Broker Bell Potter Expresses Optimism for Clinuvel’s Phase III Vitiligo Trial
Broker Bell Potter has expressed optimism regarding the upcoming phase III vitiligo trial conducted by Clinuvel Pharmaceuticals (ASX:CUV). The firm refers to the results of this study as “one of 2026’s most keenly awaited ASX biotech readouts.”
Vitiligo is a pigment disorder that leads to discoloured, blotchy skin. If successful, Clinuvel’s Scenesse treatment could potentially expand its reach to over two million Americans. The condition gained notoriety when it affected the late Michael Jackson, who famously wore a single glove to conceal early signs of the disorder on his hand. Jafaar Jackson, Michael’s nephew and actor in the biopic Michael, highlighted how vitiligo influenced the musician’s formative years.
Although vitiligo is not harmful, it can be aesthetically unpleasing and have an impact on mental health. Clinuvel’s Scenesse (afamelanotide) has already been approved by the US Food and Drug Administration (FDA) for the rare sun intolerance disorder erythropoietic protoporphyria (EPP), which affects around 5,000 Americans. Despite the small patient base, Clinuvel benefits from the high pricing typical of rare disease treatments.
The company’s vitiligo trial, CUV105, has enrolled 210 candidates. These patients receive either standard care—narrow band ultraviolet phototherapy (NB-UBV)—or NB-UBV combined with Scenesse over a 20-week period. Bell Potter suggests that given the small size of the study, the FDA may require a second phase III study. A successful outcome would heavily depend on achieving a statistically significant result on the primary endpoint, which is defined as at least 50% repigmentation across the patients’ total body surface area (excluding hands and feet), measured using the Total Vitiligo Area Scoring Index (T-VASI50).
Bell Potter estimates a 50% chance of success for the phase III trial, which is considered favorable for a drug trial. The firm also notes that there is little downside should the trial fail, as Clinuvel’s current $226 million enterprise valuation shows “little credit” for the vitiligo opportunity. The firm values Clinuvel shares at $17 a share, compared with the current price of around $9 (including $5/sh of cash).
Clinuvel expects to release results in the second half of the year, with Bell Potter suggesting the major announcement might occur closer to July rather than December, based on recruitment timing.
Other Developments in the Biotech Sector
Meanwhile, Avita Medical (ASX:AVH) had previously explored vitiligo as an extension use for its autologous spray-on skin treatment, Recell. However, new CEO Cary Vance recently announced that the company had shelved the program for now. He noted that while vitiligo presents a large market, reimbursement in the US does not currently justify the investment unless there are changes.
In another development, NeuroScientific Biopharmaceuticals (ASX:NSB) shares have entered a trading halt pending further results from its stem cell therapy program targeting Crohn’s disease. In January, the company reported results from four fistulating Crohn’s disease patients treated under the Therapeutic Goods Administration’s Special Access Scheme. About one third of Crohn’s sufferers have fistulas, which are ulcers that tunnel through the intestine or surrounding organs. Of the four patients, three achieved a clinical response, defined as closure of 50% or more of fistula openings or a minimum 50% decrease in fistula discharge. The fourth patient achieved a partial response. Management plans to provide more details once the trading halt lifts.
Pacific Edge Focuses on Profitability
Pacific Edge (ASX:PEB) has reported a net loss of NZ$35.8 million for the year to March 2026, compared to a previous deficit of NZ$29.9 million. However, the second half loss narrowed to NZ$16.7 million, compared to a previous shortfall of NZ$19.1 million. Operating revenue declined by 47% to NZ$11.5 million. The loss was attributed to the loss of Medicare coverage from April 2025, which significantly impacted US test volumes.
Post balance date, the company’s Medicare administrator Novitas issued a draft local coverage determination (LCD) that included haematuria evaluation as a covered Medicare benefit. This is positive news for the company’s haematuria-based assays, Cxbladder Triage and Triage Plus, ahead of an expected final ruling by the end of 2026. CEO Dr Peter Meintjes emphasized the company’s focus on profitability and unit economics, aiming for an “excellent” 2027.
Truscreen and Emvision Secure Funding
Moving on to cervical cancer detection, investors have oversubscribed to Truscreen Group’s (ASX:TRU) NZ$1 million placement, raising NZ$820,000. The company will raise the full amount in two tranches, with the first 110 million shares issued immediately. Shareholders will need to approve the second lot of 20 million shares, which is expected to be a formality.
Emvision Medical Devices (ASX:EMV) expects to secure $1.17 million from a federal Industry Growth Program (IGP) grant after achieving key milestones with its First Responder stroke detection project. Last June, the IGP awarded the company a $5 million grant to develop a lightweight pre-hospital brain scanner device for road and air ambulance use.
