March 31, telling investors its full-year operating revenue had risen 6% to $208M. This was underpinned by an 11% rise in product sales and royalties across all territories, along with $0.7 million worth of income from licensing.

Group revenue was boosted by sales growth in the Australian and New Zealand markets, up 17% and 10% respectively. In Australia, this increase was offset by the one-off factors of destocking and interruptions to demand for Maxigesic IV.

In Oz, the operating profit was also in good shape, with an increase of 65%.

With this variable considered in the medium term, AFT has now set the goal of reaching $300M in revenue by the end of the 2027 fiscal year.

Earnings for the year were in a slightly weaker position, with EBITDA (earnings before interest, taxes, depreciation and amortization) falling 20% to $20.9M while operating profit fell 27% to $17.6 million – in line with guidance released at the half year – and net profit after tax was down 23% to $12M.

AFT co-founder and managing director Dr Hartley Atkinson said the company had already achieved multiple goals during the 2025 fiscal year.

“Aside from continued strong growth in our core Australasian businesses, we have significantly advanced strategy to extend our reach across multiple geographies and added to our research and development pipeline,” AFT’s boss explained.

Highlights included launching Maxigesic tablets in the U.S., the launch of a proprietary antiseptic cream in mainland China, and the completion of multiple licensing agreements around the world, including Maxigesic IV in China and Brazil, Mr Atkinson flagged.

“These efforts have come at the cost of short-term earnings growth, but we are convinced they will deliver growth in long-term shareholder value.”

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Mr Atkinson added: “In a credit to our out-licensing activities, we were identified as the only company in the world last year to secure two licensing agreements into China, the world’s second largest pharma market.”

AFP shares have been trading at $2.55.

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In the background, Paradigm also has a rare disease clinal asset for Mucopolysaccharidosis (MPS) and early-stage data for acute respiratory distress syndrome, hayfever  and heart failure.

But in the field of osteoarthritis, Paradigm Biopharmaceuticals has the scientific expertise – and hard data from existing and ongoing trial results – to know it could have just  stumbled on a breakthrough drug to treat the disease. 

We’ll get to Paradigm’s flagship drug shortly.

But given the month of May is actually arthritis awareness month – the disease has an advocational calendar date – perhaps it’s a fortuitous time to dive into osteoarthritis, a disease with no cure, to fully understand what Paradigm Biopharmaceuticals is offering. 

When it comes to arthritis in general, the Arthritis Foundation predicts 1 in 4 (Americans) have been diagnosed with a form of arthritis, or similar conditions. 

Osteoarthritis is just one kind of many different arthritic diseases, but we’re going to be focusing on it for this article, while Paradigm Biopharmaceuticals’ development team is focusing on it in the clinic.

To clarify, unlike rheumatoid arthritis, which is actually an autoimmune disease, osteoarthritis is a different disease which effectively ‘attacks’ cartilage, but does not weaponise the immune system. 

“First of all, osteoarthritis is not what a lot of people [think of it], as ‘wear and tear,’” Paradigm Biopharmaceuticals Managing Director Paul Rennie told HotCopper.

“Osteoarthritis is a destructive disease that increases its intensity over time, so people might start off … with an occasional sore joint, and over time, that pain starts to become chronic.

“We know from a lot of research that the major symptoms of the disease is chronic pain and also malfunctioning joints so … what we are embarking on is trying to address the unmet medical need.

For Rennie, it all comes down to one question:

“Can we find a drug that can address those symptoms, of pain and joint dysfunction and at the same time slow down the degradation of the tissue and preserve the joint longer than what it would ordinarily be preserved,” he concluded. 

And Paradigm believes it’s found the drug it’s looking for. 

Paradigm is seeking to treat osteoarthritis with Pentosan Polysulfate Sodium (PPS).

Trademarked ‘Zilosul,’ the compound has curious beginnings as far as pharmaceutical supply chains go: it’s extracted from the processed woodchips of European beech trees. 

Polysulfate Sodium ultimately ends up mimicking glycosaminoglycans in the body, which form the basis of popular injection-based arthritis treatments.

Glycosaminoglycans are a type of carbohydrate which give the human body anti-inflammatory benefits, it can also assist with tissue repair.

But Paradigm chief Paul Rennie believes Pentosan Polysulfate Sodium could be an even better alternative – both for patients suffering with osteoarthritis, and, the company’s shareholders. 

“So what we’re doing is working with a multimodal drug called pentosan polysulfate sodium, we know that the drug does produce very significant and symptomatic relief, and we’ve just finished a phase two trial,” Rennie explained.

“We showed that pain relief and joint function was improved out to 12 months after one course of the drug – the course of the drug is 12 injections over six weeks – and then [patients got] the symptomatic relief from that administration of the drug, for 12 months.”

That, in Paul Rennie’s eyes, is what makes PPS a “breakthrough” opportunity. He says there’s nothing like that, looking at current industry standards. 

“We’re well on the way to developing a drug which can reduce those symptoms of pain and joint dysfunction, but with the additional benefit of preserving the joint so that people can then remain active and not have the problems associated with having a joint that’s completely destroyed,” Rennie said.

Perhaps also worth noting is that Pentosan Polysulfate (without the sodium) is a well-known existing drug to treat inflammation of the bladder walls, so some consumers at least are already aware of its anti-inflammatory properties as a substance.

Described as a “blockbuster opportunity,” it’s through a key relationship Paradigm is able to bring PPS forward in the market: Paradigm and a German company called bene pharmaChem are known to each other; the latter is the only PPS manufacturer approved by US regulator Food & Drug Administration – as in the big kahuna, the FDA. 

“Through the extensive interaction and collaboration with bene pharmaChem and Paradigm’s European manufacturers of the injectable formulation of PPS (iPPS), Paradigm has been able to develop its clinical product for trials,” the company writes on its website.

In other words: Paradigm has an exclusive source for the stuff, and may be the only Australian company ready to leverage that supply chain, let alone the advantage it could offer the company in the US market. 

But Paul Rennie, talking to HotCopper, left the most tantalising elements of PPS’s value proposition til last:

“We’re also very happy to report we showed in that phase two study we had a reduction in disease biomarkers, in other words, the people who received our drug had less breakdown of [joint] tissues than the people on placebo,” he explained.

“We also saw that there was an improvement in cartilage thickness in the people on our drug.” 

The implications of that product being on the market are obvious. 

What Paul Rennie wants investors to think about 

“I think from an investor’s point of view … there’s a large market that can be addressed by this drug, and there is no drug currently on the market that can both reduce the symptoms and also reduce disease progression,” Rennie noted to HotCopper.

“We believe we are well on the on the way to producing an outcome that will be very beneficial for patients, and physicians, and that should then encourage investors to say ‘well, this has potential upside.’

Paradigm recently announced both Australian and US ethics approval for their Phase 3 trial, following FDA approval of the trial design. The company anticipated dosing first subjects for the Phase 3 trial, the final phase of development, in the coming months.

“Once the markets can see that we’re just getting to having the product approved, then the share price should appreciate significantly.”

Given what other biotech companies on the bourse down under have staged in the last twelve months, there’s good reason to think he’s right. 

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Disclaimer: HotCopper had a commercial relationship with Paradigm at the time this article was crafted and published.

The company blamed changes in the American Medicaid system under Trump for hurting its bottom line.

“Post Trump administration taking office, the changing healthcare and health funding landscape has particularly impacted US health systems serving Medicaid populations,” HeraMED wrote on Monday.

One is left to note the company has done what many companies are too fearful to do at this time – directly link Trump to lost revenues.

At any rate, the US medicaid program is an NDIS-style welfare program for low-earners and disabled individuals. Hospitals receive funding under the program.

Broward Health, a ‘safety net’ medical clinic was effectively trialling HeraMED’s software in a non-clinical setting.

But a key grant which apparently enabled that program has now been cut as HeraMED highlighted that: “the average annual cut to the Medicaid budget is anticipated to be approximately $70 billion per annum, more than ten times larger than any previous annual cut made to the program.”

This is bad news for HeraMED, which has been seeking to tap into those funds by way of offering eligible products.

But what does HeraMED offer?

Its HeraCARE software supports another device called ‘HeraBEAT’ which can monitor a baby’s heartbeat; but overall, its product is effectively a biometrics software package.

“Despite positive maternal-fetal outcomes,” according to HeraMED, Broward has had to ditch the HeraCARE software. That wipes around US$100K (A$155K) of predicted revenue from the books for HeraMED.

“The agreement with Broward Health had estimated revenue in 2025 of USD$100,000 and served as an important Case Study,” the company wrote.

“Broward continued to report significant improvements to the maternal-fetal outcomes as recently as March 2025, highlighting that the decision is not related to the clinical performance or efficacy of the HeraCARE platform.”

As for what the company will do from here?

If CEO Anoushka Gungadin’s commentary was anything to go by, the company hasn’t quite figured out where yet: “We will continue to sharpen our focus where the need is urgent and the sales cycle shortest,” he wrote.

HMD last traded at 1.1cps.

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“The ACCENT trial is evaluating narmafotinib in combination with the chemotherapies gemcitabine and Abraxane in patients with advanced pancreatic cancer,” Amplia wrote on Thursday.

“Sufficient confirmed responses have now been recorded to demonstrate that narmafotinib combined with chemotherapy is superior to chemotherapy alone.”

Its drug, narmafotinib, is currently the subject of a pancreatic cancer trial which has, clearly, been on watchlists. Just look at liquidity.

Driving ATX’s +40% pop on Thursday is a dramatic shift in the number of shares trading hands each day. As of 1pm some 34.2M individual shares have moved on Amplia’s books, but over the last four weeks, the average daily amount has been only 166K.

That kind of effect is notorious for exaggerating share price gains. But Amplia’s good fortunes do also tap into a larger story for 2025 YTD – that a number of well-known biotech stocks have been, if not outperforming, then offering some good chances to make a few bags.

Currently, Amplia’s 1Y returns are up nearly +30%.

The most recent shock we saw to the healthcare sector was from, unsurprisingly, Donald Trump, who vowed to slash US drug prices.

So far, it’s not entirely clear how that will occur, and part of that uncertainty is perhaps in part why stocks like Telix and Neuren have been bouncing back from the sell-off that news caused.

ATX last traded at 8cps.

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For the uninitiated, that drug Remestemcel-L (branded Ryoncil) is more or less a stem cell treatment treating graft versus host disease.

Ryoncil has been the key value prop driving Mesoblast forward and a perhaps more meaningful FDA approval last year ultimately saw the Mesoblast share price juice to above $3.00/sh.

But that was then, and this is now. Here’s a chronology of Mesoblast’s share price YTD:

So what’s going on? The first thing to note is that when Mesoblast was above $3.00/sh, its market cap far outsized its fundamental value, at least on paper. Second, short sellers moved in.

But neither of those are particularly unusual, and there’s more going on.

The company, dual-listed on the NASDAQ, has been to some extent a victim of global uncertainty, and its exposure to the US market has had a different flavour since the world was reminded of Trump’s governance style.

But it appears shareholders are principally hungry for revenue. While Mesoblast undoubtedly has potential (and let’s remember that biotech investors are notoriously unforgiving,) in short, one could argue the company has been slow in delivering on sales.

Not helping matters for investors whose calculus reflects the above view, the company recently announced a boost in US operational activity that included the sum total of 3 children (Mesoblast’s intended patients for Ryoncil.)

That, perhaps, cemented perceptions of a slow-moving company – or at least one that wasn’t going to make a billion overnight.

All of that put together, it’s perhaps not surprising today’s news from Mesoblast on Thursday – that it has secured an exclusive ‘right’ over Ryoncil for 7 years under the FDA’s orphan drug authority – hardly moved the dial.

In fact, shares fell -0.5% in late morning trades to $1.77/sh. While that isn’t particularly dramatic, it’s far off the mood in the room leading into 2025 when any news from Mesoblast was good news.

Still: biotech companies staging shock comebacks aren’t unheard of.

MSB last traded at $1.82/sh.

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So what about countries more exposed to Australia, ready to play the part of a geopolitical defensive?

There, investors will be likely looking for a company perhaps already boasting a household name over-the-counter (OTC) medicine on its books, and maybe even an expansive product catalogue including Australia’s leading lubricating eyedrop.

Other strong value propositions would be for the stock to have a history of consistent revenue growth, a disinclination towards capital raises – and – even an overlooked $15M R&D pipeline. Plus: eight other drugs in development, as well as up to eighty licences in other countries.

If that’s enough to get your attention, it’s time to look at AFT Pharmaceuticals (ASX:AFP). 

Here’s a company that, despite its small status, could easily be considered a ‘mini-Pfizer.’ 

And it has the potential to grow as large as the real deal. 

Founded in 1997 by Hartley Atkinson – if the rumours are to be believed, from his very own garage alongside his wife – AFT Pharma has had a long-running presence both in Australia, and, on the ASX. 

Atkinson boasts a Doctorate in pharmacology and a Masters in Pharmaceutical Chemistry; credentials he picked up at the University of Otago, New Zealand.

Formerly a pharmaceutical researcher at Christchurch Hospital, and, all-rounder executive at Swiss pharmaceutical giant Roche, Atkinson clearly brings pedigree to his duties as founding chief of AFT Pharma.

For those playing from home, your kitchen medicine drawer might be closer tied to AFT Pharmaceuticals than you may think. The company owns Maxigesic, the paracetamol-ibuprofen combination available OTC at pharmacies Australia-wide.

And Maxigesic, in a way, taps into the original vision underpinning the company. That vision, principally, was to develop an opioid-free pain relief alternative for the Australian, and global, markets. 

Looking at Purdue pharma’s legal troubles, Atkinson’s cautious approach to addictive substances was nothing but prescient. But the man himself is humble on that front.

“[We] really wanted to introduce, and produce, drugs that help people and improve their health,” Hartley summarised to HotCopper.

“We were always very concerned about opioids. We thought they were a problem potentially, and one of our key projects has been the introduction and development of [an] analgesic that avoids the requirements for opioids.”

For those playing at home, that’s Maxigesic: a combination of paracetamol and ibuprofen, drugs far safer than opioids when it comes to overdose risk; addiction risk and overall more beneficial for health. 

First and foremost worth noting is that AFT Pharma has licences in up to 80 countries. That alone speaks for itself, and even with some uncertainty in the space coming out of the US at this time, the company remains exposed to Australia, New Zealand, China, Asia ex-China, Europe, and of course, the United States. 

Atkinson is also of the view the market broadly has failed to recognise AFT Pharma as a research and development company, with a $15M R&D pipeline at any given time. 

“We’re a lot smaller [than Pfizer] obviously,” Atkinson was quick to concede to HotCopper.

“The key thing, though, is that we do fund our R&D – we have extensive R&D with eight major projects in drug development funded out of profits.

“We’ve got a number of new operations around the globe and we’re investing money into those as well.”

That the company is big on research is, perhaps, evidenced by its patent base, and extensive product catalogue. 

On top of a leading painkiller brand and eyedrops, AFT is also behind: 

If you were wondering why the company bills itself as a ‘mini-Pfizer,’ that should be becoming clear.

But the prestige of its foundational member isn’t what AFT Pharmaceuticals needs to rely on. In fact, unlike some other biotech stocks, it can point to its fundamentals as testament to value proposition.

Consistent revenue growth and a profitable position are enviable for many biotech and pharmaceutical stocks (or health care if you prefer), and with a twelve monthly coming out on May 22nd, investors will be watching on.

Perhaps first and foremost worthy to note for biotech investors potentially interested in AFT, is that the company isn’t particularly fond of dilutive capital raises.

“We’re pretty careful the way we allocate capital … and we don’t raise capital either,” Atkinson said.

“We’re able to fund [operations] out of profits. Some of it’s assigned towards R&D, we spend about $15 million a year on R&D and we’re also spending money on our expansions as well.

“We’re starting up in Canada, we’ve been going in the UK for a few years, we bought a company in South Africa … we purchased [a] company in Europe about a year ago, and we’re able to do this, once again, all out of existing cash flows.”

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Disclaimer: HotCopper had a commercial relationship with AFT Pharmaceuticals at the time this article was created and published.

The impact of Trump’s announcement – made on Truth Social on Sunday – could be observed in general terms, with Health Care being the worst performing sector on the ASX, down 1.17% on a mixed trading day.

Unsurprisingly, a cluster of companies followed the trend, with Neuren Pharmaceuticals, Telix Pharmaceuticals and Clarity Pharmaceuticals being noted as some of the bourse’s worst-performing stocks early on in the session, dropping 8.05%, 8.04% and 7.20% respectively by 14:25 AEST.

In his social media post, Trump said he wanted to bring prescription drug prices in the United States into line with those in other high-income countries, and promised he would sign an executive order to that effect on Monday.

Although he did not provide much detail about how the pricing would be shifted, the President said his policy would drive towards a ‘most favored nation’ framework, with prices to drop by between 30% and 80%.

“They will rise throughout the World in order to equalize and, for the first time in many years, bring FAIRNESS TO AMERICA!” he said.

“I will be instituting a MOST FAVORED NATION’S POLICY whereby the United States will pay the same price as the Nation that pays the lowest price anywhere in the World.”

As it is now, customers in the US pay the highest prices in the world for many prescription drugs.

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The contract – signed by PME’s US-based subsidiary Visage Imaging, Inc – is based on a transactional licensing model, and involves the implementation of Visage 7 Viewer, Visage 7 Workflow and Visage 7 Open Archive, across the UI Health Care system.

Additionally, UI Health Care’s migration from its legacy PACS archive to the Visage Open Archive will also be completed by Visage, with Visage 7 also providing enterprise distribution of images integrated to UI Health Care’s electronic health record (EHR).

The go-live of the new system is targeted for the fourth quarter of 2025, and work on this will begin immediately, based on Visage’s cloud-based implementation process.

Pro Medicus CEO DR Sam Hupert said the rollout of Visage 7 would be a boost to the UI Health Care’s system, which includes 3 patient campuses and nearly 20,000 staff members – with more than 1,200 staff physicians and dentists, nearly 800 resident and fellow physicians, and over 5,300 nursing staff.

“University of Iowa Health Care is a highly respected healthcare institution that takes great pride in the comprehensive care they deliver to all Iowans,” he said.

“They join a long list of Visage 7 clients to opt for a fully cloud-based solution, which, as a result of our CloudPACS strategy, is becoming the standard in the North American healthcare IT market.”

Pro Medicus shares have risen since the news, and at 10:58 AEST, they were trading at $247.40 – a rise of 4.4.31% since the market opened.

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However, shares hadn’t responded too wildly on Monday morning – according to Cboe live pricing data at 10.45am AEST, shares were up 25% to a single cent per share on $460K worth of shares trading hands.

And herein lies the problem for Alterity: that $460K worth of shares trading hands, expressed as individual ordinary shares, means over 47.7M shares have traded hands.

That’s because Alterity, which opened on Monday a penny stock, has an eye-watering ~9 billion shares on issue. Talk about want for a consolidation.

Regardless, at least some investors were watching the news around ATH434 on Monday – no doubt informed by the run of good luck many ASX-listed biotech stocks have been clocking in recent history.

Multiple companies in that index happen to come to maturity in 2025 (at least, as long as taking applications to the TGA and FDA is concerned.) At any rate, investors will also be looking to the company’s NASDAQ performance overnight.

Regardless, Alterity was unsurprisingly bullish on Monday.

“Receiving the FDA’s Fast Track Designation for ATH434, alongside the Orphan Drug Designation we have already received, underscores the promise of this novel agent to address the urgent need for a disease modifying therapy for individuals with MSA,” ATH CEO Dr. David Stamler said.

ATH last traded at 9cps.

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That isn’t this finance journalist – once-described by HotCopper users as “self-satisfied” – niggling for the sake of it. Imugene itself came right out and said it. See for yourself:

The letter was, in effect, an addressing of dominant concerns surrounding the much-loved biotech stock in light of its recent performance metrics.

“The reality is that in fact we are [a high cash burn business],” Imugene wrote, responding to criticisms about the stock that have become common in relatively recent history.

Imugene also addressed the short position against the stock, ultimately concluding such matters are out of the company’s control. (For all intents and purposes, in Imugene’s defence, that’s true.)

But there were more micro-level concerns addressed by the company on Thursday.

When it comes to the company’s CF33, OnCARlytics and HER-Vaxx products, the company pointed to slow progress overall driven by the realities of biotech development.

“It is correct that data read outs are a little slower than expected,” Imugene wrote.

“In the MAST CF33 study, we spent some time streamlining manufacturing [and] focused enrolment on specific indications … which impeded enrolment.

“On the onCARlyrics study, this involves bringing two separate areas of oncology together … this requires educating and training the solid tumour specialist … and more time and effort at the hospital.”

Time and effort doing what, exactly, wasn’t specified

The letter could, depending on how you interpret it, read like a respectful and transparent disclosure to a retail shareholder base. If you were inclined to be more cruel, however, one might suggest it’s an announcement designed to reassure.

In what is most probably the truth, both things are true at once.

Consider the tone the letter used when discussing HER-Vaxx:

“We have not yet signed a deal with any of our programs … lack of news does not mean we are doing nothing,” Imugene wrote.

“We are actively marketing at all the major industry conferences around the world.”

When it comes to shareholder communications, the company also noted it released 27 announcements to the market this year so far. Make of that what you will.

IMU last traded at 2.3cps.

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The trial’s Safety Review Committee (SRC) has looked at cumulative safety and pharmacokinetic data – including from the second dosed cohort of participants – and concluded that there are no issues.

This means Nyrada can proceed to the third cohort, for which it is already recruiting participants. It is expecting final readouts for the Phase 1 trial to be completed by the third quarter of the 2025 calendar year.

The company’s expectations for NYR-BI03 have been bolstered by positive newsflow throughout much of last year and into 2025, starting with an announcement in February 2024 that preclinical stroke study results had shown the candidate had achieved a statistically significant neuroprotective effect, rescuing 42% of brain tissue in the penumbra region of treated animals.

This was followed by a preclinical study into coronary heart disease in October which revealed NYR-BI03 providing an 86% cardioprotective effect following myocardialischemic-reperfusion injury, a leading cause of tissue damage when blood flow is restored to the heart after injury.

Finally, last month Nyrada told investors about the results of a preclinical traumatic brain injury study which indicated a statistically significant (p = 0.043) neuroprotective effect provoked by NYR-BI03 following a penetrating traumatic brain injury.

The study in question was undertaken in collaboration with the Walter Reed Army Institute of Research and UNSW Sydney.

Nyrada has been trading at 11 cents.

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In short, the US regulator is asking for more data from Telix with regards to the drug before it allows the company to go ahead with trials.

While this isn’t a high-level death blow for Telix, it does represent a set-back, given that these procedures to pass regulatory hurdles generally take around at least six months.

(Still, at the start of the year, Telix shares clocked YoY gains of +150% – in late April, that read now sits at +81%.)

So what’s the problem? All in all, the FDA wants more information to satisfy itself.

“The FDA stated additional confirmatory clinical evidence is required to progress the application, despite a robust consultation process prior to submission and during review of the [application],” TLX wrote on Monday.

Telix also noted that FDA’s decision was not based on safety, but rather the total volume of background data available to it.

“This is a disappointing outcome for American glioma patients,” Telix continued.

“The FDA has [already] granted TLX101-CDx Orphan Drug and Fast Track designation, a tacit acknowledgement of the drug candidate’s importance in addressing a significant unmet medical need and clinically demonstrating benefit over existing medical solutions.”

But perhaps mitigating the sell-off was Telix chief Dr. Christian Behrenbruch’s suggestion the company may be able to get more data on the FDA’s desk quicker than thought.

“We have multiple go-forward pathways available to us, such as providing additional confirmatory data through several active clinical programs, including Company-led studiesWe have multiple go-forward pathways available to us, such as providing additional confirmatory data through several active clinical programs, including Company-led studies,” Behrenbruch said.

“Our immediate focus is understanding the FDA’s feedback.”

Make of that what you will.

TLX last traded at $27.10/sh.

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The company has been gearing up for this since early-ish last month when the company first flagged it was approaching US Veterans’ Affairs (and then immediately went into a trading halt.)

Still, at this current time, potential upside from placement within the US defence sector ecosystem is a fairly obvious value prop.

As for the defence sector with an eye to procurement, perrhaps part of the reason why TrivarX could travel far in that muddied landscape is because its algorithm-based heart monitoring tech can be ‘attached’ to existing ECG machines.

In short, TrivarX is really more of a software company than a healthcare company. And that nimble-footed nature could be of use to it in penetrating the US defence sector space generally.

At any rate, its upcoming and now-approved trial is to be carried out alongside the Greater Los Angeles Veterans Research and Education Foundation (GLAVREF) and the United States Department of Veterans Affairs respectively.

Without doubt, part of the calculus behind investors’ collective actions pushing shares up 8.3% in late lunch trades to 1.3cps.

“The Company is now focused on finalising site selection and patient recruitment initiatives. Given the work undertaken to date, we expect first enrolments in the coming weeks with results to follow 12- weeks after. Additional updates in this regard will be made as developments materialise,” TRI NEC David Trimboli said.

TRI last traded at 1.3cps.

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