PYC Therapeutics (ASX: PYC)
PYC Therapeutics (ASX: PYC) is progressing a clinical-stage drug, VP-001, targeting Retinitis Pigmentosa type 11, a blinding genetic eye disease of childhood with no current treatment. PYC Therapeutics, on 28 April 2025 announced that data from ongoing Phase 1/2 trials would be presented in May, showing statistically significant improvements in vision using a registrational endpoint, along with clinically meaningful gains in visual acuity and improved patient-reported quality of life. No treatment or procedure-related serious adverse events have been reported, highlighting both the safety and efficacy of VP-001. PYC is scheduled to meet with the FDA on 6 June 2025 to align on a registrational trial pathway for VP-001.
The company is also developing additional first-in-class drug candidates for other severe genetic conditions. These include therapies for Autosomal Dominant Optic Atrophy and Autosomal Dominant Polycystic Kidney Disease, both currently in clinical trials with human safety and efficacy data expected in 2025 and 2026. A fourth program for Phelan McDermid Syndrome will begin IND-enabling studies in 2025.
The completed a $146 million Entitlement Offer, extending its cash runway beyond 2027, with $138.1 million on hand as of 31 March 2025 and an additional $37.1 million received post-quarter, during Q1 2025. The funds support key clinical data readouts and program milestones. The company is on track to become a commercial-stage drug developer within 48 months, driven by clinical proof-of-concept across its pipeline and a transition to a late-stage, multi-asset clinical portfolio in 2H 2025.
Clinuvel Pharmaceuticals Ltd (CUV)
Clinuvel Pharmaceuticals Limited (ASX: CUV), on 27 March 2025 renewed its share buy-back program for additional 12 months. This allows the CUV to buy back up to 1.5 million shares, about 3% of its total shares. The buy-back will be done at Clinuvel's discretion, depending on market conditions. The aim is to support shareholders and manage capital wisely during uncertain economic times. There is no guarantee that the full 3% will be bought back.
The company completed its CUV803 study using PRENUMBRA® Instant in stroke patients. Nine patients with varying stroke severity took part, and treatment was well tolerated. Eight of nine patients showed functional improvement by day 42, and two-thirds had stable or improved brain scans. These results build on earlier findings from a similar study using an implant version of the drug. The company also continues to progress in other areas, including vitiligo and porphyria research, as well as development of cosmetic products.
The company delivered strong results for the six months to December 2024. Total revenue rose by over 21% to $43.3 million, driven by higher sales of SCENESSE®. Earnings before tax rose by 48%, reaching $21.9 million. Profit after tax was up nearly 29%. Sales grew due to more patients, more doses per patient, and more prescribers. Clinical and staff costs increased, but reductions in other expenses helped control overall spending. Clinuvel also expanded its commercial reach, with 93 specialty centers in North America and regulatory progress in both Canada and Europe. The company remains active in investor relations, with more analysts now covering the stock and increased global engagement.
(Source: Company Announcements)
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