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Medicus Pharma completes SkinJect trial enrolment – ICYMI
Proactiveinvestors NA· 2025-12-20 15:08
Core Viewpoint - Medicus Pharma has completed patient enrollment in its SkinJect clinical trial, marking a significant milestone in the development of a noninvasive treatment for basal cell carcinoma, the most common skin cancer [1][4]. Company Overview - Medicus Pharma is advancing its clinical development program for SkinJect, a novel treatment targeting non-melanoma skin diseases, particularly basal cell carcinoma [3][4]. - The company has been working on this project since the fall of 2023, with patient recruitment starting in August 2024 [4]. Clinical Trial Details - The clinical trial has enrolled 90 patients across nine sites in the United States [1][4]. - The company aims to present topline data in Q1 2026 and plans to sync with the FDA for an end-of-phase-two meeting in the first half of next year [4][8]. Treatment Methodology - SkinJect utilizes uniquely designed microneedle arrays developed from Carnegie Mellon and the University of Pittsburgh, allowing for direct application of a chemotherapeutic agent, doxorubicin, to the cancer site [6]. - This method is intended to trigger an immunogenic response and effectively kill cancer cells [6]. Market Context - Non-melanoma skin diseases, especially basal cell carcinoma, account for 5 million new cases annually in the United States and over 30 million globally [5]. - Traditional treatments like Mohs surgery are expensive and painful, highlighting the need for a more cost-effective and aesthetically pleasing alternative [5][7]. Future Outlook - The company is optimistic about the upcoming topline data and the potential for a Priority Review Voucher from the FDA, which could expedite the new drug application timeline by 10-12 months [8][9]. - The NDA is expected to be filed in late 2027 or early 2028, aligning with the company's positive momentum [8][9].
Novocure: Steady Ahead of Key Milestones
The Motley Fool· 2025-07-24 13:21
Core Viewpoint - Novocure's fiscal Q2 2025 results showed a 6% increase in revenue year-over-year, exceeding Wall Street expectations, while the company continues to develop noninvasive treatments for solid-tumor cancers [3][5]. Financial Performance - Revenue for Q2 2025 was $158.8 million, compared to $150.4 million in Q2 2024, marking a 6% increase [2]. - Earnings per share for Q2 2025 were -$0.36, slightly worse than -$0.31 in Q2 2024, but still beating expectations [2]. - Gross margin decreased to 74% from 77%, a decline of 300 basis points attributed to new product rollout costs [2][4]. - Total active patients increased from 3,963 in Q2 2024 to 4,331 in Q2 2025, a growth of 9% [2]. Product Development and Market Strategy - Revenue from the Optune Lua lung cancer treatment was $2.4 million, following its U.S. approval last fall [3]. - The company plans to seek FDA premarket approval for treatments targeting pancreatic and brain cancers by the end of the year, with trial data expected in the first half of 2026 [6]. Market Reaction - The market response to the results was muted, with Novocure's stock up about 2% in premarket trading, indicating that the results were largely in line with expectations [5]. Long-term Outlook - Despite the current progress, Novocure's stock has seen a significant decline of over 92% from its 2021 high due to previous disappointing trial results, highlighting the inherent risks in biotech investments [7].