A better day so far, but if pain persists, keep blaming Donald Trump. Pic: Getty Images
- CSL shares lead the local biotech sector’s recovery
- Nyrada and Chimeric report their trials have met key safety goals
- Saviour the moment! Good news for Mayne Pharma
Local biotechs have bounced back after Friday’s nervy turn, following President Trump’s declaration of a 100% tariff on imported pharmaceuticals.
Outside of CSL (ASX:CSL), only a handful of ASX-listed drug makers sell their wares in the US. Of course, there’s a big difference between being Australian listed and having an ‘Australian’ drug.
CSL is on the record as saying the tariff would not have a “material impact”. The company points to its sizeable US manufacturing presence, which it is expanding.
However, vaccine arm Seqirus – which CSL plans to divest by way of a demerger – may not fare so well.
CSL shares bounced more than 3% today and back over the $200 a share level.
In a brief note, broker Citi opines CSL has the “flexibility within its existing manufacturing structure” to move things around if needs be.
“Our biggest question is whether CSL’s supply chain is insulated from (any) impact.”
‘We’re OK’
On Friday Mesoblast (ASX:MSB) said – or confirmed – that its stem cell therapy Ryoncil was made in the US from material harvested from US donors.
US authorities thus deem Ryoncil to be US Country of Origin.
Telix Pharmaceuticals (ASX:TLX) also stresses its radiopharmaceuticals are made in the US (the short life of isotopes means the agents need to be made close to the customer).
Botanix Pharmaceuticals (ASX:BOT) and Clinuvel Pharmaceuticals (ASX:CUV) make their drugs in the US. Shares in the former spiked almost 10% this morning.
The impost could affect drug developers such as Chimeric Therapeutics (ASX:CHM) , Dimerix (ASX:DXB), Imugene (ASX:IMU), Syntara (ASX:SNT) and PYC Therapeutics (ASX:PYC).
But they need to get a drug to market before it becomes a potential issue.
But drug companies do have something else to fret over: the proposed ‘most favoured nation’ policy that would give US customers the same – or lower prices – than in other developed nations.
A White House announcement is pending on that one – so don’t get too relaxed.
Is 100% really set in stone?
The tariff impost supposedly will affect the US$200 billion of pharmaceuticals the US imports every year – but nothing’s ever so simple in the world of Trump.
According to some reports, European and Japanese drugs will be exempt from the impact, or at least the full whack.
Certainly, European Commission President Ursula von der Leyen thought she had a deal when she shook hands with Trump on a 15% pharma tariff.
The lion’s share of non-US drugs is sourced from Europe.
Meanwhile, global financial and asset management firm De Vere group contends the tariff push could backfire on the US by scaring off pharma investment.
“A tariff of this magnitude on high-value medicines will ripple through every part of the global health economy,” says De Vere CEO Nigel Green.
“Rather than sparking a manufacturing renaissance, it will deter investment, heighten inflationary pressure and drive sophisticated capital to markets that remain open and predictable.”
Given the “obvious” inflationary impact, investors will position for a weaker dollar and firmer pricing power elsewhere.
“Capital is fluid and it won’t wait for Washington to change course.”
Chimeric trial confirms safety – and hints of efficacy
Cancer drug developer Chimeric reports its ongoing phase I/II trial continued to show safety and efficacy at a second, higher dose.
On the latter, the drug candidate CHM CDH-17 showed “evidence of anti-tumour activity, with tumour shrinkage of up to 37%.
One patient on the first dosage showed stable disease, ten months after receiving a single dose.
Stable disease means the cancer has shrunk up to 30%.
At the second dosage level, a monitoring committee decreed the drug to be “safe for additional exploration”.
Of the four subjects treated with the higher dose, two showed a “mixed response”. That means some tumours shrunk, but others didn’t.
In the case of colorectal cancer, their disease burden declined 12%.
Neuroendocrine tumours decline 6-16%, thus falling into the ‘stable disease’ category.
Of all the tumours imaged, one decreased in size by 37%.
Chimeric “will continue to follow these responses and await the results of two additional patients at dose level two”.
The trial will enroll up to 15 patients, in view of deciding the best dose for a phase II study.
A novel Car-T therapy, the drug candidate targets CHM CDH-17, “a cancer biomarker associated with poor prognosis and metastases in the most common gastrointestinal tumours”.
Chimeric is conducting three other clinical stage oncology programs.
Nyrada passes the safety test
Nyrada (ASX:NYR) shares this morning bounced almost 10% after the company said its lead candidate Xolatryp passed a key safety hurdle.
Unblinded phase I results confirmed the agent met its primary endpoint of being safe and well tolerated, “with no dose-limiting, or dose-related safety issues”.
The trial dosed 48 healthy participants across six dosing cohorts, with 12 of them receiving a placebo.
Eight participants suffered adverse events, but not serious ones.
Xolatryp influences the body’s transient receptor potential canonical ion channels.
These conduits regulate calcium influx into cells.
“Following ischemia or injury, these ion channels are activated and let in calcium into the cell,” Bonnar says.
“That calcium builds up to the extent where they’re toxic.”
Nyrada now plans a phase IIa study targeting acute myocardial infarction.
The company believes that as an ion channel inhibitor, Xolatryp has cardioprotective properties.
Pending ethics approval, the company expects to start the next study in the March 2026 quarter.
PBS pill decision eases Mayne’s pain
Mayne Pharma (ASX:MYX) has received some much-needed good luck, with the local Pharmaceutical Benefits Scheme (PBS) approving the company’s oral contraceptive for reimbursement.
The prophylactic in question is Mayne’s Nextstellis, the only contraceptive pill containing naturally derived, plant sourced estetrol.
Without the PBS listing, Nextstellis would cost more than $328 a year, compared with the subsidised price of $31.60 for three months’ supply ($25 from next year).
Nextstellis accounts for about 10% of Mayne’s sales, albeit with a US bias.
Mayne has been in the wars since putative takeover offeror Cosette pulled its takeover offer, alleging misleading conduct on the target’s part.
Mayne wants Cosette to honour its commitment and the parties are battling it out in court.
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