Health Check: Neurotech shares soar 30% on US cannabis trial breakthrough | Stockhead
Investors say 'whoopee' after Neurotech wins formal US assent for a cannabis trial targeting autism. Pic: Getty ImagesThe US drugs gatekeeper has granted Investigational New Drug status for Neurotech’s. . .
Investors say 'whoopee' after Neurotech wins formal US assent for a cannabis trial targeting autism. Pic: Getty ImagesThe US drugs gatekeeper has granted Investigational New Drug status for Neurotech’s late-stage autism programNo signs of disharmony for Aroa’s favourable US Symphony reimbursementRyman’s retirement village sales hold up despite the “external impact of global events”. Neurotech (ASX:NTI)shares went on a 30%-plus romp this morning after the US Food and Drug Administration (FDA) granted Investigational New Drug (IND) status to its medicinal cannabis program. The company is conducting a local phase III trial – dubbed Beyond Harmony – for childhood autism spectrum disorder (ASD). Neurototech’s drug candidate NTI-164 contains only a small amount of the psychoactive ingredient THC. As with any drug, developers won’t get too far without ultimate US approval – and that requires US studies. An IND enables such trials to take place in line with FDA standards and expectations. In Neurotech’s words, an IND “establishes a formal US clinical development pathway to support potential future FDA registration”. The Australian phase III trial and the proposed US IND program “are expected to generate an integrated efficacy, safety, pharmacokinetic and regulatory data package to support Neurotech’s global development, registration and commercialisation strategy for NTI-164”. Neurotech has completed a phase II/III placebo-controlled ASD clinical trial, which showed “statistically significant benefits across a number of clinically validated measures and excellent safety”. NTI164 also applies to Paediatric Autoimmune Neuropsychiatric Disorders Associated with Streptococcal Infections (PANDAS) and Paediatric Acute-Onset Neuropsychiatric Syndrome (PANS). Collectively this unwieldy duo is known as PANDAS/PANS. The company has completed successful phase I/II trials for PANDAS/PANS, as well as Rett syndrome. Favourable reimbursement remains a goer, says AroaNZ-based woundcare houseAroa Biosurgery (ASX:ARX)is confident that favourable US reimbursement for a key growth product will continue into calendar 2027. In January, the Centers for Medicare and Medicaid Services (CMS) introduced a flat fee for outpatient skin substitute products, of US$127. 14 per square metre. CMS now indicates this pricing will continue into next year. The flat price replaced a regimen by which surgeons were paid a percentage share of the cost of the device. This gave them an incentive to use the highest priced products and upgrade their jacuzzis. The change benefited Aroa’s Symphony devices, for wounds such as difficult-to-treat diabetic foot ulcers (DFUs). That’s because several higher-priced rivals have left the market. CEO Brian Ward said the CMS stance removed “uncertainty” about a further change to a potentially less favourable pricing system. Aroa believes the reimbursement changes will contract the US market from US$10 billion a year to a mere $US1-2 billion. But Symphony will orchestrate a decent share. “Indications are that companies with business models predicated on inflated pricing may exit,” the company said. “The advantage is likely to shift to products that can demonstrate strong value and high-quality clinical evidence. “Symphony meets both requirements and Aroa’s hospital-based sales team and surgical portfolio mean the company is well placed to benefit from this new environment. ”Symphony trial is music to our earsAroa in late March released the interim results of a three-year DFU trial of Symphony. The study showed “significantly improved” healing over 12 weeks, relative to current devices. The analysis of 103 patients showed healing rates of 55% for Symphony, versus 42% for the standard of care. “Although the full dataset remains due in [late 2026], the readout provides important clinical validation ahead of Symphony’s commercial launch and supports its positioning under a tougher coverage framework,” Bell Potter says in a note. The firm says the CMS reimbursement “reset” continues to disrupt the US skin substitute market. Two Aroa rivals, Organogenesis and MiMedx reported wound-care revenue declines of at least 60% in the March quarter. Pacific gains a local EdgeStill on Kiwi companies, bladder cancer diagnostics housePacific Edge (ASX:PEB)says its Asia Pacific (APAC) business is “advancing towards profitability on a direct-cost basis”, amid increasing adoption of its Cxbladder Triage Plus assay. In its June (first) quarter update, the region accounted for 1158 commercial tests, 13% higher than in the March quarter. On an unaudited basis, APAC cash burn reduced to $170,000, 9% better, “reflecting disciplined cost management, improved pricing, and a growing contribution from commercial testing”. That’s all well and good. But students of this company would know that its fortunes hinge on the US market, where it suffered a well-documented reimbursement setback. In short, Medicare stopped funding the tests, but the company is confident this stance will be reversed. Despite the disaster, Pacific Edge’s US commercial tests declined a “modest” 2. 4% in the quarter, to 3295. That looks creditable, given the company pared its US sales team from 7. 7 full-time equivalents to five. “The company is now focused on selective investments to drive commercial execution in the US,” management said. Pacific Edge shares have gained 140% calendar year to date, amid investor expectations the Medicare administrators will play ball. Age shall not weary Ryman’s performanceSome days your columnist writes so much about Kiwi companies that he may as well migrate to Auckland. Who knows, Jacinda Ardern’s former digs in leafy Sandringham may still be up for sale after her migration to Sydney. This brings us to Trans-Tasman nursing and retirement village operatorRyman Healthcare (ASX:RYM), which reports its trading performance has held up “despite the external impacts of global events on housing market conditions”. We reckon CEO Naomi James is talking about war, rather than the Albo CGT/negative gearing two-punch housing stuff. With a March end of year balance date, Ryman reports 325 retirement living occupation sales right in the June quarter. This includes 265 resales and 60 new sales. “Volumes have remained in line with the same period last year, with all regions contributing and serviced apartments accounting for a higher proportion of the mix,” Ryman reports. “Net resales contract volumes have increased 7% on the same period last year, driven by strong demand for serviced apartments from external customers. ”‘External customers’ are those ageing baby boomers finally conceding to Father Time. Ryman is on a mission to reduce its inventory of unsold units, with a view to releasing NZ$500 million of cash by the 2028-29 year. Bedding down a recoveryMeanwhile, Ryman says there’s strong demand for Ryman’s 4700 aged-care beds, with a steady occupancy rate of 96. 1%. Ryman is NZ’s biggest aged-care operator, as well as Victoria’s “leading integrated retirement living and aged care operator”. In toto, Ryman owns and operates 47 retirement villages, nine of them in Victoria. It also has 3927 aged case beds, 759 in the state of despair. In financial rehab – rather like Victoria – Ryman narrowed its 2025-26 loss to NZ$171 million, from NZ$513m previously. Underlying earnings improved 94% to NZ$88m. Despite management’s remediation efforts, Ryman shares have lost 23% since listing on the ASX last October. To be fair, shares in Australian rivalRegis Healthcare (ASX:REG)have lost 15% over the last year. This is despite management’s April 30 proclamation that underlying earnings for the year to June 2026 would come in at around $135 million, at the top end of guidance and a tad better than last year’s $125. 8m. At Stockhead, we tell it as it is. While Aroa Biosurgery is a Stockhead advertiser, the company did not sponsor this article.