Medicus Pharma filed a National Priority Voucher application on November 17, 2025, for its SkinJect microneedle patch, a doxorubicin‑based array designed to treat basal cell carcinoma without surgery. The application aligns the product with the FDA’s national priorities of improving cancer care access, affordability, and rare‑disease treatment.
SkinJect’s Phase 2 study, which enrolled 90 patients, reported more than 60 % clinical clearance. The trial has been expanded to the United Kingdom and the United Arab Emirates, with regulatory approvals in the UK received on November 13 and patient recruitment in the UAE beginning in late October. The expanded geographic footprint strengthens the data set for a future pivotal study and supports the company’s global commercialization strategy.
The National Priority Voucher program can reduce FDA review time from the typical 10‑12 months to 1‑2 months after the final drug application is submitted. If the voucher is granted, Medicus could bring SkinJect to market significantly faster than the standard pathway, potentially accelerating the company’s first revenue‑generating product and improving patient access to a non‑invasive treatment option.
In August 2025, Medicus completed the acquisition of Antev, adding the Teverelix program—a GnRH antagonist for prostate cancer and acute urinary retention—to its pipeline. Teverelix targets a combined market opportunity of roughly $6 billion, providing a high‑margin growth engine that complements the SkinJect portfolio.
Financially, the company reported Q3 2025 cash and cash equivalents of $8.7 million, up from $5.3 million a year earlier, while operating expenses rose to $15.4 million from $2.3 million in the prior year. The increase reflects heavy investment in clinical development and the acquisition, underscoring Medicus’s focus on building a diversified oncology pipeline.
Dr. Raza Bokhari, Executive Chairman and CEO, said the company is “highly confident” in the accelerated review path and the strategic importance of both the SkinJect and Teverelix programs. He highlighted the company’s stable balance sheet and the potential for rapid market entry as key drivers of future growth.
Analysts at D. Boral Capital maintained a “Buy” rating with a $27.00 target, while the consensus recommendation across the sector is “Outperform.” The positive analyst sentiment reflects confidence in Medicus’s accelerated regulatory strategy and the breadth of its pipeline.
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