Latest Clinuvel Pharmaceuticals (ASX:CUV) News

A brutal split opened up in small caps: a few stocks surged on hard approvals and funding, while many resource names slid even after announcing big numbers. The week’s tape looked simple: investors paid for certainty and sold anything that still needs time, permits, or more cash.

A handful of small caps did the heavy lifting this week, led by a lung cancer trial green light and a steep sell-off after a capital raise. Investors paid up for clear clinical steps, but punished dilution and stocks that reopened lower and kept sliding.

CLINUVEL Pharmaceuticals reports record first-half profits and confirms CEO Philippe Wolgen’s leadership through a pivotal growth phase, prioritising its vitiligo program and Nasdaq ambitions.

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.