Latest Clinuvel Pharmaceuticals (ASX:CUV) News

Clinuvel Pharmaceuticals has initiated dosing in a preclinical study of its novel controlled-release injectable peptide platform, VLRX-L, aiming to enhance drug delivery for melanocortin-based therapies. Preliminary results are expected in the second half of 2026.

CLINUVEL Pharmaceuticals is significantly expanding its VALLAURIX RD&I Centre in Singapore with a five-year strategic investment, aiming to become a global leader in advanced peptide drug delivery.

Health Canada has requested additional information, extending its review of CLINUVEL’s SCENESSE® for erythropoietic protoporphyria (EPP) into 2026. Meanwhile, Canadian patients continue to access the treatment via a Special Access Program.

The European Medicines Agency has approved continuous bi-monthly dosing of CLINUVEL’s SCENESSE® for adult erythropoietic protoporphyria patients, removing previous annual dose limits and aligning Europe with US treatment standards.

CLINUVEL Pharmaceuticals has presented compelling new case studies demonstrating the efficacy of SCENESSE® in treating vitiligo, showing significant and stable repigmentation in patients. These findings, shared at the EADV conference, hint at a potential breakthrough for a condition with limited treatment options.

Clinuvel Pharmaceuticals has reported a robust financial year ending June 2025, marked by solid revenue growth and sustained profitability, while advancing its clinical pipeline and maintaining a strong balance sheet.

Clinuvel Pharmaceuticals has reported its ninth consecutive year of revenue and profit growth, driven by strong sales of SCENESSE® and strategic investment in vitiligo clinical trials. The company also declared its eighth consecutive dividend, underscoring financial resilience.

Clinuvel Pharmaceuticals reports steady financial growth with an 8% rise in revenue and 2% profit increase, while expanding its US commercial footprint and completing recruitment for a pivotal vitiligo trial.

CLINUVEL Pharmaceuticals is preparing to elevate its American Depository Receipt program to a Nasdaq Level II listing by the end of 2025, aiming to enhance visibility and trading access in the U.S. without altering its primary ASX listing.

CLINUVEL’s Phase II pilot study reveals afamelanotide monotherapy does not trigger repigmentation in vitiligo patients, underscoring the necessity of adjunct NB-UVB phototherapy.

CLINUVEL Pharmaceuticals announces the full-time return of Managing Director Dr Philippe Wolgen, focusing on advancing critical product development and corporate initiatives, while Acting CEO Lachlan Hay continues until September 2025.

CLINUVEL Pharmaceuticals has completed recruitment for its Phase III trial of SCENESSE® in vitiligo patients with darker skin types, setting the stage for first results in late 2026. Early clinical observations suggest promising repigmentation outcomes.