Research notes
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Research Notes
Monkey magic: FDA confirms pivotal pathway
Island Pharmaceuticals
February 4, 2026
The FDA has provided formal confirmation and alignment on Galidesivir’s Animal Rule development pathway, setting out a clear two-stage program and materially de-risking the asset. The update represents the strongest regulatory signal to date that Galidesivir is on a viable, accelerated path toward approval as a US biodefence countermeasure and supports multiple potential value levers including a Priority Review Voucher. ILA concurrently announced it has raised A$9m at A$0.35 which the company believes will be ample funding to see Galvesivir through to potential marketing approval, as well as sufficient excess to advance other opportunities in Ebola and Sudan Viruses.
1H26: Guardion on the ground
Vitrafy Life Sciences
February 4, 2026
VFY’s 1H26 update outlined continued operational progression with the first Guardion devices entering the US market, FDA registration activity starting and commercial programs advancing across animal health and human health. The outlook centres on executing near-term commercial pathways including IMV Technologies workstreams, Phase II platelet readouts in 2H26, expanded US customer engagement and scaling device supply in preparation for broader market adoption.
US competition a key question
Credit Corp
February 3, 2026
CCP’s 1H26 NPAT of ~A$44m (flat on the pcp) was ~10% under consensus/MorgE. Whilst guidance was reiterated, the compositional mix shift towards AU debt purchases for FY26 (revised upwards) and the lowering of US purchasing guidance (noting some increased competitive pricing) saw the stock close ~17% lower. Operational efficiency/productivity has improved, however delivering on US divisional growth is key to our long-term investment thesis and a key catalyst. At ~7x FY27 PE (MorgE) the valuation appears undemanding. BUY maintained.
Don’t blink and miss this
Blinklab
February 3, 2026
BlinkLab (ASX: BB1) has a number of important catalysts approaching. BB1’s core offering is a smartphone-based neuroscience diagnostic platform. Its primary ‘Software as a Medical Device’ (SaMD) product is planned to be used as an aid for the diagnosis of autism spectrum disorder (ASD). A pilot study has achieved results better than the current standard of care and supports the commencement of a pivotal study. There a several key catalysts which investors should focus on including completion and analysis of the European ADHD data set and the start of the pivotal autism study both events are expected this quarter.
Continuing to disappoint
GrainCorp
February 2, 2026
GNC provided guidance ahead of its AGM on 18 February. Despite a large east coast winter grain crop, GNC continues to disappoint with FY26 earnings guidance materially below consensus expectations. While its volume guidance is unchanged, margins have weakened given the grain trading environment has deteriorated further. Importantly, its balance sheet remains strong. We have made material revisions to our forecasts. The difficult margin environment is likely to also affect FY27 earnings. With payments to the insurer no longer required in big crop years, GNC’s fixed cost leverage should return when crop production issues around the world ultimately eventuate and global grain stocks tighten. However, we have now taken a much more conservative view on GNC’s ‘through-the-cycle’ EBITDA moving forward. GNC’s strategic assets are worth materially more than its current share price implies. However, the stock is lacking near term share price catalysts and investors will need to be patient.
Growing into its valuation
PLS Group
February 2, 2026
Strong 2Q26 with a material spodumene sales and revenue beat vs MorgansF and consensus expectations. Cash balance +12% qoq with total liquidity of ~A$1.6bn leaving significant flexibility to fund growth and consider shareholder returns. Management is assessing the potential restart of the 200ktpa Ngungaju plant and other growth options in P2000 and Colina. Upgrade to HOLD (previously TRIM) on recent share price weakness with an unchanged A$4.60ps target price.
DTC is DOA
Proteomics International Laboratories
February 2, 2026
PIQ’s commercial progress remains elusive and the strategy has quietly contracted, with the DTC (direct-to-consumer) pathway now effectively shelved. With limited commercial traction, we see investors’ optimism rests on optionality rather than commercial delivery, with the recent share price rally driven by hopes of asset monetisation (PromarkerEndo and OxiDX in particular), making the strategic and operational review a near-term test new management’s ability to reset priorities, enforce discipline and restore a credible commercial pathway. Happy to stay on the sidelines despite recent share price volatility but note that what we view as free options on the ex-DKD tests may provide material upside if and when external interest converts into a tangible monetisation outcome. No change to A$0.43 target price, but downgrade to TRIM on share price strength.
Broad based beat, margins expand, momentum builds
ResMed Inc
February 1, 2026
2Q beat across the board, with double-digit revenue and earnings growth, further gross margin expansion and solid cash generation. Sleep and respiratory sales were strong in both regions, with above-market growth in the Americas and ROW returning to market growth, while SaaS beat expectations, but remained subdued by residential care headwinds. Operating leverage improved again, with gross margin gains from manufacturing and logistics efficiencies, and FY26 guidance tightened to 62-63% (from 61-63%), reinforcing confidence in ongoing margin progression. We adjust FY26-28 forecasts modesty and move to BUY with a A$47.73 target price, viewing recent share weakness unjustified given sound fundamentals.
Guidance lifted as commercial momentum builds
Saluda Medical
February 1, 2026
2Q activity report debut did not disappoint, highlighting accelerating US commercial momentum, cost actions to reduce future operating expenses and upgraded FY26 revenue guidance. Revenue growth jumped 15% QoQ, supported by rising implanted patient volumes, and continued expansion of both sales reps and implanting physicians, while cash outflow fell 14% QoQ on a lower fixed cost base supportive of operating leverage. We believe management’s decision to lift FY26 revenue guidance c4% at this early-stage post-IPO reflects improving visibility on sales execution and demand trends, reinforcing confidence in a stronger 2H performance. We update FY26 forecasts in line with guidance, with our DCF-based TP unchanged at A$3.07. SPECULATIVE BUY maintained.
Dark skies part – when overhang meets opportunity
Neurizon Therapeutics
January 30, 2026
Following FDA clearance, the imminent start of the Ph2/3 trial and the removal of the funding overhang providing full visibility through the pivotal program, NUZ now offers one of the cleanest entry points seen in the past 18 months, with major risks cleared and a condensed catalyst runway ahead. Recent M&A activity underscores the scarcity value of ALS assets and provides a meaningful valuation anchor for NUZ if its clinical program delivers. Post recent capital raises, we update for the new share issuances which drive a reduction in our target price to A$0.28 from A$0.39, although we maintain our Speculative Buy rating, noting the high risk / high reward proposition.
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